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Matches in Nanopublications for { ?s <http://www.w3.org/2000/01/rdf-schema#label> ?o ?g. }

• definition label "definition of the class" assertion.
• assertion label "Defining a new class" assertion.
• association label "lenvima is a kinase inhibitor that is indicated for the treatment of patients with locally recurrent or metastatic progressive radioactive iodine refractory differentiated thyroid cancer dtc 1 1 in combination with everolimus for the treatment of patients with advanced renal cell carcinoma rcc following one prior anti angiogenic therapy 1 2 for the first line treatment of patients with unresectable hepatocellular carcinoma hcc 1 3 lenvima is indicated for the treatment of patients with locally recurrent or metastatic progressive radioactive iodine refractory differentiated thyroid cancer dtc lenvima is indicated in combination with everolimus for the treatment of patients with advanced renal cell carcinoma rcc following one prior anti angiogenic therapy lenvima is indicated for the first line treatment of patients with unresectable hepatocellular carcinoma hcc" assertion.
• association label "cabometyx is a kinase inhibitor indicated for the treatment of patients with advanced renal cell carcinoma rcc 1 1 patients with hepatocellular carcinoma hcc who have been previously treated with sorafenib 1 2 cabometyx is indicated for the treatment of patients with advanced renal cell carcinoma rcc cabometyx is indicated for the treatment of patients with hepatocellular carcinoma hcc who have been previously treated with sorafenib" assertion.
• association label "venclexta is a bcl 2 inhibitor indicated for the treatment of adult patients with chronic lymphocytic leukemia cll or small lymphocytic lymphoma sll 1 1 in combination with azacitidine or decitabine or low dose cytarabine for the treatment of newly diagnosed acute myeloid leukemia aml in adults who are age 75 years or older or who have comorbidities that preclude use of intensive induction chemotherapy 1 2 venclexta is indicated for the treatment of adult patients with chronic lymphocytic leukemia cll or small lymphocytic lymphoma sll venclexta is indicated in combination with azacitidine or decitabine or low dose cytarabine for the treatment of newly diagnosed acute myeloid leukemia aml in adults who are age 75 years or older or who have comorbidities that preclude use of intensive induction chemotherapy this indication is approved under accelerated approval based on response rates see clinical studies 14 2" assertion.
• association label "halaven is a microtubule inhibitor indicated for the treatment of patients with metastatic breast cancer who have previously received at least two chemotherapeutic regimens for the treatment of metastatic disease prior therapy should have included an anthracycline and a taxane in either the adjuvant or metastatic setting 1 1 unresectable or metastatic liposarcoma who have received a prior anthracycline containing regimen 1 2 halaven is indicated for the treatment of patients with metastatic breast cancer who have previously received at least two chemotherapeutic regimens for the treatment of metastatic disease prior therapy should have included an anthracycline and a taxane in either the adjuvant or metastatic setting see clinical studies 14 1 halaven is indicated for the treatment of patients with unresectable or metastatic liposarcoma who have received a prior anthracycline containing regimen see clinical studies 14 2" assertion.
• association label "orencia is a selective t cell costimulation modulator indicated for adult rheumatoid arthritis ra 1 1 1 1 juvenile idiopathic arthritis 1 2 1 2 adult psoriatic arthritis psa 1 3 1 3 important limitations of use 1 4 1 4 5 1 orencia r orencia is indicated for reducing signs and symptoms in patients 2 years of age and older with moderately to severely active polyarticular juvenile idiopathic arthritis orencia may be used as monotherapy or concomitantly with methotrexate mtx orencia is indicated for the treatment of adult patients with active psoriatic arthritis psa orencia should not be administered concomitantly with tnf antagonists orencia is not recommended for use concomitantly with other biologic rheumatoid arthritis ra therapy such as anakinra" assertion.
• association label "darzalex is indicated in combination with bortezomib melphalan and prednisone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant in combination with lenalidomide and dexamethasone or bortezomib and dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior therapy in combination with pomalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor as monotherapy for the treatment of patients with multiple myeloma who have received at least three prior lines of therapy including a proteasome inhibitor pi and an immunomodulatory agent or who are double refractory to a pi and an immunomodulatory agent darzalex is a cd38 directed cytolytic antibody indicated in combination with bortezomib melphalan and prednisone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant in combination with lenalidomide and dexamethasone or bortezomib and dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior therapy in combination with pomalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor as monotherapy for the treatment of patients with multiple myeloma who have received at least three prior lines of therapy including a proteasome inhibitor pi and an immunomodulatory agent or who are double refractory to a pi and an immunomodulatory agent 1" assertion.
• association label "empliciti is indicated in combination with pomalidomide and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor empliciti is a slamf7 directed immunostimulatory antibody indicated in 1 1" assertion.
• association label "addyi r flibanserin tablets are indicated for the treatment of premenopausal women with acquired generalized hypoactive sexual desire disorder hsdd as characterized by low sexual desire that causes marked distress or interpersonal difficulty and is not due to acquired hsdd refers to hsdd that develops in a patient who previously had no problems with sexual desire generalized hsdd refers to hsdd that occurs regardless of the type of stimulation situation or partner limitations of use addyi is indicated for the treatment of premenopausal women with acquired generalized hypoactive sexual desire disorder hsdd as characterized by low sexual desire that causes marked distress or interpersonal difficulty and is not due to 1 limitations of use 1 1" assertion.
• association label "rexulti is indicated for adjunctive treatment of major depressive disorder mdd see clinical studies 14 1 treatment of schizophrenia see clinical studies 14 2 rexulti is an atypical antipsychotic indicated for use as an adjunctive therapy to antidepressants for the treatment of major depressive disorder mdd 1 14 1 treatment of schizophrenia 1 14 2" assertion.
• association label "moxifloxacin hydrochloride is a fluoroquinolone antibacterial indicated for treating infections in adults 18 years of age and older caused by designated susceptible bacteria in the conditions listed below community acquired pneumonia 1 1 skin and skin structure infections uncomplicated 1 2 1 3 complicated intra abdominal infections 1 4 plague 1 5 acute bacterial sinusitis 1 6 acute bacterial exacerbation of chronic bronchitis 1 7 to reduce the development of drug resistant bacteria and maintain the effectiveness of moxifloxacin hydrochloride and other antibacterial drugs moxifloxacin hydrochloride should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria 1 8 moxifloxacin hydrochloride is indicated in adult patients for the treatment of community acquired pneumonia caused by susceptible isolates of streptococcus pneumoniae streptococcus pneumoniae haemophilus influenzae moraxella catarrhalis staphylococcus aureus klebsiella pneumoniae mycoplasma pneumoniae chlamydophila pneumoniae see clinical studies 14 3 mdrsp isolates are isolates resistant to two or more of the following antibacterial drugs penicillin minimum inhibitory concentrations mic 2 mcg ml 2nd generation cephalosporins for example cefuroxime macrolides tetracyclines and trimethoprim sulfamethoxazole moxifloxacin hydrochloride is indicated in adult patients for the treatment of uncomplicated skin and skin structure infections caused by susceptible isolates of methicillin susceptible staphylococcus aureus streptococcus pyogenes see clinical studies 14 4 moxifloxacin hydrochloride is indicated in adult patients for the treatment of complicated skin and skin structure infections caused by susceptible isolates of methicillin susceptible staphylococcus aureus escherichia coli klebsiella pneumoniae enterobacter cloacae see clinical studies 14 5 moxifloxacin hydrochloride is indicated in adult patients for the treatment of complicated intra abdominal infections ciai including polymicrobial infections such as abscess caused by susceptible isolates of escherichia coli bacteroides fragilis streptococcus anginosus streptococcus constellatus enterococcus faecalis proteus mirabilis clostridium perfringens bacteroides thetaiotaomicron peptostreptococcus see clinical studies 14 6 moxifloxacin hydrochloride is indicated in adult patients for the treatment of plague including pneumonic and septicemic plague due to susceptible isolates of yersinia pestis see clinical studies 14 7 moxifloxacin hydrochloride is indicated in adult patients 18 years of age and older for the treatment of acute bacterial sinusitis abs caused by susceptible isolates of or moxifloxacin hydrochloride is indicated in adult patients 18 years of age and older for the treatment of acute bacterial sinusitis abs caused by susceptible isolates of streptococcus pneumoniae haemophilus influenzae moraxella catarrhalis see clinical studies 14 1 because fluoroquinolones including moxifloxacin hydrochloride have been associated with serious adverse reactions see warnings and precautions 5 moxifloxacin hydrochloride is indicated in adult patients for the treatment of acute bacterial exacerbation of chronic bronchitis abecb caused by susceptible isolates of methicillin susceptible or moxifloxacin hydrochloride is indicated in adult patients for the treatment of acute bacterial exacerbation of chronic bronchitis abecb caused by susceptible isolates of streptococcus pneumoniae haemophilus influenzae haemophilus parainfluenzae klebsiella pneumoniae staphylococcus aureus moraxella catarrhalis see clinical studies 14 2 because fluoroquinolones including moxifloxacin hydrochloride have been associated with serious adverse reactions see warnings and precautions 5 1 5 13 and for some patients abecb is self limiting reserve moxifloxacin hydrochloride for treatment of abecb in patients who have no alternative treatment options to reduce the development of drug resistant bacteria and maintain the effectiveness of moxifloxacin hydrochloride and other antibacterial drugs moxifloxacin hydrochloride should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria when culture and susceptibility information are available they should be considered in selecting or modifying antibacterial therapy in the absence of such data local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy" assertion.
• association label "norditropin is a recombinant human growth hormone indicated for pediatric 1 1 adult 1 2 norditropin somatropin rdna origin injection is indicated for the treatment of children with growth failure due to inadequate secretion of endogenous growth hormone gh norditropin somatropin rdna origin injection is indicated for the treatment of children with short stature associated with noonan syndrome norditropin somatropin rdna origin injection is indicated for the treatment of children with short stature associated with turner syndrome norditropin somatropin rdna origin injection is indicated for the treatment of children with short stature born small for gestational age sga with no catch up growth by age 2 4 years norditropin somatropin rdna origin injection is indicated for the replacement of endogenous gh in adults with growth hormone deficiency ghd who meet either of the following two criteria adult onset ao patients who have ghd either alone or associated with multiple hormone deficiencies hypopituitarism as a result of pituitary disease hypothalamic disease surgery radiation therapy or trauma or childhood onset co patients who were gh deficient during childhood as a result of congenital genetic acquired or idiopathic causes patients who were treated with somatropin for ghd in childhood and whose epiphyses are closed should be reevaluated before continuation of somatropin therapy at the reduced dose level recommended for ghd adults according to current standards confirmation of the diagnosis of adult ghd in both" assertion.
• association label "enbrel is a tumor necrosis factor tnf blocker indicated for the treatment of rheumatoid arthritis ra 1 1 polyarticular juvenile idiopathic arthritis jia in patients aged 2 years or older 1 2 psoriatic arthritis psa 1 3 ankylosing spondylitis as 1 4 plaque psoriasis pso in patients 4 years or older 1 5 enbrel is indicated for reducing signs and symptoms inducing major clinical response inhibiting the progression of structural damage and improving physical function in patients with moderately to severely active rheumatoid arthritis ra enbrel can be initiated in combination with methotrexate mtx or used alone enbrel is indicated for reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis jia in patients ages 2 and older enbrel is indicated for reducing signs and symptoms inhibiting the progression of structural damage of active arthritis and improving physical function in patients with psoriatic arthritis psa enbrel can be used with or without methotrexate enbrel is indicated for reducing signs and symptoms in patients with active ankylosing spondylitis as enbrel is indicated for the treatment of patients 4 years or older with chronic moderate to severe plaque psoriasis pso who are candidates for systemic therapy or phototherapy" assertion.
• association label "enbrel is a tumor necrosis factor tnf blocker indicated for the treatment of rheumatoid arthritis ra 1 1 polyarticular juvenile idiopathic arthritis jia in patients aged 2 years or older 1 2 psoriatic arthritis psa 1 3 ankylosing spondylitis as 1 4 plaque psoriasis pso in patients 4 years or older 1 5 enbrel is indicated for reducing signs and symptoms inducing major clinical response inhibiting the progression of structural damage and improving physical function in patients with moderately to severely active rheumatoid arthritis ra enbrel can be initiated in combination with methotrexate mtx or used alone enbrel is indicated for reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis jia in patients ages 2 and older enbrel is indicated for reducing signs and symptoms inhibiting the progression of structural damage of active arthritis and improving physical function in patients with psoriatic arthritis psa enbrel can be used with or without methotrexate enbrel is indicated for reducing signs and symptoms in patients with active ankylosing spondylitis as enbrel is indicated for the treatment of patients 4 years or older with chronic moderate to severe plaque psoriasis pso who are candidates for systemic therapy or phototherapy" assertion.
• association label "farydak a histone deacetylase inhibitor in combination with bortezomib and dexamethasone is indicated for the treatment of patients with multiple myeloma who have received at least 2 prior regimens including bortezomib and an immunomodulatory agent this indication is approved under accelerated approval based on progression free survival see clinical studies 14 1 farydak a histone deacetylase inhibitor in combination with bortezomib and dexamethasone is indicated for the treatment of patients with multiple myeloma who have received at least 2 prior regimens including bortezomib and an immunomodulatory agent this indication is approved under accelerated approval based on progression free survival continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials 1" assertion.
• association label "elaprase is indicated for patients with hunter syndrome mucopolysaccharidosis ii mps ii elaprase has been shown to improve walking capacity in patients 5 years and older in patients 16 months to 5 years of age no data are available to demonstrate improvement in disease related symptoms or long term clinical outcome however treatment with elaprase has reduced spleen volume similarly to that of adults and children 5 years of age and older the safety and efficacy of elaprase have not been established in pediatric patients less than 16 months of age see use in specific populations 8 4 elaprase is a hydrolytic lysosomal glycosaminoglycan gag specific enzyme indicated for patients with hunter syndrome mucopolysaccharidosis ii mps ii elaprase has been shown to improve walking capacity in patients 5 years and older in patients 16 months to 5 years of age no data are available to demonstrate improvement in disease related symptoms or long term clinical outcome however treatment with elaprase has reduced spleen volume similarly to that of adults and children 5 years of age and older the safety and efficacy of elaprase have not been established in pediatric patients less than 16 months of age 1" assertion.
• association label "lantus is indicated to improve glycemic control in adults and pediatric patients with type 1 diabetes mellitus and in adults with type 2 diabetes mellitus important limitations of use lantus is not recommended for the treatment of diabetic ketoacidosis intravenous short acting insulin is the preferred treatment for this condition lantus is a long acting human insulin analog indicated to improve glycemic control in adults and pediatric patients with type 1 diabetes mellitus and in adults with type 2 diabetes mellitus 1 important limitations of use not recommended for treating diabetic ketoacidosis use intravenous short acting insulin instead" assertion.
• association label "imraldi is a tumor necrosis factor tnf blocker indicated for treatment of rheumatoid arthritis ra 1 1 juvenile idiopathic arthritis jia 1 2 psoriatic arthritis psa 1 3 ankylosing spondylitis as 1 4 adult crohn s disease cd 1 5 ulcerative colitis uc 1 6 plaque psoriasis ps 1 7 imraldi is indicated for reducing signs and symptoms inducing major clinical response inhibiting the progression of structural damage and improving physical function in adult patients with moderately to severely active rheumatoid arthritis imraldi can be used alone or in combination with methotrexate or other non biologic disease modifying anti rheumatic drugs dmards imraldi is indicated for reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients from 4 to 17 years of age and 3 kg 66 lbs imraldi can be used alone or in combination with methotrexate imraldi is indicated for reducing signs and symptoms inhibiting the progression of structural damage and improving physical function in adult patients with active psoriatic arthritis imraldi can be used alone or in combination with non biologic dmards imraldi is indicated for reducing signs and symptoms in adult patients with active ankylosing spondylitis imraldi is indicated for reducing signs and symptoms and inducing and maintaining clinical remission in adult patients with moderately to severely active crohn s disease who have had an inadequate response to conventional therapy imraldi is indicated for reducing signs and symptoms and inducing clinical remission in these patients if they have also lost response to or are intolerant to infliximab imraldi is indicated for inducing and sustaining clinical remission in adult patients with moderately to severely active ulcerative colitis who have had an inadequate response to immunosuppressants such as corticosteroids azathioprine or 6 mercaptopurine 6 mp the effectiveness of adalimumab has not been established in patients who have lost response to or were intolerant to tnf blockers see clinical studies 14 7 imraldi is indicated for the treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy and when other systemic therapies are medically less appropriate imraldi should only be administered to patients who will be closely monitored and have regular follow up visits with a physician see boxed warning 5" assertion.
• association label "imraldi is a tumor necrosis factor tnf blocker indicated for treatment of rheumatoid arthritis ra 1 1 juvenile idiopathic arthritis jia 1 2 psoriatic arthritis psa 1 3 ankylosing spondylitis as 1 4 adult crohn s disease cd 1 5 ulcerative colitis uc 1 6 plaque psoriasis ps 1 7 imraldi is indicated for reducing signs and symptoms inducing major clinical response inhibiting the progression of structural damage and improving physical function in adult patients with moderately to severely active rheumatoid arthritis imraldi can be used alone or in combination with methotrexate or other non biologic disease modifying anti rheumatic drugs dmards imraldi is indicated for reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients from 4 to 17 years of age and 3 kg 66 lbs imraldi can be used alone or in combination with methotrexate imraldi is indicated for reducing signs and symptoms inhibiting the progression of structural damage and improving physical function in adult patients with active psoriatic arthritis imraldi can be used alone or in combination with non biologic dmards imraldi is indicated for reducing signs and symptoms in adult patients with active ankylosing spondylitis imraldi is indicated for reducing signs and symptoms and inducing and maintaining clinical remission in adult patients with moderately to severely active crohn s disease who have had an inadequate response to conventional therapy imraldi is indicated for reducing signs and symptoms and inducing clinical remission in these patients if they have also lost response to or are intolerant to infliximab imraldi is indicated for inducing and sustaining clinical remission in adult patients with moderately to severely active ulcerative colitis who have had an inadequate response to immunosuppressants such as corticosteroids azathioprine or 6 mercaptopurine 6 mp the effectiveness of adalimumab has not been established in patients who have lost response to or were intolerant to tnf blockers see clinical studies 14 7 imraldi is indicated for the treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy and when other systemic therapies are medically less appropriate imraldi should only be administered to patients who will be closely monitored and have regular follow up visits with a physician see boxed warning 5" assertion.
• association label "cerdelga is indicated for the long term treatment of adult patients with gaucher disease type 1 gd1 who are cyp2d6 extensive metabolizers ems intermediate metabolizers ims or poor metabolizers pms as detected by an fda cleared test see dosage and administration 2 1 cerdelga is a glucosylceramide synthase inhibitor indicated for the long term treatment of adult patients with gaucher disease type 1 who are cyp2d6 extensive metabolizers ems intermediate metabolizers ims or poor metabolizers pms as detected by an fda cleared test 1 limitations of use cyp2d6 ultra rapid metabolizers may not achieve adequate concentrations of cerdelga to achieve a therapeutic effect 1 a specific dosage cannot be recommended for cyp2d6 indeterminate metabolizers 1 limitations of use patients who are cyp2d6 ultra rapid metabolizers urms may not achieve adequate concentrations of cerdelga to achieve a therapeutic effect see clinical studies 14 a specific dosage cannot be recommended for those patients whose cyp2d6 genotype cannot be determined indeterminate metabolizers see clinical studies 14" assertion.
• association label "afinitor is a kinase inhibitor indicated for the treatment of postmenopausal women with advanced hormone receptor positive her2 negative breast cancer in combination with exemestane after failure of treatment with letrozole or anastrozole 1 1 adults with progressive neuroendocrine tumors of pancreatic origin pnet and adults with progressive well differentiated non functional neuroendocrine tumors net of gastrointestinal gi or lung origin that are unresectable locally advanced or metastatic limitation of use 1 2 adults with advanced renal cell carcinoma rcc after failure of treatment with sunitinib or sorafenib 1 3 adults with renal angiomyolipoma and tuberous sclerosis complex tsc not requiring immediate surgery 1 4 afinitor and afinitor disperz are kinase inhibitors indicated for the treatment of adult and pediatric patients aged 1 year and older with tsc who have subependymal giant cell astrocytoma sega that requires therapeutic intervention but cannot be curatively resected 1 5 afinitor disperz is a kinase inhibitor indicated for the adjunctive treatment of adult and pediatric patients aged 2 years and older with tsc associated partial onset seizures 1 6 afinitor r afinitor is indicated for the treatment of adult patients with progressive neuroendocrine tumors of pancreatic origin pnet with unresectable locally advanced or metastatic disease afinitor is indicated for the treatment of adult patients with progressive well differentiated non functional net of gastrointestinal gi or lung origin with unresectable locally advanced or metastatic disease limitation of use see clinical studies 14 2 afinitor is indicated for the treatment of adult patients with advanced rcc after failure of treatment with sunitinib or sorafenib afinitor is indicated for the treatment of adult patients with renal angiomyolipoma and tsc not requiring immediate surgery afinitor and afinitor disperz r afinitor disperz is indicated for the adjunctive treatment of adult and pediatric patients aged 2 years and older with tsc associated partial onset seizures" assertion.
• association label "kalbitor r kalbitor is a plasma kallikrein inhibitor indicated for treatment of acute attacks of hereditary angioedema hae in patients 12 years of age and older 1" assertion.
• association label "to reduce the development of drug resistant bacteria and maintain the effectiveness of vibativ and other antibacterial drugs vibativ should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria when culture and susceptibility information are available they should be considered in selecting or modifying antibacterial therapy in the absence of such data local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy combination therapy may be clinically indicated if the documented or presumed pathogens include gram negative organisms appropriate specimens for bacteriological examination should be obtained in order to isolate and identify the causative pathogens and to determine their susceptibility to telavancin vibativ may be initiated as empiric therapy before results of these tests are known vibativ is a lipoglycopeptide antibacterial drug indicated for the treatment of the following infections in adult patients caused by designated susceptible bacteria complicated skin and skin structure infections csssi 1 1 hospital acquired and ventilator associated bacterial pneumonia habp vabp caused by susceptible isolates of staphylococcus aureus 1 2 vibativ is indicated for the treatment of adult patients with complicated skin and skin structure infections csssi caused by susceptible isolates of the following gram positive microorganisms staphylococcus aureus streptococcus pyogenes streptococcus agalactiae streptococcus anginosus s anginosus s intermedius s constellatus enterococcus faecalis vibativ is indicated for the treatment of adult patients with hospital acquired and ventilator associated bacterial pneumonia habp vabp caused by susceptible isolates of staphylococcus aureus" assertion.
• association label "alogliptin tablets are a dipeptidyl peptidase 4 dpp 4 inhibitor indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus 1 1 14 important limitations of use not for treatment of type 1 diabetes or diabetic ketoacidosis 1 1 alogliptin tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus see clinical studies 14 important limitations of use alogliptin tablets are not indicated for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis as it would not be effective in these settings" assertion.
• association label "pomalyst is a thalidomide analogue indicated in combination with dexamethasone for patients with multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor and have demonstrated disease progression on or within 6 days of completion of the last therapy 1 1 pomalyst in combination with dexamethasone is indicated for patients with multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor and have demonstrated disease progression on or within 6 days of completion of the last therapy" assertion.
• association label "stivarga is a kinase inhibitor indicated for the treatment of patients with 1 1 1 2 stivarga is indicated for the treatment of patients with metastatic colorectal cancer crc who have been previously treated with fluoropyrimidine oxaliplatin and irinotecan based chemotherapy an anti vegf therapy and if ras wild type an anti egfr therapy stivarga is indicated for the treatment of patients with locally advanced unresectable or metastatic gastrointestinal stromal tumor gist who have been previously treated with imatinib mesylate and sunitinib malate stivarga is indicated for the treatment of patients with hepatocellular carcinoma hcc who have been previously treated with sorafenib" assertion.
• association label "bleomycin for injection should be considered a palliative treatment it has been shown to be useful in the management of the following neoplasms either as a single agent or in proven combinations with other approved chemotherapeutic agents squamous cell carcinoma head and neck including mouth tongue tonsil nasopharynx oropharynx sinus palate lip buccal mucosa gingivae epiglottis skin larynx penis cervix and vulva the response to bleomycin is poorer in patients with previously irradiated head and neck cancer lymphomas hodgkin s disease non hodgkin s lymphoma testicular carcinoma embryonal cell choriocarcinoma and teratocarcinoma bleomycin has also been shown to be useful in the management of malignant pleural effusion bleomycin is effective as a sclerosing agent for the treatment of malignant pleural effusion and prevention of recurrent pleural effusions" assertion.
• association label "valacyclovir hydrochloride is a nucleoside analogue dna polymerase inhibitor indicated for adult patients 1 1 cold sores herpes labialis genital herpes treatment in immunocompetent patients initial or recurrent episode suppression in immunocompetent or hiv infected patients reduction of transmission herpes zoster pediatric patients 1 2 cold sores herpes labialis chickenpox limitations of use 1 3 the efficacy and safety of valacyclovir tablets have not been established in immunocompromised patients other than for the suppression of genital herpes in hiv infected patients cold sores herpes labialis valacyclovir tablets are indicated for treatment of cold sores herpes labialis the efficacy of valacyclovir tablets initiated after the development of clinical signs of a cold sore e g papule vesicle or ulcer has not been established genital herpes initial episode valacyclovir tablets are indicated for treatment of the initial episode of genital herpes in immunocompetent adults the efficacy of treatment with valacyclovir tablets when initiated more than 72 hours after the onset of signs and symptoms has not been established recurrent episodes valacyclovir tablets are indicated for treatment of recurrent episodes of genital herpes in immunocompetent adults the efficacy of treatment with valacyclovir tablets when initiated more than 24 hours after the onset of signs and symptoms has not been established suppressive therapy valacyclovir tablets are indicated for chronic suppressive therapy of recurrent episodes of genital herpes in immunocompetent and in hiv infected adults the efficacy and safety of valacyclovir tablets for the suppression of genital herpes beyond 1 year in immunocompetent patients and beyond 6 months in hiv infected patients have not been established reduction of transmission valacyclovir tablets are indicated for the reduction of transmission of genital herpes in immunocompetent adults the efficacy of valacyclovir tablets for the reduction of transmission of genital herpes beyond 8 months in discordant couples has not been established the efficacy of valacyclovir tablets for the reduction of transmission of genital herpes in individuals with multiple partners and non heterosexual couples has not been established safer sex practices should be used with suppressive therapy see current centers for disease control and prevention cdc sexually transmitted diseases treatment guidelines herpes zoster valacyclovir tablets are indicated for the treatment of herpes zoster shingles in immunocompetent adults the efficacy of valacyclovir tablets when initiated more than 72 hours after the onset of rash and the efficacy and safety of valacyclovir tablets for treatment of disseminated herpes zoster have not been established cold sores herpes labialis valacyclovir tablets are indicated for the treatment of cold sores herpes labialis in pediatric patients 12 years of age the efficacy of valacyclovir tablets initiated after the development of clinical signs of a cold sore e g papule vesicle or ulcer has not been established chickenpox valacyclovir tablets are indicated for the treatment of chickenpox in immunocompetent pediatric patients 2 to 18 years of age based on efficacy data from clinical studies with oral acyclovir treatment with valacyclovir tablets should be initiated within 24 hours after the onset of rash see clinical studies 14 4 the efficacy and safety of valacyclovir tablets have not been established in immunocompromised patients other than for the suppression of genital herpes in hiv infected patients with a cd4 cell count 1 cells mm 3 patients 12years of age with cold sores herpes labialis patients 2 years of age or 18 years of age with chickenpox patients 18years of age with genital herpes patients 18years of age with herpes zoster neonates and infants as suppressive therapy following neonatal herpes simplex virus hsv infection" assertion.
• association label "lansoprazole delayed release orally disintegrating tablets are a proton pump inhibitor ppi indicated for the treatment of active duodenal ulcer in adults 1 1 eradication of h pylori 1 2 maintenance of healed duodenal ulcers in adults 1 3 treatment of active benign gastric ulcer in adults 1 4 healing of non steroidal anti inflammatory drugs nsaid associated gastric ulcer in adults 1 5 risk reduction of nsaid associated gastric ulcer in adults 1 6 treatment of symptomatic gastroesophageal reflux disease gerd in adults and pediatric patients 1 year of age and older 1 7 treatment of erosive esophagitis ee in adults and pediatric patients 1 year of age and older 1 8 maintenance of healing of ee in adults 1 9 pathological hypersecretory conditions including zollinger ellison syndrome zes in adults 1 1 lansoprazole delayed release orally disintegrating tablets are indicated in adults for short term treatment for four weeks for healing and symptom relief of active duodenal ulcer see clinical studies 14 1 triple therapy lansoprazole delayed release orally disintegrating tablets amoxicillin clarithromycin lansoprazole delayed release orally disintegrating tablets in combination with amoxicillin plus clarithromycin as triple therapy is indicated in adults for the treatment of patients with h pylori h pylori h pylori see clinical studies 14 2 please refer to the full prescribing information for amoxicillin and clarithromycin dual therapy lansoprazole delayed release orally disintegrating tablets amoxicillin lansoprazole delayed release orally disintegrating tablets in combination with amoxicillin as dual therapy is indicated in adults for the treatment of patients with h pylori who are either allergic or intolerant to clarithromycin or in whom resistance to clarithromycin is known or suspected microbiology h pylori see clinical studies 14 2 please refer to the full prescribing information for amoxicillin lansoprazole delayed release orally disintegrating tablets are indicated in adults to maintain healing of duodenal ulcers controlled studies do not extend beyond 12 months see clinical studies 14 3 lansoprazole delayed release orally disintegrating tablets are indicated in adults for short term treatment up to eight weeks for healing and symptom relief of active benign gastric ulcer see clinical studies 14 4 lansoprazole delayed release orally disintegrating tablets are indicated in adults for the treatment of nsaid associated gastric ulcer in patients who continue nsaid use controlled studies did not extend beyond eight weeks see clinical studies 14 5 lansoprazole delayed release orally disintegrating tablets are indicated in adults for reducing the risk of nsaid associated gastric ulcers in patients with a history of a documented gastric ulcer who require the use of an nsaid controlled studies did not extend beyond 12 weeks see clinical studies 14 6 lansoprazole delayed release orally disintegrating tablets are indicated for short term treatment in adults and pediatric patients 12 to 17 years of age up to eight weeks and pediatric patients one to 11 years of age up to 12 weeks for the treatment of heartburn and other symptoms associated with gerd see clinical studies 14 7 lansoprazole delayed release orally disintegrating tablets are indicated for short term treatment in adults and pediatric patients 12 to 17 years of age up to eight weeks and pediatric patients one to 11 years of age up to 12 weeks for healing and symptom relief of all grades of ee for adults who do not heal with lansoprazole delayed release orally disintegrating tablets for eight weeks 5 to 1 it may be helpful to give an additional eight weeks of treatment if there is a recurrence of erosive esophagitis an additional eight week course of lansoprazole delayed release orally disintegrating tablets may be considered see clinical studies 14 8 lansoprazole delayed release orally disintegrating tablets are indicated in adults to maintain healing of ee controlled studies did not extend beyond 12 months see clinical studies 14 9 lansoprazole delayed release orally disintegrating tablets are indicated in adults for the long term treatment of pathological hypersecretory conditions including zollinger ellison syndrome see clinical studies 14 1" assertion.
• association label "allergic states control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment atopic dermatitis bronchial asthma contact dermatitis drug hypersensitivity reactions seasonal or perennial allergic rhinitis and serum sickness collagen diseases during an exacerbation or as maintenance therapy in selected cases of systemic lupus erythematosus and acute rheumatic carditis dermatologic diseases bullous dermatitis herpetiformis exfoliative dermatitis mycosis fungoides pemphigus severe erythema multiforme stevens johnson syndrome severe psoriasis and severe seborrheic dermatitis edematous states to induce a diuresis or remission of proteinuria in the nephrotic syndrome without uremia of the idiopathic type or that due to lupus erythematosus endocrine disorders primary or secondary adrenocortical insufficiency hydrocortisone or cortisone is the first choice synthetic analogs may be used in conjunction with mineralocorticoids where applicable in infancy mineralocorticoid supplementation is of particular importance congenital adrenal hyperplasia hypercalcemia associated with cancer and nonsuppurative thyroiditis gastrointestinal diseases to tide the patient over a critical period of the disease in ulcerative colitis and regional enteritis hematologic disorders idiopathic thrombocytopenic purpura in adults secondary thrombocytopenia in adults acquired autoimmune hemolytic anemia erythroblastopenia rbc anemia and congenital erythroid hypoplastic anemia miscellaneous diagnostic testing of adrenocortical hyperfunction tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy and trichinosis with neurologic or myocardial involvement neoplastic diseases for palliative management of leukemia and lymphomas in adults and acute leukemia of childhood ophthalmic diseases severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as allergic conjunctivitis keratitis allergic corneal marginal ulcers herpes zoster ophthalmicus iritis and iridocyclitis chorioretinitis anterior segment inflammation diffuse posterior uveitis and choroiditis optic neuritis and sympathetic ophthalmia respiratory diseases symptomatic sarcoidosis loeffler s syndrome not manageable by other means berylliosis fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy and aspiration pneumonitis rheumatic disorders as adjunctive therapy for short term administration to tide the patient over an acute episode or exacerbation in psoriatic arthritis rheumatoid arthritis including juvenile rheumatoid arthritis selected cases may require low dose maintenance therapy ankylosing spondylitis acute and subacute bursitis acute nonspecific tenosynovitis acute gouty arthritis post traumatic osteoarthritis synovitis of osteoarthritis and epicondylitis" assertion.
• association label "clindamycin is a lincosamide antibacterial indicated for the treatment of the following 1 1 1 2 1 3 1 4 1 5 1 6 1 7 1 8 limitation of use 1 9 to reduce the development of drug resistant bacteria and maintain the effectiveness of clindamycin in 9 sodium chloride injection and other antibacterial drugs clindamycin in 9 sodium chloride injection should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria 1 1 clindamycin in 9 sodium chloride injection is indicated for the treatment of serious infections caused by susceptible anaerobic bacteria see indications and usage 1 3 1 7 clindamycin in 9 sodium chloride injection is indicated for the treatment of serious infections due to susceptible strains of streptococci pneumococci and staphylococci its use should be reserved for penicillin allergic patients or other patients for whom in the judgment of the physician a penicillin is inappropriate because of the risk of antibacterial associated pseudomembranous colitis see boxed warning bacteriologic studies should be performed to determine the causative organisms and their susceptibility to clindamycin indicated surgical procedures should be performed in conjunction with antibacterial therapy clindamycin in 9 sodium chloride injection is indicated in the treatment of serious lower respiratory tract infections including pneumonia empyema and lung abscess caused by susceptible strains of anaerobes streptococcus pneumoniae e faecalis staphylococcus aureus clindamycin in 9 sodium chloride injection is indicated in the treatment of serious skin and skin structure infections caused by susceptible strains of streptococcus pyogenes staphylococcus aureus clindamycin in 9 sodium chloride injection is indicated in the treatment of serious gynecological infections including endometritis nongonococcal tubo ovarian abscess pelvic cellulitis and postsurgical vaginal cuff infection caused by susceptible anaerobes clindamycin in 9 sodium chloride injection is indicated in the treatment of serious intra abdominal infections including peritonitis and intra abdominal abscess caused by susceptible anaerobic organisms clindamycin in 9 sodium chloride injection is indicated in the treatment of serious septicemia caused by susceptible strains of staphylococcus aureus enterococcus faecalis clindamycin in 9 sodium chloride injection is indicated in the treatment of serious bone and joint infections including acute hematogenous osteomyelitis caused by susceptible strains of staphylococcus aureus since clindamycin does not diffuse adequately into the cerebrospinal fluid clindamycin in 9 sodium chloride injection should not be used in the treatment of meningitis see clinical pharmacology 12 3 to reduce the development of drug resistant bacteria and maintain the effectiveness of clindamycin in 9 sodium chloride injection and other antibacterial drugs clindamycin in 9 sodium chloride injection should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria when culture and susceptibility information are available they should be considered in selecting or modifying antibacterial therapy in the absence of such data local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy" assertion.
• association label "to reduce the development of drug resistant bacteria and maintain the effectiveness of demeclocycline hydrochloride tablets and other antibacterial drugs demeclocycline hydrochloride tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria when culture and susceptibility information are available they should be considered in selecting or modifying antibacterial therapy in the absence of such data local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy demeclocycline hydrochloride is indicated in the treatment of infections caused by susceptible strains of the designated microorganisms in the conditions below rocky mountain spotted fever typhus fever and the typhus group q fever rickettsialpox and tick fevers caused by rickettsiae respiratory tract infections caused by lymphogranuloma venereum due to psittacosis ornithosis due to trachoma due to although the infectious agent is not always eliminated as judged by immunofluorescence inclusion conjunctivitis caused by nongonococcal urethritis in adults caused by or relapsing fever due to chancroid caused by plague due to tularemia due to cholera caused by campylobacter fetus infections caused by brucellosis due to species in conjunction with streptomycin bartonellosis due to granuloma inguinale caused by demeclocycline hydrochloride is indicated for treatment of infections caused by the following gram negative microorganisms when bacteriologic testing indicates appropriate susceptibility to the drug species species respiratory tract infections caused by respiratory tract and urinary tract infections caused by species demeclocycline hydrochloride is indicated for treatment of infections caused by the following gram positive microorganisms when bacteriologic testing indicates appropriate susceptibility to the drug upper respiratory infections caused by pneumoniae skin and skin structure infections caused by note tetracyclines including demeclocycline are not the drugs of choice in the treatment of any type of staphylococcal infection when penicillin is contraindicated tetracyclines including demeclocycline hydrochloride are alternative drugs in the treatment of the following infections uncomplicated urethritis in men due to and for the treatment of other uncomplicated gonococcal infections infections in women caused by syphilis caused by subspecies yaws caused by subspecies listeriosis due to anthrax due to vincent s infection caused by actinomycosis caused by clostridial diseases caused by species in acute intestinal amebiasis demeclocycline hydrochloride may be a useful adjunct to amebicides in severe acne demeclocycline hydrochloride may be a useful adjunctive therapy mycoplasma pneumoniae chlamydia trachomatis chlamydia psittaci chlamydia trachomatis chlamydia trachomatis ureaplasma urealyticum chlamydia trachomatis borrelia recurrentis haemophilus ducreyi yersinia pestis francisella tularensis vibrio cholerae campylobacter fetus brucella bartonella bacilliformis calymmatobacterium granulomatis escherichia coli enterobacter aerogenes shigella acinetobacter haemophilus influenzae klebsiella streptococcus staphylococcus aureus neisseria gonorrhoeae neisseria gonorrhoeae treponema pallidum pallidum treponema pallidum pertenue listeria monocytogenes bacillus anthracis fusobacterium fusiforme actinomyces israelii clostridium" assertion.
• association label "dantrolene sodium capsules are indicated in controlling the manifestations of clinical spasticity resulting from upper motor neuron disorders e g spinal cord injury stroke cerebral palsy or multiple sclerosis it is of particular benefit to the patient whose functional rehabilitation has been retarded by the sequelae of spasticity such patients must have presumably reversible spasticity where relief of spasticity will aid in restoring residual function dantrolene sodium capsules is not indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders if improvement occurs it will ordinarily occur within the dosage titration see dosage and administration occasionally subtle but meaningful improvement in spasticity may occur with dantrolene sodium capsules therapy in such instances information regarding improvement should be solicited from the patient and those who are in constant daily contact and attendance with him brief withdrawal of dantrolene sodium capsules for a period of 2 to 4 days will frequently demonstrate exacerbation of the manifestations of spasticity and may serve to confirm a clinical impression a decision to continue the administration of dantrolene sodium capsules on a long term basis is justified if introduction of the drug into the patient s regimen produces a significant reduction in painful and or disabling spasticity such as clonus or permits a significant reduction in the intensity and or degree of nursing care required or rids the patient of any annoying manifestation of spasticity considered important by the patient himself oral dantrolene sodium capsules is also indicated preoperatively to prevent or attenuate the development of signs of malignant hyperthermia in known or strongly suspect malignant hyperthermia susceptible patients who require anesthesia and or surgery currently accepted clinical practices in the management of such patients must still be adhered to careful monitoring for early signs of malignant hyperthermia minimizing exposure to triggering mechanisms and prompt use of intravenous dantrolene sodium and indicated supportive measures should signs of malignant hyperthermia appear see also the package insert for intravenous dantrolene sodium oral dantrolene sodium capsules should be administered following a malignant hyperthermic crisis to prevent recurrence of the signs of malignant hyperthermia" assertion.
• association label "clarithromycin is a macrolide antimicrobial indicated for mild to moderate infections caused by designated susceptible bacteria in the following acute bacterial exacerbation of chronic bronchitis in adults 1 1 acute maxillary sinusitis 1 2 community acquired pneumonia 1 3 pharyngitis tonsillitis 1 4 uncomplicated skin and skin structure infections 1 5 acute otitis media in pediatric patients 1 6 treatment and prophylaxis of disseminated mycobacterial infections 1 7 helicobacter pylori 1 8 limitations of use clarithromycin extended release tablets are indicated only for acute bacterial exacerbation of chronic bronchitis acute maxillary sinusitis and community acquired pneumonia in adults 1 9 to reduce the development of drug resistant bacteria and maintain the effectiveness of clarithromycin and other antibacterial drugs clarithromycin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria 1 9 clarithromycin tablets clarithromycin for oral suspension and clarithromycin extended release tablets are indicated in adults for the treatment of mild to moderate infections caused by susceptible isolates due to haemophilus influenzae haemophilus parainfluenzae moraxella catarrhalis streptococcus pneumoniae see indications and usage 1 9 clarithromycin tablets clarithromycin for oral suspension and clarithromycin extended release tablets in adults are indicated for the treatment of mild to moderate infections caused by susceptible isolates due to haemophilus influenzae moraxella catarrhalis streptococcus pneumoniae see indications and usage 1 9 clarithromycin tablets clarithromycin for oral suspension and clarithromycin extended release tablets are indicated see indications and usage 1 9 haemophilus influenzae haemophilus parainfluenzae moraxella catarrhalis mycoplasma pneumoniae streptococcus pneumoniae chlamydophila pneumoniae clarithromycin tablets and clarithromycin for oral suspension are indicated for the treatment of mild to moderate infections caused by susceptible isolates due to streptococcus pyogenes clarithromycin tablets and clarithromycin for oral suspension are indicated for the treatment of mild to moderate infections caused by susceptible isolates due to staphylococcus aureus streptococcus pyogenes clarithromycin tablets and clarithromycin for oral suspension are indicated in pediatric patients for the treatment of mild to moderate infections caused by susceptible isolates due to haemophilus influenzae moraxella catarrhalis streptococcus pneumoniae see clinical studies 14 2 clarithromycin tablets and clarithromycin for oral suspension are indicated for the treatment of mild to moderate infections caused by susceptible isolates due to mycobacterium avium mycobacterium intracellulare see clinical studies 14 1 clarithromycin tablets are given in combination with other drugs in adults as described below to eradicate h pylori h pylori see clinical studies 14 3 clarithromycin tablets in combination with amoxicillin and prevacid lansoprazole or prilosec omeprazole delayed release capsules as triple therapy are indicated for the treatment of patients with h pylori h pylori clarithromycin tablets in combination with prilosec omeprazole capsules are indicated for the treatment of patients with an active duodenal ulcer associated with h pylori clarithromycin extended release tablets are indicated only for acute maxillary sinusitis acute bacterial exacerbation of chronic bronchitis and community acquired pneumonia in adults the efficacy and safety of clarithromycin extended release tablets in treating other infections for which clarithromycin tablets and clarithromycin for oral suspension are approved have not been established there is resistance to macrolides in certain bacterial infections caused by streptococcus pneumoniae staphylococcus aureus to reduce the development of drug resistant bacteria and maintain the effectiveness of clarithromycin and other antibacterial drugs clarithromycin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria when culture and susceptibility information are available they should be considered in selecting or modifying antibacterial therapy in the absence of such data local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy" assertion.
• association label "for all patients eplerenone tablets are contraindicated in all patients with serum potassium 5 5 meq l at initiation creatinine clearance 3 ml min or concomitant administration of strong cyp3a4 inhibitors e g ketoconazole itraconazole nefazodone troleandomycin clarithromycin ritonavir and nelfinavir see drug interactions 7 1 cyp3a4 inhibitors clinical pharmacology 12 3 pharmacokinetics for patients treated for hypertension eplerenone tablets is contraindicated for the treatment of hypertension in patients with type 2 diabetes with microalbuminuria serum creatinine 2 mg dl in males or 1 8 mg dl in females creatinine clearance 5 ml min or concomitant administration of potassium supplements or potassium sparing diuretics e g amiloride spironolactone or triamterene see warnings and precautions 5 1 hyperkalemia adverse reactions 6 2 clinical laboratory test findings 7 drug interactions clinical pharmacology 12 3 pharmacokinetics for all patients serum potassium 5 5 meq l at initiation 4 creatinine clearance 3 ml min 4 concomitant use with strong cyp3a4 inhibitors 4 7 1 for the treatment of hypertension type 2 diabetes with microalbuminuria 4 serum creatinine 2 mg dl in males 1 8 mg dl in females 4 creatinine clearance 5 ml min 4 concomitant use of potassium supplements or potassium sparing diuretics 4" assertion.
• association label "liothyronine sodium is an l triiodothyronine t3 indicated for hypothyroidism as replacement in primary thyroidal secondary pituitary and tertiary hypothalamic congenital or acquired hypothyroidism 1 1 pituitary thyroid stimulating hormone tsh suppression as an adjunct to surgery and radioiodine therapy in the management of well differentiated thyroid cancer 1 2 thyroid suppression test as a diagnostic agent in suppression tests to differentiate suspected mild hyperthyroidism or thyroid gland autonomy 1 3 limitations of use not indicated for suppression of benign thyroid nodules and nontoxic diffuse goiter in iodine sufficient patients 1 not indicated for treatment of hypothyroidism during the recovery phase of subacute thyroiditis 1 liothyronine sodium is indicated as a replacement therapy in primary thyroidal secondary pituitary and tertiary hypothalamic congenital or acquired hypothyroidism liothyronine sodium is indicated as an adjunct to surgery and radioiodine therapy in the management of well differentiated thyroid cancer liothyronine sodium is indicated as a diagnostic agent in suppression tests to differentiate suspected mild hyperthyroidism or thyroid gland autonomy limitations of use liothyronine sodium is not indicated for suppression of benign thyroid nodules and nontoxic diffuse goiter in iodine sufficient patients as there are no clinical benefits and overtreatment with liothyronine sodium may induce hyperthyroidism see warnings and precautions 5 4 liothyronine sodium is not indicated for treatment of hypothyroidism during the recovery phase of subacute thyroiditis" assertion.
• association label "metoprolol succinate extended release tablets metoprolol succinate is a beta selective adrenoceptor blocking agent 1 metoprolol succinate extended release tablets are indicated for the treatment of hypertension to lower blood pressure lowering blood pressure reduces the risk of fatal and non fatal cardiovascular events primarily strokes and myocardial infarctions 1 1 1 angina pectoris 2 1 2 heart failure for the treatment of stable symptomatic nyha class ii or iii heart failure of ischemic hypertensive or cardiomyopathic origin 3 1 3 metoprolol succinate extended release tablets are indicated for the treatment of hypertension to lower blood pressure lowering blood pressure lowers the risk of fatal and non fatal cardiovascular events primarily strokes and myocardial infarctions these benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including metoprolol control of high blood pressure should be part of comprehensive cardiovascular risk management including as appropriate lipid control diabetes management antithrombotic therapy smoking cessation exercise and limited sodium intake many patients will require more than 1 drug to achieve blood pressure goals for specific advice on goals and management see published guidelines such as those of the national high blood pressure education program s joint national committee on prevention detection evaluation and treatment of high blood pressure jnc numerous antihypertensive drugs from a variety of pharmacologic classes and with different mechanisms of action have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality and it can be concluded that it is blood pressure reduction and not some other pharmacologic property of the drugs that is largely responsible for those benefits the largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly elevated systolic or diastolic pressure causes increased cardiovascular risk and the absolute risk increase per mmhg is greater at higher blood pressures so that even modest reductions of severe hypertension can provide substantial benefit relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk so the absolute benefit is greater in patients who are at higher risk independent of their hypertension for example patients with diabetes or hyperlipidemia and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal some antihypertensive drugs have smaller blood pressure effects as monotherapy in black patients and many antihypertensive drugs have additional approved indications and effects eg on angina heart failure or diabetic kidney disease these considerations may guide selection of therapy metoprolol succinate extended release tablets may be administered with other antihypertensive agents metoprolol succinate extended release tablets are indicated in the long term treatment of angina pectoris to reduce angina attacks and to improve exercise tolerance metoprolol succinate extended release tablets are indicated for the treatment of stable symptomatic nyha class ii or iii heart failure of ischemic hypertensive or cardiomyopathic origin it was studied in patients already receiving ace inhibitors diuretics and in the majority of cases digitalis in this population metoprolol succinate extended release tablets decreased the rate of mortality plus hospitalization largely through a reduction in cardiovascular mortality and hospitalizations for heart failure" assertion.
• association label "nexavar is a kinase inhibitor indicated for the treatment of 1 1 1 2 1 3 nexavar r nexavar is indicated for the treatment of patients with advanced renal cell carcinoma rcc nexavar is indicated for the treatment of patients with locally recurrent or metastatic progressive differentiated thyroid carcinoma dtc that is refractory to radioactive iodine treatment" assertion.
• association label "when oral therapy is not feasible and the strength dosage form and route of administration of the drug reasonably lend the preparation to the treatment of the condition the intravenous or intramusculat use of solu cortef sterile powder is indicated as follows allergic states control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma atopic dermatitis contact dermatitis drug hypersensitivity reactions perennial or seasonal allergic rhinitis serum sickness transfusion reactions dermatologic diseases bullous dermatitis herpetiformis exfoliative erythroderma mycosis fungoides pemphigus severe erythema multiforme stevens johnson syndrome endocrine disorders primary or secondary adrenocortical insufficiency hydrocortisone or cortisone is the drug of choice synthetic analogs may be used in conjunction with mineralocorticoids where applicable in infancy mineralocorticoid supplementation is of particular importance congenital adrenal hyperplasia hypercalcemia associated with cancer nonsuppurative thyroiditis gastrointestinal diseases to tide the patient over a critical period of the disease in regional enteritis systemic therapy and ulcerative colitis hematologic disorders acquired autoimmune hemolytic anemia congenital erythroid hypoplastic anemia diamond blackfan anemia idiopathic thrombocytopenic purpura in adults intravenous administration only intramuscular administration is contraindicated pure red cell aplasia select cases of secondary thrombocytopenia miscellaneous trichinosis with neurologic or myocardial involvement tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy neoplastic diseases for the palliative management of leukemias and lymphomas nervous system acute exacerbations of multiple sclerosis cerebral edema associated with primary or metastatic brain tumor or craniotomy ophthalmic diseases sympathetic ophthalmia uveitis and ocular inflammatory conditions unresponsive to topical corticosteroids renal diseases to induce diuresis or remission of proteinuria in idiopathic nephrotic syndrome or that due to lupus erythematosus respiratory diseases berylliosis fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy idiopathic eosinophilic pneumonias symptomatic sarcoidosis rheumatic disorders as adjunctive therapy for short term administration to tide the patient over an acute episode or exacerbation in acute gouty arthritis acute rheumatic carditis ankylosing spondylitis psoriatic arthritis rheumatoid arthritis including juvenile rheumatoid arthritis selected cases may require low dose maintenance therapy for the treatment of dermatomyositis temporal arteritis polymyositis and systemic lupus erythematosus" assertion.
• association label "hydrocortisone tablets usp are indicated in the following conditions endocrine disorders primary or secondary adrenocortical insufficiency hydrocortisone or cortisone is the first choice synthetic analogs may be used in conjunction with mineralocorticoids where applicable in infancy mineralocorticoid supplementation is of particular importance congenital adrenal hyperplasia nonsuppurative thyroiditis hypercalcemia associated with cancer rheumatic disorders as adjunctive therapy for short term administration to tide the patient over an acute episode or exacerbation in psoriatic arthritis rheumatoid arthritis including juvenile rheumatoid arthritis selected cases may require low dose maintenance therapy ankylosing spondylitis acute and subacute bursitis acute nonspecific tenosynovitis acute gouty arthritis post traumatic osteoarthritis synovitis of osteoarthritis epicondylitis collagen diseases during an exacerbation or as maintenance therapy in selected cases of systemic lupus erythematosus systemic dermatomyositis polymyositis acute rheumatic carditis dermatologic diseases pemphigus bullous dermatitis herpetiformis severe erythema multiforme stevens johnson syndrome exfoliative dermatitis mycosis fungoides severe psoriasis severe seborrheic dermatitis allergic states control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment seasonal or perennial allergic rhinitis serum sickness bronchial asthma contact dermatitis atopic dermatitis drug hypersensitivity reactions ophthalmic diseases severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as allergic conjunctivitis keratitis allergic corneal marginal ulcers herpes zoster ophthalmicus iritis and iridocyclitis chorioretinitis anterior segment inflammation diffuse posterior uveitis and choroiditis optic neuritis sympathetic ophthalmia respiratory diseases symptomatic sarcoidosis loeffler s syndrome not manageable by other means berylliosis fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy aspiration pneumonitis hematologic disorders idiopathic thrombocytopenic purpura in adults secondary thrombocytopenia in adults acquired autoimmune hemolytic anemia erythroblastopenia rbc anemia congenital erythroid hypoplastic anemia neoplastic diseases for palliative management of leukemias and lymphomas in adults acute leukemia of childhood edematous states to induce a diuresis or remission of proteinuria in the nephrotic syndrome without uremia of the idiopathic type or that due to lupus erythematosus gastrointestinal diseases to tide the patient over a critical period of the disease in ulcerative colitis regional enteritis nervous system acute exacerbations of multiple sclerosis miscellaneous tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy trichinosis with neurologic or myocardial involvement" assertion.
• association label "doxycycline hyclate tablets are tetracycline class drugs indicated for rickettsial infections 1 1 sexually transmitted infections 1 2 respiratory tract infections 1 3 specific bacterial infections 1 4 ophthalmic infections 1 5 anthrax including inhalational anthrax post exposure 1 6 alternative treatment for selected infections when penicillin is contraindicated 1 7 adjunctive therapy for acute intestinal amebiasis and severe acne 1 8 prophylaxis of malaria 1 9 to reduce the development of drug resistant bacteria and maintain the effectiveness of doxycycline hyclate tablets and other antibacterial drugs doxycycline hyclate tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria 1 1 doxycycline hyclate tablets are indicated for treatment of rocky mountain spotted fever typhus fever and the typhus group q fever rickettsial pox and tick fevers caused by rickettsiae doxycycline hyclate tablets are indicated for treatment of the following sexually transmitted infections uncomplicated urethral endocervical or rectal infections caused by chlamydia trachomatis nongonococcal urethritis caused by ureaplasma urealyticum lymphogranuloma venereum caused by chlamydia trachomatis granuloma inguinale caused by klebsiella granulomatis uncomplicated gonorrhea caused by neisseria gonorrhoeae chancroid caused by haemophilus ducreyi doxycycline hyclate tablets are indicated for treatment of the following respiratory tract infections respiratory tract infections caused by mycoplasma pneumoniae psittacosis ornithosis caused by chlamydophila psittaci because many strains of the following groups of microorganisms have been shown to be resistant to doxycycline culture and susceptibility testing are recommended doxycycline is indicated for treatment of infections caused by the following microorganisms when bacteriological testing indicates appropriate susceptibility to the drug respiratory tract infections caused by haemophilus influenzae respiratory tract infections caused by klebsiella species upper respiratory infections caused by streptococcus pneumoniae doxycycline hyclate tablets are indicated for treatment of the following specific bacterial infections relapsing fever due to borrelia recurrentis plague due to yersinia pestis tularemia due to francisella tularensis cholera caused by vibrio cholerae campylobacter fetus infections caused by campylobacter fetus brucellosis due to brucella bartonellosis due to bartonella bacilliformis because many strains of the following groups of microorganisms have been shown to be resistant to doxycycline culture and susceptibility testing are recommended doxycycline hyclate tablets are indicated for treatment of infections caused by the following gram negative microorganisms when bacteriological testing indicates appropriate susceptibility to the drug escherichia coli enterobacter aerogenes shigella acinetobacter urinary tract infections caused by klebsiella doxycycline hyclate tablets are indicated for treatment of the following ophthalmic infections trachoma caused by chlamydia trachomatis inclusion conjunctivitis caused by chlamydia trachomatis doxycycline hyclate tablets are indicated for the treatment of anthrax due to bacillus anthracis bacillus anthracis doxycycline hyclate tablets are indicted as an alternative treatment for the following selected infections when penicillin is contraindicated syphilis caused by treponema pallidum yaws caused by treponema pallidum pertenue listeriosis due to listeria monocytogenes vincent s infection caused by fusobacterium fusiforme actinomycosis caused by actinomyces israelii infections caused by clostridium in acute intestinal amebiasis doxycycline hyclate tablets may be a useful adjunct to amebicides in severe acne doxycycline hyclate tablets may be useful adjunctive therapy doxycycline hyclate tablets are indicated for the prophylaxis of malaria due to plasmodium falciparum see dosage and administration 2 4 patient counseling information 17 to reduce the development of drug resistant bacteria and maintain the effectiveness of doxycycline hyclate tablets and other antibacterial drugs doxycycline hyclate tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria when culture and susceptibility information are available they should be considered in selecting or modifying antibacterial therapy in the absence of such data local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy" assertion.
• association label "lamotrigine tablets is an antiepileptic drug aed indicated for epilepsy adjunctive therapy in patients 2 years of age 1 1 partial seizures primary generalized tonic clonic seizures generalized seizures of lennox gastaut syndrome conversion to monotherapy in patients with partial seizures who are receiving treatment with carbamazepine phenobarbital phenytoin primidone or valproate as the single aed epilepsy monotherapy in patients 16 years of age 1 1 maintenance treatment of bipolar i disorder to delay the time to occurrence of mood episodes in patients treated for acute mood episodes with standard therapy bipolar disorder in patients 18 years of age 1 2 adjunctive therapy lamotrigine tablets are indicated as adjunctive therapy for the following seizure types in patients 2 years of age partial seizures primary generalized tonic clonic seizures generalized seizures of lennox gastaut syndrome monotherapy lamotrigine tablets are indicated for conversion to monotherapy in adults 16 years of age with partial seizures who are receiving treatment with carbamazepine phenytoin phenobarbital primidone or valproate as the single antiepileptic drug aed safety and effectiveness of lamotrigine tablets have not been established 1 as initial monotherapy 2 for conversion to monotherapy from aeds other than carbamazepine phenytoin phenobarbital primidone or valproate or 3 for simultaneous conversion to monotherapy from 2 or more concomitant aeds lamotrigine tablets are indicated for the maintenance treatment of bipolar i disorder to delay the time to occurrence of mood episodes depression mania hypomania mixed episodes in adults 18 years of age treated for acute mood episodes with standard therapy the effectiveness of lamotrigine tablets in the acute treatment of mood episodes has not been established the effectiveness of lamotrigine tablets as maintenance treatment was established in 2 placebo controlled trials in patients with bipolar i disorder as defined by dsm iv the physician who elects to prescribe lamotrigine tablets for periods extending beyond 16 weeks should periodically re evaluate the long term usefulness of the drug for the individual patient see clinical studies 14 2" assertion.
• association label "nipent is indicated as single agent treatment for both untreated and alpha interferon refractory hairy cell leukemia patients with active disease as defined by clinically significant anemia neutropenia thrombocytopenia or disease related symptoms" assertion.
• association label "prednisolone sodium phosphate oral solution 15 mg prednisolone per 5 ml is indicated in the following conditions 1 allergic states control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in adult and pediatric populations with seasonal or perennial allergic rhinitis asthma contact dermatitis atopic dermatitis serum sickness drug hypersensitivity reactions 2 dermatologic diseases pemphigus bullous dermatitis herpetiformis severe erythema multiforme stevens johnson syndrome exfoliative erythroderma mycosis fungoides 3 edematous states to induce diuresis or remission of proteinuria in nephrotic syndrome in adults with lupus erythematosus and in adults and pediatric populations with idiopathic nephrotic syndrome without uremia 4 endocrine disorders primary or secondary adrenocortical insufficiency hydrocortisone or cortisone is the first choice synthetic analogs may be used in conjunction with mineralocorticoids where applicable in infancy mineralocorticoid supplementation is of particular importance congenital adrenal hyperplasia hypercalcemia associated with cancer nonsuppurative thyroiditis 5 gastrointestinal diseases to tide the patient over a critical period of the disease in ulcerative colitis regional enteritis 6 hematologic disorders idiopathic thrombocytopenic purpura in adults selected cases of secondary thrombocytopenia acquired autoimmune hemolytic anemia pure red cell aplasia diamond blackfan anemia 7 neoplastic diseases for the treatment of acute leukemia and aggressive lymphomas in adults and children 8 nervous system acute exacerbations of multiple sclerosis 9 ophthalmic diseases uveitis and ocular inflammatory conditions unresponsive to topical corticosteroids temporal arteritis sympathetic ophthalmia 1 respiratory diseases symptomatic sarcoidosis idiopathic eosinophilic pneumonias fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy asthma as distinct from allergic asthma listed above under allergic states hypersensitivity pneumonitis idiopathic pulmonary fibrosis acute exacerbations of chronic obstructive pulmonary disease copd and pneumocystis carinii pneumonia pcp associated with hypoxemia occurring in an hiv individual who is also under treatment with appropriate anti pcp antibiotics studies support the efficacy of systemic corticosteroids for the treatment of these conditions allergic bronchopulmonary aspergillosis idiopathic bronchiolitis obliterans with organizing pneumonia 11 rheumatic disorders as adjunctive therapy for short term administration to tide the patient over an acute episode or exacerbation in psoriatic arthritis rheumatoid arthritis including juvenile rheumatoid arthritis selected cases may require low dose maintenance therapy ankylosing spondylitis acute and subacute bursitis acute nonspecific tenosynovitis acute gouty arthritis epicondylitis for the treatment of systemic lupus erythematosus dermatomyositis polymyositis polymyalgia rheumatica sjogren s syndrome relapsing polychondritis and certain cases of vasculitis 12 miscellaneous tuberculous meningitis with subarachnoid block or impending block tuberculosis with enlarged mediastinal lymph nodes causing respiratory difficulty and tuberculosis with pleural or pericardial effusion appropriate antituberculous chemotherapy must be used concurrently when treating any tuberculosis complications trichinosis with neurologic or myocardial involvement acute or chronic solid organ rejection with or without other agents" assertion.
• association label "micardis is an angiotensin ii receptor blocker arb indicated for treatment of hypertension to lower blood pressure lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events primarily strokes and myocardial infarctions 1 1 cardiovascular cv risk reduction in patients unable to take ace inhibitors 1 2 micardis is indicated for the treatment of hypertension to lower blood pressure lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events primarily strokes and myocardial infarctions these benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs control of high blood pressure should be part of comprehensive cardiovascular risk management including as appropriate lipid control diabetes management antithrombotic therapy smoking cessation exercise and limited sodium intake many patients will require more than one drug to achieve blood pressure goals for specific advice on goals and management see published guidelines such as those of the national high blood pressure education program s joint national committee on prevention detection evaluation and treatment of high blood pressure jnc numerous antihypertensive drugs from a variety of pharmacologic classes and with different mechanisms of action have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality and it can be concluded that it is blood pressure reduction and not some other pharmacologic property of the drugs that is largely responsible for those benefits the largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly elevated systolic or diastolic pressure causes increased cardiovascular risk and the absolute risk increase per mmhg is greater at higher blood pressures so that even modest reductions of severe hypertension can provide substantial benefit relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk so the absolute benefit is greater in patients who are at higher risk independent of their hypertension for example patients with diabetes or hyperlipidemia and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal some antihypertensive drugs have smaller blood pressure effects as monotherapy in black patients and many antihypertensive drugs have additional approved indications and effects e g on angina heart failure or diabetic kidney disease these considerations may guide selection of therapy micardis may be used alone or in combination with other antihypertensive agents see clinical studies 14 1 micardis is indicated for reduction of the risk of myocardial infarction stroke or death from cardiovascular causes in patients 55 years of age or older at high risk of developing major cardiovascular events who are unable to take ace inhibitors high risk for cardiovascular events can be evidenced by a history of coronary artery disease peripheral arterial disease stroke transient ischemic attack or high risk diabetes insulin dependent or non insulin dependent with evidence of end organ damage see clinical studies 14 2 see clinical studies 14 2 studies of telmisartan in this setting do not exclude the possibility that telmisartan may not preserve a meaningful fraction of the effect of the ace inhibitor to which it was compared consider using the ace inhibitor first and if it is stopped for cough only consider re trying the ace inhibitor after the cough resolves use of telmisartan with an ace inhibitor is not recommended see warnings and precautions 5 6" assertion.
• association label "cimetidine tablets are indicated in most patients heal within 4 weeks and there is rarely reason to use cimetidine tablets at full dosage for longer than 6 to 8 weeks see concomitant antacids should be given as needed for relief of pain however simultaneous administration of cimetidine tablets and antacids is not recommended since antacids have been reported to interfere with the absorption of cimetidine 1 short term treatment of active duodenal ulcer dosage and administration duodenal ulcer patients have been maintained on continued treatment with cimetidine tablets 4 mg at bedtime for periods of up to 5 years 2 maintenance therapy for duodenal ulcer patients at reduced dosage after healing of active ulcer there is no information concerning usefulness of treatment periods of longer than 8 weeks 3 short term treatment of active benign gastric ulcer erosive esophagitis diagnosed by endoscopy treatment is indicated for 12 weeks for healing of lesions and control of symptoms the use of cimetidine tablets beyond 12 weeks has not been established see 4 erosive gastroesophageal reflux gerd dosage and administration gerd i e zollinger ellison syndrome systemic mastocytosis multiple endocrine adenomas 5 the treatment of pathological hypersecretory conditions" assertion.
• association label "doxazosin tablets usp are indicated for the treatment of both the urinary outflow obstruction and obstructive and irritative symptoms associated with bph obstructive symptoms hesitation intermittency dribbling weak urinary stream incomplete emptying of the bladder and irritative symptoms nocturia daytime frequency urgency burning doxazosin tablets usp may be used in all bph patients whether hypertensive or normotensive in patients with hypertension and bph both conditions were effectively treated with doxazosin tablets usp monotherapy doxazosin tablets usp provide rapid improvement in symptoms and urinary flow rate in 66 to 71 of patients sustained improvements with doxazosin tablets usp were seen in patients treated for up to 14 weeks in double blind studies and up to 2 years in open label studies doxazosin tablets usp are indicated for the treatment of hypertension to lower blood pressure lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events primarily strokes and myocardial infarctions these benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including this drug control of high blood pressure should be part of comprehensive cardiovascular risk management including as appropriate lipid control diabetes management antithrombotic therapy smoking cessation exercise and limited sodium intake many patients will require more than one drug to achieve blood pressure goals for specific advice on goals and management see published guidelines such as those of the national high blood pressure education program s joint national committee on prevention detection evaluation and treatment of high blood pressure jnc numerous antihypertensive drugs from a variety of pharmacologic classes and with different mechanisms of action have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality and it can be concluded that it is blood pressure reduction and not some other pharmacologic property of the drugs that is largely responsible for those benefits the largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly elevated systolic or diastolic pressure causes increased cardiovascular risk and the absolute risk increase per mmhg is greater at higher blood pressures so that even modest reductions of severe hypertension can provide substantial benefit relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk so the absolute benefit is greater in patients who are at higher risk independent of their hypertension for example patients with diabetes or hyperlipidemia and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal some antihypertensive drugs have smaller blood pressure effects as monotherapy in black patients and many antihypertensive drugs have additional approved indications and effects e g on angina heart failure or diabetic kidney disease these considerations may guide selection of therapy doxazosin tablets usp may be used alone or in combination with diuretics beta adrenergic blocking agents calcium channel blockers or angiotensin converting enzyme inhibitors" assertion.
• association label "oseltamivir phosphate for oral suspension is an influenza neuraminidase inhibitor nai indicated for treatment of acute uncomplicated influenza a and b in patients 2 weeks of age and older who have been symptomatic for no more than 48 hours 1 1 prophylaxis of influenza a and b in patients 1 year and older 1 2 limitations of use not a substitute for annual influenza vaccination 1 3 consider available information on influenza drug susceptibility patterns and treatment effects when deciding whether to use 1 3 not recommended for patients with end stage renal disease not undergoing dialysis 1 3 oseltamivir phosphate for oral suspension is indicated for the treatment of acute uncomplicated illness due to influenza a and b infection in patients 2 weeks of age and older who have been symptomatic for no more than 48 hours oseltamivir phosphate for oral suspension is indicated for the prophylaxis of influenza a and b in patients 1 year and older oseltamivir phosphate for oral suspension is not a substitute for early influenza vaccination on an annual basis as recommended by the centers for disease control and prevention advisory committee on immunization practices influenza viruses change over time emergence of resistance substitutions could decrease drug effectiveness other factors for example changes in viral virulence might also diminish clinical benefit of antiviral drugs prescribers should consider available information on influenza drug susceptibility patterns and treatment effects when deciding whether to use oseltamivir phosphate for oral suspension see microbiology 12 4 oseltamivir phosphate for oral suspension is not recommended for patients with end stage renal disease not undergoing dialysis see dosage and administration 2 4 use in specific populations 8 6" assertion.
• association label "conversion of atrial fibrillation flutter in patients with symptomatic atrial fibrillation flutter whose symptoms are not adequately controlled by measures that reduce the rate of ventricular response quinidine gluconate is indicated as a means of restoring normal sinus rhythm if this use of quinidine gluconate does not restore sinus rhythm within a reasonable time see dosage and administration reduction of frequency of relapse into atrial fibrillation flutter chronic therapy with quinidine gluconate is indicated for some patients at high risk of symptomatic atrial fibrillation flutter generally patients who have had previous episodes of atrial fibrillation flutter that were so frequent and poorly tolerated as to outweigh in the judgment of the physician and the patient the risks of prophylactic therapy with quinidine gluconate the increased risk of death should specifically be considered quinidine gluconate should be used only after alternative measures e g use of other drugs to control the ventricular rate have been found to be inadequate in patients with histories of frequent symptomatic episodes of atrial fibrillation flutter the goal of therapy should be an increase in the average time between episodes in most patients the tachyarrhythmia will recur suppression of ventricular arrhythmias quinidine gluconate is also indicated for the suppression of recurrent documented ventricular arrhythmias such as sustained ventricular tachycardia that in the judgment of the physician are life threatening because of the proarrhythmic effects of quinidine its use with ventricular arrhythmias of lesser severity is generally not recommended and treatment of patients with asymptomatic ventricular premature contractions should be avoided where possible therapy should be guided by the results of programmed electrical stimulation and or holter monitoring with exercise antiarrhythmic drugs including quinidine gluconate have not been shown to enhance survival in patients with ventricular arrhythmias" assertion.
• association label "levothyroxine sodium for injection is indicated for the treatment of myxedema coma important limitations of use the relative bioavailability between levothyroxine sodium for injection and oral levothyroxine products has not been established caution should be used when switching patients from oral levothyroxine products to levothyroxine sodium for injection as accurate dosing conversion has not been studied levothyroxine sodium is an l thyroxine product levothyroxine t 4 1 important limitations of use the relative bioavailability of this drug has not been established use caution when converting patients from oral to intravenous levothyroxine 1" assertion.
• association label "tekturna is a renin inhibitor ri indicated for the treatment of hypertension in adults and children 6 years of age and older to lower blood pressure 1 1 lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events primarily strokes and myocardial infarctions tekturna is indicated for the treatment of hypertension in adults and children 6 years of age and older to lower blood pressure lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events primarily strokes and myocardial infarctions these benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes there are no controlled trials demonstrating risk reduction with tekturna control of high blood pressure should be part of comprehensive cardiovascular risk management including as appropriate lipid control diabetes management antithrombotic therapy smoking cessation exercise and limited sodium intake many patients will require more than 1 drug to achieve blood pressure goals for specific advice on goals and management see published guidelines such as those of the national high blood pressure education program s joint national committee on prevention detection evaluation and treatment of high blood pressure jnc numerous antihypertensive drugs from a variety of pharmacologic classes and with different mechanisms of action have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality and it can be concluded that it is blood pressure reduction and not some other pharmacologic property of the drugs that is largely responsible for those benefits the largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke but reductions in myocardial infarction and cardiovascular mortality have also been seen regularly elevated systolic or diastolic pressure causes increased cardiovascular risk and the absolute risk increase per mmhg is greater at higher blood pressures so that even modest reductions of severe hypertension can provide substantial benefit relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk so the absolute benefit is greater in patients who are at higher risk independent of their hypertension e g patients with diabetes or hyperlipidemia and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal some antihypertensive drugs have smaller blood pressure effects as monotherapy in black patients and many antihypertensive drugs have additional approved indications and effects e g on angina heart failure or diabetic kidney disease these considerations may guide selection of therapy" assertion.
• association label "cefaclor is indicated in the treatment of the following infections when caused by susceptible strains of the designated microorganisms otitis media streptococcus pneumoniae haemophilus influenzae streptococcus pyogenes note b haemophilus influenzae in vitro lower respiratory tract infections streptococcus pneumoniae haemophilus influenzae streptococcus pyogenes note b haemophilus influenzae in vitro pharyngitis and tonsillitis streptococcus pyogenes note urinary tract infections escherichia coli proteus mirabilis klebsiella skin and skin structure infections staphylococcus aureus streptococcus pyogenes appropriate culture and susceptibility studies should be performed to determine susceptibility of the causative organism to cefaclor to reduce the development of drug resistant bacteria and maintain the effectiveness of cefaclor for oral suspension and other antibacterial drugs cefaclor for oral suspension should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria when culture and susceptibility information are available they should be considered in selecting or modifying antibacterial therapy in the absence of such data local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy" assertion.
• association label "for the management of manifestations of psychotic disorders for the treatment of schizophrenia to control nausea and vomiting for relief of restlessness and apprehension before surgery for acute intermittent porphyria as an adjunct in the treatment of tetanus to control the manifestations of the manic type of manic depressive illness for relief of intractable hiccups for the treatment of severe behavioral problems in children 1 to 12 years of age marked by combativeness and or explosive hyperexcitable behavior out of proportion to immediate provocations and in the short term treatment of hyperactive children who show excessive motor activity with accompanying conduct disorders consisting of some or all of the following symptoms impulsivity difficulty sustaining attention aggressivity mood lability and poor frustration tolerance" assertion.
• association label "doxycycline hyclate tablets are tetracycline class drugs indicated for rickettsial infections 1 1 sexually transmitted infections 1 2 respiratory tract infections 1 3 specific bacterial infections 1 4 ophthalmic infections 1 5 anthrax including inhalational anthrax post exposure 1 6 alternative treatment for selected infections when penicillin is contraindicated 1 7 adjunctive therapy for acute intestinal amebiasis and severe acne 1 8 prophylaxis of malaria 1 9 to reduce the development of drug resistant bacteria and maintain the effectiveness of doxycycline hyclate tablets and other antibacterial drugs doxycycline hyclate tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria 1 1 doxycycline hyclate tablets are indicated for treatment of rocky mountain spotted fever typhus fever and the typhus group q fever rickettsial pox and tick fevers caused by rickettsiae doxycycline hyclate tablets are indicated for treatment of the following sexually transmitted infections uncomplicated urethral endocervical or rectal infections caused by chlamydia trachomatis nongonococcal urethritis caused by ureaplasma urealyticum lymphogranuloma venereum caused by chlamydia trachomatis granuloma inguinale caused by klebsiella granulomatis uncomplicated gonorrhea caused by neisseria gonorrhoeae chancroid caused by haemophilus ducreyi doxycycline hyclate tablets are indicated for treatment of the following respiratory tract infections respiratory tract infections caused by mycoplasma pneumoniae psittacosis ornithosis caused by chlamydophila psittaci because many strains of the following groups of microorganisms have been shown to be resistant to doxycycline culture and susceptibility testing are recommended doxycycline is indicated for treatment of infections caused by the following microorganisms when bacteriological testing indicates appropriate susceptibility to the drug respiratory tract infections caused by haemophilus influenzae respiratory tract infections caused by klebsiella species upper respiratory infections caused by streptococcus pneumoniae doxycycline hyclate tablets are indicated for treatment of the following specific bacterial infections relapsing fever due to borrelia recurrentis plague due to yersinia pestis tularemia due to francisella tularensis cholera caused by vibrio cholerae campylobacter fetus infections caused by campylobacter fetus brucellosis due to brucella bartonellosis due to bartonella bacilliformis because many strains of the following groups of microorganisms have been shown to be resistant to doxycycline culture and susceptibility testing are recommended doxycycline hyclate tablets are indicated for treatment of infections caused by the following gram negative microorganisms when bacteriological testing indicates appropriate susceptibility to the drug escherichia coli enterobacter aerogenes shigella acinetobacter urinary tract infections caused by klebsiella doxycycline hyclate tablets are indicated for treatment of the following ophthalmic infections trachoma caused by chlamydia trachomatis inclusion conjunctivitis caused by chlamydia trachomatis doxycycline hyclate tablets are indicated for the treatment of anthrax due to bacillus anthracis bacillus anthracis doxycycline hyclate tablets are indicted as an alternative treatment for the following selected infections when penicillin is contraindicated syphilis caused by treponema pallidum yaws caused by treponema pallidum pertenue listeriosis due to listeria monocytogenes vincent s infection caused by fusobacterium fusiforme actinomycosis caused by actinomyces israelii infections caused by clostridium in acute intestinal amebiasis doxycycline hyclate tablets may be a useful adjunct to amebicides in severe acne doxycycline hyclate tablets may be useful adjunctive therapy doxycycline hyclate tablets are indicated for the prophylaxis of malaria due to plasmodium falciparum see dosage and administration 2 4 patient counseling information 17 to reduce the development of drug resistant bacteria and maintain the effectiveness of doxycycline hyclate tablets and other antibacterial drugs doxycycline hyclate tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria when culture and susceptibility information are available they should be considered in selecting or modifying antibacterial therapy in the absence of such data local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy" assertion.
• association label "when oral therapy is not feasible the intramuscular use control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma atopic dermatitis contact dermatitis drug hypersensitivity reactions perennial or seasonal allergic rhinitis serum sickness transfusion reactions bullous dermatitis herpetiformis exfoliative erythroderma mycosis fungoides pemphigus severe erythema multiforme stevens johnson syndrome congenital adrenal hyperplasia hypercalcemia associated with cancer nonsuppurative thyroiditis hydrocortisone or cortisone is the drug of choice in primary or secondary adrenocortical insufficiency synthetic analogs may be used in conjunction with mineralocorticoids where applicable in infancy mineralocorticoid supplementation is of particular importance to tide the patient over a critical period of the disease in regional enteritis and ulcerative colitis acquired autoimmune hemolytic anemia diamond blackfan anemia pure red cell aplasia selected cases of secondary thrombocytopenia trichinosis with neurologic or myocardial involvement tuberculous meningitis with subarachnoid block or impending block when used with appropriate antituberculous chemotherapy for palliative management of leukemias and lymphomas acute exacerbations of multiple sclerosis cerebral edema associated with primary or metastatic brain tumor or craniotomy sympathetic ophthalmia temporal arteritis uveitis and ocular inflammatory conditions unresponsive to topical corticosteroids to induce diuresis or remission of proteinuria in idiopathic nephrotic syndrome or that due to lupus erythematosus berylliosis fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy idiopathic eosinophilic pneumonias symptomatic sarcoidosis as adjunctive therapy for short term administration to tide the patient over an acute episode or exacerbation in acute gouty arthritis acute rheumatic carditis ankylosing spondylitis psoriatic arthritis rheumatoid arthritis including juvenile rheumatoid arthritis selected cases may require low dose maintenance therapy for the treatment of dermatomyositis polymyositis and systemic lupus erythematosus the intra articular or soft tissue administration the intralesional administration betamethasone sodium phosphate and betamethasone acetate injectable suspension may also be useful in cystic tumors of an aponeurosis or tendon ganglia" assertion.
• association label "endometriosis danazol capsules are indicated for the treatment of endometriosis amenable to hormonal management fibrocystic breast disease most cases of symptomatic fibrocystic breast disease may be treated by simple measures e g padded brassieres and analgesics in infrequent patients symptoms of pain and tenderness may be severe enough to warrant treatment by suppression of ovarian function danazol capsules are usually effective in decreasing nodularity pain and tenderness it should be stressed to the patient that this treatment is not innocuous in that it involves considerable alterations of hormone levels and that recurrence of symptoms is very common after cessation of therapy hereditary angioedema danazol capsules are indicated for the prevention of attacks of angioedema of all types cutaneous abdominal laryngeal in males and females" assertion.
• association label "hydrocortisone tablets usp are indicated in the following conditions endocrine disorders primary or secondary adrenocortical insufficiency hydrocortisone or cortisone is the first choice synthetic analogs may be used in conjunction with mineralocorticoids where applicable in infancy mineralocorticoid supplementation is of particular importance congenital adrenal hyperplasia nonsuppurative thyroiditis hypercalcemia associated with cancer rheumatic disorders as adjunctive therapy for short term administration to tide the patient over an acute episode or exacerbation in psoriatic arthritis rheumatoid arthritis including juvenile rheumatoid arthritis selected cases may require low dose maintenance therapy ankylosing spondylitis acute and subacute bursitis acute nonspecific tenosynovitis acute gouty arthritis post traumatic osteoarthritis synovitis of osteoarthritis epicondylitis collagen diseases during an exacerbation or as maintenance therapy in selected cases of systemic lupus erythematosus systemic dermatomyositis polymyositis acute rheumatic carditis dermatologic diseases pemphigus bullous dermatitis herpetiformis severe erythema multiforme stevens johnson syndrome exfoliative dermatitis mycosis fungoides severe psoriasis severe seborrheic dermatitis allergic states control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment seasonal or perennial allergic rhinitis serum sickness bronchial asthma contact dermatitis atopic dermatitis drug hypersensitivity reactions ophthalmic diseases severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as allergic conjunctivitis keratitis allergic corneal marginal ulcers herpes zoster ophthalmicus iritis and iridocyclitis chorioretinitis anterior segment inflammation diffuse posterior uveitis and choroiditis optic neuritis sympathetic ophthalmia respiratory diseases symptomatic sarcoidosis loeffler s syndrome not manageable by other means berylliosis fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy aspiration pneumonitis hematologic disorders idiopathic thrombocytopenic purpura in adults secondary thrombocytopenia in adults acquired autoimmune hemolytic anemia erythroblastopenia rbc anemia congenital erythroid hypoplastic anemia neoplastic diseases for palliative management of leukemias and lymphomas in adults acute leukemia of childhood edematous states to induce a diuresis or remission of proteinuria in the nephrotic syndrome without uremia of the idiopathic type or that due to lupus erythematosus gastrointestinal diseases to tide the patient over a critical period of the disease in ulcerative colitis regional enteritis nervous system acute exacerbations of multiple sclerosis miscellaneous tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy trichinosis with neurologic or myocardial involvement" assertion.
• association label "etidronate disodium tablets usp are indicated for the treatment of symptomatic paget s disease of bone and in the prevention and treatment of heterotopic ossification following total hip replacement or due to spinal cord injury etidronate disodium tablets are not approved for the treatment of osteoporosis etidronate disodium tablets are indicated for the treatment of symptomatic paget s disease of bone etidronate disodium therapy usually arrests or significantly impedes the disease process as evidenced by in addition reductions in pagetically elevated cardiac output and skin temperature have been observed in some patients in many patients the disease process will be suppressed for a period of at least one year following cessation of therapy the upper limit of this period has not been determined the effects of the etidronate disodium treatment in patients with asymptomatic paget s disease have not been studied however etidronate disodium treatment of such patients may be warranted if extensive involvement threatens irreversible neurologic damage major joints or major weight bearing bones etidronate disodium tablets are indicated in the prevention and treatment of heterotopic ossification following total hip replacement or due to spinal cord injury etidronate disodium tablets reduce the incidence of clinically important heterotopic bone by about two thirds among those patients who form heterotopic bone etidronate disodium tablets retard the progression of immature lesions and reduces the severity by at least half follow up data at least 9 months post therapy suggests these benefits persist in total hip replacement patients in spinal cord injury patients" assertion.
• association label "hydrocortisone tablets usp are indicated in the following conditions endocrine disorders primary or secondary adrenocortical insufficiency hydrocortisone or cortisone is the first choice synthetic analogs may be used in conjunction with mineralocorticoids where applicable in infancy mineralocorticoid supplementation is of particular importance congenital adrenal hyperplasia nonsuppurative thyroiditis hypercalcemia associated with cancer rheumatic disorders as adjunctive therapy for short term administration to tide the patient over an acute episode or exacerbation in psoriatic arthritis rheumatoid arthritis including juvenile rheumatoid arthritis selected cases may require low dose maintenance therapy ankylosing spondylitis acute and subacute bursitis acute nonspecific tenosynovitis acute gouty arthritis post traumatic osteoarthritis synovitis of osteoarthritis epicondylitis collagen diseases during an exacerbation or as maintenance therapy in selected cases of systemic lupus erythematosus systemic dermatomyositis polymyositis acute rheumatic carditis dermatologic diseases pemphigus bullous dermatitis herpetiformis severe erythema multiforme stevens johnson syndrome exfoliative dermatitis mycosis fungoides severe psoriasis severe seborrheic dermatitis allergic states control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment seasonal or perennial allergic rhinitis serum sickness bronchial asthma contact dermatitis atopic dermatitis drug hypersensitivity reactions ophthalmic diseases severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as allergic conjunctivitis keratitis allergic corneal marginal ulcers herpes zoster ophthalmicus iritis and iridocyclitis chorioretinitis anterior segment inflammation diffuse posterior uveitis and choroiditis optic neuritis sympathetic ophthalmia respiratory diseases symptomatic sarcoidosis loeffler s syndrome not manageable by other means berylliosis fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy aspiration pneumonitis hematologic disorders idiopathic thrombocytopenic purpura in adults secondary thrombocytopenia in adults acquired autoimmune hemolytic anemia erythroblastopenia rbc anemia congenital erythroid hypoplastic anemia neoplastic diseases for palliative management of leukemias and lymphomas in adults acute leukemia of childhood edematous states to induce a diuresis or remission of proteinuria in the nephrotic syndrome without uremia of the idiopathic type or that due to lupus erythematosus gastrointestinal diseases to tide the patient over a critical period of the disease in ulcerative colitis regional enteritis nervous system acute exacerbations of multiple sclerosis miscellaneous tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy trichinosis with neurologic or myocardial involvement" assertion.
• association label "multaq r see clinical studies 14 multaq is an antiarrhythmic drug indicated to reduce the risk of hospitalization for atrial fibrillation af in patients in sinus rhythm with a history of paroxysmal or persistent af 1 14" assertion.
• association label "trientine hydrochloride capsule is indicated in the treatment of patients with wilson s disease who are intolerant of penicillamine clinical experience with trientine hydrochloride capsule is limited and alternate dosing regimens have not been well characterized all endpoints in determining an individual patient s dose have not been well defined trientine hydrochloride capsule and penicillamine cannot be considered interchangeable trientine hydrochloride capsule should be used when continued treatment with penicillamine is no longer possible because of intolerable or life endangering side effects unlike penicillamine trientine hydrochloride capsule is not recommended in cystinuria or rheumatoid arthritis the absence of a sulfhydryl moiety renders it incapable of binding cystine and therefore it is of no use in cystinuria in 15 patients with rheumatoid arthritis trientine hydrochloride capsule was reported not to be effective in improving any clinical or biochemical parameter after 12 weeks of treatment trientine hydrochloride capsule is not indicated for treatment of biliary cirrhosis" assertion.
• association label "penicillin g sodium for injection usp is indicated in the treatment of serious infections caused by susceptible strains of the designated microorganisms in the conditions listed below appropriate culture and susceptibility tests should be done before treatment in order to isolate and identify organisms causing infection and to determine their susceptibility to penicillin g therapy with penicillin g sodium for injection usp may be initiated before results of such tests are known when there is reason to believe the infection may involve any of the organisms listed below however once these results become available appropriate therapy should be continued clinical indication infecting organism septicemia empyema pneumonia pericarditis endocarditis meningitis streptococcus pyogenes group a b hemolytic streptococcus other b hemolytic streptococci including groups c h g l and m streptococcus pneumoniae staphylococcus penicillinase producing strains anthrax bacillus anthracis actinomycosis cervico facial disease and thoracic and abdominal disease actinomyces israelil botulism adjunctive therapy to antitoxin gas gangrene and tetanus adjunctive therapy to human tetanus immune globulin clostridium species diphtheria adjunctive therapy to antitoxin and prevention of the carrier state corynebacterium diphtheriae erysipelothrix endocarditis erysipelothrix rhusiopthiae fusospirochetosis severe infections of the oropharynx vincent s lower respiratory tract and genital area fusobacterium species and spirochetes listeria infections including meningitis and endocarditis listeria monocytogenes pasteurella infections including bacteremia and meningitis pasteurella multocida haverhill fever streptobacillus moniliformis rat bite fever spirillum minus or streptobacillus moniliformis disseminated gonococcal infections neisseria gonorrhoeae penicillin susceptible syphilis congenital and neurosyphilis treponema pallidum meningococcal meningitis and or septicemia neisseria meningitidis gram negative bacillary infections bacteremias escherichia coli enterobacter aerogenes alcaligenes faecalis salmonella shigella proteus mirabilis is not the drug of choice in the treatment of gram negative bacillary infections to reduce the development of drug resistant bacteria and maintain the effectiveness of penicillin g sodium and other antibacterial drugs penicillin g sodium should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria when culture and susceptibility information are available they should be considered in selecting or modifying antibacterial therapy in the absence of such data local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy" assertion.
• association label "this product is a liquid antiseborrheic antifungal preparation useful for the treatment of seborrheic dermatitis of the scalp dandruff and tinea versicolor urea hydrates and is useful for conditions such as dry scalp" assertion.
• association label "ranitidine tablets are indicated in 1 short term treatment of active duodenal ulcer most patients heal within 4 weeks studies available to date have not assessed the safety of ranitidine in uncomplicated duodenal ulcer for periods of more than 8 weeks 2 maintenance therapy for duodenal ulcer patients at reduced dosage after healing of acute ulcers no placebo controlled comparative studies have been carried out for periods of longer than 1 year 3 the treatment of pathological hypersecretory conditions e g zollinger ellison syndrome and systemic mastocytosis 4 short term treatment of active benign gastric ulcer most patients heal within 6 weeks and the usefulness of further treatment has not been demonstrated studies available to date have not assessed the safety of ranitidine in uncomplicated benign gastric ulcer for periods of more than 6 weeks 5 maintenance therapy for gastric ulcer patients at reduced dosage after healing of acute ulcers placebo controlled studies have been carried out for 1 year 6 treatment of gerd symptomatic relief commonly occurs within 24 hours after starting therapy with ranitidine tablets 15 mg twice daily 7 treatment of endoscopically diagnosed erosive esophagitis symptomatic relief of heartburn commonly occurs within 24 hours of therapy initiation with ranitidine tablets 15 mg 4 times daily 8 maintenance of healing of erosive esophagitis placebo controlled trials have been carried out for 48 weeks concomitant antacids should be given as needed for pain relief to patients with active duodenal ulcer active benign gastric ulcer hypersecretory states gerd and erosive esophagitis" assertion.
• association label "cedax ceftibuten is indicated for the treatment of individuals with mild to moderate infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below see dosage and administration clinical studies acute bacterial exacerbations of chronic bronchitis haemophilus influenzae moraxella catarrhalis streptococcus pneumoniae note moraxella catarrhalis acute bacterial otitis media haemophilus influenzae moraxella catarrhalis streptococcus pyogenes note streptococcus pneumoniae only streptococcus pneumoniae pharyngitis and tonsillitis streptococcus pyogenes note streptococcus pyogenes" assertion.
• association label "for the treatment of superficial ocular infections involving the conjunctiva and or cornea caused by organisms susceptible to erythromycin for prophylaxis of ophthalmia neonatorum due to n gonorrhoeae or c trachomatis the effectiveness of erythromycin in the prevention of ophthalmia caused by penicillinase producing n gonorrhoeae for infants born to mothers with clinically apparent gonorrhea intravenous or intramuscular injections of aqueous crystalline penicillin g should be given a single dose of 5 units for term infants or 2 units for infants of low birth weight topical prophylaxis alone is inadequate for these infants" assertion.
• association label "doripenem for injection is a penem antibacterial indicated in the treatment of the following infections caused by designated susceptible bacteria complicated intra abdominal infections 1 1 complicated urinary tract infections including pyelonephritis 1 2 to reduce the development of drug resistant bacteria and maintain the effectiveness of doripenem for injection and other antibacterial drugs doripenem for injection should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria 1 3 doripenem for injection is indicated as a single agent for the treatment of complicated intra abdominal infections caused by escherichia coli klebsiella pneumoniae pseudomonas aeruginosa bacteroides caccae bacteroides fragilis bacteroides thetaiotaomicron bacteroides uniformis bacteroides vulgatus streptococcus intermedius streptococcus constellatus peptostreptococcus micros doripenem for injection is indicated as a single agent for the treatment of complicated urinary tract infections including pyelonephritis caused by escherichia coli klebsiella pneumoniae proteus mirabilis pseudomonas aeruginosa acinetobacter baumannii to reduce the development of drug resistant bacteria and maintain the effectiveness of doripenem for injection and other antibacterial drugs doripenem for injection should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria when culture and susceptibility information are available they should be considered in selecting and modifying antibacterial therapy in the absence of such data local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy" assertion.
• association label "ofloxacin otic solution 3 is indicated for the treatment of infections caused by susceptible isolates of the designated microorganisms in the specific conditions listed below otitis externa in adults and pediatric patients 6 months and older due to escherichia coli pseudomonas aeruginosa and staphylococcus aureus chronic suppurative otitis media in patients 12 years and older with perforated tympanic membranes due to proteus mirabilis pseudomonas aeruginosa and staphylococcus aureus acute otitis media in pediatric patients one year and older with tympanostomy tubes due to haemophilus influenzae moraxella catarrhalis pseudomonas aeruginosa staphylococcus aureus and streptococcus pneumoniae" assertion.
• association label "hydrocortisone acetate suppositories are indicated for use in inflamed hemorrhoids post irradiation factitial proctitis as an adjunct in the treatment of chronic ulcerative colitis cryptitis and other inflammatory conditions of anorectum and pruritus ani" assertion.
• association label "bimatoprost ophthalmic solution 3 is indicated for the reduction of elevated intraocular pressure in patients with open angle glaucoma or ocular hypertension bimatoprost ophthalmic solution 3 is a prostaglandin analog indicated for the reduction of elevated intraocular pressure in patients with open angle glaucoma or ocular hypertension" assertion.
• association label "gleostine is an alkylating drug indicated for the treatment of patients with 1 1 gleostine is indicated for the treatment of patients with primary and metastatic brain tumors following appropriate surgical and or radiotherapeutic procedures gleostine is indicated as a component of combination chemotherapy for the treatment of patients with hodgkin s lymphoma whose disease has progressed following initial chemotherapy" assertion.
• association label "prochlorperazine maleate tablets are indicated for the control of severe nausea and vomiting prochlorperazine maleate tablets are also indicated for the treatment of schizophrenia prochlorperazine is effective for the short term treatment of generalized non psychotic anxiety however prochlorperazine maleate tablets are not the first drug to be used in therapy for most patients with non psychotic anxiety because certain risks associated with its use are not shared by common alternative treatments e g benzodiazepines when used in the treatment of non psychotic anxiety prochlorperazine maleate tablets should not be administered at doses of more than 2 mg per day or for longer than 12 weeks because the use of prochlorperazine maleate tablets at higher doses or for longer intervals may cause persistent tardive dyskinesia that may prove irreversible see warnings the effectiveness of prochlorperazine as treatment for non psychotic anxiety was established in 4 week clinical studies of outpatients with generalized anxiety disorder this evidence does not predict that prochlorperazine maleate tablets will be useful in patients with other non psychotic conditions in which anxiety or signs that mimic anxiety are found e g physical illness organic mental conditions agitated depression character pathologies etc prochlorperazine has not been shown effective in the management of behavioral complications in patients with mental retardation" assertion.
• association label "milnacipran hcl tablets are indicated for the management of fibromyalgia milnacipran hcl tablets are not approved for use in pediatric patients see use in specific populations 8 4 milnacipran hcl tablets are a selective serotonin and norepinephrine reuptake inhibitor snri indicated for the management of fibromyalgia 1 milnacipran hcl tablets are not approved for use in pediatric patients 1" assertion.
• association label "amantadine hydrochloride capsules usp are indicated for the prophylaxis and treatment of signs and symptoms of infection caused by various strains of influenza a virus amantadine hydrochloride capsules usp are also indicated in the treatment of parkinsonism and drug induced extrapyramidal reactions influenza a prophylaxis amantadine hydrochloride capsules usp are indicated for chemoprophylaxis against signs and symptoms of influenza a virus infection because amantadine hydrochloride does not completely prevent the host immune response to influenza a infection individuals who take this drug may still develop immune responses to natural disease or vaccination and may be protected when later exposed to antigenically related viruses following vaccination during an influenza a outbreak amantadine hydrochloride capsules usp prophylaxis should be considered for the 2 to 4 week time period required to develop an antibody response influenza a treatment amantadine hydrochloride capsules usp are also indicated in the treatment of uncomplicated respiratory tract illness caused by influenza a virus strains especially when administered early in the course of illness there are no well controlled clinical studies demonstrating that treatment with amantadine hydrochloride capsules usp will avoid the development of influenza a virus pneumonitis or other complications in high risk patients there is no clinical evidence indicating that amantadine hydrochloride capsules usp are effective in the prophylaxis or treatment of viral respiratory tract illnesses other than those caused by influenza a virus strains the following points should be considered before initiating treatment or prophylaxis with amantadine hydrochloride capsules usp amantadine hydrochloride capsules usp is not a substitute for early vaccination on an annual basis as recommended by the centers for disease control and prevention advisory committee on immunization practices influenza viruses change over time emergence of resistance mutations could decrease drug effectiveness other factors for example changes in viral virulence might also diminish clinical benefit of antiviral drugs prescribers should consider available information on influenza drug susceptibility patterns and treatment effects when deciding whether to use amantadine hydrochloride capsules usp parkinson s disease syndrome amantadine hydrochloride capsules usp are indicated in the treatment of idiopathic parkinson s disease paralysis agitans postencephalitic parkinsonism and symptomatic parkinsonism which may follow injury to the nervous system by carbon monoxide intoxication it is indicated in those elderly patients believed to develop parkinsonism in association with cerebral arteriosclerosis in the treatment of parkinson s disease amantadine hydrochloride capsules usp are less effective than levodopa 3 3 4 dihydroxyphenyl l alanine and its efficacy in comparison with the anticholinergic antiparkinson drugs has not yet been established drug induced extrapyramidal reactions amantadine hydrochloride capsules usp are indicated in the treatment of drug induced extrapyramidal reactions although anticholinergic type side effects have been noted with amantadine hydrochloride capsules usp when used in patients with drug induced extrapyramidal reactions there is a lower incidence of these side effects than that observed with the anticholinergic antiparkinson drugs" assertion.
• association label "prednisone tablets are indicated in the following conditions 1 endocrine disorders primary or secondary adrenocortical insufficiency hydrocortisone or cortisone is the first choice synthetic analogs may be used in conjunction with mineralocorticoids where applicable in infancy mineralocorticoid supplementation is of particular importance congenital adrenal hyperplasia nonsuppurative thyroiditis hypercalcemia associated with cancer 2 rheumatic disorders as adjunctive therapy for short term administration to tide the patient over an acute episode or exacerbation in psoriatic arthritis rheumatoid arthritis including juvenile rheumatoid arthritis selected cases may require low dose maintenance therapy ankylosing spondylitis acute and subacute bursitis acute nonspecific tenosynovitis acute gouty arthritis post traumatic osteoarthritis synovitis of osteoarthritis epicondylitis 3 collagen diseases during an exacerbation or as maintenance therapy in selected cases of systemic lupus erythematosus systemic dermatomyositis polymyositis acute rheumatic carditis 4 dermatologic diseases pemphigus bullous dermatitis herpetiformis severe erythema multiforme stevens johnson syndrome exfoliative dermatitis mycosis fungoides severe psoriasis severe seborrheic dermatitis 5 allergic states control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment seasonal or perennial allergic rhinitis bronchial asthma contact dermatitis atopic dermatitis serum sickness drug hypersensitivity reactions 6 ophthalmic diseases severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as allergic corneal marginal ulcers herpes zoster ophthalmicus anterior segment inflammation diffuse posterior uveitis and choroiditis sympathetic ophthalmia allergic conjunctivitis keratitis chorioretinitis optic neuritis iritis and iridocyclitis 7 respiratory diseases symptomatic sarcoidosis loeffler s syndrome not manageable by other means berylliosis fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy aspiration pneumonitis 8 hematologic disorders idiopathic thrombocytopenic purpura in adults secondary thrombocytopenia in adults acquired autoimmune hemolytic anemia erythroblastopenia rbc anemia congenital erythroid hypoplastic anemia 9 neoplastic diseases for palliative management of leukemias and lymphomas in adults acute leukemia of childhood 1 edematous states to induce a diuresis or remission of proteinuria in the nephrotic syndrome without uremia of the idiopathic type or that due to lupus erythematosus 11 gastrointestinal diseases to tide the patient over a critical period of the disease in ulcerative colitis regional enteritis 12 nervous system acute exacerbations of multiple sclerosis 13 miscellaneous tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy trichinosis with neurologic or myocardial involvement" assertion.
• association label "doxycycline hyclate tablets are tetracycline class drugs indicated for rickettsial infections 1 1 sexually transmitted infections 1 2 respiratory tract infections 1 3 specific bacterial infections 1 4 ophthalmic infections 1 5 anthrax including inhalational anthrax post exposure 1 6 alternative treatment for selected infections when penicillin is contraindicated 1 7 adjunctive therapy for acute intestinal amebiasis and severe acne 1 8 prophylaxis of malaria 1 9 to reduce the development of drug resistant bacteria and maintain the effectiveness of doxycycline hyclate tablets and other antibacterial drugs doxycycline hyclate tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria 1 1 doxycycline hyclate tablets are indicated for treatment of rocky mountain spotted fever typhus fever and the typhus group q fever rickettsial pox and tick fevers caused by rickettsiae doxycycline hyclate tablets are indicated for treatment of the following sexually transmitted infections uncomplicated urethral endocervical or rectal infections caused by chlamydia trachomatis nongonococcal urethritis caused by ureaplasma urealyticum lymphogranuloma venereum caused by chlamydia trachomatis granuloma inguinale caused by klebsiella granulomatis uncomplicated gonorrhea caused by neisseria gonorrhoeae chancroid caused by haemophilus ducreyi doxycycline hyclate tablets are indicated for treatment of the following respiratory tract infections respiratory tract infections caused by mycoplasma pneumoniae psittacosis ornithosis caused by chlamydophila psittaci because many strains of the following groups of microorganisms have been shown to be resistant to doxycycline culture and susceptibility testing are recommended doxycycline is indicated for treatment of infections caused by the following microorganisms when bacteriological testing indicates appropriate susceptibility to the drug respiratory tract infections caused by haemophilus influenzae respiratory tract infections caused by klebsiella species upper respiratory infections caused by streptococcus pneumoniae doxycycline hyclate tablets are indicated for treatment of the following specific bacterial infections relapsing fever due to borrelia recurrentis plague due to yersinia pestis tularemia due to francisella tularensis cholera caused by vibrio cholerae campylobacter fetus infections caused by campylobacter fetus brucellosis due to brucella bartonellosis due to bartonella bacilliformis because many strains of the following groups of microorganisms have been shown to be resistant to doxycycline culture and susceptibility testing are recommended doxycycline hyclate tablets are indicated for treatment of infections caused by the following gram negative microorganisms when bacteriological testing indicates appropriate susceptibility to the drug escherichia coli enterobacter aerogenes shigella acinetobacter urinary tract infections caused by klebsiella doxycycline hyclate tablets are indicated for treatment of the following ophthalmic infections trachoma caused by chlamydia trachomatis inclusion conjunctivitis caused by chlamydia trachomatis doxycycline hyclate tablets are indicated for the treatment of anthrax due to bacillus anthracis bacillus anthracis doxycycline hyclate tablets are indicted as an alternative treatment for the following selected infections when penicillin is contraindicated syphilis caused by treponema pallidum yaws caused by treponema pallidum pertenue listeriosis due to listeria monocytogenes vincent s infection caused by fusobacterium fusiforme actinomycosis caused by actinomyces israelii infections caused by clostridium in acute intestinal amebiasis doxycycline hyclate tablets may be a useful adjunct to amebicides in severe acne doxycycline hyclate tablets may be useful adjunctive therapy doxycycline hyclate tablets are indicated for the prophylaxis of malaria due to plasmodium falciparum see dosage and administration 2 4 patient counseling information 17 to reduce the development of drug resistant bacteria and maintain the effectiveness of doxycycline hyclate tablets and other antibacterial drugs doxycycline hyclate tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria when culture and susceptibility information are available they should be considered in selecting or modifying antibacterial therapy in the absence of such data local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy" assertion.
• association label "ertaczo r trichophyton rubrum trichophyton mentagrophytes epidermophyton floccosum clinical studies 14 ertaczo cream 2 is an azole antifungal indicated for the topical treatment of interdigital tinea pedis in immunocompetent patients 12 years of age and older caused by trichophyton rubrum trichophyton mentagrophytes epidermophyton floccosum 1" assertion.
• association label "ciprofloxacin tablets usp are indicated for the treatment of infections caused by susceptible isolates of the designated microorganisms in the conditions and patient populations listed below ciprofloxacin is a fluoroquinolone antibacterial indicated in adults 18 years of age with infections caused by designated susceptible bacteria and in pediatric patients where indicated 1 1 1 2 1 3 1 4 1 5 1 6 1 7 1 8 1 9 1 1 1 11 1 12 1 13 1 14 1 16 ciprofloxacin tablets are indicated in adult patients for treatment of urinary tract infections caused by escherichia coli klebsiella pneumoniae enterobacter cloacae serratia marcescens proteus mirabilis providencia rettgeri morganella morganii citrobacter koseri citrobacter freundii pseudomonas aeruginosa staphylococcus epidermidis staphylococcus saprophyticus enterococcus faecalis ciprofloxacin tablets are indicated in adult female patients for treatment of acute uncomplicated cystitis caused by escherichia coli staphylococcus saprophyticus ciprofloxacin tablets are indicated in adult patients for treatment of chronic bacterial prostatitis caused by escherichia coli proteus mirabilis ciprofloxacin tablets are indicated in adult patients for treatment of lower respiratory tract infections caused by escherichia coli klebsiella pneumoniae enterobacter cloacae proteus mirabilis pseudomonas aeruginosa haemophilus influenzae haemophilus parainfluenzae streptococcus pneumoniae moraxella catarrhalis see indications and usage 1 15 ciprofloxacin tablets are indicated in adult patients for treatment of acute sinusitis caused by haemophilus influenzae streptococcus pneumoniae moraxella catarrhalis ciprofloxacin tablets are indicated in adult patients for treatment of skin and skin structure infections caused by escherichia coli klebsiella pneumoniae enterobacter cloacae proteus mirabilis proteus vulgaris providencia stuartii morganella morganii citrobacter freundii pseudomonas aeruginosa staphylococcus aureus staphylococcus epidermidis streptococcus pyogenes ciprofloxacin tablets are indicated in adult patients for treatment of bone and joint infections caused by enterobacter cloacae serratia marcescens pseudomonas aeruginosa ciprofloxacin tablets are indicated in adult patients for treatment of complicated intra abdominal infections used in combination with metronidazole caused by escherichia coli pseudomonas aeruginosa proteus mirabilis klebsiella pneumoniae bacteroides fragilis ciprofloxacin tablets are indicated in adult patients for treatment of infectious diarrhea caused by escherichia coli campylobacter jejuni shigella boydii shigella dysenteriae shigella flexneri shigella sonnei ciprofloxacin tablets are indicated in adult patients for treatment of typhoid fever enteric fever caused by salmonella typhi ciprofloxacin tablets are indicated in adult patients for treatment of uncomplicated cervical and urethral gonorrhea due to neisseria gonorrhoeae see warnings and precautions 5 16 ciprofloxacin tablets are indicated in pediatric patients one to 17 years of age for treatment of complicated urinary tract infections cuti and pyelonephritis due to escherichia coli see indications and usage 1 15 use in specific populations 8 4 ciprofloxacin tablets are indicated in adults and pediatric patients from birth to 17 years of age for inhalational anthrax post exposure to reduce the incidence or progression of disease following exposure to aerosolized bacillus anthracis ciprofloxacin serum concentrations achieved in humans served as a surrogate endpoint reasonably likely to predict clinical benefit and provided the initial basis for approval of this indication 1 see clinical studies 14 2 ciprofloxacin tablets are indicated for treatment of plague including pneumonic and septicemic plague due to yersinia pestis y pestis see clinical studies 14 3 although effective in clinical trials ciprofloxacin is not a drug of first choice in the pediatric population due to an increased incidence of adverse events compared to controls including events related to joints and or surrounding tissues see warnings and precautions 5 11 adverse reactions 6 1 use in specific populations 8 4 nonclinical toxicology 13 2 ciprofloxacin tablets are not a drug of first choice in the treatment of presumed or confirmed pneumonia secondary to streptococcus pneumoniae see indications and usage 1 4 to reduce the development of drug resistant bacteria and maintain the effectiveness of ciprofloxacin tablets and other antibacterial drugs ciprofloxacin tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria when culture and susceptibility information are available they should be considered in selecting or modifying antibacterial therapy in the absence of such data local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy if anaerobic organisms are suspected of contributing to the infection appropriate therapy should be administered appropriate culture and susceptibility tests should be performed before treatment in order to isolate and identify organisms causing infection and to determine their susceptibility to ciprofloxacin therapy with ciprofloxacin tablets may be initiated before results of these tests are known once results become available appropriate therapy should be continued as with other drugs some isolates of pseudomonas aeruginosa" assertion.
• association label "prednisolone sodium phosphate oral solution 15 mg prednisolone per 5 ml is indicated in the following conditions 1 allergic states control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in adult and pediatric populations with seasonal or perennial allergic rhinitis asthma contact dermatitis atopic dermatitis serum sickness drug hypersensitivity reactions 2 dermatologic diseases pemphigus bullous dermatitis herpetiformis severe erythema multiforme stevens johnson syndrome exfoliative erythroderma mycosis fungoides 3 edematous states to induce diuresis or remission of proteinuria in nephrotic syndrome in adults with lupus erythematosus and in adults and pediatric populations with idiopathic nephrotic syndrome without uremia 4 endocrine disorders primary or secondary adrenocortical insufficiency hydrocortisone or cortisone is the first choice synthetic analogs may be used in conjunction with mineralocorticoids where applicable in infancy mineralocorticoid supplementation is of particular importance congenital adrenal hyperplasia hypercalcemia associated with cancer nonsuppurative thyroiditis 5 gastrointestinal diseases to tide the patient over a critical period of the disease in ulcerative colitis regional enteritis 6 hematologic disorders idiopathic thrombocytopenic purpura in adults selected cases of secondary thrombocytopenia acquired autoimmune hemolytic anemia pure red cell aplasia diamond blackfan anemia 7 neoplastic diseases for the treatment of acute leukemia and aggressive lymphomas in adults and children 8 nervous system acute exacerbations of multiple sclerosis 9 ophthalmic diseases uveitis and ocular inflammatory conditions unresponsive to topical corticosteroids temporal arteritis sympathetic ophthalmia 1 respiratory diseases symptomatic sarcoidosis idiopathic eosinophilic pneumonias fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy asthma as distinct from allergic asthma listed above under allergic states hypersensitivity pneumonitis idiopathic pulmonary fibrosis acute exacerbations of chronic obstructive pulmonary disease copd and pneumocystis carinii pneumonia pcp associated with hypoxemia occurring in an hiv individual who is also under treatment with appropriate anti pcp antibiotics studies support the efficacy of systemic corticosteroids for the treatment of these conditions allergic bronchopulmonary aspergillosis idiopathic bronchiolitis obliterans with organizing pneumonia 11 rheumatic disorders as adjunctive therapy for short term administration to tide the patient over an acute episode or exacerbation in psoriatic arthritis rheumatoid arthritis including juvenile rheumatoid arthritis selected cases may require low dose maintenance therapy ankylosing spondylitis acute and subacute bursitis acute nonspecific tenosynovitis acute gouty arthritis epicondylitis for the treatment of systemic lupus erythematosus dermatomyositis polymyositis polymyalgia rheumatica sjogren s syndrome relapsing polychondritis and certain cases of vasculitis 12 miscellaneous tuberculous meningitis with subarachnoid block or impending block tuberculosis with enlarged mediastinal lymph nodes causing respiratory difficulty and tuberculosis with pleural or pericardial effusion appropriate antituberculous chemotherapy must be used concurrently when treating any tuberculosis complications trichinosis with neurologic or myocardial involvement acute or chronic solid organ rejection with or without other agents" assertion.
• association label "dextroamphetamine sulfate extended release capsules are indicated in narcolepsy attention deficit disorder with hyperactivity as an integral part of a total treatment program that typically includes other measures psychological educational social for patients ages 6 years to 16 years with this syndrome a diagnosis of attention deficit hyperactivity disorder adhd dsm iv implies the presence of the hyperactive impulsive or inattentive symptoms that caused impairment and were present before age 7 years the symptoms must cause clinically significant impairment e g in social academic or occupational functioning and be present in 2 or more settings e g school or work and at home the symptoms must not be better accounted for by another mental disorder for the inattentive type at least 6 of the following symptoms must have persisted for at least 6 months lack of attention to details careless mistakes lack of sustained attention poor listener failure to follow through on tasks poor organization avoids tasks requiring sustained mental effort loses things easily distracted forgetful for the hyperactive impulsive type at least 6 of the following symptoms must have persisted for at least 6 months fidgeting squirming leaving seat inappropriate running climbing difficulty with quiet activities on the go excessive talking blurting answers can t wait turn intrusive the combined type requires both inattentive and hyperactive impulsive criteria to be met special diagnostic considerations specific etiology of this syndrome is unknown and there is no single diagnostic test adequate diagnosis requires the use of medical and special psychological educational and social resources learning may or may not be impaired the diagnosis must be based upon a complete history and evaluation of the patient and not solely on the presences of the required number of dsm iv characteristics need for comprehensive treatment program dextroamphetamine sulfate extended release capsules are indicated as an integral part of a total treatment program for adhd that may include other measures psychological educational social for patients with this syndrome drug treatment may not be indicated for all patients with this syndrome stimulants are not intended for use in patients who exhibit symptoms secondary to environmental factors and or other primary psychiatric disorders including psychosis appropriate educational placement is essential and psychosocial intervention is often helpful when remedial measures alone are insufficient the decision to prescribe stimulant medication will depend upon the physician s assessment of the chronicity and severity of the patient s symptoms" assertion.
• association label "condylox gel 5 is indicated for the topical treatment of anogenital warts external genital warts and perianal warts this product is not precautions although anogenital warts have a characteristic appearance histopathologic confirmation should be obtained if there is any doubt of the diagnosis differentiating warts from squamous cell carcinoma and bowenoid papulosis is of particular concern squamous cell carcinoma may also be associated with human papillomavirus which should not be treated with condylox gel 5" assertion.
• association label "metaproterenol sulfate tablets are indicated as a bronchodilator for bronchial asthma and for reversible bronchospasm which may occur in association with bronchitis and emphysema" assertion.
• association label "verapamil hydrochloride tablets usp are indicated for the treatment of the following angina 1 angina at rest including vasospastic prinzmetal s variant angina unstable crescendo pre infarction angina 2 chronic stable angina classic effort associated angina arrhythmias 1 in association with digitalis for the control of ventricular rate at rest and during stress in patients with chronic atrial flutter and or atrial fibrillation see warnings accessory bypass tract 2 prophylaxis of repetitive paroxysmal supraventricular tachycardia essential hypertension verapamil hydrochloride tablets are indicated for the treatment of hypertension to lower blood pressure lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events primarily strokes and myocardial infarctions these benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including this drug control of high blood pressure should be part of comprehensive cardiovascular risk management including as appropriate lipid control diabetes management antithrombotic therapy smoking cessation exercise and limited sodium intake many patients will require more than one drug to achieve blood pressure goals for specific advice on goals and management see published guidelines such as those of the national high blood pressure education program s joint national committee on prevention detection evaluation and treatment of high blood pressure jnc numerous antihypertensive drugs from a variety of pharmacologic classes and with different mechanisms of action have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality and it can be concluded that it is blood pressure reduction and not some other pharmacologic property of the drugs that is largely responsible for those benefits the largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly elevated systolic or diastolic pressure causes increased cardiovascular risk and the absolute risk increase per mmhg is greater at higher blood pressures so that even modest reductions of severe hypertension can provide substantial benefit relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk so the absolute benefit is greater in patients who are at higher risk independent of their hypertension for example patients with diabetes or hyperlipidemia and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal some antihypertensive drugs have smaller blood pressure effects as monotherapy in black patients and many antihypertensive drugs have additional approved indications and effects e g on angina heart failure or diabetic kidney disease these considerations may guide selection of therapy" assertion.
• association label "minocycline hydrochloride capsules usp are indicated in the treatment of the following infections due to susceptible strains of the designated microorganisms rocky mountain spotted fever typhus fever and the typhus group q fever rickettsialpox and tick fevers caused by rickettsiae respiratory tract infections caused by mycoplasma pneumoniae lymphogranuloma venereum caused by chlamydia trachomatis psittacosis ornithosis due to chlamydia psittaci trachoma caused by chlamydia trachomatis although the infectious agent is not always eliminated as judged by immunofluorescence inclusion conjunctivitis caused by chlamydia trachomatis nongonococcal urethritis endocervical or rectal infections in adults caused by ureaplasma urealyticum or chlamydia trachomatis relapsing fever due to borrelia recurrentis chancroid caused by haemophilus ducreyi plague due to yersinia pestis tularemia due to francisella tularensis cholera caused by vibrio cholerae campylobacter fetus infections caused by campylobacter fetus brucellosis due to brucella species in conjunction with streptomycin bartonellosis due to bartonella bacilliformis granuloma inguinale caused by calymmatobacterium granulomatis minocycline is indicated for the treatment of infections caused by the following gram negative microorganisms when bacteriologic testing indicates appropriate susceptibility to the drug escherichia coli enterobacter aerogenes shigella species acinetobacter species respiratory tract infections caused by haemophilus influenzae respiratory tract and urinary tract infections caused by klebsiella species minocycline hydrochloride capsules usp are indicated for the treatment of infections caused by the following gram positive microorganisms when bacteriologic testing indicates appropriate susceptibility to the drug upper respiratory tract infections caused by streptococcus pneumoniae skin and skin structure infections caused by staphylococcus aureus note minocycline is not the drug of choice in the treatment of any type of staphylococcal infection when penicillin is contraindicated minocycline is an alternative drug in the treatment of the following infections uncomplicated urethritis in men due to neisseria gonorrhoeae and for the treatment of other gonococcal infections infections in women caused by neisseria gonorrhoeae syphilis caused by treponema pallidum subspecies pallidum yaws caused by treponema pallidum subspecies pertenue listeriosis due to listeria monocytogenes anthrax due to bacillus anthracis vincent s infection caused by fusobacterium fusiforme actinomycosis caused by actinomyces israelii infections caused by clostridium species in acute intestinal amebiasis minocycline may be a useful adjunct to amebicides in severe acne minocycline may be useful adjunctive therapy oral minocycline is indicated in the treatment of asymptomatic carriers of neisseria meningitidis to eliminate meningococci from the nasopharynx in order to preserve the usefulness of minocycline in the treatment of asymptomatic meningococcal carriers diagnostic laboratory procedures including serotyping and susceptibility testing should be performed to establish the carrier state and the correct treatment it is recommended that the prophylactic use of minocycline be reserved for situations in which the risk of meningococcal meningitis is high oral minocycline is not indicated for the treatment of meningococcal infection although no controlled clinical efficacy studies have been conducted limited clinical data show that oral minocycline hydrochloride has been used successfully in the treatment of infections caused by mycobacterium marinum to reduce the development of drug resistant bacteria and maintain the effectiveness of minocycline hydrochloride capsules usp and other antibacterial drugs minocycline hydrochloride capsules usp should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria when culture and susceptibility information are available they should be considered in selecting or modifying antibacterial therapy in the absence of such data local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy close" assertion.
• association label "acetylcysteine solution usp is indicated as adjuvant therapy for patients with abnormal viscid or inspissated mucous secretions in such conditions as chronic bronchopulmonary disease chronic emphysema emphysema with bronchitis chronic asthmatic bronchitis tuberculosis bronchiectasis and primary amyloidosis of the lung acute bronchopulmonary disease pneumonia bronchitis tracheobronchitis pulmonary complications of cystic fibrosis tracheostomy care pulmonary complications associated with surgery use during anesthesia post traumatic chest conditions atelectasis due to mucous obstruction diagnostic bronchial studies bronchograms bronchospirometry and bronchial wedge catheterization acetylcysteine solution usp administered orally is indicated as an antidote to prevent or lessen hepatic injury which may occur following the ingestion of a potentially hepatotoxic quantity of acetaminophen it is essential to initiate treatment as soon as possible after the overdose and in any case within 24 hours of ingestion" assertion.
• association label "omeprazole delayed release capsules are a proton pump inhibitor ppi indicated for the treatment of active duodenal ulcer in adults 1 1 eradication of helicobacter pylori to reduce the risk of duodenal ulcer recurrence in adults 1 2 treatment of active benign gastric ulcer in adults 1 3 treatment of symptomatic gastroesophageal reflux disease gerd in patients 2 years of age and older 1 4 maintenance of healing of ee due to acid mediated gerd in patients 2 years of age and older 1 6 pathologic hypersecretory conditions in adults 1 7 omeprazole delayed release capsules are a proton pump inhibitor ppi indicated for the treatment of active duodenal ulcer in adults 1 1 eradication of helicobacter pylori to reduce the risk of duodenal ulcer recurrence in adults 1 2 treatment of active benign gastric ulcer in adults 1 3 treatment of symptomatic gastroesophageal reflux disease gerd in patients 2 years of age and older 1 4 maintenance of healing of ee due to acid mediated gerd in patients 2 years of age and older 1 6 pathologic hypersecretory conditions in adults 1 7 omeprazole delayed release capsules are indicated for short term treatment of active duodenal ulcer in adults most patients heal within four weeks some patients may require an additional four weeks of therapy eradication of h pylori has been shown to reduce the risk of duodenal ulcer recurrence triple therapy omeprazole delayed release capsules in combination with clarithromycin and amoxicillin is indicated for treatment of patients with h pylori infection and duodenal ulcer disease active or up to 1 year history to eradicate h pylori in adults dual therapy omeprazole delayed release capsules in combination with clarithromycin are indicated for treatment of patients with h pylori infection and duodenal ulcer disease to eradicate h pylori in adults among patients who fail therapy omeprazole delayed release capsules with clarithromycin is more likely to be associated with the development of clarithromycin resistance as compared with triple therapy in patients who fail therapy susceptibility testing should be done if resistance to clarithromycin is demonstrated or susceptibility testing is not possible alternative antimicrobial therapy should be instituted see clinical pharmacology 12 4 and the clarithromycin prescribing information microbiology sectio n omeprazole delayed release capsules are indicated for short term treatment 4 to 8 weeks of active benign gastric ulcer in adults omeprazole delayed release capsules are indicated for the treatment of heartburn and other symptoms associated with gerd for up to 4 weeks in patients 2 years of age and older pediatric patients 2 years of age to adults omeprazole delayed release capsules are indicated for the short term treatment 4 to 8 weeks of ee due to acid mediated gerd that has been diagnosed by endoscopy in patients 2 years of age and older the efficacy of omeprazole delayed release capsules used for longer than 8 weeks in patients with ee has not been established if a patient does not respond to 8 weeks of treatment an additional 4 weeks of treatment may be given if there is recurrence of ee or gerd symptoms e g heartburn additional 4 to 8 week courses of omeprazole delayed release capsules may be considered omeprazole delayed release capsules are indicated for the maintenance healing of ee due to acid mediated gerd in patients 2 years of age and older controlled studies do not extend beyond 12 months omeprazole delayed release capsules are indicated for the long term treatment of pathological hypersecretory conditions e g zollinger ellison syndrome multiple endocrine adenomas and systemic mastocytosis in adults" assertion.
• association label "for the management of moderately severe to severe essential hypertension and in uncomplicated cases of malignant hypertension" assertion.
• association label "viracept in combination with other antiretroviral agents is indicated for the treatment of hiv infection in the clinical studies described below efficacy was evaluated by the percent of patients with plasma hiv rna 4 copies ml studies 511 and 542 or 5 copies ml study actg 364 using the roche rt pcr amplicor hiv 1 monitor or 5 copies ml using the roche hiv 1 ultrasensitive assay study avanti 3 in the analysis presented in each figure patients who terminated the study early for any reason switched therapy due to inadequate efficacy or who had a missing hiv rna measurement that was either preceded or followed by a measurement above the limit of assay quantification were considered to have hiv rna above 4 copies ml above 5 copies ml or above 5 copies ml at subsequent time points depending on the assay that was used study 511 was a double blind randomized placebo controlled trial comparing treatment with zidovudine zdv 2 mg tid and lamivudine 3tc 15 mg bid plus 2 doses of viracept 75 mg and 5 mg tid to zidovudine 2 mg tid and lamivudine 15 mg bid alone in 297 antiretroviral naive hiv 1 infected patients median age 35 years range 21 to 63 89 male and 78 caucasian mean baseline cd4 cell count was 288 cells mm 3 1 figure 1 figure 2 study 542 is an ongoing randomized open label trial comparing the hiv rna suppression achieved by viracept 125 mg bid versus viracept 75 mg tid in patients also receiving stavudine d4t 3 4 mg bid and lamivudine 3tc 15 mg bid patients had a median age of 36 years range 18 to 83 were 84 male and were 91 caucasian patients had received less than 6 months of therapy with nucleoside transcriptase inhibitors and were naive to protease inhibitors mean baseline cd4 cell count was 296 cells mm 3 1 results showed that there was no significant difference in mean cd4 cell count among treatment groups the mean increases from baseline for the bid and tid arms were 15 cells mm 3 3 the percent of patients with hiv rna 4 copies ml is summarized in figure 3 the outcomes of patients through 48 weeks of treatment are summarized in table 8 figure 3 study 542 percentage of patients with hiv rna below 4 copies ml table 8 outcomes of randomized treatment through 48 weeks outcome viracept 125 mg bid regimen viracept 75 mg tid regimen number of patients evaluable twelve patients in the bid arm and fourteen patients in the tid arm had not yet reached 48 weeks of therapy 323 192 hiv rna 4 198 61 111 58 hiv rna 4 46 14 22 11 discontinued due to viracept toxicity these rates only reflect dose limiting toxicities that were counted as the initial reason for treatment failure in the analysis see adverse reactions 9 3 2 1 discontinued due to other antiretroviral agents toxicity 3 1 3 2 others consent withdrawn lost to follow up intercurrent illness noncompliance or missing data all assumed as failures 67 21 54 28 study avanti 3 was a placebo controlled randomized double blind study designed to evaluate the safety and efficacy of viracept 75 mg tid in combination with zidovudine zdv 3 mg bid and lamivudine 3tc 15 mg bid n 53 versus placebo in combination with zdv and 3tc n 52 administered to antiretroviral naive patients with hiv infection and a cd4 cell count between 15 and 5 cells ul patients had a mean age of 35 range 22 59 were 89 male and 88 caucasian mean baseline cd4 cell count was 3 4 cells mm 3 1 study actg 364 was a randomized double blind study that evaluated the combination of viracept 75 mg tid and or efavirenz 6 mg qd with 2 nrtis either didanosine ddi d4t ddi 3tc or d4t 3tc in patients with prolonged prior nucleoside exposure who had completed 2 previous actg studies patients had a mean age of 41 years range 18 to 75 were 88 male and were 74 caucasian mean baseline cd4 cell count was 389 cells mm 3 1 the percent of patients with plasma hiv rna 5 copies ml at 48 weeks was 42 62 and 72 for the viracept n 66 efv n 65 and viracept efv n 64 treatment groups respectively the 4 drug combination of viracept efv 2 nrtis was more effective in suppressing plasma hiv rna in these patients than either 3 drug regimen" assertion.
• association label "when oral therapy is not feasible and the strength dosage form and route of administration of the drug reasonably lend the preparation to the treatment of the condition the intramuscular use of methylprednisolone acetate injectable suspension is indicated as follows allergic states control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma atopic dermatitis contact dermatitis drug hypersensitivity reactions seasonal or perennial allergic rhinitis serum sickness transfusion reactions dermatologic diseases bullous dermatitis herpetiformis exfoliative erythroderma mycosis fungoides pemphigus severe erythema multiforme stevens johnson syndrome endocrine disorders primary or secondary adrenocortical insufficiency hydrocortisone or cortisone is the drug of choice synthetic analogs may be used in conjunction with mineralocorticoids where applicable in infancy mineralocorticoid supplementation is of particular importance congenital adrenal hyperplasia hypercalcemia associated with cancer nonsuppurative thyroiditis gastrointestinal diseases to tide the patient over a critical period of the disease in regional enteritis systemic therapy and ulcerative colitis hematologic disorders acquired autoimmune hemolytic anemia congenital erythroid hypoplastic anemia diamond blackfan anemia pure red cell aplasia select cases of secondary thrombocytopenia miscellaneous trichinosis with neurologic or myocardial involvement tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy neoplastic diseases for palliative management of leukemias and lymphomas nervous system acute exacerbations of multiple sclerosis cerebral edema associated with primary or metastatic brain tumor or craniotomy ophthalmic diseases sympathetic ophthalmia temporal arteritis uveitis and ocular inflammatory conditions unresponsive to topical corticosteroids renal diseases to induce diuresis or remission of proteinuria in idiopathic nephrotic syndrome or that due to lupus erythematosus respiratory diseases berylliosis fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy idiopathic eosinophilic pneumonias symptomatic sarcoidosis rheumatic disorders as adjunctive therapy for short term administration to tide the patient over an acute episode or exacerbation in acute gouty arthritis acute rheumatic carditis ankylosing spondylitis psoriatic arthritis rheumatoid arthritis including juvenile rheumatoid arthritis selected cases may require low dose maintenance therapy for the treatment of dermatomyositis polymyositis and systemic lupus erythematosus see warnings methylprednisolone acetate injectable suspension is indicated as adjunctive therapy for short term administration to tide the patient over an acute episode or exacerbation in acute gouty arthritis acute and subacute bursitis acute nonspecific tenosynovitis epicondylitis rheumatoid arthritis synovitis of osteoarthritis methylprednisolone acetate injectable suspension is indicated for intralesional use in alopecia areata discoid lupus erythematosus keloids localized hypertrophic infiltrated inflammatory lesions of granuloma annulare lichen planus lichen simplex chronicus neurodermatitis and psoriatic plaques necrobiosis lipoidica diabeticorum methylprednisolone acetate injectable suspension also may be useful in cystic tumors of an aponeurosis or tendon ganglia" assertion.
• association label "procysbi is indicated for the treatment of nephropathic cystinosis in adults and pediatric patients 1 year of age and older procysbi is a cystine depleting agent indicated for the treatment of nephropathic cystinosis in adults and pediatric patients 1 year of age and older 1" assertion.
• association label "prednisolone syrup prednisolone oral solution usp is indicated in the following conditions 1 endocrine disorders primary or secondary adrenocortical insufficiency hydrocortisone or cortisone is the first choice synthetic analogs may be used in conjunction with mineralocorticoids where applicable in infancy mineralocorticoid supplementation is of particular importance congenital adrenal hyperplasia nonsuppurative thyroiditis hypercalcemia associated with cancer 2 rheumatic disorders as adjunctive therapy for short term administration to tide the patient over an acute episode or exacerbation in psoriatic arthritis rheumatoid arthritis including juvenile rheumatoid arthritis selected cases may require low dose maintenance therapy ankylosing spondylitis acute and subacute bursitis acute nonspecific tenosynovitis acute gouty arthritis post traumatic osteoarthritis synovitis of osteoarthritis epicondylitis 3 collagen diseases during an exacerbation or as maintenance therapy in selected cases of systemic lupus erythematosus acute rheumatic carditis 4 dermatologic diseases pemphigus bullous dermatitis herpetiformis severe erythema multiforme stevens johnson syndrome exfoliative dermatitis mycosis fungoides severe psoriasis severe seborrheic dermatitis 5 allergic states control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment seasonal or perennial allergic rhinitis bronchial asthma contact dermatitis atopic dermatitis serum sickness drug hypersensitivity reactions 6 ophthalmic diseases severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as allergic corneal marginal ulcers herpes zoster ophthalmicus anterior segment inflammation diffuse posterior uveitis and choroiditis sympathetic ophthalmia allergic conjunctivitis keratitis chorioretinitis optic neuritis iritis and iridocyclitis 7 respiratory diseases symptomatic sarcoidosis loeffler s syndrome not manageable by other means berylliosis fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate chemotherapy aspiration pneumonitis 8 hematologic disorders idiopathic thrombocytopenic purpura in adults secondary thrombocytopenia in adults acquired autoimmune hemolytic anemia erythroblastopenia rbc anemia congenital erythroid hypoplastic anemia 9 neoplastic diseases for palliative management of leukemias and lymphomas in adults acute leukemia of childhood 1 edematous states to induce a diuresis or remission of proteinuria in the nephrotic syndrome without uremia of the idiopathic type or that due to lupus erythematosus 11 gastrointestinal diseases to tide the patient over a critical period of the disease in ulcerative colitis regional enteritis 12 miscellaneous tuberculous meningitis with subarachnoid block or impending block used concurrently with appropriate antituberculous chemotherapy trichinosis with neurologic or myocardial involvement in addition to the above indications prednisolone syrup prednisolone oral solution usp is indicated for systemic dermatomyositis polymyositis" assertion.
• association label "prednisolone sodium phosphate oral solution 15 mg prednisolone per 5 ml is indicated in the following conditions 1 allergic states control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in adult and pediatric populations with seasonal or perennial allergic rhinitis asthma contact dermatitis atopic dermatitis serum sickness drug hypersensitivity reactions 2 dermatologic diseases pemphigus bullous dermatitis herpetiformis severe erythema multiforme stevens johnson syndrome exfoliative erythroderma mycosis fungoides 3 edematous states to induce diuresis or remission of proteinuria in nephrotic syndrome in adults with lupus erythematosus and in adults and pediatric populations with idiopathic nephrotic syndrome without uremia 4 endocrine disorders primary or secondary adrenocortical insufficiency hydrocortisone or cortisone is the first choice synthetic analogs may be used in conjunction with mineralocorticoids where applicable in infancy mineralocorticoid supplementation is of particular importance congenital adrenal hyperplasia hypercalcemia associated with cancer nonsuppurative thyroiditis 5 gastrointestinal diseases to tide the patient over a critical period of the disease in ulcerative colitis regional enteritis 6 hematologic disorders idiopathic thrombocytopenic purpura in adults selected cases of secondary thrombocytopenia acquired autoimmune hemolytic anemia pure red cell aplasia diamond blackfan anemia 7 neoplastic diseases for the treatment of acute leukemia and aggressive lymphomas in adults and children 8 nervous system acute exacerbations of multiple sclerosis 9 ophthalmic diseases uveitis and ocular inflammatory conditions unresponsive to topical corticosteroids temporal arteritis sympathetic ophthalmia 1 respiratory diseases symptomatic sarcoidosis idiopathic eosinophilic pneumonias fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy asthma as distinct from allergic asthma listed above under allergic states hypersensitivity pneumonitis idiopathic pulmonary fibrosis acute exacerbations of chronic obstructive pulmonary disease copd and pneumocystis carinii pneumonia pcp associated with hypoxemia occurring in an hiv individual who is also under treatment with appropriate anti pcp antibiotics studies support the efficacy of systemic corticosteroids for the treatment of these conditions allergic bronchopulmonary aspergillosis idiopathic bronchiolitis obliterans with organizing pneumonia 11 rheumatic disorders as adjunctive therapy for short term administration to tide the patient over an acute episode or exacerbation in psoriatic arthritis rheumatoid arthritis including juvenile rheumatoid arthritis selected cases may require low dose maintenance therapy ankylosing spondylitis acute and subacute bursitis acute nonspecific tenosynovitis acute gouty arthritis epicondylitis for the treatment of systemic lupus erythematosus dermatomyositis polymyositis polymyalgia rheumatica sjogren s syndrome relapsing polychondritis and certain cases of vasculitis 12 miscellaneous tuberculous meningitis with subarachnoid block or impending block tuberculosis with enlarged mediastinal lymph nodes causing respiratory difficulty and tuberculosis with pleural or pericardial effusion appropriate antituberculous chemotherapy must be used concurrently when treating any tuberculosis complications trichinosis with neurologic or myocardial involvement acute or chronic solid organ rejection with or without other agents" assertion.
• association label "to reduce the development of drug resistant bacteria and maintain the effectiveness of ofloxacin tablets and other antibacterial drugs ofloxacin tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria when culture and susceptibility information are available they should be considered in selecting or modifying antibacterial therapy in the absence of such data local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy ofloxacin tablets are indicated for the treatment of adults with mild to moderate infections unless otherwise indicated caused by susceptible strains of the designated microorganisms in the infections listed below please see dosage and administration acute bacterial exacerbations of chronic bronchitis abecb haemophilus influenzae streptococcus pneumoniae because fluoroquinolones including ofloxacin have been associated with serious adverse reactions see warnings community acquired pneumonia haemophilus influenzae streptococcus pneumoniae uncomplicated skin and skin structure infections staphylococcus aureus streptococcus pyogenes or proteus mirabilis acute uncomplicated urethral and cervical gonorrhea neisseria gonorrhoeae warnings nongonococcal urethritis and cervicitis chlamydia trachomatis warnings mixed infections of the urethra and cervix chlamydia trachomatis neisseria gonorrhoeae warnings acute pelvic inflammatory disease chlamydia trachomatis neisseria gonorrhoeae warnings note if anaerobic microorganisms are suspected of contributing to the infection appropriate therapy for anaerobic pathogens should be administered uncomplicated cystitis citrobacter diversus enterobacter aerogenes escherichia coli klebsiella pneumoniae proteus mirabilis or pseudomonas aeruginosa because fluoroquinolones including ofloxacin have been associated with serious adverse reactions see warnings complicated urinary tract infections escherichia coli klebsiella pneumoniae proteus mirabilis citrobacter diversus pseudomonas aeruginosa prostatitis escherichia coli although treatment of infections due to this organism in this organ system demonstrated a clinically significant outcome efficacy was studied in fewer than 1 patients appropriate culture and susceptibility tests should be performed before treatment in order to isolate and identify organisms causing the infection and to determine their susceptibility to ofloxacin therapy with ofloxacin may be initiated before results of these tests are known once results become available appropriate therapy should be continued as with other drugs in this class some strains of pseudomonas aeruginosa may develop resistance fairly rapidly during treatment with ofloxacin culture and susceptibility testing performed periodically during therapy will provide information not only on the therapeutic effect of the antimicrobial agent but also on the possible emergence of bacterial resistance" assertion.
• association label "allergic states control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment atopic dermatitis bronchial asthma contact dermatitis drug hypersensitivity reactions seasonal or perennial allergic rhinitis and serum sickness collagen diseases during an exacerbation or as maintenance therapy in selected cases of systemic lupus erythematosus and acute rheumatic carditis dermatologic diseases bullous dermatitis herpetiformis exfoliative dermatitis mycosis fungoides pemphigus severe erythema multiforme stevens johnson syndrome severe psoriasis and severe seborrheic dermatitis edematous states to induce a diuresis or remission of proteinuria in the nephrotic syndrome without uremia of the idiopathic type or that due to lupus erythematosus endocrine disorders primary or secondary adrenocortical insufficiency hydrocortisone or cortisone is the first choice synthetic analogs may be used in conjunction with mineralocorticoids where applicable in infancy mineralocorticoid supplementation is of particular importance congenital adrenal hyperplasia hypercalcemia associated with cancer and nonsuppurative thyroiditis gastrointestinal diseases to tide the patient over a critical period of the disease in ulcerative colitis and regional enteritis hematologic disorders idiopathic thrombocytopenic purpura in adults secondary thrombocytopenia in adults acquired autoimmune hemolytic anemia erythroblastopenia rbc anemia and congenital erythroid hypoplastic anemia miscellaneous diagnostic testing of adrenocortical hyperfunction tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy and trichinosis with neurologic or myocardial involvement neoplastic diseases for palliative management of leukemia and lymphomas in adults and acute leukemia of childhood ophthalmic diseases severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as allergic conjunctivitis keratitis allergic corneal marginal ulcers herpes zoster ophthalmicus iritis and iridocyclitis chorioretinitis anterior segment inflammation diffuse posterior uveitis and choroiditis optic neuritis and sympathetic ophthalmia respiratory diseases symptomatic sarcoidosis loeffler s syndrome not manageable by other means berylliosis fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy and aspiration pneumonitis rheumatic disorders as adjunctive therapy for short term administration to tide the patient over an acute episode or exacerbation in psoriatic arthritis rheumatoid arthritis including juvenile rheumatoid arthritis selected cases may require low dose maintenance therapy ankylosing spondylitis acute and subacute bursitis acute nonspecific tenosynovitis acute gouty arthritis post traumatic osteoarthritis synovitis of osteoarthritis and epicondylitis" assertion.
• association label "prednisone tablets are indicated in the following conditions 1 endocrine disorders primary or secondary adrenocortical insufficiency hydrocortisone or cortisone is the first choice synthetic analogs may be used in conjunction with mineralocorticoids where applicable in infancy mineralocorticoid supplementation is of particular importance congenital adrenal hyperplasia nonsuppurative thyroiditis hypercalcemia associated with cancer 2 rheumatic disorders as adjunctive therapy for short term administration to tide the patient over an acute episode or exacerbation in psoriatic arthritis rheumatoid arthritis including juvenile rheumatoid arthritis selected cases may require low dose maintenance therapy ankylosing spondylitis acute and subacute bursitis acute nonspecific tenosynovitis acute gouty arthritis post traumatic osteoarthritis synovitis of osteoarthritis epicondylitis 3 collagen diseases during an exacerbation or as maintenance therapy in selected cases of systemic lupus erythematosus systemic dermatomyositis polymyositis acute rheumatic carditis 4 dermatologic diseases pemphigus bullous dermatitis herpetiformis severe erythema multiforme stevens johnson syndrome exfoliative dermatitis mycosis fungoides severe psoriasis severe seborrheic dermatitis 5 allergic states control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment seasonal or perennial allergic rhinitis bronchial asthma contact dermatitis atopic dermatitis serum sickness drug hypersensitivity reactions 6 ophthalmic diseases severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as allergic corneal marginal ulcers herpes zoster ophthalmicus anterior segment inflammation diffuse posterior uveitis and choroiditis sympathetic ophthalmia allergic conjunctivitis keratitis chorioretinitis optic neuritis iritis and iridocyclitis 7 respiratory diseases symptomatic sarcoidosis loeffler s syndrome not manageable by other means berylliosis fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy aspiration pneumonitis 8 hematologic disorders idiopathic thrombocytopenic purpura in adults secondary thrombocytopenia in adults acquired autoimmune hemolytic anemia erythroblastopenia rbc anemia congenital erythroid hypoplastic anemia 9 neoplastic diseases for palliative management of leukemias and lymphomas in adults acute leukemia of childhood 1 edematous states to induce a diuresis or remission of proteinuria in the nephrotic syndrome without uremia of the idiopathic type or that due to lupus erythematosus 11 gastrointestinal diseases to tide the patient over a critical period of the disease in ulcerative colitis regional enteritis 12 nervous system acute exacerbations of multiple sclerosis 13 miscellaneous tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy trichinosis with neurologic or myocardial involvement" assertion.
• association label "indications and usage for the treatment of the following conditions steroid responsive inflammatory conditions of the palpebral and bulbar conjunctiva cornea and anterior segment of the globe such as allergic conjunctivitis acne rosacea superficial punctate keratitis herpes zoster keratitis iritis cyclitis selected infective conjunctivitis when the inherent hazard of steroid use is accepted to obtain an advisable diminution in edema and inflammation corneal injury from chemical or thermal burns or penetration of foreign bodies steroid responsive inflammatory conditions of the external auditory meatus such as allergic otitis externa selected purulent and nonpurulent infective otitis externa when the hazard of steroid use is accepted to obtain an advisable diminution in edema and inflammation" assertion.
• association label "zoledronic acid injection is a bisphosphonate indicated for zoledronic acid injection is indicated for treatment of osteoporosis in postmenopausal women in postmenopausal women with osteoporosis diagnosed by bone mineral density bmd or prevalent vertebral fracture zoledronic acid injection reduces the incidence of fractures hip vertebral and non vertebral osteoporosis related fractures in patients at high risk of fracture defined as a recent low trauma hip fracture zoledronic acid injection reduces the incidence of new clinical fractures see clinical studies 14 1 zoledronic acid injection is indicated for prevention of osteoporosis in postmenopausal women see clinical studies 14 2 zoledronic acid injection is indicated for treatment to increase bone mass in men with osteoporosis see clinical studies 14 3 zoledronic acid injection is indicated for the treatment and prevention of glucocorticoid induced osteoporosis in men and women who are either initiating or continuing systemic glucocorticoids in a daily dosage equivalent to 7 5 mg or greater of prednisone and who are expected to remain on glucocorticoids for at least 12 months see clinical studies 14 4 zoledronic acid injection is indicated for treatment of paget s disease of bone in men and women treatment is indicated in patients with paget s disease of bone with elevations in serum alkaline phosphatase of two times or higher than the upper limit of the age specific normal reference range or those who are symptomatic or those at risk for complications from their disease see clinical studies 14 5 the safety and effectiveness of zoledronic acid injection for the treatment of osteoporosis is based on clinical data of three years duration the optimal duration of use has not been determined all patients on bisphosphonate therapy should have the need for continued therapy re evaluated on a periodic basis patients at low risk for fracture should be considered for drug discontinuation after 3 to 5 years of use patients who discontinue therapy should have their risk for fracture re evaluated periodically" assertion.
• association label "when oral therapy is not feasible and the strength dosage form and route of administration of the drug reasonably lend the preparation to the treatment of the condition the intravenous or intramusculat use of solu cortef sterile powder is indicated as follows allergic states control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma atopic dermatitis contact dermatitis drug hypersensitivity reactions perennial or seasonal allergic rhinitis serum sickness transfusion reactions dermatologic diseases bullous dermatitis herpetiformis exfoliative erythroderma mycosis fungoides pemphigus severe erythema multiforme stevens johnson syndrome endocrine disorders primary or secondary adrenocortical insufficiency hydrocortisone or cortisone is the drug of choice synthetic analogs may be used in conjunction with mineralocorticoids where applicable in infancy mineralocorticoid supplementation is of particular importance congenital adrenal hyperplasia hypercalcemia associated with cancer nonsuppurative thyroiditis gastrointestinal diseases to tide the patient over a critical period of the disease in regional enteritis systemic therapy and ulcerative colitis hematologic disorders acquired autoimmune hemolytic anemia congenital erythroid hypoplastic anemia diamond blackfan anemia idiopathic thrombocytopenic purpura in adults intravenous administration only intramuscular administration is contraindicated pure red cell aplasia select cases of secondary thrombocytopenia miscellaneous trichinosis with neurologic or myocardial involvement tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy neoplastic diseases for the palliative management of leukemias and lymphomas nervous system acute exacerbations of multiple sclerosis cerebral edema associated with primary or metastatic brain tumor or craniotomy ophthalmic diseases sympathetic ophthalmia uveitis and ocular inflammatory conditions unresponsive to topical corticosteroids renal diseases to induce diuresis or remission of proteinuria in idiopathic nephrotic syndrome or that due to lupus erythematosus respiratory diseases berylliosis fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy idiopathic eosinophilic pneumonias symptomatic sarcoidosis rheumatic disorders as adjunctive therapy for short term administration to tide the patient over an acute episode or exacerbation in acute gouty arthritis acute rheumatic carditis ankylosing spondylitis psoriatic arthritis rheumatoid arthritis including juvenile rheumatoid arthritis selected cases may require low dose maintenance therapy for the treatment of dermatomyositis temporal arteritis polymyositis and systemic lupus erythematosus" assertion.
• association label "abilify is an atypical antipsychotic indicated as oral formulations for the treatment of schizophrenia 1 1 adults efficacy was established in four 4 6 week trials and one maintenance trial in patients with schizophrenia 14 1 adolescents ages 13 17 efficacy was established in one 6 week trial in patients with schizophrenia 14 1 acute treatment of manic or mixed episodes associated with bipolar i disorder as monotherapy and as an adjunct to lithium or valproate 1 2 adults efficacy was established in four 3 week monotherapy trials and one 6 week adjunctive trial in patients with manic or mixed episodes 14 2 pediatric patients ages 1 17 efficacy was established in one 4 week monotherapy trial in patients with manic or mixed episodes 14 2 maintenance treatment of bipolar i disorder both as monotherapy and as an adjunct to lithium or valproate 1 2 adults efficacy was established in one maintenance monotherapy trial and in one maintenance adjunctive trial 14 2 adjunctive treatment of major depressive disorder mdd 1 3 adults efficacy was established in two 6 week trials in patients with mdd who had an inadequate response to antidepressant therapy during the current episode 14 3 treatment of irritability associated with autistic disorder 1 4 pediatric patients ages 6 17 years efficacy was established in two 8 week trials in patients with autistic disorder 14 4 as an injection for the acute treatment of agitation associated with schizophrenia or bipolar i disorder 1 5 adults efficacy was established in three 24 hour trials in agitated patients with schizophrenia or manic mixed episodes of bipolar i disorder 14 5 abilify is indicated for the treatment of schizophrenia the efficacy of abilify was established in four 4 6 week trials in adults and one 6 week trial in adolescents 13 to 17 years maintenance efficacy was demonstrated in one trial in adults and can be extrapolated to adolescents see clinical studies 14 1 acute treatment of manic and mixed episodes abilify is indicated for the acute treatment of manic and mixed episodes associated with bipolar i disorder both as monotherapy and as an adjunct to lithium or valproate efficacy as monotherapy was established in four 3 week monotherapy trials in adults and one 4 week monotherapy trial in pediatric patients 1 to 17 years efficacy as adjunctive therapy was established in one 6 week adjunctive trial in adults see clinical studies 14 2 maintenance treatment of bipolar i disorder abilify is indicated for the maintenance treatment of bipolar i disorder both as monotherapy and as an adjunct to either lithium or valproate maintenance efficacy was demonstrated in one monotherapy maintenance trial and in one adjunctive maintenance trial in adults see clinical studies 14 2 abilify is indicated for use as an adjunctive therapy to antidepressants for the treatment of major depressive disorder mdd efficacy was established in two 6 week trials in adults with mdd who had an inadequate response to antidepressant therapy during the current episode see clinical studies 14 3 abilify is indicated for the treatment of irritability associated with autistic disorder efficacy was established in two 8 week trials in pediatric patients aged 6 to 17 years with irritability associated with autistic disorder including symptoms of aggression towards others deliberate self injuriousness temper tantrums and quickly changing moods see clinical studies 14 4 abilify injection is indicated for the acute treatment of agitation associated with schizophrenia or bipolar disorder manic or mixed psychomotor agitation is defined in dsm iv as excessive motor activity associated with a feeling of inner tension patients experiencing agitation often manifest behaviors that interfere with their diagnosis and care eg threatening behaviors escalating or urgently distressing behavior or self exhausting behavior leading clinicians to the use of intramuscular antipsychotic medications to achieve immediate control of the agitation efficacy was established in three short term 24 hour trials in adults see clinical studies 14 5 psychiatric disorders in children and adolescents are often serious mental disorders with variable symptom profiles that are not always congruent with adult diagnostic criteria it is recommended that psychotropic medication therapy for pediatric patients only be initiated after a thorough diagnostic evaluation has been conducted and careful consideration given to the risks associated with medication treatment medication treatment for pediatric patients with schizophrenia bipolar i disorder and irritability associated with autistic disorder is indicated as part of a total treatment program that often includes psychological educational and social interventions" assertion.

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