Irland - engelsk - HPRA (Health Products Regulatory Authority)

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

USA - engelsk - NLM (National Library of Medicine)

avera mckennan hospital - propafenone hydrochloride (unii: 33xch0hocd) (propafenone - unii:68iqx3t69u) - propafenone hydrochloride 225 mg

Irland - engelsk - HPRA (Health Products Regulatory Authority)

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

Irland - engelsk - HPRA (Health Products Regulatory Authority)

accord healthcare ireland ltd. - propafenone hydrochloride - film-coated tablet - 300 milligram(s) - antiarrhythmics, class ic; propafenone

USA - engelsk - NLM (National Library of Medicine)

bryant ranch prepack - propafenone hydrochloride (unii: 33xch0hocd) (propafenone - unii:68iqx3t69u) - 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 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 tablets 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 tablets 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. clinical trials of propafenone hydrochloride tablets did not include sufficient numbers of subjects aged 65 and older to determine whether they respond differently from younger subjects. other reported clinical experience has not identified differences in responses between the elderly and younger subjects. in general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

USA - engelsk - NLM (National Library of Medicine)

bryant ranch prepack - propafenone hydrochloride (unii: 33xch0hocd) (propafenone - unii:68iqx3t69u) - 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

USA - engelsk - NLM (National Library of Medicine)

bryant ranch prepack - propafenone hydrochloride (unii: 33xch0hocd) (propafenone - unii:68iqx3t69u) - 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

USA - engelsk - 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.

Malta - engelsk - Medicines Authority

central procurement & supplies unit ub002 industrial estate, san gwann sgn 3000, malta - propafenone hydrochloride - film-coated tablet - propafenone hydrochloride 150 milligram(s) - cardiac therapy

Malta - engelsk - Medicines Authority

accord healthcare limited sage house, 319, pinner road, north harrow, middlesex ha1 4hf, united kingdom - propafenone hydrochloride - film-coated tablet - propafenone hydrochloride 150 mg - cardiac therapy