Matches in Nanopublications for { ?s <http://www.w3.org/2000/01/rdf-schema#label> ?o ?g. }
- 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 "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 "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 "the use of metoclopramide tablets is recommended for adults only therapy should not exceed 12 weeks in duration symptomatic gastroesophageal reflux metoclopramide tablets are indicated as short term 4 to 12 weeks therapy for adults with symptomatic documented gastroesophageal reflux who fail to respond to conventional therapy the principal effect of metoclopramide is on symptoms of postprandial and daytime heartburn with less observed effect on nocturnal symptoms if symptoms are confined to particular situations such as following the evening meal use of metoclopramide as single doses prior to the provocative situation should be considered rather than using the drug throughout the day healing of esophageal ulcers and erosions has been endoscopically demonstrated at the end of a 12 week trial using doses of 15 mg q i d as there is no documented correlation between symptoms and healing of esophageal lesions patients with documented lesions should be monitored endoscopically diabetic gastroparesis diabetic gastric stasis metoclopramide tablets are indicated for the relief of symptoms associated with acute and recurrent diabetic gastric stasis the usual manifestations of delayed gastric emptying e g nausea vomiting heartburn persistent fullness after meals and anorexia appear to respond to metoclopramide within different time intervals significant relief of nausea occurs early and continues to improve over a three week period relief of vomiting and anorexia may precede the relief of abdominal fullness by one week or more" assertion.
- association label "amphotericin b for injection usp should be administered primarily to patients with progressive potentially life threatening fungal infections this potent drug should not be used to treat noninvasive fungal infections such as oral thrush vaginal candidiasis and esophageal candidiasis in patients with normal neutrophil counts amphotericin b for injection usp is specifically intended to treat potentially life threatening fungal infections aspergillosis cryptococcosis torulosis north american blastomycosis systemic candidiasis coccidioido mycosis histoplasmosis zygomycosis including mucormycosis due to susceptible species of the genera absidia mucor rhizopus conidiobolus basidiobolus amphotericin b may be useful in the treatment of american mucocutaneous leishmaniasis but it is not the drug of choice as primary therapy" 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 "arestin is indicated as an adjunct to scaling and root planing procedures for reduction of pocket depth in patients with adult periodontitis arestin may be used as part of a periodontal maintenance program which includes good oral hygiene and scaling and root planing" assertion.
- association label "cefuroxime axetil tablets are a cephalosporin antibacterial drug indicated for the treatment of the following infections due to susceptible bacteria 1 pharyngitis tonsillitis adults and pediatric patients 1 1 acute bacterial otitis media pediatric patients 1 2 acute bacterial maxillary sinusitis adults and pediatric patients 1 3 acute bacterial exacerbations of chronic bronchitis adults and pediatric patients 13 years and older 1 4 uncomplicated skin and skin structure infections adults and pediatric patients 13 years and older 1 5 uncomplicated urinary tract infections adults and pediatric patients 13 years and older 1 6 uncomplicated gonorrhea adults and pediatric patients 13 years and older 1 7 early lyme disease adults and pediatric patients 13 years and older 1 8 to reduce the development of drug resistant bacteria and maintain the effectiveness of cefuroxime axetil tablets and other antibacterial drugs cefuroxime axetil tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria cefuroxime axetil tablets are indicated for the treatment of adult patients and pediatric patients 13 years and older with mild to moderate pharyngitis tonsillitis caused by susceptible strains of streptococcus pyogenes limitations of use the efficacy of cefuroxime axetil tablets in the prevention of rheumatic fever was not established in clinical trials the efficacy of cefuroxime axetil tablets in the treatment of penicillin resistant strains of streptococcus pyogenes cefuroxime axetil tablets are indicated for the treatment of pediatric patients who can swallow tablets whole with acute bacterial otitis media caused by susceptible strains of streptococcus pneumoniae haemophilus influenzae moraxella catarrhalis streptococcus pyogenes cefuroxime axetil tablets are indicated for the treatment of adult and pediatric patients 13 years and older with mild to moderate acute bacterial maxillary sinusitis caused by susceptible strains of streptococcus pneumoniae haemophilus influenzae limitations of use the effectiveness of cefuroxime axetil tablets for sinus infections caused by b lactamase producing haemophilus influenzae moraxella catarrhalis see clinical studies 14 1 cefuroxime axetil tablets are indicated for the treatment of adult patients and pediatric patients aged 13 and older with mild to moderate acute bacterial exacerbations of chronic bronchitis caused by susceptible strains b lactamase negative strains or b lactamase negative strains cefuroxime axetil tablets are indicated for the treatment of adult patients and pediatric patients aged 13 and older with mild to moderate acute bacterial exacerbations of chronic bronchitis caused by susceptible strains of streptococcus pneumoniae haemophilus influenzae haemophilus parainfluenzae cefuroxime axetil tablets are indicated for the treatment of adult patients and pediatric patients aged 13 and older with uncomplicated skin and skin structure infections caused by susceptible strains of staphylococcus aureus streptococcus pyogenes cefuroxime axetil tablets are indicated for the treatment of adult patients and pediatric patients aged 13 and older with uncomplicated urinary tract infections caused by susceptible strains of escherichia coli klebsiella pneumoniae cefuroxime axetil tablets are indicated for the treatment of adult patients and pediatric patients aged 13 and older with uncomplicated gonorrhea urethral and endocervical caused by penicillinase producing and non penicillinase producing susceptible strains of neisseria gonorrhoeae neisseria gonorrhoeae cefuroxime axetil tablets are indicated for the treatment of adult patients and pediatric patients aged 13 and older with early lyme disease erythema migrans caused by susceptible strains of borrelia burgdorferi to reduce the development of drug resistant bacteria and maintain the effectiveness of cefuroxime axetil tablets and other antibacterial drugs cefuroxime axetil 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 "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 "loteprednol etabonate is indicated for the treatment of 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 conjunctivitides when the inherent hazard of steroid use is accepted to obtain an advisable diminution in edema and inflammation loteprednol etabonate is less effective than prednisolone acetate 1 in two 28 day controlled clinical studies in acute anterior uveitis where 72 of patients treated with loteprednol etabonate experienced resolution of anterior chamber cells compared to 87 of patients treated with prednisolone acetate 1 the incidence of patients with clinically significant increases in iop 1 mmhg was 1 with loteprednol etabonate and 6 with prednisolone acetate 1 loteprednol etabonate should not be used in patients who require a more potent corticosteroid for this indication loteprednol etabonate is also indicated for the treatment of post operative inflammation following ocular surgery" assertion.
- STX1B-mutation label "STX1B mutation" assertion.
- regulatory-element-within-the-first-intron-of-FTO label "regulatory element within the first intron of FTO" assertion.
- early-human-adipogenesis label "early human adipogenesis" assertion.
- relative-neocortex-size label "Relative size of the neocortex" assertion.
- spi label "In the context of Digital Humanities research, usage of the Linked Data Scopes ontology contributes to transparency of the research." assertion.
- newclass label "short ID of new class" assertion.
- description label "description of the class" assertion.
- name label "the name of the class" assertion.
- restrictiontype label "select type of restriction" assertion.
- property label "the property on which the restriction is applied" assertion.
- class label "URI of existing class" assertion.
- assertion label "Defining a new class by a property restriction" assertion.
- spi label "mutations in STX1B are associated with epilepsy" assertion.
- spi label "In the context of Digital Humanities research, usage of the Linked Data Scopes ontology contributes to transparency of the research." assertion.
- creator label "ORCID of creator" assertion.
- assertion label "Additional nanopublication creators" assertion.
- patterned-cell-remodeling label "patterned cell remodeling" assertion.
- ciliopathy-mouse-model label "ciliopathy mouse model" assertion.
- spi label "Dysregulation of sonic hedgehog signaling causes hearing loss in ciliopathy mouse models." assertion.
- spi label "Pseudo-repeats in doublecortin contributes to microtubule stabilization" assertion.
- automatedDiscovery label "Automated Discovery" 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 "cortef tablets are indicated in the following conditions 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 as adjunctive therapy for short term administration to tide the patient over an acute episode or exacerbation in psoriatic arthritis during an exacerbation or as maintenance therapy in selected cases of systemic lupus erythematosus pemphigus control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment seasonal or perennial allergic rhinitis severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as allergic conjunctivitis symptomatic sarcoidosis idiopathic thrombocytopenic purpura in adults for palliative management of leukemias and lymphomas in adults to induce a diuresis or remission of proteinuria in the nephrotic syndrome without uremia of the idiopathic type or that due to lupus erythematosus to tide the patient over a critical period of the disease in ulcerative colitis acute exacerbations of multiple sclerosis tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy" assertion.
- association label "mebendazole tablets are indicated for the treatment of enterobius vermicularis trichuris trichiura ascaris lumbricoides ancylostoma duodenale necator americanus efficacy varies as a function of such factors as preexisting diarrhea and gastrointestinal transit time degree of infection and helminth strains efficacy rates derived from various studies are shown in the table below pinworm enterobiasis whipworm trichuriasis common roundworm ascariasis hookworm cure rates 95 68 98 96 egg reduction 93 99 99" assertion.
- association label "cefpodoxime proxetil is indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the conditions listed below recommended dosages durations of therapy and applicable patient populations vary among these infections please see dosage and administration acute otitis media streptococcus pneumoniae streptococcus pyogenes haemophilus influenzae moraxella branhamella catarrhalis pharyngitis and or tonsillitis streptococcus pyogenes note community acquired pneumonia s pneumoniae h influenzae acute bacterial exacerbation of chronic bronchitis s pneumoniae h influenzae m catarrhalis h influenzae acute uncomplicated urethral and cervical gonorrhea neisseria gonorrhoeae acute uncomplicated ano rectal infections in women neisseria gonorrhoeae note n gonorrhoeae n gonorrhoeae uncomplicated skin and skin structure infections staphylococcus aureus streptococcus pyogenes note dosage and administration acute maxillary sinusitis haemophilus influenzae streptococcus pneumoniae moraxella catarrhalis uncomplicated urinary tract infections cystitis escherichia coli klebsiella pneumoniae proteus mirabilis staphylococcus saprophyticus note clinical studies appropriate specimens for bacteriological examination should be obtained in order to isolate and identify causative organisms and to determine their susceptibility to cefpodoxime therapy may be instituted while awaiting the results of these studies once these results become available antimicrobial therapy should be adjusted accordingly to reduce the development of drug resistant bacteria and maintain the effectiveness of cefpodoxime proxetil for oral suspension usp and other antibacterial drugs cefpodoxime proxetil for oral suspension 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" assertion.
- association label "olmesartan medoxomil 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 the class to which this drug principally belongs there are no controlled trials demonstrating risk reduction with olmesartan medoxomil tablets usp 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 it may be used alone or in combination with other antihypertensive agents olmesartan medoxomil tablets usp are an angiotensin ii receptor blocker arb indicated for the treatment of hypertension alone or with other antihypertensive agents to lower blood pressure lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events primarily strokes and myocardial infarctions 1" assertion.
- association label "desmopressin acetate injection is indicated for patients with hemophilia a with factor viii coagulant activity levels greater than 5 desmopressin acetate injection will often maintain hemostasis in patients with hemophilia a during surgical procedures and postoperatively when administered 3 minutes prior to scheduled procedure desmopressin acetate injection will also stop bleeding in hemophilia a patients with episodes of spontaneous or trauma induced injuries such as hemarthroses intramuscular hematomas or mucosal bleeding desmopressin acetate injection is not indicated for the treatment of hemophilia a with factor viii coagulant activity levels equal to or less than 5 or for the treatment of hemophilia b or in patients who have factor viii antibodies in certain clinical situations it may be justified to try desmopressin acetate injection in patients with factor viii levels between 2 to 5 however these patients should be carefully monitored desmopressin acetate injection is indicated for patients with mild to moderate classic von willebrand s disease type i with factor viii levels greater than 5 desmopressin acetate injection will often maintain hemostasis in patients with mild to moderate von willebrand s disease during surgical procedures and postoperatively when administered 3 minutes prior to the scheduled procedure desmopressin acetate injection will usually stop bleeding in mild to moderate von willebrand s patients with episodes of spontaneous or trauma induced injuries such as hemarthroses intramuscular hematomas or mucosal bleeding those von willebrand s disease patients who are least likely to respond are those with severe homozygous von willebrand s disease with factor viii coagulant activity and factor viii von willebrand factor antigen levels less than 1 other patients may respond in a variable fashion depending on the type of molecular defect they have bleeding time and factor viii coagulant activity ristocetin cofactor activity and von willebrand factor antigen should be checked during administration of desmopressin acetate injection to ensure that adequate levels are being achieved desmopressin acetate injection is not indicated for the treatment of severe classic von willebrand s disease type i and when there is evidence of an abnormal molecular form of factor viii antigen see warnings desmopressin acetate injection 4 mcg per ml is indicated as antidiuretic replacement therapy in the management of central cranial diabetes insipidus and for the management of the temporary polyuria and polydipsia following head trauma or surgery in the pituitary region desmopressin acetate injection is ineffective for the treatment of nephrogenic diabetes insipidus acetate injection is also available as an intranasal preparation however this means of delivery can be compromised by a variety of factors that can make nasal insufflation ineffective or inappropriate these include poor intranasal absorption nasal congestion and blockage nasal discharge atrophy of nasal mucosa and severe atrophic rhinitis intranasal delivery may be inappropriate where there is an impaired level of consciousness in addition cranial surgical procedures such as transsphenoidal hypophysectomy create situations where an alternative route of administration is needed as in cases of nasal packing or recovery from surgery" assertion.
- association label "gentamicin sulfate ophthalmic solution is indicated in the topical treatment of ocular bacterial infections including conjunctivitis keratitis keratoconjunctivitis corneal ulcers blepharitis blepharoconjunctivitis acute meibomianitis and dacryocystitis caused by susceptible strains of the following microorganisms staphylococcus aureus staphylococcus epidermidis streptococcus pyogenes streptococcus pneumoniae enterobacter aerogenes escherichia coli haemophilus influenzae klebsiella pneumoniae neisseria gonorrhoeae pseudomonas aeruginosa and serratia marcescens" assertion.
- association label "bortezomib for injection is a proteasome inhibitor indicated for treatment of patients with multiple myeloma 1 1 treatment of patients with mantle cell lymphoma who have received at least 1 prior therapy 1 2 bortezomib for injection is indicated for the treatment of patients with multiple myeloma bortezomib for injection is indicated for the treatment of patients with mantle cell lymphoma who have received at least 1 prior therapy" assertion.
- association label "molindone hydrochloride tablets usp are indicated for the management of schizophrenia the efficacy of molindone hydrochloride tablets usp in schizophrenia was established in clinical studies which enrolled newly hospitalized and chronically hospitalized acutely ill schizophrenic patients as subjects" assertion.
- association label "major depressive disorder the efficacy of paroxetine extended release tablets in the treatment of a major depressive episode was established in two 12 week controlled trials of outpatients whose diagnoses corresponded to the dsm iv category of major depressive disorder see clinical pharmacology clinical trials a major depressive episode dsm iv implies a prominent and relatively persistent nearly every day for at least 2 weeks depressed mood or loss of interest or pleasure in nearly all activities representing a change from previous functioning and includes the presence of at least 5 of the following 9 symptoms during the same 2 week period depressed mood markedly diminished interest or pleasure in usual activities significant change in weight and or appetite insomnia or hypersomnia psychomotor agitation or retardation increased fatigue feelings of guilt or worthlessness slowed thinking or impaired concentration a suicide attempt or suicidal ideation the antidepressant action of paroxetine in hospitalized depressed patients has not been adequately studied paroxetine extended release tablets have not been systematically evaluated beyond 12 weeks in controlled clinical trials however the effectiveness of immediate release paroxetine hydrochloride in maintaining a response in major depressive disorder for up to 1 year has been demonstrated in a placebo controlled trial see clinical pharmacology clinical trials see dosage and administration panic disorder the efficacy of paroxetine extended release tablets was established in two 1 week trials in panic disorder patients whose diagnoses corresponded to the dsm iv category of panic disorder see clinical pharmacology clinical trials panic disorder dsm iv is characterized by recurrent unexpected panic attacks i e a discrete period of intense fear or discomfort in which 4 or more of the following symptoms develop abruptly and reach a peak within 1 minutes 1 palpitations pounding heart or accelerated heart rate 2 sweating 3 trembling or shaking 4 sensations of shortness of breath or smothering 5 feeling of choking 6 chest pain or discomfort 7 nausea or abdominal distress 8 feeling dizzy unsteady lightheaded or faint 9 derealization feelings of unreality or depersonalization being detached from oneself 1 fear of losing control 11 fear of dying 12 paresthesias numbness or tingling sensations 13 chills or hot flushes long term maintenance of efficacy with the immediate release formulation of paroxetine was demonstrated in a 3 month relapse prevention trial in this trial patients with panic disorder assigned to immediate release paroxetine demonstrated a lower relapse rate compared to patients on placebo see clinical pharmacology clinical trials see dosage and administration social anxiety disorder the efficacy of paroxetine extended release tablets as a treatment for social anxiety disorder has been established in part on the basis of extrapolation from the established effectiveness of the immediate release formulation of paroxetine in addition the efficacy of paroxetine extended release tablets was established in a 12 week trial in adult outpatients with social anxiety disorder dsm iv paroxetine extended release tablets have not been studied in children or adolescents with social phobia see clinical pharmacology clinical trials the effectiveness of paroxetine extended release tablets in long term treatment of social anxiety disorder i e for more than 12 weeks has not been systematically evaluated in adequate and well controlled trials therefore the physician who elects to prescribe paroxetine extended release tablets for extended periods should periodically re evaluate the long term usefulness of the drug for the individual patient see dosage and administration premenstrual dysphoric disorder the efficacy of paroxetine extended release tablets in the treatment of pmdd has been established in 3 placebo controlled trials see clinical pharmacology clinical trials the essential features of pmdd according to dsm iv include markedly depressed mood anxiety or tension affective lability and persistent anger or irritability other features include decreased interest in usual activities difficulty concentrating lack of energy change in appetite or sleep and feeling out of control physical symptoms associated with pmdd include breast tenderness headache joint and muscle pain bloating and weight gain these symptoms occur regularly during the luteal phase and remit within a few days following the onset of menses the disturbance markedly interferes with work or school or with usual social activities and relationships with others in making the diagnosis care should be taken to rule out other cyclical mood disorders that may be exacerbated by treatment with an antidepressant the effectiveness of paroxetine extended release tablets in long term use that is for more than 3 menstrual cycles has not been systematically evaluated in controlled trials therefore the physician who elects to use paroxetine extended release tablets for extended periods should periodically re evaluate the long term usefulness of the drug for the individual patient see dosage and administration" assertion.
- association label "doxorubicin hydrochloride hcl for injection is an anthracycline topoisomerase ii inhibitor indicated as a component of multiagent adjuvant chemotherapy for treatment of women with axillary lymph node involvement following resection of primary breast cancer 1 1 for the treatment of acute lymphoblastic leukemia acute myeloblastic leukemia hodgkin lymphoma non hodgkin lymphoma metastatic breast cancer metastatic wilms tumor metastatic neuroblastoma metastatic soft tissue sarcoma metastatic bone sarcomas metastatic ovarian carcinoma metastatic transitional cell bladder carcinoma metastatic thyroid carcinoma metastatic gastric carcinoma metastatic bronchogenic carcinoma 1 2 doxorubicin hcl for injection is indicated as a component of multi agent adjuvant chemotherapy for treatment of women with axillary lymph node involvement following resection of primary breast cancer see clinical studies 14 doxorubicin hcl for injection is indicated for the treatment of acute lymphoblastic leukemia acute myeloblastic leukemia hodgkin lymphoma non hodgkin lymphoma nhl metastatic breast cancer metastatic wilms tumor metastatic neuroblastoma metastatic soft tissue sarcoma metastatic bone sarcoma metastatic ovarian carcinoma metastatic transitional cell bladder carcinoma metastatic thyroid carcinoma metastatic gastric carcinoma metastatic bronchogenic carcinoma" assertion.
- association label "teniposide injection in combination with other approved anticancer agents is indicated for induction therapy in patients with refractory childhood acute lymphoblastic leukemia" assertion.
- association label "fluconazole is indicated for the treatment of vaginal candidiasis vaginal yeast infections due to candida oropharyngeal and esophageal candidiasis in open noncomparative studies of relatively small numbers of patients fluconazole was also effective for the treatment of urinary tract infections peritonitis and systemic infections including candidemia disseminated candidiasis and pneumonia candida candida cryptococcal meningitis before prescribing fluconazole for aids patients with cryptococcal meningitis please see section studies comparing fluconazole to amphotericin b in non hiv infected patients have not been conducted clinical studies fluconazole is also indicated to decrease the incidence of candidiasis in patients undergoing bone marrow transplantation who receive cytotoxic chemotherapy and or radiation therapy specimens for fungal culture and other relevant laboratory studies serology histopathology should be obtained prior to therapy to isolate and identify causative organisms therapy may be instituted before the results of the cultures and other laboratory studies are known however once these results become available anti infective therapy should be adjusted accordingly" 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 "crixivan in combination with antiretroviral agents is indicated for the treatment of hiv infection this indication is based on two clinical trials of approximately 1 year duration that demonstrated 1 a reduction in the risk of aids defining illnesses or death 2 a prolonged suppression of hiv rna in all clinical studies with the exception of actg 32 the amplicor hiv monitor assay was used to determine the level of circulating hiv rna in serum this is an experimental use of the assay hiv rna results should not be directly compared to results from other trials using different hiv rna assays or using other sample sources study actg 32 was a multicenter randomized double blind clinical endpoint trial to compare the effect of crixivan in combination with zidovudine and lamivudine with that of zidovudine plus lamivudine on the progression to an aids defining illness adi or death patients were protease inhibitor and lamivudine naive and zidovudine experienced with cd4 cell counts of 2 cells mm 3 3 1 table 4 figures 1 2 table 4 actg 32 number of patients with aids defining illness or death endpoint idv zdv l zdv l idv indinavir zdv zidovudine l lamivudine hiv progression or death 35 6 1 63 1 9 death the number of deaths is inadequate to assess the impact of indinavir on survival 1 1 7 19 3 3 study actg 32 figure 1 indinavir protocol actg 32 zidovudine experienced plasma viral rna proportions below 4 copies ml study actg 32 figure 2 actg 32 zidovudine experienced cd4 cell counts mean change from baseline study 28 a double blind multicenter randomized clinical endpoint trial conducted in brazil compared the effects of crixivan plus zidovudine with those of crixivan alone or zidovudine alone on the progression to an adi or death and on surrogate marker responses all patients were antiretroviral naive with cd4 cell counts of 5 to 25 cells mm 3 3 1 table 5 figures 3 4 table 5 protocol 28 number of patients with aids defining illness or death endpoint idv zdv idv zdv hiv progression or death 21 6 3 27 8 1 62 18 7 death the number of deaths is inadequate to assess the impact of indinavir on survival 8 2 4 5 1 5 11 3 3 study 28 figure 3 indinavir protocol 28 zidovudine naive viral rna proportions below 5 copies ml in serum study 28 figure 4 indinavir protocol 28 zidovudine naive cd4 cell counts mean change from baseline study 35 was a multicenter randomized trial in 97 hiv 1 seropositive patients who were zidovudine experienced median exposure 3 months protease inhibitor and lamivudine naive with mean baseline cd4 count 175 cells mm 3 1 1 figures 5 6 7 study 35 figure 5 indinavir protocol 35 zidovudine experienced viral rna mean log1 change from baseline in serum study 35 figure 6 indinavir protocol 35 zidovudine experienced viral rna proportions below 5 copies ml in serum study 35 figure 7 indinavir protocol 35 zidovudine experienced cd4 cell counts mean change from baseline study 6 1 15 93 1 12 94 was a dose ranging study in which patients were initially treated with crixivan at a dose of 2 4 g day followed by 2 4 g day study 19 6 23 94 4 1 95 was a randomized comparison of crixivan 6 mg every 6 hours crixivan plus zidovudine and zidovudine alone table 6 table 6 genotypic resistance at 24 weeks treatment group resistance n includes patients with non amplifiable virus at 24 weeks who had amplifiable virus at week resistance idv 2 4 g day 31 37 84 2 4 g day 9 21 43 1 17 6 idv zdv 4 22 18 1 22 5 zdv 1 18 6 11 17 65" assertion.
- association label "to reduce the development of drug resistant bacteria and maintain the effectiveness of ery tab and other antibacterial drugs ery tab 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 r r ery tab tablets are indicated in the treatment of infections caused by susceptible strains of the designated microorganisms in the diseases listed below r upper respiratory tract infections of mild to moderate degree caused by when used concomitantly with adequate doses of sulfonamides since many strains of are not susceptible to the erythromycin concentrations ordinarily achieved see appropriate sulfonamide labeling for prescribing information streptococcus pyogenes streptococcus pneumoniae haemophilus influenzae h influenzae lower respiratory tract infections of mild to moderate severity caused by or streptococcus pyogenes streptococcus pneumoniae listeriosis caused by listeria monocytogenes respiratory tract infections due to mycoplasma pneumoniae skin and skin structure infections of mild to moderate severity caused by or resistant staphylococci may emerge during treatment streptococcus pyogenes staphylococcus aureus pertussis whooping cough caused by erythromycin is effective in eliminating the organism from the nasopharynx of infected individuals rendering them noninfectious some clinical studies suggest that erythromycin may be helpful in the prophylaxis of pertussis in exposed susceptible individuals bordetella pertussis diphtheria infections due to as an adjunct to antitoxin to prevent establishment of carriers and to eradicate the organism in carriers corynebacterium diphtheriae erythrasma in the treatment of infections due to corynebacterium minutissimum intestinal amebiasis caused by oral erythromycins only extraenteric amebiasis requires treatment with other agents entamoeba histolytica acute pelvic inflammatory disease caused by erythrocin lactobionate i v erythromycin lactobionate for injection usp followed by erythromycin base orally as an alternative drug in treatment of acute pelvic inflammatory disease caused by in female patients with a history of sensitivity to penicillin patients should have a serologic test for syphilis before receiving erythromycin as treatment of gonorrhea and a follow up serologic test for syphilis after 3 months neisseria gonorrhoeae r n gonorrhoeae erythromycins are indicated for treatment of the following infections caused by conjunctivitis of the newborn pneumonia of infancy and urogenital infections during pregnancy when tetracyclines are contraindicated or not tolerated erythromycin is indicated for the treatment of uncomplicated urethral endocervical or rectal infections in adults due to chlamydia trachomatis chlamydia trachomatis when tetracyclines are contraindicated or not tolerated erythromycin is indicated for the treatment of nongonococcal urethritis caused by ureaplasma urealyticum primary syphilis caused by erythromycin oral forms only is an alternative choice of treatment for primary syphilis in patients allergic to the penicillins in treatment of primary syphilis spinal fluid should be examined before treatment and as part of the follow up after therapy treponema pallidum legionnaires disease caused by although no controlled clinical efficacy studies have been conducted and limited preliminary clinical data suggest that erythromycin may be effective in treating legionnaires disease legionella pneumophila in vitro penicillin is considered by the american heart association to be the drug of choice in the prevention of initial attacks of rheumatic fever treatment of streptococcus pyogenes infections of the upper respiratory tract e g tonsillitis or pharyngitis erythromycin is indicated for the treatment of penicillin allergic patients the therapeutic dose should be administered for ten days 4 penicillin or sulfonamides are considered by the american heart association to be the drugs of choice in the prevention of recurrent attacks of rheumatic fever in patients who are allergic to penicillin and sulfonamides oral erythromycin is recommended by the american heart association in the long term prophylaxis of streptococcal pharyngitis for the prevention of recurrent attacks of rheumatic fever 4" assertion.
- association label "paliperidone is an atypical antipsychotic agent indicated for treatment of schizophrenia 1 1 adults efficacy was established in three 6 week trials and one maintenance trial 14 1 adolescents ages 12 to 17 efficacy was established in one 6 week trial 14 1 treatment of schizoaffective disorder as monotherapy and as an adjunct to mood stabilizers and or antidepressants 1 2 efficacy was established in two 6 week trials in adult patients 14 2 paliperidone extended release tablets are indicated for the treatment of schizophrenia see clinical studies 14 1 the efficacy of paliperidone in schizophrenia was established in three 6 week trials in adults and one 6 week trial in adolescents as well as one maintenance trial in adults paliperidone extended release tablets are indicated for the treatment of schizoaffective disorder as monotherapy and an adjunct to mood stabilizers and or antidepressant therapy see clinical studies 14 2 the efficacy of paliperidone in schizoaffective disorder was established in two 6 week trials in adults" assertion.
- association label "fluocinolone acetonide topical oil is a corticosteroid indicated for the topical treatment of atopic dermatitis in adult patients 1 1 topical treatment of moderate to severe atopic dermatitis in pediatric patients 3 months and older for up to 4 weeks 1 2 limitations of use apply the least amount to cover affected areas discontinue when disease is controlled 1 3 do not use in the diaper area 1 3 do not use on the face axillae or groin 1 3 6 2 8 4 fluocinolone acetonide topical oil is indicated for the topical treatment of atopic dermatitis in adult patients fluocinolone acetonide topical oil is indicated for the topical treatment of moderate to severe atopic dermatitis in pediatric patients 3 months and older for up to 4 weeks safety and effectiveness in pediatric patients younger than 3 months of age have not been established apply the least amount of fluocinolone acetonide topical oil needed to cover the affected areas as with other corticosteroids fluocinolone acetonide topical oil should be discontinued when control of disease is achieved contact the physician if no improvement is seen within 2 weeks fluocinolone acetonide topical oil should not be applied to the diaper area diapers or plastic pants may constitute occlusive use fluocinolone acetonide topical oil should not be used on the face axillae or groin unless directed by the physician application to intertriginous areas should be avoided due to the increased risk of local adverse reactions see adverse reactions 6 use in specific populations 8 4" assertion.
- association label "a intravenous or intramuscular administration 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 those products labeled for intravenous or intramuscular use are indicated as follows 1 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 acute adrenocortical insufficiency hydrocortisone or cortisone is the drug of choice mineralocorticoid supplementation may be necessary particularly when synthetic analogs are used preoperatively and in the event of serious trauma or illness in patients with known adrenal insufficiency or when adrenocortical reserve is doubtful shock unresponsive to conventional therapy if adrenocortical insufficiency exists or is suspected 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 post traumatic osteoarthritis synovitis of osteoarthritis rheumatoid arthritis including juvenile rheumatoid arthritis selected cases may require low dose maintenance therapy acute and subacute bursitis epicondylitis acute nonspecific tenosynovitis acute gouty arthritis psoriatic arthritis ankylosing spondylitis 3 collagen diseases during an exacerbation or as maintenance therapy in selected cases of systemic lupus erythematosus acute rheumatic carditis 4 dermatologic diseases pemphigus severe erythema multiforme stevens johnson syndrome exfoliative dermatitis bullous dermatitis herpetiformis severe seborrheic dermatitis severe psoriasis mycosis fungoides 5 allergic states control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in bronchial asthma contact dermatitis atopic dermatitis serum sickness seasonal or perennial allergic rhinitis drug hypersensitivity reactions urticarial transfusion reactions acute noninfectious laryngeal edema epinephrine is the drug of first choice 6 ophthalmic diseases severe acute and chronic allergic and inflammatory processes involving the eye such as herpes zoster ophthalmicus iritis iridocyclitis chorioretinitis diffuse posterior uveitis and choroiditis optic neuritis sympathetic ophthalmia anterior segment inflammation allergic conjunctivitis allergic corneal marginal ulcers keratitis 7 gastrointestinal diseases to tide the patient over a critical period of the disease in ulcerative colitis systemic therapy regional enteritis systemic therapy 8 respiratory diseases symptomatic sarcoidosis berylliosis fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate anti tuberculosis chemotherapy loeffler s syndrome not manageable by other means aspiration pneumonitis 9 hematologic disorders acquired autoimmune hemolytic anemia idiopathic thrombocytopenic purpura in adults i v only i m administration is contraindicated secondary thrombocytopenia in adults erythroblastopenia rbc anemia congenital erythroid hypoplastic anemia 1 neoplastic diseases for palliative management of leukemias and lymphomas in adults acute leukemic of childhood 11 edematous states to induce diuresis or remission of proteinuria in the nephrotic syndrome without uremia of the idiopathic type or that due to lupus erythematosus 12 nervous system acute exacerbations of multiple sclerosis 13 miscellaneous tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate anti tuberculosis chemotherapy trichinosis with neurologic or myocardial involvement diagnostic testing of adrenocortical hyperfunction cerebral edema of diverse etiologies in conjunction with adequate neurological evaluation and management b intra articular or soft tissue administration when the strength and dosage form of the drug lend the preparation to the treatment of the condition those products labeled for intra articular or soft tissue administration are indicated as adjunctive therapy for short term administration to tide the patient over an acute episode or exacerbation in synovitis of osteoarthritis rheumatoid arthritis acute and subacute bursitis acute gouty arthritis epicondylitis acute nonspecific tenosynovitis post traumatic osteoarthritis c intralesional administration when the strength and dosage form of the drug lend the preparation to the treatment of the condition those products labeled for intralesional administration are indicated for keloids localized hypertrophic infiltrated inflammatory lesions of lichen planus psoriatic plaques granuloma annulare and lichen simplex chronicus neurodermatitis discoid lupus erythematosus necrobiosis lipoidica diabeticorum alopecia areata they also may be useful in cystic tumors of an aponeurosis tendon ganglia" assertion.
- association label "cefixime is a cephalosporin antibacterial drug indicated in the treatment of adults and pediatric patients six months and older with the following infections uncomplicated urinary tract infections 1 1 otitis media 1 2 pharyngitis and tonsillitis 1 3 acute exacerbations of chronic bronchitis 1 4 uncomplicated gonorrhea cervical urethral 1 5 to reduce the development of drug resistant bacteria and maintain the effectiveness of cefixime and other antibacterial drugs cefixime for oral suspension and cefixime capsules should be used only to treat infections that are proven or strongly suspected to be caused by bacteria 1 6 cefixime for oral suspension and cefixime capsule is indicated in the treatment of adults and pediatric patients six months of age or older with uncomplicated urinary tract infections caused by susceptible isolates of escherichia coli proteus mirabilis cefixime for oral suspension and cefixime capsule is indicated in the treatment of adults and pediatric patients six months of age or older with otitis media caused by susceptible isolates of haemophilus influenzae moraxella catarrhalis streptococcus pyogenes streptococcus pyogenes note for patients with otitis media caused by streptococcus pneumoniae see clinical studies 14 cefixime for oral suspension and cefixime capsule is indicated in the treatment of adults and pediatric patients six months of age or older with pharyngitis and tonsillitis caused by susceptible isolates of streptococcus pyogenes note penicillin is the usual drug of choice in the treatment of streptococcus pyogenes infections cefixime for oral suspension and cefixime capsule is generally effective in the eradication of streptococcus pyogenes from the nasopharynx however data establishing the efficacy of cefixime for oral suspension and cefixime capsule in the subsequent prevention of rheumatic fever is not available cefixime for oral suspension and cefixime capsule is indicated in the treatment of adults and pediatric patients six months of age or older with acute exacerbations of chronic bronchitis caused by susceptible isolates of streptococcus pneumoniae haemophilus influenzae cefixime for oral suspension and cefixime capsule is indicated in the treatment of adults and pediatric patients six months of age or older with uncomplicated gonorrhea cervical urethral caused by susceptible isolates of neisseria gonorrhoeae to reduce the development of drug resistant bacteria and maintain the effectiveness of cefixime and other antibacterial drugs cefixime for oral suspension and cefixime capsule 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 antimicrobial 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 r r 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 rheumatic disorders the intra articular or soft tissue administration the intralesional administration celestone soluspan injectable suspension may also be useful in cystic tumors of an aponeurosis or tendon ganglia" assertion.
- association label "eraxis is indicated for use in adults for the treatment of the following fungal infections listed below specimens for fungal culture and other relevant laboratory studies including histopathology should be obtained prior to therapy to isolate and identify causative organism s therapy may be instituted before the results of the cultures and other laboratory studies known however once these results become available antifungal therapy should be adjusted accordingly anidulafungin is an echinocandin antifungal indicated in adults for the treatment of candidemia and other forms of candida 1 1 esophageal candidiasis 1 2 limitations of use has not been studied in endocarditis osteomyelitis and meningitis due to candida 1 3 eraxis is indicated for the treatment of candidemia and the following candida see clinical studies 14 1 clinical pharmacology microbiology 12 4 eraxis is indicated for the treatment of esophageal candidiasis see clinical studies 14 2 table 1 eraxis has not been studied in endocarditis osteomyelitis and meningitis due to candida" assertion.
- association label "before instituting treatment with ceftriaxone appropriate specimens should be obtained for isolation of the causative organism and for determination of its susceptibility to the drug therapy may be instituted prior to obtaining results of susceptibility testing to reduce the development of drug resistant bacteria and maintain the effectiveness of ceftriaxone for injection usp and other antibacterial drugs ceftriaxone for injection 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 ceftriaxone for injection usp is indicated for the treatment of the following infections when caused by susceptible organisms lower respiratory tract infections caused by streptococcus pneumoniae staphylococcus aureus haemophilus influenzae haemophilus parainfluenzae klebsiella pneumoniae escherichia coli enterobacter aerogenes proteus mirabilis serratia marcescens acute bacterial otitis media caused by streptococcus pneumoniae haemophilus influenzae moraxella catarrhalis note in one study lower clinical cure rates were observed with a single dose of ceftriaxone for injection usp compared to 1 days of oral therapy in a second study comparable cure rates were observed between single dose ceftriaxone for injection usp and the comparator the potentially lower clinical cure rate of ceftriaxone for injection usp should be balanced against the potential advantages of parenteral therapy see clinical studies skin and skin structure infections caused by staphylococcus aureus staphylococcus epidermidis streptococcus pyogenes escherichia coli enterobacter cloacae klebsiella oxytoca klebsiella pneumoniae proteus mirabilis morganella morganii pseudomonas aeruginosa serratia marcescens acinetobacter calcoaceticus bacteroides fragilis peptostreptococcus urinary tract infections complicated and uncomplicated caused by escherichia coli proteus mirabilis proteus vulgaris morganella morganii klebsiella pneumoniae uncomplicated gonorrhea cervical urethral and rectal caused by neisseria gonorrhoeae neisseria gonorrhoeae pelvic inflammatory disease caused by neisseria gonorrhoeae chlamydia trachomatis chlamydia trachomatis bacterial septicemia caused by staphylococcus aureus streptococcus pneumoniae escherichia coli haemophilus influenzae klebsiella pneumoniae bone and joint infections caused by staphylococcus aureus streptococcus pneumoniae escherichia coli proteus mirabilis klebsiella pneumoniae enterobacter intra abdominal infections caused by escherichia coli klebsiella pneumoniae bacteroides fragilis clostridium clostridium difficile peptostreptococcus meningitis caused by haemophilus influenzae neisseria meningitidis streptococcus pneumoniae staphylococcus epidermidis escherichia coli efficacy for this organism in this organ system was studied in fewer than ten infections surgical prophylaxis the preoperative administration of a single 1 g dose of ceftriaxone for injection usp may reduce the incidence of postoperative infections in patients undergoing surgical procedures classified as contaminated or potentially contaminated e g vaginal or abdominal hysterectomy or cholecystectomy for chronic calculous cholecystitis in high risk patients such as those over 7 years of age with acute cholecystitis not requiring therapeutic antimicrobials obstructive jaundice or common duct bile stones and in surgical patients for whom infection at the operative site would present serious risk e g during coronary artery bypass surgery although ceftriaxone for injection usp has been shown to have been as effective as cefazolin in the prevention of infection following coronary artery bypass surgery no placebo controlled trials have been conducted to evaluate any cephalosporin antibiotic in the prevention of infection following coronary artery bypass surgery when administered prior to surgical procedures for which it is indicated a single 1 g dose of ceftriaxone for injection usp provides protection from most infections due to susceptible organisms throughout the course of the procedure" 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 "ampicillin for injection usp is indicated in the treatment of infections caused by susceptible strains of the designated organisms in the following conditions respiratory tract infections treptococcus pneumoniae staphylococcus aureus h influenzae bacterial meningitis septicemia and endocarditis streptococcus spp e coli proteus mirabilis and salmonella spp urinary tract infections e coli roteus mirabilis gastrointestinal infections salmonella typhi salmonella spp shigella spp bacteriology studies to determine the causative organisms and their susceptibility to ampicillin should be performed therapy may be instituted prior to obtaining results of susceptibility testing it is advisable to reserve the parenteral form of this drug for moderately severe and severe infections and for patients who are unable to take the oral forms a change to oral ampicillin may be made as soon as appropriate to reduce the development of drug resistant bacteria and maintain the effectiveness of ampicillin for injection usp and other antibacterial drugs ampicillin for injection 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 indicated surgical procedures should be performed" assertion.
- association label "prazosin hydrochloride capsules 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 prazosin hydrochloride capsules usp can be used alone or in combination with other antihypertensive drugs such as diuretics or beta adrenergic blocking agents" assertion.
- association label "docetaxel injection is a microtubule inhibitor indicated for breast cancer bc single agent for locally advanced or metastatic bc after chemotherapy failure and with doxorubicin and cyclophosphamide as adjuvant treatment of operable node positive bc 1 1 non small cell lung cancer nsclc single agent for locally advanced or metastatic nsclc after platinum therapy failure and with cisplatin for unresectable locally advanced or metastatic untreated nsclc 1 2 hormone refractory prostate cancer hrpc with prednisone in androgen independent hormone refractory metastatic prostate cancer 1 3 gastric adenocarcinoma gc with cisplatin and fluorouracil for untreated advanced gc including the gastroesophageal junction 1 4 squamous cell carcinoma of the head and neck cancer scchn with cisplatin and fluorouracil for induction treatment of locally advanced scchn 1 5 docetaxel injection is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of prior chemotherapy docetaxel injection in combination with doxorubicin and cyclophosphamide is indicated for the adjuvant treatment of patients with operable node positive breast cancer docetaxel injection as a single agent is indicated for the treatment of patients with locally advanced or metastatic non small cell lung cancer after failure of prior platinum based chemotherapy docetaxel injection in combination with cisplatin is indicated for the treatment of patients with unresectable locally advanced or metastatic non small cell lung cancer who have not previously received chemotherapy for this condition docetaxel injection in combination with prednisone is indicated for the treatment of patients with androgen independent hormone refractory metastatic prostate cancer docetaxel injection in combination with cisplatin and fluorouracil is indicated for the treatment of patients with advanced gastric adenocarcinoma including adenocarcinoma of the gastroesophageal junction who have not received prior chemotherapy for advanced disease docetaxel injection in combination with cisplatin and fluorouracil is indicated for the induction treatment of patients with locally advanced squamous cell carcinoma of the head and neck scchn" 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 "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 "methimazole is indicated in the medical treatment of hyperthyroidism long term therapy may lead to remission of the disease methimazole may be used to ameliorate hyperthyroidism in preparation for subtotal thyroidectomy or radioactive iodine therapy methimazole is also used when thyroidectomy is contraindicated or not advisable" assertion.
- association label "for endometriosis see reverse side synarel is indicated for treatment of central precocious puberty cpp the diagnosis of central precocious puberty cpp for central precocious puberty see reverse side synarel is indicated for management of endometriosis including pain relief and reduction of endometriotic lesions experience with synarel for the management of endometriosis has been limited to women 18 years of age and older treated for 6 months" 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 "voriconazole for injection is an azole antifungal indicated for the treatment of adults and pediatric patients 2 years of age and older with invasive aspergillosis 1 1 candidemia non neutropenics and other deep tissue candida 1 2 esophageal candidiasis 1 3 serious fungal infections caused by scedosporium apiospermum fusarium fusarium solani 1 4 voriconazole is indicated in adults and pediatric patients 2 years of age and older for the treatment of invasive apergillosis ia in clinical trials the majority of isolates recovered were aspergillus fumigatus there was a small number of cases of culture proven disease due to species of aspergillus other than a fumigatus see clinical studies 14 1 14 5 12 4 voriconazole is indicated in adults and pediatric patients 2 years of age and older for the treatment of candidemia in non neutropenic patients and the following candida infections disseminated infections in skin and infections in abdomen kidney bladder wall and wounds see clinical studies 14 2 14 5 12 4 voriconazole is indicated in adults and pediatric patients 2 years of age and older for the treatment of esophageal candidiasis ec in adults and pediatric patients 2 years of age and older see clinical studies 14 3 14 5 12 4 voriconazole is indicated for the treatment of serious fungal infections caused by scedosporium apiospermum asexual form of pseudallescheria boydii and fusarium spp including fusarium solani in adults and pediatric patients 2 years of age and older intolerant of or refractory to other therapy see clinical studies 14 4 12 4 specimens for fungal culture and other relevant laboratory studies including histopathology should be obtained prior to therapy to isolate and identify causative organism s therapy may be instituted before the results of the cultures and other laboratory studies are known however once these results become available antifungal therapy should be adjusted accordingly" assertion.
- association label "attention deficit disorders narcolepsy attention deficit disorders methylphenidate hydrochloride chewable tablets are indicated as an integral part of a total treatment program which typically includes other remedial measures psychological educational social for a stabilizing effect in children with a behavioral syndrome characterized by the following group of developmentally inappropriate symptoms moderate to severe distractibility short attention span hyperactivity emotional lability and impulsivity the diagnosis of this syndrome should not be made with finality when these symptoms are only of comparatively recent origin nonlocalizing soft neurological signs learning disability and abnormal eeg may or may not be present and a diagnosis of central nervous system dysfunction may or may not be warranted special diagnostic considerations specific etiology of this syndrome is unknown and there is no single diagnostic test adequate diagnosis requires the use not only of medical but of special psychological educational and social resources characteristics commonly reported include chronic history of short attention span distractibility emotional lability impulsivity and moderate to severe hyperactivity minor neurological signs and abnormal eeg learning may or may not be impaired the diagnosis must be based upon a complete history and evaluation of the child and not solely on the presence of one or more of these characteristics drug treatment is not indicated for all children with this syndrome stimulants are not intended for use in the child who exhibits symptoms secondary to environmental factors and or primary psychiatric disorders including psychosis appropriate educational placement is essential and psychosocial intervention is generally necessary 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 child s symptoms" assertion.
- association label "carmustine for injection usp is indicated as palliative therapy as a single agent or in established combination therapy in the following brain tumors glioblastoma brainstem glioma medulloblastoma astrocytoma ependymoma and metastatic brain tumors multiple myeloma in combination with prednisone relapsed or refractory hodgkin s lymphoma in combination with other approved drugs relapsed or refractory non hodgkin s lymphomas in combination with other approved drugs carmustine for injection usp is a nitrosourea indicated as palliative therapy as a single agent or in established combination therapy with other approved chemotherapeutic agents in the following brain tumors glioblastoma brainstem glioma medulloblastoma astrocytoma ependymoma and metastatic brain tumors 1 multiple myeloma in combination with prednisone 1 relapsed or refractory hodgkin s lymphoma in combination with other approved drugs 1 relapsed or refractory non hodgkin s lymphomas in combination with other approved drugs 1" assertion.
- association label "tirosint is l thyroxine t4 indicated for adults and pediatric patients 6 years and older with hypothyroidism as replacement therapy in primary thyroidal secondary pituitary and tertiary hypothalamic congenital or acquired hypothyroidism 1 pituitary thyrotropin thyroid stimulating hormone tsh suppression as an adjunct to surgery and radioiodine therapy in the management of thyrotropin dependent well differentiated thyroid cancer 1 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 transient hypothyroidism during the recovery phase of subacute thyroiditis 1 hypothyroidism tirosint is indicated as a replacement therapy in adults and pediatric patients 6 years and older with primary thyroidal secondary pituitary and tertiary hypothalamic congenital or acquired hypothyroidism pituitary thyrotropin thyroid stimulating hormone tsh suppression tirosint is indicated as an adjunct to surgery and radioiodine therapy in the management of adults and pediatric patients 6 years and older with thyrotropin dependent well differentiated thyroid cancer limitations of use tirosint 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 tirosint may induce hyperthyroidism see warnings and precautions 5 4 tirosint is not indicated for treatment of transient hypothyroidism during the recovery phase of subacute thyroiditis" assertion.
- association label "risedronate sodium tablets are a bisphosphonate indicated for treatment and prevention of postmenopausal osteoporosis 1 1 treatment to increase bone mass in men with osteoporosis 1 2 treatment and prevention of glucocorticoid induced osteoporosis 1 3 treatment of paget s disease 1 4 limitations of use optimal duration of use has not been determined for patients at low risk for fracture consider drug discontinuation after 3 to 5 years of use 1 5 risedronate sodium tablets are indicated for the treatment and prevention of osteoporosis in postmenopausal women in postmenopausal women with osteoporosis risedronate sodium tablets reduce the incidence of vertebral fractures and a composite endpoint of nonvertebral osteoporosis related fractures see clinical studies 14 1 14 2 risedronate sodium tablets are indicated for treatment to increase bone mass in men with osteoporosis risedronate sodium tablets are indicated for the treatment and prevention of glucocorticoid induced osteoporosis in men and women who are either initiating or continuing systemic glucocorticoid treatment daily dosage of greater than or equal to 7 5 mg of prednisone or equivalent for chronic diseases patients treated with glucocorticoids should receive adequate amounts of calcium and vitamin d risedronate sodium tablets are indicated for treatment of paget s disease of bone in men and women the optimal duration of use has not been determined the safety and effectiveness of risedronate sodium tablets for the treatment of osteoporosis are based on clinical data of three years duration 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 "prozac is indicated for the treatment of major depressive disorder adult see clinical trials a major depressive episode dsm iv implies a prominent and relatively persistent nearly every day for at least 2 weeks depressed or dysphoric mood that usually interferes with daily functioning and includes at least 5 of the following 9 symptoms depressed mood loss of interest in usual activities significant change in weight and or appetite insomnia or hypersomnia psychomotor agitation or retardation increased fatigue feelings of guilt or worthlessness slowed thinking or impaired concentration a suicide attempt or suicidal ideation the effects of prozac in hospitalized depressed patients have not been adequately studied the efficacy of prozac 2 mg once daily in maintaining a response in major depressive disorder for up to 38 weeks following 12 weeks of open label acute treatment 5 weeks total was demonstrated in a placebo controlled trial the efficacy of prozac weekly once weekly in maintaining a response in major depressive disorder has been demonstrated in a placebo controlled trial for up to 25 weeks following open label acute treatment of 13 weeks with prozac 2 mg daily for a total treatment of 38 weeks however it is unknown whether or not prozac weekly given on a once weekly basis provides the same level of protection from relapse as that provided by prozac 2 mg daily see clinical trials pediatric children and adolescents see clinical trials the usefulness of the drug in adult and pediatric patients receiving fluoxetine for extended periods should be reevaluated periodically adult the efficacy of prozac was established in 13 week trials with obsessive compulsive outpatients whose diagnoses corresponded most closely to the dsm iii r category of ocd see clinical trials ocd is characterized by recurrent and persistent ideas thoughts impulses or images obsessions that are ego dystonic and or repetitive purposeful and intentional behaviors compulsions that are recognized by the person as excessive or unreasonable the effectiveness of prozac in long term use i e for more than 13 weeks has not been systematically evaluated in placebo controlled trials therefore the physician who elects to use prozac for extended periods should periodically reevaluate the long term usefulness of the drug for the individual patient see dosage and administration pediatric children and adolescents see clinical trials prozac is indicated for the treatment of binge eating and vomiting behaviors in patients with moderate to severe bulimia nervosa the efficacy of prozac was established in 8 to 16 week trials for adult outpatients with moderate to severe bulimia nervosa i e at least 3 bulimic episodes per week for 6 months see clinical trials the efficacy of prozac 6 mg day in maintaining a response in patients with bulimia who responded during an 8 week acute treatment phase while taking prozac 6 mg day and were then observed for relapse during a period of up to 52 weeks was demonstrated in a placebo controlled trial see clinical trials see dosage and administration prozac is indicated for the treatment of panic disorder with or without agoraphobia as defined in dsm iv panic disorder is characterized by the occurrence of unexpected panic attacks and associated concern about having additional attacks worry about the implications or consequences of the attacks and or a significant change in behavior related to the attacks the efficacy of prozac was established in two 12 week clinical trials in patients whose diagnoses corresponded to the dsm iv category of panic disorder see clinical trials panic disorder dsm iv is characterized by recurrent unexpected panic attacks i e a discrete period of intense fear or discomfort in which 4 or more of the following symptoms develop abruptly and reach a peak within 1 minutes 1 palpitations pounding heart or accelerated heart rate 2 sweating 3 trembling or shaking 4 sensations of shortness of breath or smothering 5 feeling of choking 6 chest pain or discomfort 7 nausea or abdominal distress 8 feeling dizzy unsteady lightheaded or faint 9 fear of losing control 1 fear of dying 11 paresthesias numbness or tingling sensations 12 chills or hot flashes the effectiveness of prozac in long term use i e for more than 12 weeks has not been established in placebo controlled trials therefore the physician who elects to use prozac for extended periods should periodically reevaluate the long term usefulness of the drug for the individual patient see dosage and administration" assertion.
- association label "androxy tm testicular failure due to cryptorchidism bilateral torsion orchitis vanishing testis syndrome or orchidectomy idiopathic gonadotropin or luteinizing hormone releasing hormone lhrh deficiency or pituitary hypothalamic injury from tumors trauma or radiation appropriate adrenal cortical and thyroid hormone replacement therapy are still necessary however and are actually of primary importance if the above conditions occur prior to puberty androgen replacement therapy will be needed during the adolescent years for development of secondary sexual characteristics prolonged androgen treatment will be required to maintain sexual characteristics in these and other males who develop testosterone deficiency after puberty androxy tm see warnings androxy tm" 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 "dactinomycin for injection as part of a combination chemotherapy and or multi modality treatment regimen is indicated for the treatment of wilms tumor childhood rhabdomyosarcoma ewing s sarcoma and metastatic nonseminomatous testicular cancer dactinomycin for injection is indicated as a single agent or as part of a combination chemotherapy regimen for the treatment of gestational trophoblastic neoplasia dactinomycin for injection as a component of regional perfusion is indicated for the palliative and or adjunctive treatment of locally recurrent or locoregional solid malignancies" 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 "terbutaline sulfate injection usp is indicated for the prevention and reversal of bronchospasm in patients 12 years of age and older with asthma and reversible bronchospasm associated with bronchitis and emphysema" 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 "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 "methylprednisolone tablets usp are indicated in the following conditions 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 as adjunctive therapy for short term administration to tide the patient over an acute episode or exacerbation in during an exacerbation or as maintenance therapy in selected cases of bullous dermatitis herpetiformis severe erythema multiforme stevens johnson syndrome severe seborrheic dermatitis exfoliative dermatitis mycosis fungoides pemphigus severe psoriasis control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment seasonal or perennial allergic rhinitis drug hypersensitivity reactions serum sickness contact dermatitis bronchial asthma atopic dermatitis 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 keratitis optic neuritis allergic conjunctivitis chorioretinitis iritis and iridocyclitis symptomatic sarcoidosis berylliosis loeffler s syndrome not manageable by other means fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy aspiration pneumonitis idiopathic thrombocytopenic purpura in adults secondary thrombocytopenia in adults acquired autoimmune hemolytic anemia erythroblastopenia rbc anemia congenital erythroid hypoplastic anemia for palliative management of leukemias and lymphomas in adults acute leukemia of childhood to induce a diuresis or remission of proteinuria in the nephrotic syndrome without uremia of the idiopathic type or that due to lupus erythematosus to tide the patient over a critical period of the disease in ulcerative colitis regional enteritis acute exacerbations of multiple sclerosis tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy trichinosis with neurologic or myocardial involvement" 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 "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 "pantoprazole sodium delayed release tablets are indicated for pantoprazole sodium delayed release tablet is a proton pump inhibitor indicated for the following short term treatment of erosive esophagitis associated with gastroesophageal reflux disease gerd 1 1 maintenance of healing of erosive esophagitis 1 2 pathological hypersecretory conditions including zollinger ellison syndrome 1 3 pantoprazole sodium delayed release tablets are indicated in adults for the short term treatment up to 8 weeks in the healing and symptomatic relief of erosive esophagitis for those adult patients who have not healed after 8 weeks of treatment an additional 8 week course of pantoprazole sodium delayed release tablets may be considered safety of treatment beyond 8 weeks in pediatric patients has not been established pediatric indication and usage information in pediatric patients ages five years and older with erosive esophagitis associated with gerd is approved for wyeth pharmaceuticals inc s pantoprazole sodium delayed release tablets however due to wyeth pharmaceuticals inc s marketing exclusivity rights this drug product is not labeled with that pediatric information pantoprazole sodium delayed release tablets are indicated for maintenance of healing of erosive esophagitis and reduction in relapse rates of daytime and nighttime heartburn symptoms in adult patients with gerd controlled studies did not extend beyond 12 months pantoprazole sodium delayed release tablets are indicated for the long term treatment of pathological hypersecretory conditions including zollinger ellison syndrome" assertion.
- association label "dorzolamide hydrochloride ophthalmic solution 2 is indicated in the treatment of elevated intraocular pressure in patients with ocular hypertension or open angle glaucoma dorzolamide hydrochloride ophthalmic solution 2 is a carbonic anhydrase inhibitor indicated in the treatment of elevated intraocular pressure in patients with ocular hypertension or open angle glaucoma 1" assertion.
- cohort label "Adults" assertion.
- association label "Other off-label therapies that have been used to treat HSDD include transdermal testosterone for peri- and post-menopausal women, and oral bupropion and buspirone" assertion.
- MONDO_0001821 label "Hypoactive sexual desire disorder (HSDD)" assertion.
- MONDO_0001821 label "Hypoactive sexual desire disorder (HSDD)" assertion.
- MONDO_0001821 label "Hypoactive sexual desire disorder (HSDD)" assertion.
- association label "Other off-label therapies that have been used to treat HSDD include transdermal testosterone for peri- and post-menopausal women, and oral bupropion and buspirone" assertion.
- cohort label "Adults" assertion.
- association label "Patients with irritable bowel syndrome have long been known to benefit from TCAs; the number needed to treat for symptomatic benefit over placebo is 3.5" assertion.
- cohort label "Adults" assertion.
- association label "Based on a randomized, double-blind trial,35 amitriptyline was recommended as a treatment option for interstitial cystitis or bladder pain, with the greatest symptom improvement in patients tolerating a daily dose of 50 mg" assertion.
- cohort label "Adults" assertion.
- MONDO_0018301 label "Interstitial cystitis" assertion.
- MONDO_0018301 label "Interstitial cystitis" assertion.
- cohort label "Adults" assertion.
- association label "TCAs can serve as first-line or augmenting drugs for neuropathic pain, headache, migraine, gastrointestinal syndromes, fibromyalgia, pelvic pain, insomnia, and psychiatric conditions other than depression." assertion.
- association label "glipizide tablets are indicated as an adjunct to diet for the control of hyperglycemia and its associated symptomatology in patients with non insulin dependent diabetes mellitus niddm type ii formerly known as maturity onset diabetes after an adequate trial of dietary therapy has proved unsatisfactory in initiating treatment for non insulin dependent diabetes diet should be emphasized as the primary form of treatment caloric restriction and weight loss are essential in the obese diabetic patient proper dietary management alone may be effective in controlling the blood glucose and symptoms of hyperglycemia the importance of regular physical activity should also be stressed and cardiovascular risk factors should be identified and corrective measures taken where possible if this treatment program fails to reduce symptoms and or blood glucose the use of an oral sulfonylurea or insulin should be considered use of glipizide must be viewed by both the physician and patient as a treatment in addition to diet and not as a substitute for diet or as a convenient mechanism for avoiding dietary restraint furthermore loss of blood glucose control on diet alone also may be transient thus requiring only short term administration of glipizide during maintenance programs glipizide should be discontinued if satisfactory lowering of blood glucose is no longer achieved judgements should be based on regular clinical and laboratory evaluations in considering the use of glipizide in asymptomatic patients it should be recognized that controlling blood glucose in non insulin dependent diabetes has not been definitely established to be effective in preventing the long term cardiovascular or neural complications of diabetes" 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 intramuscular use of solu medrol 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 selected 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 "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 "doryx mpc is a tetracycline class drug 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 in acute intestinal amebiasis and severe acne 1 8 prophylaxis of malaria 1 9 usage to reduce the development of drug resistant bacteria and maintain the effectiveness of doxycycline hyclate doryx mpc and other antibacterial drugs doryx mpc tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria 1 1 doryx mpc is indicated for treatment of rocky mountain spotted fever typhus fever and the typhus group q fever rickettsialpox and tick fevers caused by rickettsiae doryx mpc is indicated for treatment of the following sexually transmitted infections uncomplicated urethral endocervical or rectal infections in adults 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 doryx mpc is 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 haemophilus influenzae klebsiella streptococcus pneumoniae doryx mpc is 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 doryx mpc is 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 species acinetobacter species urinary tract infections caused by klebsiella species doryx mpc is indicated for treatment of the following ophthalmic infections trachoma caused by chlamydia trachomatis inclusion conjunctivitis caused by chlamydia trachomatis doryx mpc is indicated for treatment of anthrax due to bacillus anthracis bacillus anthracis doryx mpc is indicated 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 doryx mpc may be a useful adjunct to amebicides in severe acne doryx mpc may be useful adjunctive therapy doryx mpc is indicated for the prophylaxis of malaria due to plasmodium falciparum see dosage and administration 2 2 patient counseling information 17 to reduce the development of drug resistant bacteria and maintain the effectiveness of doryx mpc and other antibacterial drugs doryx mpc 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.