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mylan pharmaceuticals inc. - venlafaxine hydrochloride (unii: 7d7rx5a8mo) (venlafaxine - unii:grz5rcb1qg) - venlafaxine 25 mg - venlafaxine tablets are indicated for the treatment of major depressive disorder. the efficacy of venlafaxine tablets in the treatment of major depressive disorder was established in 6-week controlled trials of adult outpatients whose diagnoses corresponded most closely to the dsm-iii or dsm-iii-r category of major depression and in a 4-week controlled trial of inpatients meeting diagnostic criteria for major depression with melancholia (see clinical trials). a major depressive episode implies a prominent and relatively persistent depressed or dysphoric mood that usually interferes with daily functioning (nearly every day for at least 2 weeks); it should include at least four of the following eight symptoms: change in appetite, change in sleep, psychomotor agitation or retardation, loss of interest in usual activities or decrease in sexual drive, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and a suicide attempt or suicidal ideation. the efficacy of venlafa

United States - English - NLM (National Library of Medicine)

mylan pharmaceuticals inc. - buprenorphine hydrochloride (unii: 56w8mw3en1) (buprenorphine - unii:40d3scr4gz) - buprenorphine 2 mg - buprenorphine sublingual tablets are indicated for the treatment of opioid dependence and are preferred for induction. buprenorphine sublingual tablets should be used as part of a complete treatment plan to include counseling and psychosocial support. buprenorphine sublingual tablets are contraindicated in patients with a history of hypersensitivity to buprenorphine, as serious adverse reactions, including anaphylactic shock, have been reported [see warnings and precautions (5.9) ]. the data on use of buprenorphine, the active ingredient in buprenorphine sublingual tablets, in pregnancy, are limited; however, these data do not indicate an increased risk of major malformations specifically due to buprenorphine exposure. there are limited data from randomized clinical trials in women maintained on buprenorphine that were not designed appropriately to assess the risk of major malformations [see data] . observational studies have reported on congenital malformations among buprenorphine-exposed pregnancies, but w

United States - English - NLM (National Library of Medicine)

mylan pharmaceuticals inc. - escitalopram oxalate (unii: 5u85dbw7lo) (escitalopram - unii:4o4s742any) - escitalopram 5 mg - escitalopram tablets are indicated for the acute and maintenance treatment of major depressive disorder in adults and in adolescents 12 to 17 years of age [see clinical studies (14.1) ]. a major depressive episode (dsm-iv) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed or dysphoric mood that usually interferes with daily functioning, and includes at least five of the following nine symptoms: depressed mood, loss of interest in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, a suicide attempt or suicidal ideation. escitalopram tablets are indicated for the acute treatment of generalized anxiety disorder (gad) in adults [see clinical studies (14.2) ]. generalized anxiety disorder (dsm-iv) is characterized by excessive anxiety and worry (apprehensive expectation) that is persistent for at l

United States - English - NLM (National Library of Medicine)

mylan pharmaceuticals inc. - zolpidem tartrate (unii: wy6w63843k) (zolpidem - unii:7k383oqi23) - zolpidem tartrate 5 mg - zolpidem tartrate tablets are indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation. zolpidem tartrate tablets have been shown to decrease sleep latency for up to 35 days in controlled clinical studies [see clinical studies (14)] . the clinical trials performed in support of efficacy were 4-5 weeks in duration with the final formal assessments of sleep latency performed at the end of treatment. zolpidem tartrate tablets are contraindicated in patients with known hypersensitivity to zolpidem. observed reactions include anaphylaxis and angioedema [see warnings and precautions (5.3)] . neonates born to mothers using zolpidem late in the third trimester of pregnancy have been reported to experience symptoms of respiratory depression and sedation [see clinical considerations and data] . published data on the use of zolpidem during pregnancy have not reported a clear association with zolpidem and major birth defects [see data]. oral administration of zolpidem to pre

United States - English - NLM (National Library of Medicine)

mylan pharmaceuticals inc. - lisinopril (unii: e7199s1ywr) (lisinopril anhydrous - unii:7q3p4bs2fd), hydrochlorothiazide (unii: 0j48lph2th) (hydrochlorothiazide - unii:0j48lph2th) - lisinopril 10 mg - lisinopril and hydrochlorothiazide tablets are indicated for the treatment of hypertension, to lower blood pressure. lowering blood pressure lowers the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. these benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including lisinopril and hydrochlorothiazide. control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. many patients will require more than 1 drug to achieve blood pressure goals. for specific advice on goals and management, see published guidelines, such as those of the national high blood pressure education program’s joint national committee on prevention, detection, evaluation, and treatment of high blood pressure (jnc). numerous antihypertensive drugs, from a vari

United States - English - NLM (National Library of Medicine)

mylan pharmaceuticals inc. - pioglitazone hydrochloride (unii: jqt35npk6c) (pioglitazone - unii:x4ov71u42s), metformin hydrochloride (unii: 786z46389e) (metformin - unii:9100l32l2n) - pioglitazone 15 mg - pioglitazone and metformin hydrochloride tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both pioglitazone and metformin is appropriate [see clinical studies (14)] . important limitations of use pioglitazone exerts its antihyperglycemic effect only in the presence of endogenous insulin. pioglitazone and metformin hydrochloride tablets should not be used to treat type 1 diabetes or diabetic ketoacidosis, as it would not be effective in these settings. use caution in patients with liver disease [see warnings and precautions (5.5)] . limited data with pioglitazone and metformin hydrochloride tablets or pioglitazone in pregnant women are not sufficient to determine a drug-associated risk for major birth defects or miscarriage. published studies with metformin use during pregnancy have not reported a clear association with metformin and major birth defect or miscarriage risk [see data]. there are risks to the mother a

United States - English - NLM (National Library of Medicine)

mylan pharmaceuticals inc. - sulindac (unii: 184sns8vuh) (sulindac - unii:184sns8vuh) - sulindac 150 mg - carefully consider the potential benefits and risks of sulindac tablets and other treatment options before deciding to use sulindac tablets. use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see warnings). sulindac tablets are indicated for acute or long-term use in the relief of signs and symptoms of the following: * the safety and effectiveness of sulindac have not been established in rheumatoid arthritis patients who are designated in the american rheumatism association classification as functional class iv (incapacitated, largely or wholly bedridden, or confined to wheelchair; little or no self-care). sulindac tablets are contraindicated in patients with known hypersensitivity to sulindac or the excipients (see description). sulindac should not be given to patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other nsaids. severe, rarely fatal, anaphylactic/anaphylactoid reactions to nsaids have been re

United States - English - NLM (National Library of Medicine)

mylan pharmaceuticals inc. - risedronate sodium (unii: ofg5exg60l) (risedronic acid - unii:km2z91756z) - risedronate sodium 5 mg - risedronate sodium tablets are indicated for the treatment and prevention of osteoporosis in postmenopausal women. in postmenopausal women with osteoporosis, risedronate reduces the incidence of vertebral fractures and a composite endpoint of nonvertebral osteoporosis-related fractures [see clinical studies (14.1, 14.2) ]. risedronate sodium tablets are indicated for treatment to increase bone mass in men with osteoporosis. risedronate sodium tablets are indicated for the treatment and prevention of glucocorticoid-induced osteoporosis in men and women who are either initiating or continuing systemic glucocorticoid treatment (daily dosage of greater than or equal to 7.5 mg of prednisone or equivalent) for chronic diseases. patients treated with glucocorticoids should receive adequate amounts of calcium and vitamin d. risedronate sodium tablets are indicated for treatment of paget’s disease of bone in men and women. the optimal duration of use has not been determined. the safety and effectiveness of risedronate

United States - English - NLM (National Library of Medicine)

mylan pharmaceuticals inc. - nadolol (unii: fen504330v) (nadolol - unii:fen504330v) - nadolol 20 mg - nadolol tablets are indicated for the long-term management of patients with angina pectoris. nadolol tablets are indicated for the treatment of hypertension, to lower blood pressure. lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. these benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs. there are no controlled trials demonstrating risk reduction with nadolol tablets. control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. many patients will require more than one drug to achieve blood pressure goals. for specific advice on goals and management, see published guidelines, such as those of the national high blood pressure educati

United States - English - NLM (National Library of Medicine)

mylan pharmaceuticals inc. - felodipine (unii: ol961r6o2c) (felodipine - unii:ol961r6o2c) - felodipine 2.5 mg - felodipine extended-release tablets are indicated for the treatment of hypertension, to lower blood pressure. lowering blood pressure lowers the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. these benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including felodipine. control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise and limited sodium intake. many patients will require more than one drug to achieve blood pressure goals. for specific advice on goals and management, see published guidelines, such as those of the national high blood pressure education program’s joint national committee on prevention, detection, evaluation, and treatment of high blood pressure (jnc). numerous antihypertensive drugs, from a variety of pharmacologic classes an