Matches in Nanopublications for { ?s <http://www.w3.org/2000/01/rdf-schema#label> ?o ?g. }
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- association label "gemcitabine for injection is a nucleoside metabolic inhibitor indicated in combination with carboplatin for the treatment of advanced ovarian cancer that has relapsed at least 6 months after completion of platinum based therapy 1 1 in combination with paclitaxel for first line treatment of metastatic breast cancer after failure of prior anthracycline containing adjuvant chemotherapy unless anthracyclines were clinically contraindicated 1 2 in combination with cisplatin for the treatment of non small cell lung cancer 1 3 as a single agent for the treatment of pancreatic cancer 1 4 gemcitabine for injection in combination with carboplatin is indicated for the treatment of patients with advanced ovarian cancer that has relapsed at least 6 months after completion of platinum based therapy gemcitabine for injection in combination with paclitaxel is indicated for the first line treatment of patients with metastatic breast cancer after failure of prior anthracycline containing adjuvant chemotherapy unless anthracyclines were clinically contraindicated gemcitabine for injection is indicated in combination with cisplatin for the first line treatment of patients with inoperable locally advanced stage iiia or iiib or metastatic stage iv non small cell lung cancer gemcitabine for injection is indicated as first line treatment for patients with locally advanced nonresectable stage ii or stage iii or metastatic stage iv adenocarcinoma of the pancreas gemcitabine for injection is indicated for patients previously treated with 5 fu" assertion.
- association label "intravenous administration is usually reserved for life threatening arrhythmias or those occurring under anesthesia 1 supraventricular arrhythmia intravenous propranolol is indicated for the short term treatment of supraventricular tachycardia including wolff parkinson white syndrome and thyrotoxicosis to decrease ventricular rate use in patients with atrial flutter or atrial fibrillation should be reserved for arrythmias unresponsive to standard therapy or when more prolonged control is required reversion to normal sinus rhythm has occasionally been observed predominantly in patients with sinus or atrial tachycardia 2 ventricular tachycardias with the exception of those induced by catecholamines or digitalis propranolol is not the drug of first choice in critical situations when cardioversion techniques or other drugs are not indicated or are not effective propranolol may be considered if after consideration of the risks involved propranolol is used it should be given intravenously in low dosage and very slowly as the failing heart requires some sympathetic drive for maintenance of myocardial tone see dosage and administration some patients may respond with complete reversion to normal sinus rhythm but reduction in ventricular rate is more likely ventricular arrhythmias do not respond to propranolol as predictably as do the supraventricular arrhythmias intravenous propranolol is indicated for the treatment of persistent premature ventricular extrasystoles that impair the well being of the patient and do not respond to conventional measures 3 tachyarrhythmias of digitalis intoxication intravenous propranolol is indicated to control ventricular rate in life threatening digitalis induced arrhythmias severe bradycardia may occur see overdosage 4 resistant tachyarrhythmias due to excessive catecholamine action during anesthesia intravenous propranolol is indicated to abolish tachyarrhythmias due to excessive catecholamine action during anesthesia when other measures fail these arrhythmias may arise because of release of endogenous catecholamines or administration of catecholamines all general inhalation anesthetics produce some degree of myocardial depression therefore when propranolol is used to treat arrhythmias during anesthesia it should be used with extreme caution usually with constant monitoring of the ecg and central venous pressure see warnings" assertion.
- association label "stromectol is indicated for the treatment of the following infections strongyloidiasis of the intestinal tract strongyloides stercoralis this indication is based on clinical studies of both comparative and open label designs in which 64 1 of infected patients were cured following a single 2 mcg kg dose of ivermectin see clinical pharmacology clinical studies onchocerciasis onchocerca volvulus this indication is based on randomized double blind placebo controlled and comparative studies conducted in 1427 patients in onchocerciasis endemic areas of west africa the comparative studies used diethylcarbamazine citrate dec c note stromectol has no activity against adult onchocerca volvulus" assertion.
- association label "prednisone tablets usp are indicated in the following conditions 1 endocrine disorders primary or secondary adrenocortical insufficiency hydrocortisone or cortisone is the first choice synthetic analogs may be used in conjunction with mineralocorticoids where applicable in infancy mineralocorticoid supplementation is of particular importance congenital adrenal hyperplasia 2 rheumatic disorders as adjunctive therapy for short term administration to tide the patient over an acute episode or exacerbation in psoriatic arthritis 3 collagen diseases during an exacerbation or as maintenance therapy in selected cases of systemic lupus erythematosus 4 dermatologic diseases pemphigus 5 allergic states control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment seasonal or perennial allergic rhinitis 6 ophthalmic diseases severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as allergic corneal marginal ulcers 7 respiratory diseases symptomatic sarcoidosis 8 hematologic disorders idiopathic thrombocytopenic purpura in adults 9 neoplastic diseases for palliative management of leukemias and lymphomas in adults 1 edematous states to induce a diuresis or remission of proteinuria in the nephrotic syndrome without uremia of the idiopathic type or that due to lupus erythematosus 11 gastrointestinal diseases to tide the patient over a critical period of the disease in ulcerative colitis 12 nervous system acute exacerbations of multiple sclerosis 13 miscellaneous tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy" assertion.
- association label "methotrexate is indicated in the treatment of gestational choriocarcinoma chorioadenoma destruens and hydatidiform mole in acute lymphocytic leukemia methotrexate is indicated in the prophylaxis of meningeal leukemia and is used in maintenance therapy in combination with other chemotherapeutic agents methotrexate is also indicated in the treatment of meningeal leukemia methotrexate is used alone or in combination with other anticancer agents in the treatment of breast cancer epidermoid cancers of the head and neck advanced mycosis fungoides cutaneous t cell lymphoma and lung cancer particularly squamous cell and small cell types methotrexate is also used in combination with other chemotherapeutic agents in the treatment of advanced stage non hodgkin s lymphomas methotrexate in high doses followed by leucovorin rescue in combination with other chemotherapeutic agents is effective in prolonging relapse free survival in patients with non metastatic osteosarcoma who have undergone surgical resection or amputation for the primary tumor methotrexate is indicated in the symptomatic control of severe recalcitrant disabling psoriasis that is not adequately responsive to other forms of therapy but only when the diagnosis has been established as by a biopsy and or after dermatologic consultation methotrexate is indicated in the management of selected adults with severe active rheumatoid arthritis acr criteria or children with active polyarticular course juvenile rheumatoid arthritis who have had an insufficient therapeutic response to or are intolerant of an adequate trial of first line therapy including full dose non steroidal anti inflammatory agents nsaids aspirin nsaids and or low dose steroids may be continued although the possibility of increased toxicity with concomitant use of nsaids including salicylates has not been fully explored see precautions drug interactions" assertion.
- association label "methazolamide tablets usp is indicated in the treatment of ocular conditions where lowering intraocular pressure is likely to be of therapeutic benefit such as chronic open angle glaucoma secondary glaucoma and preoperatively in acute angle closure glaucoma where lowering the intraocular pressure is desired before surgery" assertion.
- association label "fluoxetine capsules usp are a selective serotonin reuptake inhibitor indicated for acute and maintenance treatment of major depressive disorder mdd in adult and pediatric patients aged 8 to 18 years 1 1 acute and maintenance treatment of obsessive compulsive disorder ocd in adult and pediatric patients aged 7 to 17 years 1 2 acute and maintenance treatment of bulimia nervosa in adult patients 1 3 acute treatment of panic disorder with or without agoraphobia in adult patients 1 4 fluoxetine capsules usp and olanzapine in combination acute treatment of depressive episodes associated with bipolar i disorder in adults 1 5 fluoxetine capsules usp are indicated for the acute and maintenance treatment of major depressive disorder in adult patients and in pediatric patients aged 8 to 18 years see clinical studies 14 1 the usefulness of the drug in adult and pediatric patients receiving fluoxetine for extended periods should periodically be re evaluated see dosage and administration 2 1 fluoxetine capsules usp are indicated for the acute and maintenance treatment of obsessions and compulsions in adult patients and in pediatric patients aged 7 to 17 years with obsessive compulsive disorder ocd see clinical studies 14 2 the effectiveness of fluoxetine capsules usp 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 fluoxetine capsules usp for extended periods should periodically re evaluate the long term usefulness of the drug for the individual patient see dosage and administration 2 2 fluoxetine capsules usp are indicated for the acute and maintenance treatment of binge eating and vomiting behaviors in adult patients with moderate to severe bulimia nervosa see clinical studies 14 3 the physician who elects to use fluoxetine capsules usp for extended periods should periodically re evaluate the long term usefulness of the drug for the individual patient see dosage and administration 2 3 fluoxetine capsules usp are indicated for the acute treatment of panic disorder with or without agoraphobia in adult patients see clinical studies 14 4 the effectiveness of fluoxetine capsules usp 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 fluoxetine capsules usp for extended periods should periodically re evaluate the long term usefulness of the drug for the individual patient see dosage and administration 2 4 when using fluoxetine capsules usp and olanzapine in combination also refer to the clinical studies section of the package insert for olanzapine and fluoxetine hydrochloride capsules fluoxetine capsules usp and olanzapine in combination is indicated for the acute treatment of depressive episodes associated with bipolar i disorder in adult patients fluoxetine capsules usp monotherapy is not indicated for the treatment of depressive episodes associated with bipolar i disorder" 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 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 "priftin is a rifamycin antimycobacterial drug indicated in patients 12 years of age and older for the treatment of active pulmonary tuberculosis tb caused by mycobacterium tuberculosis 1 1 priftin is indicated for the treatment of latent tuberculosis infection ltbi caused by m tuberculosis 1 2 see limitations of use 1 1 1 2 priftin a r mycobacterium tuberculosis see dosage and administration 2 1 clinical studies 14 1 limitations of use do not use priftin monotherapy in either the initial or the continuation phases of active antituberculous treatment priftin should not be used once weekly in the continuation phase regimen in combination with isoniazid inh in hiv infected patients with active pulmonary tuberculosis because of a higher rate of failure and or relapse with rifampin rif resistant organisms see warnings and precautions 5 3 clinical studies 14 1 priftin has not been studied as part of the initial phase treatment regimen in hiv infected patients with active pulmonary tuberculosis priftin is indicated in adults and children 2 years and older for the treatment of latent tuberculosis infection caused by mycobacterium tuberculosis see clinical studies 14 2 limitations of use active tuberculosis disease should be ruled out before initiating treatment for latent tuberculosis infection priftin must always be used in combination with isoniazid as a 12 week once weekly regimen for the treatment of latent tuberculosis infection see dosage and administration 2 2 clinical studies 14 2 priftin in combination with isoniazid is not recommended for individuals presumed to be exposed to rifamycin resistant or isoniazid resistant m tuberculosis" assertion.
- association label "aveed is indicated for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone primary hypogonadism congenital or acquired testicular failure due to cryptorchidism bilateral torsion orchitis vanishing testis syndrome orchiectomy klinefelter s syndrome chemotherapy or toxic damage from alcohol or heavy metals these men usually have low serum testosterone concentrations and gonadotropins follicle stimulating hormone fsh luteinizing hormone lh above the normal range hypogonadotropic hypogonadism congenital or acquired gonadotropin or luteinizing hormone releasing hormone lhrh deficiency or pituitary hypothalamic injury from tumors trauma or radiation these men have low testosterone serum concentrations but have gonadotropins in the normal or low range aveed should only be used in patients who require testosterone replacement therapy and in whom the benefits of the product outweigh the serious risks of pulmonary oil microembolism and anaphylaxis limitations of use safety and efficacy of aveed in men with age related hypogonadism also referred to as late onset hypogonadism have not been established safety and efficacy of aveed in males less than 18 years old have not been established see use in specific populations 8 4 aveed testosterone undecanoate injection is an androgen indicated for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone o primary hypogonadism congenital or acquired 1 o hypogonadotropic hypogonadism congenital or acquired 1 aveed should only be used in patients who require testosterone replacement therapy and in whom the benefits of the product outweigh the serious risks of pulmonary oil microembolism and anaphylaxis 1 limitations of use safety and efficacy of aveed in men with age related hypogonadism have not been established 1 safety and efficacy of aveed in males less than 18 years old have not been established 1 8 4" assertion.
- association label "cimetidine tablets are indicated in most patients heal within 4 weeks and there is rarely reason to use cimetidine tablets at full dosage for longer than 6 to 8 weeks see concomitant antacids should be given as needed for relief of pain however simultaneous administration of cimetidine tablets and antacids is not recommended since antacids have been reported to interfere with the absorption of cimetidine 1 short term treatment of active duodenal ulcer dosage and administration duodenal ulcer patients have been maintained on continued treatment with cimetidine tablets 4 mg at bedtime for periods of up to 5 years 2 maintenance therapy for duodenal ulcer patients at reduced dosage after healing of active ulcer there is no information concerning usefulness of treatment periods of longer than 8 weeks 3 short term treatment of active benign gastric ulcer erosive esophagitis diagnosed by endoscopy treatment is indicated for 12 weeks for healing of lesions and control of symptoms the use of cimetidine tablets beyond 12 weeks has not been established see 4 erosive gastroesophageal reflux gerd dosage and administration gerd i e zollinger ellison syndrome systemic mastocytosis multiple endocrine adenomas 5 the treatment of pathological hypersecretory conditions" assertion.
- association label "famciclovir a prodrug of penciclovir is a nucleoside analog dna polymerase inhibitor indicated for immunocompetent adult patients 1 1 herpes labialis cold sores treatment of recurrent episodes genital herpes treatment of recurrent episodes suppressive therapy of recurrent episodes herpes zoster shingles hiv infected adult patients 1 2 treatment of recurrent episodes of orolabial or genital herpes limitation of use 1 3 the efficacy and safety of famciclovir have not been established for patients 18 years of age immunocompromised patients other than for the treatment of recurrent episodes of orolabial or genital herpes in hiv infected patients black and african american patients with recurrent genital herpes herpes labialis cold sores genital herpes recurrent episodes suppressive therapy herpes zoster shingles recurrent orolabial or genital herpes famciclovir tablets are indicated for the treatment of recurrent episodes of orolabial or genital herpes in hiv infected adults the efficacy of famciclovir tablets when initiated more than 48 hours after onset of symptoms or lesions has not been established the efficacy and safety of famciclovir tablets have not been established for patients 18 years of age patients with first episode of genital herpes patients with ophthalmic zoster immunocompromised patients other than for the treatment of recurrent orolabial or genital herpes in hiv infected patients black and african american patients with recurrent genital herpes" assertion.
- association label "indapamide tablets are indicated for the treatment of hypertension alone or in combination with other antihypertensive drugs indapamide tablets are also indicated for the treatment of salt and fluid retention associated with congestive heart failure the routine use of diuretics in an otherwise healthy woman is inappropriate and exposes mother and fetus to unnecessary hazard see below precautions diuretics do not prevent development of toxemia of pregnancy and there is no satisfactory evidence that they are useful in the treatment of developed toxemia edema during pregnancy may arise from pathological causes or from the physiologic and mechanical consequences of pregnancy indapamide is indicated in pregnancy when edema is due to pathologic causes just as it is in the absence of pregnancy however see below dependent edema in pregnancy resulting from restriction of venous return by the expanded uterus is properly treated through elevation of the lower extremities and use of support hose use of diuretics to lower intravascular volume in this case is illogical and unnecessary there is hypervolemia during normal pregnancy which is not harmful to either the fetus or the mother in the absence of cardiovascular disease but which is associated with edema including generalized edema in the majority of pregnant women if this edema produces discomfort increased recumbency will often provide relief in rare instances this edema may cause extreme discomfort which is not relieved by rest in these cases a short course of diuretics may provide relief and may be appropriate precautions" assertion.
- association label "gemcitabine for injection is a nucleoside metabolic inhibitor indicated in combination with carboplatin for the treatment of advanced ovarian cancer that has relapsed at least 6 months after completion of platinum based therapy 1 1 in combination with paclitaxel for first line treatment of metastatic breast cancer after failure of prior anthracycline containing adjuvant chemotherapy unless anthracyclines were clinically contraindicated 1 2 in combination with cisplatin for the treatment of non small cell lung cancer 1 3 as a single agent for the treatment of pancreatic cancer 1 4 gemcitabine for injection in combination with carboplatin is indicated for the treatment of patients with advanced ovarian cancer that has relapsed at least 6 months after completion of platinum based therapy gemcitabine for injection in combination with paclitaxel is indicated for the first line treatment of patients with metastatic breast cancer after failure of prior anthracycline containing adjuvant chemotherapy unless anthracyclines were clinically contraindicated gemcitabine for injection is indicated in combination with cisplatin for the first line treatment of patients with inoperable locally advanced stage iiia or iiib or metastatic stage iv non small cell lung cancer gemcitabine for injection is indicated as first line treatment for patients with locally advanced nonresectable stage ii or stage iii or metastatic stage iv adenocarcinoma of the pancreas gemcitabine for injection is indicated for patients previously treated with 5 fu" assertion.
- association label "malaria hydroxychloroquine sulfate tablets are indicated for the treatment of uncomplicated malaria due to p falciparum p malariae p ovale p vivax hydroxychloroquine sulfate tablets are indicated for the prophylaxis of malaria in geographic areas where chloroquine resistance is not reported limitations of use in malaria hydroxychloroquine sulfate tablets are not recommended for the treatment of complicated malaria hydroxychloroquine sulfate tablets are not effective against chloroquine or hydroxychloroquine resistant strains of plasmodium clinical pharmacology microbiology plasmodium hydroxychloroquine sulfate tablets are not recommended for malaria prophylaxis in geographic areas where chloroquine resistance occurs hydroxychloroquine sulfate tablets do not prevent relapses of p vivax p ovale p vivax p ovale clinical pharmacology microbiology prior to prescribing hydroxychloroquine sulfate tablets for the treatment or prophylaxis of malaria consult the centers for disease control and prevention cdc malaria website http www cdc gov malaria lupus erythematosus hydroxychloroquine sulfate tablets are indicated for the treatment of chronic discoid lupus erythematosus and systemic lupus erythematosus in adults rheumatoid arthritis hydroxychloroquine sulfate tablets are indicated for the treatment of acute and chronic rheumatoid arthritis in adults" assertion.
- association label "parenteral sedatives hypnotics for the short term treatment of insomnia since they appear to lose their effectiveness for sleep induction and sleep maintenance after 2 weeks see clinical pharmacology preanesthetics anticonvulsant in anesthetic doses in the emergency control of certain acute convulsive episodes e g those associated with status epilepticus cholera eclampsia meningitis tetanus and toxic reactions to strychnine or local anesthetics" assertion.
- association label "almotriptan malate tablets are a 5ht 1b 1d acute treatment of migraine attacks in adults with a history of migraine with or without aura 1 1 acute treatment of migraine headache pain in adolescents age 12 to 17 years with a history of migraine with or without aura and who have migraine attacks usually lasting 4 hours or more 1 1 important limitations use only after a clear diagnosis of migraine has been established 1 2 in adolescents age 12 to 17 years efficacy of almotriptan malate tablets on migraine associated symptoms was not established 1 2 not intended for the prophylactic therapy of migraine 1 2 not indicated for the treatment of cluster headache 1 2 adults almotriptan malate tablets are indicated for the acute treatment of migraine attacks in patients with a history of migraine with or without aura adolescents age 12 to 17 years almotriptan malate tablets are indicated for the acute treatment of migraine headache pain in patients with a history of migraine attacks with or without aura usually lasting 4 hours or more when untreated almotriptan malate tablets should only be used where a clear diagnosis of migraine has been established if a patient has no response for the first migraine attack treated with almotriptan malate tablets the diagnosis of migraine should be reconsidered before almotriptan malate tablets are administered to treat any subsequent attacks in adolescents age 12 to 17 years efficacy of almotriptan malate tablets on migraine associated symptoms nausea photophobia and phonophobia was not established almotriptan malate tablets are not intended for the prophylactic therapy of migraine or for use in the management of hemiplegic or basilar migraine see contraindications 4 7 safety and effectiveness of almotriptan malate tablets have not been established for cluster headache which is present in an older predominantly male population" assertion.
- spi label "Obesity when accompanied by metabolic abnormality is closely associated with knee osteoarthritis." assertion.
- nanopub label "add the URI of the nanopublication here" assertion.
- assertion label "Submitting a formalization paper to the Data Science special issue 2021" assertion.
- association label "moxatag is a penicillin class antibacterial indicated for the treatment of tonsillitis and or pharyngitis secondary to streptococcus pyogenes 1 tonsillitis and or pharyngitis moxatag is a penicillin class antibacterial indicated for the treatment of tonsillitis and or pharyngitis secondary to streptococcus pyogenes s pyogenes to reduce the development of drug resistant bacteria and maintain the effectiveness of moxatag and other antibacterial drugs moxatag 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 "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 "treatment of malaria plasmodium falciparum conversion of atrial fibrillation flutter treatment of ventricular arrhythmias antiarrhythmic drugs including quinidine have not been shown to enhance survival in patients with ventricular arrhythmias" assertion.
- association label "ciprofloxacin tablets usp are indicated for the treatment of infections caused by susceptible isolates of the designated microorganisms in the conditions and patient populations listed below ciprofloxacin is a fluoroquinolone antibacterial indicated in adults 18 years of age with infections caused by designated susceptible bacteria and in pediatric patients where indicated 1 1 1 2 1 3 1 4 1 5 1 6 1 7 1 8 1 9 1 1 1 11 1 12 1 13 1 14 1 16 ciprofloxacin tablets are indicated in adult patients for treatment of urinary tract infections caused by escherichia coli klebsiella pneumoniae enterobacter cloacae serratia marcescens proteus mirabilis providencia rettgeri morganella morganii citrobacter koseri citrobacter freundii pseudomonas aeruginosa staphylococcus epidermidis staphylococcus saprophyticus enterococcus faecalis ciprofloxacin tablets are indicated in adult female patients for treatment of acute uncomplicated cystitis caused by escherichia coli staphylococcus saprophyticus ciprofloxacin tablets are indicated in adult patients for treatment of chronic bacterial prostatitis caused by escherichia coli proteus mirabilis ciprofloxacin tablets are indicated in adult patients for treatment of lower respiratory tract infections caused by escherichia coli klebsiella pneumoniae enterobacter cloacae proteus mirabilis pseudomonas aeruginosa haemophilus influenzae haemophilus parainfluenzae streptococcus pneumoniae moraxella catarrhalis see indications and usage 1 15 ciprofloxacin tablets are indicated in adult patients for treatment of acute sinusitis caused by haemophilus influenzae streptococcus pneumoniae moraxella catarrhalis ciprofloxacin tablets are indicated in adult patients for treatment of skin and skin structure infections caused by escherichia coli klebsiella pneumoniae enterobacter cloacae proteus mirabilis proteus vulgaris providencia stuartii morganella morganii citrobacter freundii pseudomonas aeruginosa staphylococcus aureus staphylococcus epidermidis streptococcus pyogenes ciprofloxacin tablets are indicated in adult patients for treatment of bone and joint infections caused by enterobacter cloacae serratia marcescens pseudomonas aeruginosa ciprofloxacin tablets are indicated in adult patients for treatment of complicated intra abdominal infections used in combination with metronidazole caused by escherichia coli pseudomonas aeruginosa proteus mirabilis klebsiella pneumoniae bacteroides fragilis ciprofloxacin tablets are indicated in adult patients for treatment of infectious diarrhea caused by escherichia coli campylobacter jejuni shigella boydii shigella dysenteriae shigella flexneri shigella sonnei ciprofloxacin tablets are indicated in adult patients for treatment of typhoid fever enteric fever caused by salmonella typhi ciprofloxacin tablets are indicated in adult patients for treatment of uncomplicated cervical and urethral gonorrhea due to neisseria gonorrhoeae see warnings and precautions 5 16 ciprofloxacin tablets are indicated in pediatric patients one to 17 years of age for treatment of complicated urinary tract infections cuti and pyelonephritis due to escherichia coli see indications and usage 1 15 use in specific populations 8 4 ciprofloxacin tablets are indicated in adults and pediatric patients from birth to 17 years of age for inhalational anthrax post exposure to reduce the incidence or progression of disease following exposure to aerosolized bacillus anthracis ciprofloxacin serum concentrations achieved in humans served as a surrogate endpoint reasonably likely to predict clinical benefit and provided the initial basis for approval of this indication 1 see clinical studies 14 2 ciprofloxacin tablets are indicated for treatment of plague including pneumonic and septicemic plague due to yersinia pestis y pestis see clinical studies 14 3 although effective in clinical trials ciprofloxacin is not a drug of first choice in the pediatric population due to an increased incidence of adverse events compared to controls including events related to joints and or surrounding tissues see warnings and precautions 5 11 adverse reactions 6 1 use in specific populations 8 4 nonclinical toxicology 13 2 ciprofloxacin tablets are not a drug of first choice in the treatment of presumed or confirmed pneumonia secondary to streptococcus pneumoniae see indications and usage 1 4 to reduce the development of drug resistant bacteria and maintain the effectiveness of ciprofloxacin tablets and other antibacterial drugs ciprofloxacin tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria when culture and susceptibility information are available they should be considered in selecting or modifying antibacterial therapy in the absence of such data local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy if anaerobic organisms are suspected of contributing to the infection appropriate therapy should be administered appropriate culture and susceptibility tests should be performed before treatment in order to isolate and identify organisms causing infection and to determine their susceptibility to ciprofloxacin therapy with ciprofloxacin tablets may be initiated before results of these tests are known once results become available appropriate therapy should be continued as with other drugs some isolates of pseudomonas aeruginosa" assertion.
- association label "prednisolone sodium phosphate oral solution 15 mg prednisolone per 5 ml is indicated in the following conditions 1 allergic states control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in adult and pediatric populations with seasonal or perennial allergic rhinitis asthma contact dermatitis atopic dermatitis serum sickness drug hypersensitivity reactions 2 dermatologic diseases pemphigus bullous dermatitis herpetiformis severe erythema multiforme stevens johnson syndrome exfoliative erythroderma mycosis fungoides 3 edematous states to induce diuresis or remission of proteinuria in nephrotic syndrome in adults with lupus erythematosus and in adults and pediatric populations with idiopathic nephrotic syndrome without uremia 4 endocrine disorders primary or secondary adrenocortical insufficiency hydrocortisone or cortisone is the first choice synthetic analogs may be used in conjunction with mineralocorticoids where applicable in infancy mineralocorticoid supplementation is of particular importance congenital adrenal hyperplasia hypercalcemia associated with cancer nonsuppurative thyroiditis 5 gastrointestinal diseases to tide the patient over a critical period of the disease in ulcerative colitis regional enteritis 6 hematologic disorders idiopathic thrombocytopenic purpura in adults selected cases of secondary thrombocytopenia acquired autoimmune hemolytic anemia pure red cell aplasia diamond blackfan anemia 7 neoplastic diseases for the treatment of acute leukemia and aggressive lymphomas in adults and children 8 nervous system acute exacerbations of multiple sclerosis 9 ophthalmic diseases uveitis and ocular inflammatory conditions unresponsive to topical corticosteroids temporal arteritis sympathetic ophthalmia 1 respiratory diseases symptomatic sarcoidosis idiopathic eosinophilic pneumonias fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy asthma as distinct from allergic asthma listed above under allergic states hypersensitivity pneumonitis idiopathic pulmonary fibrosis acute exacerbations of chronic obstructive pulmonary disease copd and pneumocystis carinii pneumonia pcp associated with hypoxemia occurring in an hiv individual who is also under treatment with appropriate anti pcp antibiotics studies support the efficacy of systemic corticosteroids for the treatment of these conditions allergic bronchopulmonary aspergillosis idiopathic bronchiolitis obliterans with organizing pneumonia 11 rheumatic disorders as adjunctive therapy for short term administration to tide the patient over an acute episode or exacerbation in psoriatic arthritis rheumatoid arthritis including juvenile rheumatoid arthritis selected cases may require low dose maintenance therapy ankylosing spondylitis acute and subacute bursitis acute nonspecific tenosynovitis acute gouty arthritis epicondylitis for the treatment of systemic lupus erythematosus dermatomyositis polymyositis polymyalgia rheumatica sjogren s syndrome relapsing polychondritis and certain cases of vasculitis 12 miscellaneous tuberculous meningitis with subarachnoid block or impending block tuberculosis with enlarged mediastinal lymph nodes causing respiratory difficulty and tuberculosis with pleural or pericardial effusion appropriate antituberculous chemotherapy must be used concurrently when treating any tuberculosis complications trichinosis with neurologic or myocardial involvement acute or chronic solid organ rejection with or without other agents" assertion.
- association label "tinidazole is a nitroimidazole antimicrobial indicated for 1 1 1 2 1 3 1 4 8 1 to reduce the development of drug resistant bacteria and maintain the effectiveness of tinidazole and other antibacterial drugs tinidazole should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria 1 5 tinidazole is indicated for the treatment of trichomoniasis caused by trichomonas vaginalis see clinical studies 14 1 tinidazole is indicated for the treatment of giardiasis caused by giardia duodenalis g lamblia see clinical studies 14 2 tinidazole is indicated for the treatment of intestinal amebiasis and amebic liver abscess caused by entamoeba histolytica see clinical studies 14 3 14 4 tinidazole is indicated for the treatment of bacterial vaginosis formerly referred to as haemophilus gardnerella adult women see use in specific populations 8 1 14 5 other pathogens commonly associated with vulvovaginitis such as trichomonas vaginalis chlamydia trachomatis neisseria gonorrhoeae candida albicans herpes simplex to reduce the development of drug resistant bacteria and maintain the effectiveness of tinidazole and other antibacterial drugs tinidazole 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 "diethylpropion hydrochloride is indicated in the management of exogenous obesity as a short term adjunct a few weeks in a regimen of weight reduction based on caloric restriction in patients with an initial body mass index bmi of 3 kg m or higher and who have not responded to appropriate weight reducing regimen diet and or exercise alone below is a chart of bmi based on various heights and weights bmi is calculated by taking the patient s weight in kilograms kg divided by the patient s height in meters m squared metric conversions are as follows pounds divided by 2 2 kg inches x 254 meters 2 body mass index bmi kg m 2 weight pounds height feet inches 5 5 3 5 6 5 9 6 6 3 14 27 25 23 21 19 18 15 29 27 24 22 2 19 16 31 28 26 24 22 2 17 33 3 28 25 23 21 18 35 32 29 27 25 23 19 37 34 31 28 26 24 2 39 36 32 3 27 25 21 41 37 34 31 29 26 22 43 39 36 33 3 28 23 45 41 37 34 31 29 24 47 43 39 36 33 3 25 49 44 4 37 34 31 the usefulness of agents of this class see should be measured against possible risk factors inherent in their use such as those described below diethylpropion hydrochloride is indicated for use as monotherapy only clinical pharmacology" assertion.
- association label "ciprofloxacin tablets usp are indicated for the treatment of infections caused by susceptible isolates of the designated microorganisms in the conditions and patient populations listed below ciprofloxacin is a fluoroquinolone antibacterial indicated in adults 18 years of age with infections caused by designated susceptible bacteria and in pediatric patients where indicated 1 1 1 2 1 3 1 4 1 5 1 6 1 7 1 8 1 9 1 1 1 11 1 12 1 13 1 14 1 16 ciprofloxacin tablets are indicated in adult patients for treatment of urinary tract infections caused by escherichia coli klebsiella pneumoniae enterobacter cloacae serratia marcescens proteus mirabilis providencia rettgeri morganella morganii citrobacter koseri citrobacter freundii pseudomonas aeruginosa staphylococcus epidermidis staphylococcus saprophyticus enterococcus faecalis ciprofloxacin tablets are indicated in adult female patients for treatment of acute uncomplicated cystitis caused by escherichia coli staphylococcus saprophyticus ciprofloxacin tablets are indicated in adult patients for treatment of chronic bacterial prostatitis caused by escherichia coli proteus mirabilis ciprofloxacin tablets are indicated in adult patients for treatment of lower respiratory tract infections caused by escherichia coli klebsiella pneumoniae enterobacter cloacae proteus mirabilis pseudomonas aeruginosa haemophilus influenzae haemophilus parainfluenzae streptococcus pneumoniae moraxella catarrhalis see indications and usage 1 15 ciprofloxacin tablets are indicated in adult patients for treatment of acute sinusitis caused by haemophilus influenzae streptococcus pneumoniae moraxella catarrhalis ciprofloxacin tablets are indicated in adult patients for treatment of skin and skin structure infections caused by escherichia coli klebsiella pneumoniae enterobacter cloacae proteus mirabilis proteus vulgaris providencia stuartii morganella morganii citrobacter freundii pseudomonas aeruginosa staphylococcus aureus staphylococcus epidermidis streptococcus pyogenes ciprofloxacin tablets are indicated in adult patients for treatment of bone and joint infections caused by enterobacter cloacae serratia marcescens pseudomonas aeruginosa ciprofloxacin tablets are indicated in adult patients for treatment of complicated intra abdominal infections used in combination with metronidazole caused by escherichia coli pseudomonas aeruginosa proteus mirabilis klebsiella pneumoniae bacteroides fragilis ciprofloxacin tablets are indicated in adult patients for treatment of infectious diarrhea caused by escherichia coli campylobacter jejuni shigella boydii shigella dysenteriae shigella flexneri shigella sonnei ciprofloxacin tablets are indicated in adult patients for treatment of typhoid fever enteric fever caused by salmonella typhi ciprofloxacin tablets are indicated in adult patients for treatment of uncomplicated cervical and urethral gonorrhea due to neisseria gonorrhoeae see warnings and precautions 5 16 ciprofloxacin tablets are indicated in pediatric patients one to 17 years of age for treatment of complicated urinary tract infections cuti and pyelonephritis due to escherichia coli see indications and usage 1 15 use in specific populations 8 4 ciprofloxacin tablets are indicated in adults and pediatric patients from birth to 17 years of age for inhalational anthrax post exposure to reduce the incidence or progression of disease following exposure to aerosolized bacillus anthracis ciprofloxacin serum concentrations achieved in humans served as a surrogate endpoint reasonably likely to predict clinical benefit and provided the initial basis for approval of this indication 1 see clinical studies 14 2 ciprofloxacin tablets are indicated for treatment of plague including pneumonic and septicemic plague due to yersinia pestis y pestis see clinical studies 14 3 although effective in clinical trials ciprofloxacin is not a drug of first choice in the pediatric population due to an increased incidence of adverse events compared to controls including events related to joints and or surrounding tissues see warnings and precautions 5 11 adverse reactions 6 1 use in specific populations 8 4 nonclinical toxicology 13 2 ciprofloxacin tablets are not a drug of first choice in the treatment of presumed or confirmed pneumonia secondary to streptococcus pneumoniae see indications and usage 1 4 to reduce the development of drug resistant bacteria and maintain the effectiveness of ciprofloxacin tablets and other antibacterial drugs ciprofloxacin tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria when culture and susceptibility information are available they should be considered in selecting or modifying antibacterial therapy in the absence of such data local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy if anaerobic organisms are suspected of contributing to the infection appropriate therapy should be administered appropriate culture and susceptibility tests should be performed before treatment in order to isolate and identify organisms causing infection and to determine their susceptibility to ciprofloxacin therapy with ciprofloxacin tablets may be initiated before results of these tests are known once results become available appropriate therapy should be continued as with other drugs some isolates of pseudomonas aeruginosa" assertion.
- association label "to reduce the development of drug resistant bacteria and maintain the effectiveness of neomycin sulfate tablets and other antibacterial drugs neomycin sulfate 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 suppression of intestinal bacteria neomycin sulfate tablets are indicated as adjunctive therapy as part of a regimen for the suppression of the normal bacterial flora of the bowel e g preoperative preparation of the bowel it is given concomitantly with erythromycin enteric coated base see dosage and administration hepatic coma portal systemic encephalopathy neomycin sulfate has been shown to be effective adjunctive therapy in hepatic coma by reduction of the ammonia forming bacteria in the intestinal tract the subsequent reduction in blood ammonia has resulted in neurologic improvement" assertion.
- association label "qmiiz odt is a non steroidal anti inflammatory drug indicated for osteoarthritis in adults oa 1 1 rheumatoid arthritis in adults ra 1 2 juvenile rheumatoid arthritis jra pauciarticular and polyarticular course in pediatric patients who weigh greater than or equal to 6 kg 1 3 qmiiz odt is indicated for relief of the signs and symptoms of osteoarthritis in adults see clinical studies 14 1 qmiiz odt is indicated for relief of the signs and symptoms of rheumatoid arthritis in adults see clinical studies 14 1 qmiiz odt is indicated for relief of the signs and symptoms of pauciarticular or polyarticular course juvenile rheumatoid arthritis in pediatric patients who weigh greater than or equal to 6 kg see dosage and administration 2 4 14 2" assertion.
- association label "metformin hydrochloride tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 1 years of age and older with type 2 diabetes mellitus metformin hydrochloride extended release tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus metformin hydrochloride tablets are a biguanide indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 1 years of age and older with type 2 diabetes mellitus 1 metformin hydrochloride extended release tablets are a biguanide indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus 1" assertion.
- association label "hydrocortisone tablets usp are indicated in the following conditions endocrine disorders primary or secondary adrenocortical insufficiency hydrocortisone or cortisone is the first choice synthetic analogs may be used in conjunction with mineralocorticoids where applicable in infancy mineralocorticoid supplementation is of particular importance congenital adrenal hyperplasia nonsuppurative thyroiditis hypercalcemia associated with cancer rheumatic disorders as adjunctive therapy for short term administration to tide the patient over an acute episode or exacerbation in psoriatic arthritis rheumatoid arthritis including juvenile rheumatoid arthritis selected cases may require low dose maintenance therapy ankylosing spondylitis acute and subacute bursitis acute nonspecific tenosynovitis acute gouty arthritis post traumatic osteoarthritis synovitis of osteoarthritis epicondylitis collagen diseases during an exacerbation or as maintenance therapy in selected cases of systemic lupus erythematosus systemic dermatomyositis polymyositis acute rheumatic carditis dermatologic diseases pemphigus bullous dermatitis herpetiformis severe erythema multiforme stevens johnson syndrome exfoliative dermatitis mycosis fungoides severe psoriasis severe seborrheic dermatitis allergic states control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment seasonal or perennial allergic rhinitis serum sickness bronchial asthma contact dermatitis atopic dermatitis drug hypersensitivity reactions ophthalmic diseases severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as allergic conjunctivitis keratitis allergic corneal marginal ulcers herpes zoster ophthalmicus iritis and iridocyclitis chorioretinitis anterior segment inflammation diffuse posterior uveitis and choroiditis optic neuritis sympathetic ophthalmia respiratory diseases symptomatic sarcoidosis loeffler s syndrome not manageable by other means berylliosis fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy aspiration pneumonitis hematologic disorders idiopathic thrombocytopenic purpura in adults secondary thrombocytopenia in adults acquired autoimmune hemolytic anemia erythroblastopenia rbc anemia congenital erythroid hypoplastic anemia neoplastic diseases for palliative management of leukemias and lymphomas in adults acute leukemia of childhood edematous states to induce a diuresis or remission of proteinuria in the nephrotic syndrome without uremia of the idiopathic type or that due to lupus erythematosus gastrointestinal diseases to tide the patient over a critical period of the disease in ulcerative colitis regional enteritis nervous system acute exacerbations of multiple sclerosis miscellaneous tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy trichinosis with neurologic or myocardial involvement" assertion.
- association label "acetylcysteine is indicated as adjuvant therapy for patients with abnormal viscid or inspissated mucous secretions in such conditions as chronic bronchopulmonary disease chronic emphysema emphysema with bronchitis chronic asthmatic bronchitis tuberculosis bronchiectasis and primary amyloidosis of the lung acetylcysteine administered orally is indicated as an antidote to prevent or lessen hepatic injury which may occur following the ingestion of a potentially hepatotoxic quantity of acetaminophen it is essential to initiate treatment as soon as possible after the overdose and in any case within 24 hours of ingestion" assertion.
- association label "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 "azithromycin for oral suspension usp is indicated for the treatment of patients with mild to moderate infections pneumonia see warnings dosage and administration adults acute bacterial exacerbations of chronic obstructive pulmonary disease due to haemophilus influenzae moraxella catarrhalis or streptococcus pneumoniae acute bacterial sinusitis due to haemophilus influenzae moraxella catarrhalis or streptococcus pneumoniae community acquired pneumonia due to chlamydophila pneumoniae haemophilus influenzae mycoplasma pneumoniae or streptococcus pneumoniae in patients appropriate for oral therapy note azithromycin should not be used in patients with pneumonia who are judged to be inappropriate for oral therapy because of moderate to severe illness or risk factors such as any of the following patients with cystic fibrosis patients with nosocomially acquired infections patients with known or suspected bacteremia patients requiring hospitalization elderly or debilitated patients or patients with significant underlying health problems that may compromise their ability to respond to their illness including immunodeficiency or functional asplenia pharyngitis tonsillitis caused by streptococcus pyogenes as an alternative to first line therapy in individuals who cannot use first line therapy note penicillin by the intramuscular route is the usual drug of choice in the treatment of streptococcus pyogenes infection and the prophylaxis of rheumatic fever azithromycin for oral suspension usp is often effective in the eradication of susceptible strains of streptococcus pyogenes from the nasopharynx because some strains are resistant to azithromycin for oral suspension usp susceptibility tests should be performed when patients are treated with azithromycin for oral suspension usp data establishing efficacy of azithromycin in subsequent prevention of rheumatic fever are not available uncomplicated skin and skin structure infections due to staphylococcus aureus streptococcus pyogenes or streptococcus agalactiae abscesses usually require surgical drainage urethritis and cervicitis due to chlamydia trachomatis or neisseria gonorrhoeae genital ulcer disease in men due to haemophilus ducreyi chancroid due to the small number of women included in clinical trials the efficacy of azithromycin in the treatment of chancroid in women has not been established azithromycin for oral suspension usp at the recommended dose should not be relied upon to treat syphilis antimicrobial agents used in high doses for short periods of time to treat non gonococcal urethritis may mask or delay the symptoms of incubating syphilis all patients with sexually transmitted urethritis or cervicitis should have a serologic test for syphilis and appropriate cultures for gonorrhea performed at the time of diagnosis appropriate antimicrobial therapy and follow up tests for these diseases should be initiated if infection is confirmed appropriate culture and susceptibility tests should be performed before treatment to determine the causative organism and its susceptibility to azithromycin usp therapy with azithromycin for oral suspension usp may be initiated before results of these tests are known once the results become available antimicrobial therapy should be adjusted accordingly to reduce the development of drug resistant bacteria and maintain the effectiveness of azithromycin for oral suspension usp and other antibacterial drugs azithromycin 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 pediatric patients see precautions pediatric use clinical studies pediatric patients acute otitis media caused by haemophilus influenzae moraxella catarrhalis or streptococcus pneumoniae for specific dosage recommendation see dosage and administration community acquired pneumonia due to chlamydophila pneumoniae haemophilus influenzae mycoplasma pneumoniae or streptococcus pneumoniae in patients appropriate for oral therapy for specific dosage recommendation see dosage and administration note azithromycin should not be used in pediatric patients with pneumonia who are judged to be inappropriate for oral therapy because of moderate to severe illness or risk factors such as any of the following patients with cystic fibrosis patients with nosocomially acquired infections patients with known or suspected bacteremia patients requiring hospitalization or patients with significant underlying health problems that may compromise their ability to respond to their illness including immunodeficiency or functional asplenia pharyngitis tonsillitis caused by streptococcus pyogenes as an alternative to first line therapy in individuals who cannot use first line therapy for specific dosage recommendation see dosage and administration note penicillin by the intramuscular route is the usual drug of choice in the treatment of streptococcus pyogenes infection and the prophylaxis of rheumatic fever azithromycin for oral suspension usp is often effective in the eradication of susceptible strains of streptococcus pyogenes from the nasopharynx because some strains are resistant to azithromycin for oral suspension usp susceptibility tests should be performed when patients are treated with azithromycin for oral suspension usp data establishing efficacy of azithromycin in subsequent prevention of rheumatic fever are not available appropriate culture and susceptibility tests should be performed before treatment to determine the causative organism and its susceptibility to azithromycin therapy with azithromycin for oral suspension usp may be initiated before results of these tests are known once the results become available antimicrobial therapy should be adjusted accordingly" 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 "primary skin infections impetigo contagiosa superficial folliculitis ecthyma furunculosis sycosis barbae and pyoderma gangrenosum secondary skin infections infectious eczematoid dermatitis pustular acne pustular psoriasis infected seborrheic dermatitis infected contact dermatitis including poison ivy infected excoriations and bacterial superinfections of fungal or viral infections note gentamicin is a bactericidal agent that is not effective against viruses or fungi in skin infections it is useful in the treatment of infected skin cysts and certain other skin abscesses when preceded by incision and drainage to permit adequate contact between the antibiotic and the infecting bacteria good results have been obtained in the treatment of infected stasis and other skin ulcers infected superficial burns paronychia infected insect bites and stings infected lacerations and abrasions and wounds from minor surgery patients sensitive to neomycin can be treated with gentamicin although regular observation of patients sensitive to topical antibiotics is advisable when such patients are treated with any topical antibiotic gentamicin cream is recommended for wet oozing primary infections and greasy secondary infections such as pustular acne or infected seborrheic dermatitis and where a water washable cream preparation is desired gentamicin ointment helps retain moisture and has been useful in infection on dry eczematous or psoriatic skin gentamicin cream and ointment have been used successfully in infants over one year of age as well as in adults and children" assertion.
- association label "symptomatic trichomoniasis metronidazole tablets usp are indicated for the treatment of t vaginalis infection in females and males when the presence of the trichomonad has been confirmed by appropriate laboratory procedures wet smears and or cultures asymptomatic trichomoniasis metronidazole tablets usp are indicated in the treatment of asymptomatic t vaginalis infection in females when the organism is associated with endocervicitis cervicitis or cervical erosion since there is evidence that presence of the trichomonad can interfere with accurate assessment of abnormal cytological smears additional smears should be performed after eradication of the parasite treatment of asymptomatic sexual partners t vaginalis infection is a venereal disease therefore asymptomatic sexual partners of treated patients should be treated simultaneously if the organism has been found to be present in order to prevent reinfection of the partner the decision as to whether to treat an asymptomatic male partner who has a negative culture or one for whom no culture has been attempted is an individual one in making this decision it should be noted that there is evidence that a woman may become reinfected if her sexual partner is not treated also since there can be considerable difficulty in isolating the organism from the asymptomatic male carrier negative smears and cultures cannot be relied upon in this regard in any event the sexual partner should be treated with metronidazole tablets usp in cases of reinfection amebiasis metronidazole tablets usp are indicated in the treatment of acute intestinal amebiasis amebic dysentery and amebic liver abscess in amebic liver abscess metronidazole tablet therapy does not obviate the need for aspiration or drainage of pus anaerobic bacterial infections metronidazole tablets usp are indicated in the treatment of serious infections caused by susceptible anaerobic bacteria indicated surgical procedures should be performed in conjunction with metronidazole tablet therapy in a mixed aerobic and anaerobic infection antimicrobials appropriate for the treatment of the aerobic infection should be used in addition to metronidazole tablets usp intra abdominal infections including peritonitis intra abdominal abscess and liver abscess caused by bacteroides species including the b fragilis group b fragilis b distasonis b ovatus b thetaiotaomicron b vulgatus clostridium species eubacterium species peptococcus species and peptostreptococcus species skin and skin structure infections caused by bacteroides species including the b fragilis group clostridium species peptococcus species peptostreptococcus species and fusobacterium species gynecologic infections including endometritis endomyometritis tubo ovarian abscess and postsurgical vaginal cuff infection caused by bacteroides species including the b fragilis group clostridium species peptococcus species peptostreptococcus species and fusobacterium species bacterial septicemia caused by bacteroides species including the b fragilis group and clostridium species bone and joint infections as adjunctive therapy caused by bacteroides species including the b fragilis group central nervous system cns infections including meningitis and brain abscess caused by bacteroides species including the b fragilis group lower respiratory tract infections including pneumonia empyema and lung abscess caused by bacteroides species including the b fragilis group endocarditis caused by bacteroides species including the b fragilis group to reduce the development of drug resistant bacteria and maintain the effectiveness of metronidazole tablets usp and other antibacterial drugs metronidazole tablets 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 "acarbose tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus" assertion.
- ecm-bound-cancer-cell label "cancer cell engaged in extracellular matrix" assertion.
- glycocalyx-bulk label "glycocalyx bulk" assertion.
- association label "to reduce the development of drug resistant bacteria and maintain the effectiveness of demeclocycline hydrochloride tablets and other antibacterial drugs demeclocycline hydrochloride tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria when culture and susceptibility information are available they should be considered in selecting or modifying antibacterial therapy in the absence of such data local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy demeclocycline hydrochloride is indicated in the treatment of infections caused by susceptible strains of the designated microorganisms in the conditions below rocky mountain spotted fever typhus fever and the typhus group q fever rickettsialpox and tick fevers caused by rickettsiae respiratory tract infections caused by lymphogranuloma venereum due to psittacosis ornithosis due to trachoma due to although the infectious agent is not always eliminated as judged by immunofluorescence inclusion conjunctivitis caused by nongonococcal urethritis in adults caused by or relapsing fever due to chancroid caused by plague due to tularemia due to cholera caused by campylobacter fetus infections caused by brucellosis due to species in conjunction with streptomycin bartonellosis due to granuloma inguinale caused by demeclocycline hydrochloride is indicated for treatment of infections caused by the following gram negative microorganisms when bacteriologic testing indicates appropriate susceptibility to the drug species species respiratory tract infections caused by respiratory tract and urinary tract infections caused by species demeclocycline hydrochloride is indicated for treatment of infections caused by the following gram positive microorganisms when bacteriologic testing indicates appropriate susceptibility to the drug upper respiratory infections caused by pneumoniae skin and skin structure infections caused by note tetracyclines including demeclocycline are not the drugs of choice in the treatment of any type of staphylococcal infection when penicillin is contraindicated tetracyclines including demeclocycline hydrochloride are alternative drugs in the treatment of the following infections uncomplicated urethritis in men due to and for the treatment of other uncomplicated gonococcal infections infections in women caused by syphilis caused by subspecies yaws caused by subspecies listeriosis due to anthrax due to vincent s infection caused by actinomycosis caused by clostridial diseases caused by species in acute intestinal amebiasis demeclocycline hydrochloride may be a useful adjunct to amebicides in severe acne demeclocycline hydrochloride may be a useful adjunctive therapy mycoplasma pneumoniae chlamydia trachomatis chlamydia psittaci chlamydia trachomatis chlamydia trachomatis ureaplasma urealyticum chlamydia trachomatis borrelia recurrentis haemophilus ducreyi yersinia pestis francisella tularensis vibrio cholerae campylobacter fetus brucella bartonella bacilliformis calymmatobacterium granulomatis escherichia coli enterobacter aerogenes shigella acinetobacter haemophilus influenzae klebsiella streptococcus staphylococcus aureus neisseria gonorrhoeae neisseria gonorrhoeae treponema pallidum pallidum treponema pallidum pertenue listeria monocytogenes bacillus anthracis fusobacterium fusiforme actinomyces israelii clostridium" assertion.
- association label "pimecrolimus cream 1 is indicated as second line therapy for the short term and non continuous chronic treatment of mild to moderate atopic dermatitis in non immunocompromised adults and children 2 years of age and older who have failed to respond adequately to other topical prescription treatments or when those treatments are not advisable pimecrolimus cream 1 is not indicated for use in children less than 2 years of age warnings and precautions 5 1 use in specific populations 8 4 pimecrolimus cream 1 is a calcineurin inhibitor immunosuppressant indicated as second line therapy for the short term and non continuous chronic treatment of mild to moderate atopic dermatitis in non immunocompromised adults and children 2 years of age and older who have failed to respond adequately to other topical prescription treatments or when those treatments are not advisable 1" 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 "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 "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 "the efficacy of paroxetine the effects of paroxetine in hospitalized depressed patients have not been adequately studied the efficacy of paroxetine in maintaining a response in major depressive disorder for up to 1 year was demonstrated in a placebo controlled trial see clinical pharmacology clinical trials nevertheless the physician who elects to use paroxetine for extended periods should periodically re evaluate the long term usefulness of the drug for the individual patient the efficacy of paroxetine was established in two 12 week trials with obsessive compulsive outpatients whose diagnoses corresponded most closely to the dsm iiir category of obsessive compulsive disorder see clinical pharmacology clinical trials obsessive compulsive disorder 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 long term maintenance of efficacy was demonstrated in a 6 month relapse prevention trial in this trial patients assigned to paroxetine showed a lower relapse rate compared to patients on placebo see clinical pharmacology clinical trials nevertheless the physician who elects to use paroxetine the efficacy of paroxetine was established in three 1 to 12 week trials in panic disorder patients whose diagnoses corresponded to the dsm iiir 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 was demonstrated in a 3 month relapse prevention trial in this trial patients with panic disorder assigned to paroxetine demonstrated a lower relapse rate compared to patients on placebo see clinical pharmacology clinical trials nevertheless the physician who prescribes paroxetine for extended periods should periodically re evaluate the long term usefulness of the drug for the individual patient the efficacy of paroxetine was established in three 12 week trials in adult patients with social anxiety disorder dsm iv paroxetine has not been studied in children or adolescents with social phobia see clinical pharmacology clinical trials the effectiveness of paroxetine 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 for extended periods should periodically re evaluate the long term usefulness of the drug for the individual patient see dosage and administration the efficacy of paroxetine in the treatment of gad was established in two 8 week placebo controlled trials in adults with gad paroxetine has not been studied in children or adolescents with generalized anxiety disorder see clinical pharmacology clinical trials generalized anxiety disorder dsm iv is characterized by excessive anxiety and worry apprehensive expectation that is persistent for at least 6 months and which the person finds difficult to control it must be associated with at least 3 of the following 6 symptoms restlessness or feeling keyed up or on edge being easily fatigued difficulty concentrating or mind going blank irritability muscle tension sleep disturbance the efficacy of paroxetine in maintaining a response in patients with generalized anxiety disorder who responded during an 8 week acute treatment phase while taking paroxetine and were then observed for relapse during a period of up to 24 weeks was demonstrated in a placebo controlled trial see clinical pharmacology clinical trials nevertheless the physician who elects to use paroxetine 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 "to reduce the development of drug resistant bacteria and maintain the effectiveness of demeclocycline hydrochloride tablets and other antibacterial drugs demeclocycline hydrochloride tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria when culture and susceptibility information are available they should be considered in selecting or modifying antibacterial therapy in the absence of such data local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy demeclocycline hydrochloride is indicated in the treatment of infections caused by susceptible strains of the designated microorganisms in the conditions below rocky mountain spotted fever typhus fever and the typhus group q fever rickettsialpox and tick fevers caused by rickettsiae respiratory tract infections caused by lymphogranuloma venereum due to psittacosis ornithosis due to trachoma due to although the infectious agent is not always eliminated as judged by immunofluorescence inclusion conjunctivitis caused by nongonococcal urethritis in adults caused by or relapsing fever due to chancroid caused by plague due to tularemia due to cholera caused by campylobacter fetus infections caused by brucellosis due to species in conjunction with streptomycin bartonellosis due to granuloma inguinale caused by demeclocycline hydrochloride is indicated for treatment of infections caused by the following gram negative microorganisms when bacteriologic testing indicates appropriate susceptibility to the drug species species respiratory tract infections caused by respiratory tract and urinary tract infections caused by species demeclocycline hydrochloride is indicated for treatment of infections caused by the following gram positive microorganisms when bacteriologic testing indicates appropriate susceptibility to the drug upper respiratory infections caused by pneumoniae skin and skin structure infections caused by note tetracyclines including demeclocycline are not the drugs of choice in the treatment of any type of staphylococcal infection when penicillin is contraindicated tetracyclines including demeclocycline hydrochloride are alternative drugs in the treatment of the following infections uncomplicated urethritis in men due to and for the treatment of other uncomplicated gonococcal infections infections in women caused by syphilis caused by subspecies yaws caused by subspecies listeriosis due to anthrax due to vincent s infection caused by actinomycosis caused by clostridial diseases caused by species in acute intestinal amebiasis demeclocycline hydrochloride may be a useful adjunct to amebicides in severe acne demeclocycline hydrochloride may be a useful adjunctive therapy mycoplasma pneumoniae chlamydia trachomatis chlamydia psittaci chlamydia trachomatis chlamydia trachomatis ureaplasma urealyticum chlamydia trachomatis borrelia recurrentis haemophilus ducreyi yersinia pestis francisella tularensis vibrio cholerae campylobacter fetus brucella bartonella bacilliformis calymmatobacterium granulomatis escherichia coli enterobacter aerogenes shigella acinetobacter haemophilus influenzae klebsiella streptococcus staphylococcus aureus neisseria gonorrhoeae neisseria gonorrhoeae treponema pallidum pallidum treponema pallidum pertenue listeria monocytogenes bacillus anthracis fusobacterium fusiforme actinomyces israelii clostridium" assertion.
- association label "isradipine capsules are indicated in the management of hypertension it may be used alone or concurrently with thiazide type diuretics" assertion.
- association label "amantadine hydrochloride capsules usp are indicated for the prophylaxis and treatment of signs and symptoms of infection caused by various strains of influenza a virus amantadine hydrochloride capsules usp are also indicated in the treatment of parkinsonism and drug induced extrapyramidal reactions influenza a prophylaxis amantadine hydrochloride capsules usp are indicated for chemoprophylaxis against signs and symptoms of influenza a virus infection because amantadine hydrochloride does not completely prevent the host immune response to influenza a infection individuals who take this drug may still develop immune responses to natural disease or vaccination and may be protected when later exposed to antigenically related viruses following vaccination during an influenza a outbreak amantadine hydrochloride capsules usp prophylaxis should be considered for the 2 to 4 week time period required to develop an antibody response influenza a treatment amantadine hydrochloride capsules usp are also indicated in the treatment of uncomplicated respiratory tract illness caused by influenza a virus strains especially when administered early in the course of illness there are no well controlled clinical studies demonstrating that treatment with amantadine hydrochloride capsules usp will avoid the development of influenza a virus pneumonitis or other complications in high risk patients there is no clinical evidence indicating that amantadine hydrochloride capsules usp are effective in the prophylaxis or treatment of viral respiratory tract illnesses other than those caused by influenza a virus strains the following points should be considered before initiating treatment or prophylaxis with amantadine hydrochloride capsules usp amantadine hydrochloride capsules usp is not a substitute for early vaccination on an annual basis as recommended by the centers for disease control and prevention advisory committee on immunization practices influenza viruses change over time emergence of resistance mutations could decrease drug effectiveness other factors for example changes in viral virulence might also diminish clinical benefit of antiviral drugs prescribers should consider available information on influenza drug susceptibility patterns and treatment effects when deciding whether to use amantadine hydrochloride capsules usp parkinson s disease syndrome amantadine hydrochloride capsules usp are indicated in the treatment of idiopathic parkinson s disease paralysis agitans postencephalitic parkinsonism and symptomatic parkinsonism which may follow injury to the nervous system by carbon monoxide intoxication it is indicated in those elderly patients believed to develop parkinsonism in association with cerebral arteriosclerosis in the treatment of parkinson s disease amantadine hydrochloride capsules usp are less effective than levodopa 3 3 4 dihydroxyphenyl l alanine and its efficacy in comparison with the anticholinergic antiparkinson drugs has not yet been established drug induced extrapyramidal reactions amantadine hydrochloride capsules usp are indicated in the treatment of drug induced extrapyramidal reactions although anticholinergic type side effects have been noted with amantadine hydrochloride capsules usp when used in patients with drug induced extrapyramidal reactions there is a lower incidence of these side effects than that observed with the anticholinergic antiparkinson drugs" assertion.