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)

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)

par pharmaceutical, inc. - propafenone hydrochloride (unii: 33xch0hocd) (propafenone - unii:68iqx3t69u) - propafenone hydrochloride 150 mg - propafenone hydrochloride tablets are 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 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. 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. treat documented ventricular arrhythmias, such as sustained ventricular tachycardia that, in the judgment of the physician, are life

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

ani pharmaceuticals, inc. - propafenone hydrochloride (unii: 33xch0hocd) (propafenone - unii:68iqx3t69u) - propafenone hydrochloride 150 mg - propafenone hydrochloride tablets are indicated to: usage considerations: propafenone hydrochloride tablets are contraindicated in the following circumstances: risk summary there are no studies of propafenone hydrochloride tablets in pregnant women. available data from published case reports and several decades of postmarketing experience with use of propafenone hydrochloride tablets 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]), there was evidence of adverse developmental outcomes when administered to pregnant rabbits and rats during organogenesis or when administered to pregnant rat

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

sun pharmaceutical industries, inc. - propafenone hydrochloride (unii: 33xch0hocd) (propafenone - unii:68iqx3t69u) - propafenone hydrochloride 150 mg - propafenone hydrochloride tablets are indicated to: usage considerations: propafenone hydrochloride tablets are contraindicated in the following circumstances: risk summary there are no studies of propafenone hydrochloride tablets in pregnant women. available data from published case reports and several decades of postmarketing experience with use of propafenone hydrochloride tablets 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]), there was evidence of adverse developmental outcomes when administered to pregnant rabbits and rats during organogenesis or when administered to pregnant rats d

Ireland - English - HPRA (Health Products Regulatory Authority)

accord healthcare limited - propafenone hydrochloride - film-coated tablet - 150 milligram(s) - antiarrhythmics, class ic; propafenone

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 

Ireland - English - HPRA (Health Products Regulatory Authority)

accord healthcare ireland ltd. - propafenone hydrochloride - film-coated tablet - 150 milligram(s) - antiarrhythmics, class ic; propafenone

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

avkare, inc. - propafenone hydrochloride (unii: 33xch0hocd) (propafenone - unii:68iqx3t69u) - propafenone hydrochloride 325 mg - propafenone hcl extended release capsules is 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: - the use of propafenone er capsules in patients with permanent af or in patients exclusively with atrial flutter or paroxysmal supraventricular tachycardia (psvt) has not been evaluated. do not use propafenone er capsules 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 functional atrioventricular (av) nodal refractory period is recommended. - the effect of propafenone on mortality has not been determined [see boxed warning]. propafenone er capsules is contraindicated in the following circumstances: • heart failure • cardiogenic shock • sinoatrial, atrioventricular

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

par pharmaceutical, inc. - propafenone hydrochloride (unii: 33xch0hocd) (propafenone - unii:68iqx3t69u) - propafenone hydrochloride 325 mg - propafenone hcl extended release capsules, usp 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: - the use of propafenone er capsules in patients with permanent af or in patients exclusively with atrial flutter or paroxysmal supraventricular tachycardia (psvt) has not been evaluated. do not use propafenone er capsules 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 functional atrioventricular (av) nodal refractory period is recommended. - the effect of propafenone on mortality has not been determined [see boxed warning]. propafenone er capsules is contraindicated in the following circumstances: • heart failure • cardiogenic shock • sinoatrial, atrioventricular, and in