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

mylan pharmaceuticals inc. - propafenone hydrochloride (unii: 33xch0hocd) (propafenone - unii:68iqx3t69u) - propafenone hydrochloride 225 mg - propafenone hydrochloride extended-release capsules are indicated to prolong the time to recurrence of symptomatic atrial fibrillation (af) in patients with episodic (most likely paroxysmal or persistent) af who do not have structural heart disease. usage considerations: propafenone hydrochloride extended-release capsules are contraindicated in the following circumstances: in the absence of studies in pregnant women, available data from published case reports and several decades of postmarketing experience with use of propafenone hydrochloride in pregnancy have not identified any drug-associated risks of miscarriage, birth defects, or adverse maternal or fetal outcomes. untreated arrhythmias during pregnancy may pose a risk to the pregnant woman and fetus (see clinical considerations). propafenone and its metabolite, 5-oh-propafenone, cross the placenta in humans. in animal studies, propafenone was not teratogenic. at maternally toxic doses (ranging from 2 to 6 times the maximum recommended human dose [mrhd]

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

prasco laboratories - propafenone hydrochloride (unii: 33xch0hocd) (propafenone - unii:68iqx3t69u) - propafenone hydrochloride 225 mg - propafenone hydrochloride extended-release (sr) capsules are indicated to prolong the time to recurrence of symptomatic atrial fibrillation (af) in patients with episodic (most likely paroxysmal or persistent) af who do not have structural heart disease. usage considerations: propafenone hydrochloride extended-release (sr) capsules are contraindicated in the following circumstances:   risk summary there are no studies of propafenone hydrochloride extended-release (sr) capsules in pregnant women. available data from published case reports and several decades of postmarketing experience with use of propafenone hydrochloride extended-release (sr) capsules in pregnancy have not identified any drug-associated risks of miscarriage, birth defects, or adverse maternal or fetal outcomes. untreated arrhythmias during pregnancy may pose a risk to the pregnant woman and fetus (see clinical considerations). propafenone and its metabolite, 5-oh-propafenone, cross the placenta in humans. in animal studies, propafenone was

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

american health packaging - propafenone hydrochloride (unii: 33xch0hocd) (propafenone - unii:68iqx3t69u) - propafenone hydrochloride 150 mg - propafenone hydrochloride is indicated to: - prolong the time to recurrence of paroxysmal atrial fibrillation/flutter (paf) associated with disabling symptoms in patients without structural heart disease. - prolong the time to recurrence of paroxysmal supraventricular tachycardia (psvt) associated with disabling symptoms in patients without structural heart disease. - treat documented ventricular arrhythmias, such as sustained ventricular tachycardia that, in the judgment of the physician, are life-threatening. initiate treatment in the hospital. usage considerations: - the use of propafenone hydrochloride tablets in patients with permanent atrial fibrillation (af) or in patients exclusively with atrial flutter or psvt has not been evaluated. do not use propafenone hydrochloride tablets to control ventricular rate during af. - some patients with atrial flutter treated with propafenone have developed 1:1 conduction, producing an increase in ventricular rate. concomitant treatment with drugs that increase the f

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

nivagen pharmaceuticals, inc. - drospirenone (unii: n295j34a25) (drospirenone - unii:n295j34a25), ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u) - drospirenone 3 mg - drospirenone and ethinyl estradiol tablets are indicated for use by women to prevent pregnancy. do not prescribe drospirenone and ethinyl estradiol tablets to women who are known to have the following: - renal impairment - adrenal insufficiency - 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 cerebrovascular disease[see warnings and precautions (5.1)] have coronary artery disease[see warnings and precautions (5.1)] have thrombogenic valvular or thrombogenic rhythm diseases of the heart (for example, subacute bacterial endocarditis with valvular disease, or atrial fibrillation)[see warnings and precautions (5.1)] have inherited or acquired hypercoagulopathies[see warnings and precautions (5.1)] have uncontrolled hypertension[see warnings and precautions (5.5)] have d

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

preferred pharmaceuticals, inc. - hydroquinone (unii: xv74c1n1ae) (hydroquinone - unii:xv74c1n1ae) - hydroquinone 40 mg in 1 g - hydroquinone usp, 4% skin bleaching cream is indicated for the gradual bleaching of hyperpigmented skin conditions such as chloasma, melasma, freckles, senile lentigines, and other unwanted areas of melanin hyperpigmentation. prior history of sensitivity or allergic reaction to hydroquinone or to any of the ingredients of the product. the safety of topical hydroquinone use during pregnancy or for children (12 years and under) has not been established.

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

apotex corp - eplerenone (unii: 6995v82d0b) (eplerenone - unii:6995v82d0b) - eplerenone 25 mg - eplerenone tablets are indicated to improve survival of stable patients with left ventricular (lv) systolic dysfunction (ejection fraction ≤40%) and clinical evidence of congestive heart failure (chf) after an acute myocardial infarction (mi). eplerenone tablets are indicated for the treatment of hypertension, to lower blood pressure. lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular (cv) events, primarily strokes and mi. these benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes. control of high blood pressure should be part of comprehensive cv 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 j

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

american health packaging - eplerenone (unii: 6995v82d0b) (eplerenone - unii:6995v82d0b) - eplerenone 25 mg - eplerenone tablets are indicated to improve survival of stable patients with left ventricular (lv) systolic dysfunction (ejection fraction less than or equal to 40%) and clinical evidence of congestive heart failure (chf) after an acute myocardial infarction (mi). eplerenone tablets are indicated for the treatment of hypertension, to lower blood pressure. lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular (cv) events, primarily strokes and mi. these benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes. control of high blood pressure should be part of comprehensive cv 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

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

actavis pharma, inc. - propafenone hydrochloride (unii: 33xch0hocd) (propafenone - unii:68iqx3t69u) - propafenone hydrochloride 150 mg - propafenone hydrochloride is indicated to: - prolong the time to recurrence of paroxysmal atrial fibrillation/flutter (paf) associated with disabling symptoms in patients without structural heart disease. - prolong the time to recurrence of paroxysmal supraventricular tachycardia (psvt) associated with disabling symptoms in patients without structural heart disease. - treat documented ventricular arrhythmias, such as sustained ventricular tachycardia that, in the judgment of the physician, are life-threatening. initiate treatment in the hospital. usage considerations: - the use of propafenone hydrochloride tablets in patients with permanent atrial fibrillation (af) or in patients exclusively with atrial flutter or psvt has not been evaluated. do not use propafenone hydrochloride tablets to control ventricular rate during af. - some patients with atrial flutter treated with propafenone have developed 1:1 conduction, producing an increase in ventricular rate. concomitant treatment with drugs that increase the 

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

rebel distributors corp - propafenone (unii: 68iqx3t69u) (propafenone - unii:68iqx3t69u) - propafenone 325 mg - propafenone extended release capsules are indicated to prolong the time to recurrence of symptomatic atrial fibrillation in patients without structural heart disease. the use of propafenone er capsules in patients with permanent atrial fibrillation or in patients exclusively with atrial flutter or psvt has not been evaluated. propafenone er capsules should not be used to control ventricular rate during atrial fibrillation. the effect of propafenone er capsules on mortality has not been determined (see black box warnings ). propafenone er capsules are contraindicated in the presence of congestive heart failure, cardiogenic shock, sinoatrial, atrioventricular and intraventricular disorders of impulse generation or conduction (e.g., sick sinus node syndrome, atrioventricular block) in the absence of an artificial pacemaker, bradycardia, marked hypotension, bronchospastic disorders, electrolyte imbalance, or hypersensitivity to the drug.

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

ncs healthcare of ky, inc dba vangard labs - propafenone hydrochloride (unii: 33xch0hocd) (propafenone - unii:68iqx3t69u) - propafenone hydrochloride 150 mg - in patients without structural heart disease, propafenone hcl is indicated to prolong the time to recurrence of - –paroxysmal atrial fibrillation/flutter (paf) associated with disabling symptoms. - –paroxysmal supraventricular tachycardia (psvt) associated with disabling symptoms. as with other agents, some patients with atrial flutter treated with propafenone have developed 1:1 conduction, producing an increase in ventricular rate. concomitant treatment with drugs that increase the functional av refractory period is recommended. the use of propafenone hcl in patients with chronic atrial fibrillation has not been evaluated. propafenone hcl should not be used to control ventricular rate during atrial fibrillation. propafenone hcl is also indicated for the treatment of - –documented ventricular arrhythmias, such as sustained ventricular tachycardia, that, in the judgement of the physician, are life-threatening. because of the proarrhythmic effects of propafenone hcl, its use with lesser ventricular arrhythmias