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

a-s medication solutions - propafenone hydrochloride (unii: 33xch0hocd) (propafenone - unii:68iqx3t69u) - propafenone hydrochloride 225 mg - propafenone hydrochloride tablets are indicated to: usage considerations: propafenone hydrochloride tablets are contraindicated in the following circumstances: pregnancy category c. there are no adequate and well-controlled studies in pregnant women. propafenone hydrochloride tablets should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. animal data: teratogenic effects: propafenone has been shown to be embryotoxic (decreased survival) in rabbits and rats when given in oral maternally toxic doses of 150 mg/kg day (about 3 times the maximum recommended human dose [mrhd] on a mg/m2 basis) and 600 mg/kg/day (about 6 times the mrhd on a mg/m2 basis), respectively. although maternally tolerated doses (up to 270 mg/kg/day, about 3 times the mrhd on a mg/m2 basis) produced no evidence of embryotoxicity in rats, post-implantation loss was elevated in all rabbit treatment groups (doses as low as 15 mg/kg/day, about 1/3 the mrhd on a mg/m2 basis). non-teratogenic

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

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)

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)

actavis pharma, 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: - the use of propafenone hydrochloride extended-release 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 hydrochloride extended-release 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 hydrochloride extended-release capsules are contraindicated in the following circumstances: - heart failure - cardiogenic shock - sinoatrial, atrioventricular, and intraventricular disorders of impulse generation or conduction (e.g., sick sinus node syndrome, av block) in the absence of an artificial pacemaker - known brugada syndrome - bradycardia - marked hypotension - bronchospastic disorders or severe obstructive pulmonary disease - marked electrolyte imbalance risk summary 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 extended-release 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 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 during mid-gestation through weaning of their offspring (see data) . the estimated background risks of major birth defects and miscarriage for the indicated populations are 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 miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. clinical considerations disease-associated maternal and/or embryo/fetal risk: the incidence of vt is increased and may be more symptomatic during pregnancy. ventricular arrhythmias most often occur in pregnant women with underlying cardiomyopathy, congenital heart disease, valvular heart disease, or mitral valve prolapse. breakthrough arrhythmias may also occur during pregnancy, as therapeutic treatment levels may be difficult to maintain due to the increased volume of distribution and increased drug metabolism inherent in the pregnant state. fetal/neonatal adverse reactions: propafenone and its metabolite have been shown to cross the placenta. adverse reactions such as fetal/neonatal arrhythmias have been associated with the use of other antiarrhythmic agents by pregnant women. fetal/neonatal monitoring for signs and symptoms of arrhythmia is recommended during and after treatment of pregnant women with propafenone. labor or delivery: risk of arrhythmias may increase during labor and delivery. patients treated with propafenone hydrochloride extended-release capsules should be monitored continuously for arrhythmias during labor and delivery [see warnings and precautions (5.1)] . data propafenone has been shown to cause embryo-fetal mortality in rabbits and rats when given orally during organogenesis at maternally toxic doses of 150 mg/kg/day (rabbit: maternal mortality, decreased body weight gain and food consumption at approximately 3 times the mrhd on a mg/m2 basis) and 600 mg/kg/day (rat: maternal decreased body weight gain and food consumption at approximately 6 times the mrhd on a mg/m2 basis). in addition, a maternally toxic dose of 600 mg/kg/day (approximately 6 times the mrhd on a mg/m2 basis) also caused decreased fetal weights in rats. increased placental weights and delayed ossification occurred in rabbits at a dose of 30 mg/kg/day (less than the mrhd on a mg/m2 basis) in the absence of maternal toxicity. no adverse developmental outcomes in the absence of maternal toxicity were seen following oral doses of 15 mg/kg/day to rabbits or up to 270 mg/kg/day to rats administered during organogenesis (equivalent to 0.3 times or approximately 3 times the mrhd on a mg/m2 basis, respectively). in an oral study, female rats received propafenone up to 500 mg/kg/day from mid-gestation through weaning. at 90 mg/kg/day (equivalent to the mrhd on a mg/m2 basis), there were no adverse developmental outcomes in the absence of maternal toxicity. however, doses ≥180 mg/kg/day (2 or more times the mrhd on a mg/m2 basis) produced increases in maternal deaths and resulted in reductions in neonatal survival, body weight gain, and delayed development in the presence of maternal toxicity. risk summary propafenone and its active metabolite, 5-oh-propafenone, are present in human milk, but the levels are likely to be low. there are no data on the effects of propafenone on the breastfed infant or the effects on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for propafenone and any potential adverse effects on the breastfed infant from propafenone or from the underlying maternal condition. infertility males: based on human and animal studies, propafenone hydrochloride may transiently impair spermatogenesis in males. evaluation of the effects on spermatogenesis was performed in 11 healthy males given oral propafenone 300 mg b.i.d. for 4 days, which was then increased to 300 mg t.i.d. for an additional 4 days. study findings included a 28% reduction in semen sample volume on treatment day 8 and a 27% reduction in sperm count 64 days after treatment (both values remained within the laboratories normal reference range). these effects were not seen in follow-up visits up to 120 days after treatment. reversible decreases in spermatogenesis have been demonstrated in monkeys, dogs, and rabbits after lethal or near-lethal intravenous doses of propafenone [see nonclinical toxicology (13.1)]. the safety and effectiveness of propafenone in pediatric patients have not been established. of the total number of subjects in phase 3 clinical trials of propafenone hydrochloride 46% were 65 and older, while 16% were 75 and older. no overall differences in safety or effectiveness were observed between these subjects and younger subjects, but greater sensitivity of some older individuals at higher doses cannot be ruled out. the effect of age on the pharmacokinetics and pharmacodynamics of propafenone has not been studied.

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

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

glenmark pharmaceuticals inc., usa - 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: risk summary 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 extended-release 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 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 during mid-gestation through weaning of their offspring (see data) . the estimated background risks of major birth defects and miscarriage for the indicated populations are 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 miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. clinical considerations disease-associated maternal and/or embryo/fetal risk: the incidence of vt is increased and may be more symptomatic during pregnancy. ventricular arrhythmias most often occur in pregnant women with underlying cardiomyopathy, congenital heart disease, valvular heart disease, or mitral valve prolapse. breakthrough arrhythmias may also occur during pregnancy, as therapeutic treatment levels may be difficult to maintain due to the increased volume of distribution and increased drug metabolism inherent in the pregnant state. fetal/neonatal adverse reactions: propafenone and its metabolite have been shown to cross the placenta. adverse reactions such as fetal/neonatal arrhythmias have been associated with the use of other antiarrhythmic agents by pregnant women. fetal/neonatal monitoring for signs and symptoms of arrhythmia is recommended during and after treatment of pregnant women with propafenone. labor or delivery: risk of arrhythmias may increase during labor and delivery. patients treated with propafenone hydrochloride extended-release capsules should be monitored continuously for arrhythmias during labor and delivery [see warnings and precautions (5.1)] . data propafenone has been shown to cause embryo-fetal mortality in rabbits and rats when given orally during organogenesis at maternally toxic doses of 150 mg/kg/day (rabbit: maternal mortality, decreased body weight gain and food consumption at approximately 3 times the mrhd on a mg/m2 basis) and 600 mg/kg/day (rat: maternal decreased body weight gain and food consumption at approximately 6 times the mrhd on a mg/m2 basis). in addition, a maternally toxic dose of 600 mg/kg/day (approximately 6 times the mrhd on a mg/m2 basis) also caused decreased fetal weights in rats. increased placental weights and delayed ossification occurred in rabbits at a dose of 30 mg/kg/day (less than the mrhd on a mg/m2 basis) in the absence of maternal toxicity. no adverse developmental outcomes in the absence of maternal toxicity were seen following oral doses of 15 mg/kg/day to rabbits or up to 270 mg/kg/day to rats administered during organogenesis (equivalent to 0.3 times or approximately 3 times the mrhd on a mg/m2 basis, respectively). in an oral study, female rats received propafenone up to 500 mg/kg/day from mid-gestation through weaning. at 90 mg/kg/day (equivalent to the mrhd on a mg/m2 basis), there were no adverse developmental outcomes in the absence of maternal toxicity. however, doses ≥180 mg/kg/day (2 or more times the mrhd on a mg/m2 basis) produced increases in maternal deaths and resulted in reductions in neonatal survival, body weight gain, and delayed development in the presence of maternal toxicity. risk summary propafenone and its active metabolite, 5-oh-propafenone, are present in human milk, but the levels are likely to be low. there are no data on the effects of propafenone on the breastfed infant or the effects on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for propafenone and any potential adverse effects on the breastfed infant from propafenone or from the underlying maternal condition. infertility males: based on human and animal studies, propafenone hydrochloride extended-release capsules may transiently impair spermatogenesis in males. evaluation of the effects on spermatogenesis was performed in 11 healthy males given oral propafenone 300 mg b.i.d. for 4 days, which was then increased to 300 mg t.i.d. for an additional 4 days. study findings included a 28% reduction in semen sample volume on treatment day 8 and a 27% reduction in sperm count 64 days after treatment (both values remained within the laboratories normal reference range). these effects were not seen in follow-up visits up to 120 days after treatment. reversible decreases in spermatogenesis have been demonstrated in monkeys, dogs, and rabbits after lethal or near-lethal intravenous doses of propafenone [see nonclinical toxicology (13.1 )]. the safety and effectiveness of propafenone in pediatric patients have not been established. of the total number of subjects in phase 3 clinical trials of propafenone hydrochloride extended-release 46% were 65 and older, while 16% were 75 and older. no overall differences in safety or effectiveness were observed between these subjects and younger subjects, but greater sensitivity of some older individuals at higher doses cannot be ruled out. the effect of age on the pharmacokinetics and pharmacodynamics of propafenone has not been studied.

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)

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