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

mylan pharmaceuticals inc. - indomethacin (unii: xxe1cet956) (indomethacin - unii:xxe1cet956) - indomethacin 25 mg - indomethacin capsules are indicated for: indomethacin capsules are contraindicated in the following patients: use of nsaids, including indomethacin capsules, during the third trimester of pregnancy increases the risk of premature closure of the fetal ductus arteriosus. avoid use of nsaids, including indomethacin capsules, in pregnant women starting at 30 weeks of gestation (third trimester). there are no adequate and well-controlled studies of indomethacin capsules in pregnant women. data from observational studies regarding potential embryofetal risks of nsaid use in women in the first or second trimesters of pregnancy are inconclusive. in the general u.s. population, all clinically recognized pregnancies, regardless of drug exposure, have a background rate of 2 to 4% for major malformations, and 15 to 20% for pregnancy loss. in animal reproduction studies, retarded fetal ossification was observed with administration of indomethacin to mice and rats during organogenesis at doses 0.1 and 0.2 times, respective

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

mylan pharmaceuticals inc. - clindamycin phosphate (unii: eh6d7113i8) (clindamycin - unii:3u02el437c) - clindamycin 5 mg in 1 g - clindamycin phosphate and benzoyl peroxide gel, 1%/5% is indicated for the topical treatment of acne vulgaris. clindamycin phosphate and benzoyl peroxide gel, 1%/5% is contraindicated in those individuals who have shown hypersensitivity to any of its components or to lincomycin. it is also contraindicated in those having a history of regional enteritis, ulcerative colitis, or antibiotic-associated colitis.

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

mylan pharmaceuticals inc. - clopidogrel bisulfate (unii: 08i79htp27) (clopidogrel - unii:a74586sno7) - clopidogrel 75 mg - in patients with established peripheral arterial disease or with a history of recent myocardial infarction (mi) or recent stroke clopidogrel tablets are indicated to reduce the rate of mi and stroke. clopidogrel tablets are contraindicated in patients with active pathological bleeding such as peptic ulcer or intracranial hemorrhage. clopidogrel tablets are contraindicated in patients with hypersensitivity (e.g., anaphylaxis) to clopidogrel or any component of the product [see adverse reactions (6.2)] . available data from cases reported in published literature and postmarketing surveillance with clopidogrel use in pregnant women have not identified any drug-associated risks for major birth defects or miscarriage [see data] . there are risks to the pregnant woman and fetus associated with myocardial infarction and stroke [see clinical considerations] . no evidence of fetotoxicity was observed when clopidogrel was administered to pregnant rats and rabbits during organogenesis at doses corresponding to 65 and 78

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

mylan pharmaceuticals inc. - norethindrone acetate (unii: 9s44lic7oj) (norethindrone - unii:t18f433x4s), ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u) - norethindrone acetate 1 mg - norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets are indicated for use by women to prevent pregnancy [see clinical studies  (14)] . the efficacy of norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets in women with a body mass index (bmi) of > 35 kg/m2 has not been evaluated. do not prescribe norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets to women who are known to have the following conditions:     ●    a high risk of arterial or venous thrombotic diseases. examples include women who are known to:         ○    smoke, if over age 35 [see boxed warning and warnings and precautions (5.1)]         ○    have deep vein thrombosis or pulmonary embolism, now or in the past [see warnings and precautions (5.1)]         ○    have inherited or acquired hypercoagulopathies [see warnings and precautions (5.1)]         ○    have cerebrovascular disease [see warnings and precautions (5.1)]         ○    have coronary artery disease

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

mylan pharmaceuticals inc. - ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u), norethindrone acetate (unii: 9s44lic7oj) (norethindrone - unii:t18f433x4s) - ethinyl estradiol 20 ug - norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets are indicated for use by females of reproductive age to prevent pregnancy [see clinical studies (14)] . the efficacy of norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets in women with a body mass index (bmi) of more than 35 kg/m2 has not been evaluated. do not prescribe norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets to women who are known to have the following conditions: there is little or no increased risk of birth defects in women who inadvertently use cocs during early pregnancy. epidemiologic studies and meta-analyses have not found an increased risk of genital or non-genital birth defects (including cardiac anomalies and limb reduction defects) following exposure to low dose cocs prior to conception or during early pregnancy. the administration of cocs to induce withdrawal bleeding should not be used as a test for pregnancy. cocs should not be used during preg

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

mylan pharmaceuticals inc. - eprosartan mesylate (unii: 8n2l1nx8s3) (eprosartan - unii:2kh13z0s0y) - eprosartan 600 mg - eprosartan mesylate tablets are indicated for the treatment of hypertension. they may be used alone or in combination with other antihypertensives such as diuretics and calcium channel blockers. eprosartan mesylate tablets are contraindicated in patients who are hypersensitive to this product or any of its components. do not co-administer aliskiren with eprosartan in patients with diabetes (see precautions: drug interactions).

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

mylan pharmaceuticals inc. - galantamine hydrobromide (unii: mj4ptd2vvw) (galantamine - unii:0d3q044kca) - galantamine 4 mg - galantamine tablets are indicated for the treatment of mild to moderate dementia of the alzheimer’s type. galantamine tablets are contraindicated in patients with known hypersensitivity to galantamine hydrobromide or to any excipients used in the formulation. there are no adequate and well-controlled studies in pregnant women. in studies conducted in animals, administration of galantamine during pregnancy resulted in developmental toxicity (increased incidence of morphological abnormalities and decreased growth in offspring) at doses similar to or greater than those used clinically. galantamine tablets should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. in rats, administration of galantamine (oral doses of 2 mg/kg/day, 8 mg/kg/day, or 16 mg/kg/day), from day 14 (females) or day 60 (males) prior to mating and continuing in females through the period of organogenesis, resulted in an increased incidence of fetal skeletal variations at the two highest doses. th

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

mylan pharmaceuticals inc. - perphenazine (unii: fta7xxy4ez) (perphenazine - unii:fta7xxy4ez) - perphenazine 2 mg - perphenazine tablets are indicated for use in the treatment of schizophrenia and for the control of severe nausea and vomiting in adults. perphenazine tablets have not been shown effective for the management of behavioral complications in patients with mental retardation. perphenazine products are contraindicated in comatose or greatly obtunded patients and in patients receiving large doses of central nervous system depressants (barbiturates, alcohol, narcotics, analgesics, or antihistamines); in the presence of existing blood dyscrasias, bone marrow depression, or liver damage; and in patients who have shown hypersensitivity to perphenazine products, their components, or related compounds. perphenazine products are also contraindicated in patients with suspected or established subcortical brain damage, with or without hypothalamic damage, since a hyperthermic reaction with temperatures in excess of 104°f may occur in such patients, sometimes not until 14 to 16 hours after drug administration. total body ice-

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

mylan pharmaceuticals inc. - azathioprine (unii: mrk240iy2l) (azathioprine - unii:mrk240iy2l) - azathioprine 50 mg - azathioprine tablets are indicated as an adjunct for the prevention of rejection in renal homotransplantation. it is also indicated for the management of active rheumatoid arthritis to reduce signs and symptoms. azathioprine tablets are indicated as an adjunct for the prevention of rejection in renal homotransplantation. experience with over 16,000 transplants shows a 5-year patient survival of 35% to 55%, but this is dependent on donor, match for hla antigens, anti-donor or anti-b-cell alloantigen antibody, and other variables. the effect of azathioprine tablets on these variables has not been tested in controlled trials. azathioprine tablets are indicated for the treatment of active rheumatoid arthritis (ra) to reduce signs and symptoms. aspirin, non-steroidal anti-inflammatory drugs and/or low dose glucocorticoids may be continued during treatment with azathioprine tablets. the combined use of azathioprine tablets with disease modifying anti-rheumatic drugs (dmards) has not been studied for either added be

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

mylan pharmaceuticals inc. - ipratropium bromide (unii: j697uz2a9j) (ipratropium - unii:gr88g0i6ul), albuterol sulfate (unii: 021sef3731) (albuterol - unii:qf8svz843e) - ipratropium bromide anhydrous 0.5 mg in 3 ml - ipratropium bromide and albuterol sulfate inhalation solution is indicated for the treatment of bronchospasm associated with copd in patients requiring more than one bronchodilator. ipratropium bromide and albuterol sulfate inhalation solution is contraindicated in patients with a history of hypersensitivity to any of its components, or to atropine and its derivatives. ipratropium bromide and albuterol sulfate inhalation solution 0.5 mg/3 mg per 3 ml patient's instructions for use read this patient information completely every time your prescription is filled as information may have changed. keep these instructions with your medication as you may want to read them again. ipratropium bromide and albuterol sulfate inhalation solution should only be used under the direction of a physician. your physician and pharmacist have more information about ipratropium bromide and albuterol sulfate inhalation solution and the condition for which it has been prescribed. contact them if you have additional questions