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

cosette pharmaceuticals, inc. - betaine (unii: 3scv180c9w) (betaine - unii:3scv180c9w) - betaine anhydrous for oral solution is indicated for the treatment of homocystinuria to decrease elevated homocysteine blood concentrations in pediatric and adult patients. included within the category of homocystinuria are - cystathionine beta-synthase (cbs) deficiency - 5,10-methylenetetrahydrofolate reductase (mthfr) deficiency - cobalamin cofactor metabolism (cbl) defect none. risk summary available data from a limited number of published case reports and post marketing experience with betaine anhydrous for oral solution use in pregnancy have not identified any drug associated risks for major birth defects, miscarriage, or adverse maternal or fetal outcomes. animal reproduction studies have not been conducted with betaine. the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. in the u.s. general population, the estimated background risk of major birth defects and

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

cosette pharmaceuticals, inc. - mometasone furoate (unii: 04201gdn4r) (mometasone - unii:8hr4qj6dw8) - mometasone furoate 1 mg in 1 g - mometasone furoate cream, usp, 0.1% is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 2 years of age or older. mometasone furoate cream, usp, 0.1% is contraindicated in those patients with a history of hypersensitivity to any of the components in the preparation. teratogenic effects pregnancy category c: there are no adequate and well-controlled studies in pregnant women. therefore, mometasone furoate cream, usp, 0.1% should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. corticosteroids have been shown to be teratogenic in laboratory animals when administered systemically at relatively low dosage levels. some corticosteroids have been shown to be teratogenic after dermal application in laboratory animals. when administered to pregnant rats, rabbits, and mice, mometasone furoate increased fetal malformations. the doses that produced malf

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

cosette pharmaceuticals, inc. - mometasone furoate (unii: 04201gdn4r) (mometasone - unii:8hr4qj6dw8) - mometasone furoate cream 0.1% is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 2 years of age or older. mometasone furoate cream 0.1% is contraindicated in those patients with a history of hypersensitivity to any of the components in the preparation. teratogenic effects pregnancy category c: there are no adequate and well-controlled studies in pregnant women. therefore, mometasone furoate cream 0.1% should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. corticosteroids have been shown to be teratogenic in laboratory animals when administered systemically at relatively low dosage levels. some corticosteroids have been shown to be teratogenic after dermal application in laboratory animals. when administered to pregnant rats, rabbits, and mice, mometasone furoate increased fetal malformations. the doses that prod

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

cosette pharmaceuticals, inc. - mometasone furoate (unii: 04201gdn4r) (mometasone - unii:8hr4qj6dw8) - mometasone furoate 1 mg in 1 g - mometasone furoate, usp ointment 0.1% is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 2 years of age or older. mometasone furoate, usp ointment 0.1% is contraindicated in those patients with a history of hypersensitivity to any of the components in the preparation. teratogenic effects pregnancy category c: there are no adequate and well-controlled studies in pregnant women. therefore, mometasone furoate, usp ointment 0.1% should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. corticosteroids have been shown to be teratogenic in laboratory animals when administered systemically at relatively low dosage levels. some corticosteroids have been shown to be teratogenic after dermal application in laboratory animals. when administered to pregnant rats, rabbits, and mice, mometasone furoate increased fetal malformations. the doses that produce

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

cosette pharmaceuticals, inc. - mometasone furoate (unii: 04201gdn4r) (mometasone - unii:8hr4qj6dw8) - mometasone furoate, usp ointment 0.1% is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 2 years of age or older. mometasone furoate, usp ointment 0.1% is contraindicated in those patients with a history of hypersensitivity to any of the components in the preparation. teratogenic effects pregnancy category c: there are no adequate and well-controlled studies in pregnant women. therefore, mometasone furoate, usp ointment 0.1% should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. corticosteroids have been shown to be teratogenic in laboratory animals when administered systemically at relatively low dosage levels. some corticosteroids have been shown to be teratogenic after dermal application in laboratory animals. when administered to pregnant rats, rabbits, and mice, mometasone furoate increased fetal malform

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

cosette pharmaceuticals, inc. - ergotamine tartrate (unii: mru5xh3b48) (ergotamine - unii:pr834q503t), caffeine (unii: 3g6a5w338e) (caffeine - unii:3g6a5w338e) - ergotamine tartrate 2 mg - ergotamine tartrate and caffeine indicated as therapy to abort or prevent vascular headache, e.g., migraine, migraine variants or so-called “histaminic cephalalgia”. coadministration of ergotamine with potent cyp 3a4 inhibitors (ritonavir, nelfinavir, indinavir, erythromycin, clarithromycin, and troleandomycin) has been associated with acute ergot toxicity (ergotism) characterized by vasospasm and ischemia of the extremities (see precautions: drug interactions), with some cases resulting in amputation. there have been rare reports of cerebral ischemia in patients on protease inhibitor therapy when ergotamine tartrate and caffeine was coadministered, at least one resulting in death. because of the increased risk for ergotism and other serious vasospastic adverse events, ergotamine use is contraindicated with these drugs and other potent inhibitors of cyp 3a4 (e.g., ketoconazole, itraconazole) (see warnings: cyp 3a4 inhibitors). ergotamine tartrate and caffeine may caus

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

cosette pharmaceuticals, inc. - olmesartan medoxomil (unii: 6m97xtv3hd) (olmesartan - unii:8w1iqp3u10), amlodipine besylate (unii: 864v2q084h) (amlodipine - unii:1j444qc288), hydrochlorothiazide (unii: 0j48lph2th) (hydrochlorothiazide - unii:0j48lph2th) - tribenzor is indicated for the treatment of hypertension, alone or with other antihypertensive agents, to lower blood pressure. lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular (cv) 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 tribenzor. 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, det

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

cosette pharmaceuticals, inc. - amlodipine besylate (unii: 864v2q084h) (amlodipine - unii:1j444qc288), olmesartan medoxomil (unii: 6m97xtv3hd) (olmesartan - unii:8w1iqp3u10) - azor is indicated for the treatment of hypertension, alone or with other antihypertensive agents, to lower blood pressure. lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular (cv) 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 azor. 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, ev

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

cosette pharmaceuticals, inc. - olmesartan medoxomil (unii: 6m97xtv3hd) (olmesartan - unii:8w1iqp3u10) - benicar is indicated for the treatment of hypertension in adults and children six years of age and older, to lower blood pressure. lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. these benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs. there are no controlled trials demonstrating risk reduction with benicar. 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, detecti

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

cosette pharmaceuticals, inc. - desoximetasone (unii: 4e07gxb7au) (desoximetasone - unii:4e07gxb7au) - desoximetasone 2.5 mg in 1 g - desoximetasone ointment, usp 0.25% is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. desoximetasone ointment is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.