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

mayne pharma - methylphenidate hydrochloride (unii: 4b3sc438hi) (methylphenidate - unii:207zz9qz49) - methylphenidate hydrochloride 20 mg - methylphenidate hydrochloride extended-release capsules (la) are indicated for the treatment of attention deficit hyperactivity disorder (adhd). the efficacy of methylphenidate hydrochloride extended-release capsules (la) in the treatment of adhd was established in 1 controlled trial of children aged 6 to 12 who met dsm-iv criteria for adhd (see clinical pharmacology). a diagnosis of attention deficit hyperactivity disorder (adhd; dsm-iv) implies the presence of hyperactive-impulsive or inattentive symptoms that caused impairment and were present before age 7 years. the symptoms must cause clinically significant impairment, e.g., in social, academic, or occupational functioning, and be present in 2 or more settings, e.g., school (or work) and at home. the symptoms must not be better accounted for by another mental disorder. for the inattentive type, at least 6 of the following symptoms must have persisted for at least 6 months: lack of attention to details/careless mistakes; lack of sustained attention; poor

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

golden state medical supply, inc. - trospium chloride (unii: 1e6682427e) (trospium - unii:t4y8ork057) - trospium chloride 60 mg - trospium chloride extended-release capsules are a muscarinic antagonist indicated for the treatment of overactive bladder (oab) with symptoms of urge urinary incontinence, urgency, and urinary frequency. trospium chloride extended-release capsules are contraindicated in patients with: - urinary retention - gastric retention - uncontrolled narrow-angle glaucoma - known hypersensitivity to the drug or its ingredients. angioedema, rash and anaphylactic reaction have been reported. teratogenic effects pregnancy category c : there are no adequate and well-controlled studies of trospium chloride extended-release capsules in pregnant women.  trospium chloride extended-release capsules should be used during pregnancy only if the potential benefit to the patient outweighs the risk to the patient and fetus. women who become pregnant during trospium chloride extended-release capsules treatment are encouraged to contact their physician. trospium chloride was not teratogenic at statistically significant levels in rats

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

bluepoint laboratories - trospium chloride (unii: 1e6682427e) (trospium - unii:t4y8ork057) - trospium chloride 60 mg - trospium chloride extended-release capsules are a muscarinic antagonist indicated for the treatment of overactive bladder (oab) with symptoms of urge urinary incontinence, urgency, and urinary frequency. trospium chloride extended-release capsules are contraindicated in patients with: - urinary retention - gastric retention - uncontrolled narrow-angle glaucoma - known hypersensitivity to the drug or its ingredients. angioedema, rash and anaphylactic reaction have been reported. teratogenic effects pregnancy category c : there are no adequate and well-controlled studies of trospium chloride extended-release capsules in pregnant women.  trospium chloride extended-release capsules should be used during pregnancy only if the potential benefit to the patient outweighs the risk to the patient and fetus. women who become pregnant during trospium chloride extended-release capsules treatment are encouraged to contact their physician. trospium chloride was not teratogenic at statistically significant levels in rats

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

actavis pharma, inc. - trospium chloride (unii: 1e6682427e) (trospium - unii:t4y8ork057) - trospium chloride 60 mg - trospium chloride extended-release capsules are a muscarinic antagonist indicated for the treatment of overactive bladder (oab) with symptoms of urge urinary incontinence, urgency, and urinary frequency. trospium chloride extended-release capsules are contraindicated in patients with: - urinary retention - gastric retention - uncontrolled narrow-angle glaucoma - known hypersensitivity to the drug or its ingredients. angioedema, rash and anaphylactic reaction have been reported. teratogenic effects pregnancy category c : there are no adequate and well-controlled studies of trospium chloride extended-release capsules in pregnant women.  trospium chloride extended-release capsules should be used during pregnancy only if the potential benefit to the patient outweighs the risk to the patient and fetus. women who become pregnant during trospium chloride extended-release capsules treatment are encouraged to contact their physician. trospium chloride was not teratogenic at statistically significant levels in rats

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

major pharmaceuticals - fexofenadine hydrochloride (unii: 2s068b75zu) (fexofenadine - unii:e6582loh6v) - fexofenadine hydrochloride 30 mg - fexofenadine hydrochloride tablets are indicated for the relief of symptoms associated with seasonal allergic rhinitis in adults and children 6 years of age and older. fexofenadine hydrochloride tablets are indicated for treatment of uncomplicated skin manifestations of chronic idiopathic urticaria in adults and children 6 of age and older . fexofenadine hydrochloride tablets are contraindicated in patients with known hypersensitivity to fexofenadine and any of the ingredients of fexofenadine hydrochloride. rare cases of hypersensitivity reactions with manifestations such as angioedema, chest tightness, dyspnea, flushing and systemic anaphylaxis have been reported. teratogenic effects: pregnancy category c. there was no evidence of teratogenicity in rats or rabbits at oral doses of terfenadine up to 300 mg/kg (which led to fexofenadine exposures that were approximately 4 and 30 times, respectively, the exposure at the maximum recommended human daily oral dose of 180 mg of fexofenadine hydrochloride based on c

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

solco healthcare u.s., llc - metformin hydrochloride (unii: 786z46389e) (metformin - unii:9100l32l2n) - metformin hydrochloride 500 mg - metformin hydrochloride tablets is indicated as an adjunct to diet and exercise to improve glycemic control in adults and children with type 2 diabetes mellitus. metformin hydrochloride tablets are contraindicated in patients with: - renal disease or renal dysfunction (e.g., as suggested by serum creatinine levels ≥1.5 mg/dl [males], ≥1.4 mg/dl [females] or abnormal creatinine clearance), which may also result from conditions such as cardiovascular collapse (shock), acute myocardial infarction, and septicemia (see warnings and precautions ). - known hypersensitivity to metformin hydrochloride. - acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma. diabetic ketoacidosis should be treated with insulin. metformin hydrochloride tablets should be temporarily discontinued in patients undergoing radiologic studies involving intravascular administration of iodinated contrast materials, because use of such products may result in acute alteration of renal function. (see also prec

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

aurobindo pharma limited - amiodarone hydrochloride (unii: 976728sy6z) (amiodarone - unii:n3rq532iut) - amiodarone hydrochloride 200 mg - amiodarone hydrochloride tablets are indicated for the treatment of documented, life-threatening recurrent ventricular fibrillation and life-threatening recurrent hemodynamically unstable tachycardia in adults who have not responded to adequate doses of other available antiarrhythmics or when alternative agents cannot be tolerated. - cardiogenic shock. - sick sinus syndrome, second- or third-degree atrioventricular block, bradycardia leading to syncope without a functioning pacemaker. - known hypersensitivity to the drug or to any of its components, including iodine. risk summary available data from postmarketing reports and published case series indicate that amiodarone use in pregnant women may increase the risk for fetal adverse effects including neonatal hypo- and hyperthyroidism, neonatal bradycardia, neurodevelopmental abnormalities, preterm birth and fetal growth restriction. amiodarone and its metabolite, desethylamiodarone (dea), cross the placenta. untreated underlying arrhythmias, including ventric

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

major pharmaceuticals - amiodarone hydrochloride (unii: 976728sy6z) (amiodarone - unii:n3rq532iut) - amiodarone hydrochloride 200 mg - amiodarone hydrochloride tablets are indicated for the treatment of documented, life-threatening recurrent ventricular fibrillation and life-threatening recurrent hemodynamically unstable tachycardia in adults who have not responded to adequate doses of other available antiarrhythmics or when alternative agents cannot be tolerated. risk summary available data from postmarketing reports and published case series indicate that amiodarone use in pregnant women may increase the risk for fetal adverse effects including neonatal hypo- and hyperthyroidism, neonatal bradycardia, neurodevelopmental abnormalities, preterm birth and fetal growth restriction. amiodarone and its metabolite, desethylamiodarone (dea), cross the placenta. untreated underlying arrhythmias, including ventricular arrhythmias, during pregnancy pose a risk to the mother and fetus (see clinical considerations). in animal studies, administration of amiodarone to rabbits, rats, and mice during organogenesis resulted in embryo- fetal toxicity at dos

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

apotex corp - amiodarone hydrochloride (unii: 976728sy6z) (amiodarone - unii:n3rq532iut) - amiodarone hydrochloride 200 mg - amiodarone hydrochloride tablets are indicated for the treatment of documented, life-threatening recurrent ventricular fibrillation and life-threatening recurrent hemodynamically unstable tachycardia in adults who have not responded to adequate doses of other available antiarrhythmics or when alternative agents cannot be tolerated. - cardiogenic shock. - sick sinus syndrome, second- or third-degree atrioventricular block, bradycardia leading to syncope without a functioning pacemaker. - known hypersensitivity to the drug or to any of its components, including iodine. risk summary available data from postmarketing reports and published case series indicate that amiodarone use in pregnant women may increase the risk for fetal adverse effects including neonatal hypo- and hyperthyroidism, neonatal bradycardia, neurodevelopmental abnormalities, preterm birth and fetal growth restriction. amiodarone and its metabolite, desethylamiodarone (dea), cross the placenta. untreated underlying arrhythmias, including ventric

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

zydus pharmaceuticals usa inc. - amiodarone hydrochloride (unii: 976728sy6z) (amiodarone - unii:n3rq532iut) - amiodarone hydrochloride 200 mg - amiodarone hydrochloride tablets are indicated for the treatment of documented, life-threatening recurrent ventricular fibrillation and life-threatening recurrent hemodynamically unstable tachycardia in adults who have not responded to adequate doses of other available antiarrhythmics or when alternative agents cannot be tolerated. - cardiogenic shock. - sick sinus syndrome, second- or third-degree atrioventricular block, bradycardia leading to syncope without a functioning pacemaker. - known hypersensitivity to the drug or to any of its components, including iodine. risk summary available data from postmarketing reports and published case series indicate that amiodarone use in pregnant women may increase the risk for fetal adverse effects including neonatal hypo- and hyperthyroidism, neonatal bradycardia, neurodevelopmental abnormalities, preterm birth and fetal growth restriction. amiodarone and its metabolite, desethylamiodarone (dea), cross the placenta. untreated u