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

remedyrepack inc. - amiodarone hydrochloride (unii: 976728sy6z) (amiodarone - unii:n3rq532iut) - amiodarone hydrochloride injection is indicated for initiation of treatment and prophylaxis of frequently recurring ventricular fibrillation (vf) and hemodynamically unstable ventricular tachycardia (vt) in patients refractory to other therapy. amiodarone hydrochloride injection also can be used to treat patients with vt/vf for whom oral amiodarone is indicated, but who are unable to take oral medication. during or after treatment with amiodarone hydrochloride injection, patients may be transferred to oral amiodarone therapy [see dosage and administration ( 2)] . use amiodarone hydrochloride injection for acute treatment until the patient's ventricular arrhythmias are stabilized. most patients will require this therapy for 48 to 96 hours, but amiodarone hydrochloride injection may be safely administered for longer periods if necessary. amiodarone is contraindicated in patients with: - known hypersensitivity to any of the components of amiodarone, including iodine. hype

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

general injectables and vaccines, inc. - amiodarone hydrochloride (unii: 976728sy6z) (amiodarone - unii:n3rq532iut) - amiodarone hydrochloride injection is indicated for initiation of treatment and prophylaxis of frequently recurring ventricular fibrillation (vf) and hemodynamically unstable ventricular tachycardia (vt) in patients refractory to other therapy. amiodarone hydrochloride injection also can be used to treat patients with vt/vf for whom oral amiodarone is indicated, but who are unable to take oral medication. during or after treatment with amiodarone hydrochloride injection, patients may be transferred to oral amiodarone is indicated, but who are unable to take oral medication. during or after treatment with amiodarone hydrochloride injection, patients may be transferred to oral amiodarone therapy [see dosage and administration (2)]. use amiodarone hydrochloride injection for acute treatment until the patient's ventricular arrhythmias are stabilized. most patients will require this therapy for 48 to 96 hours, but amiodarone hydrochloride injection may be safely administered for longer periods if necessary. amioda

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

bryant ranch prepack - amiodarone hydrochloride (unii: 976728sy6z) (amiodarone - unii:n3rq532iut) - 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)

medical purchasing solutions, llc - amiodarone hydrochloride (unii: 976728sy6z) (amiodarone - unii:n3rq532iut) - amiodarone injection is indicated for initiation of treatment and prophylaxis of frequently recurring ventricular fibrillation (vf) and hemodynamically unstable ventricular tachycardia (vt) in patients refractory to other therapy. amiodarone also can be used to treat patients with vt/vf for whom oral amiodarone is indicated, but who are unable to take oral medication. during or after treatment with amiodarone, patients may be transferred to oral amiodarone therapy [see dosage and administration ( 2)] . use amiodarone for acute treatment until the patient's ventricular arrhythmias are stabilized. most patients will require this therapy for 48 to 96 hours, but amiodarone may be safely administered for longer periods if necessary. amiodarone is contraindicated in patients with: - known hypersensitivity to any of the components of amiodarone injection, including iodine. hypersensitivity reactions may involve rash, angioedema, cutaneous/mucosal hemorrhage (

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

upsher-smith laboratories, llc - amiodarone hydrochloride (unii: 976728sy6z) (amiodarone - unii:n3rq532iut) - amiodarone hydrochloride 100 mg - pacerone is 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 post-marketing 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

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

hf acquisition co llc, dba healthfirst - amiodarone hydrochloride (unii: 976728sy6z) (amiodarone - unii:n3rq532iut) - amiodarone hydrochloride injection is indicated for initiation of treatment and prophylaxis of frequently recurring ventricular fibrillation (vf) and hemodynamically unstable ventricular tachycardia (vt) in patients refractory to other therapy. amiodarone also can be used to treat patients with vt/vf for whom oral amiodarone is indicated, but who are unable to take oral medication. during or after treatment with amiodarone, patients may be transferred to oral amiodarone therapy [see dosage and administration ( 2)]. use amiodarone for acute treatment until the patient's ventricular arrhythmias are stabilized. most patients will require this therapy for 48 to 96 hours, but amiodarone may be safely administered for longer periods if necessary. amiodarone is contraindicated in patients with: • known hypersensitivity to any of the components of amiodarone hydrochloride injection, including iodine. hypersensitivity reactions may involve rash, angioedema, cutaneous/mucosal hemorrhage (bleeding), fever, arthralgias (joint pains), eosinophilia (abnormal blood counts), urticaria (hives), thrombotic thrombocytopenic purpura, or severe periarteritis (inflammation around blood vessels). • cardiogenic shock • marked sinus bradycardia • second- or third-degree atrio-ventricular (av) block unless a functioning pacemaker is available. 8.1 pregnancy pregnancy category d [see warnings and precautions (5.8)]. teratogenic effects amiodarone and desethylamiodarone cross the placenta. reported risks include: • neonatal bradycardia, qt prolongation, and periodic ventricular extrasystoles • neonatal hypothyroidism (with or without goiter) detected antenatally or in the newborn and reported even after a few days of exposure • neonatal hyperthyroxinemia • neurodevelopmental abnormalities independent of thyroid function, including speech delay and difficulties with written language and arithmetic, delayed motor development, and ataxia. • jerk nystagmus with synchronous head titubation • fetal growth retardation • premature birth amiodarone has caused a variety of adverse effects in animals. amiodarone was given intravenously to rabbits at dosages of 5 mg/kg per day, 10 mg/kg per day, or 25 mg/kg per day (about 0.1, 0.3, and 0.7 times the human intravenous maintenance dose of 0.5 mg/min on a body surface area basis), during gestation days 8 to 16 (organogenesis). the incidence of maternal deaths increased with increasing dose and occurred in all treated groups, and controls. mean fetal weights were significantly decreased in the low and middle dose groups and embryotoxicity (as manifested by fewer full- term fetuses and increased resorptions) occurred at dosages of 10 mg/kg and above. there were no significant differences in the number of minor fetal abnormalities and no major fetal abnormalities were observed. amiodarone was administered by continuous intravenous infusion to rats at dosages of 25 mg/kg per day, 50 mg/kg per day, or 100 mg/kg per day (about 0.3, 0.7, and 1.3 times the human intravenous maintenance dose of 0.5 mg/min on a body surface area basis) during gestation days 8 to 16 (organogenesis). maternal toxicity (manifest as reduced weight gain and food consumption) and embryotoxicity (manifest as increased resorptions, decreased live litter size and fetal body weights, and delayed sternal and metacarpal ossification) were observed in the 100 mg/kg group. the delayed ossification was reversible and related to decreased fetal weight. fetal thyroid tissues appeared normal in all groups. nonteratogenic effects very high concentrations of amiodarone and desethylamiodarone may be found in testes. elevated follicle-stimulating hormone and luteinizing hormone levels, suggestive of testicular dysfunction, have been reported in men on long-term amiodarone treatment. while planning pregnancy after discontinuation of amiodarone treatment, consider the long half-life of amiodarone and its metabolite dea. 8.2 labor and delivery it is not known whether the use of amiodarone during labor or delivery has any immediate or delayed adverse effects. preclinical studies in rodents have not shown any effect on the duration of gestation or on parturition. 8.3 nursing mothers amiodarone and one of its major metabolites, desethylamiodarone (dea), are excreted in human milk, suggesting that breast-feeding could expose the nursing infant to a significant dose of the drug. nursing offspring of lactating rats administered amiodarone have demonstrated reduced viability and reduced body weight gains. the risk of exposing the infant to amiodarone must be weighed against the potential benefit of arrhythmia suppression in the mother. advise the mother to discontinue nursing. 8.4 pediatric use the safety and effectiveness of amiodarone in pediatric patients have not been established; therefore, the use of amiodarone in pediatric patients is not recommended. in a pediatric trial of 61 patients, aged 30 days to 15 years, hypotension (36%), bradycardia (20%), and av block (15%) were common dose-related adverse reactions and were severe or life-threatening in some cases. injection site reactions were seen in 5 (25%) of the 20 patients receiving intravenous amiodarone through a peripheral vein irrespective of dose regimen. amiodarone hydrochloride injection contains the preservative benzyl alcohol [see description (11)]. there have been reports of fatal "gasping syndrome" in neonates (children less than one month of age) following the administration of intravenous solutions containing the preservative benzyl alcohol. symptoms include a striking onset of gasping respiration, hypotension, bradycardia, and cardiovascular collapse. 8.5 geriatric use clinical studies of amiodarone did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. other reported clinical experience has not identified differences in responses between the elderly and younger patients. carefully consider dose selection in an elderly patient. in general, start at the low end of the dosing range in the elderly to reflect the greater frequency of decreased hepatic, renal, or cardiac function, and concomitant disease or other drug therapy.

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

waymade healthcare plc - amiodarone hydrochloride - oral tablet - 200mg

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

mawdsley-brooks & company ltd - amiodarone hydrochloride - oral tablet - 100mg

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

upsher-smith laboratories, llc - amiodarone hydrochloride (unii: 976728sy6z) (amiodarone - unii:n3rq532iut) - amiodarone hydrochloride 400 mg - because of its life-threatening side effects and the substantial management difficulties associated with its use (see warnings below), pacerone® (amiodarone hydrochloride) tablets are indicated only for the treatment of the following documented, life-threatening recurrent ventricular arrhythmias when these have not responded to documented adequate doses of other available antiarrhythmics or when alternative agents could not be tolerated. - recurrent ventricular fibrillation. - recurrent hemodynamically unstable ventricular tachycardia. as is the case for other antiarrhythmic agents, there is no evidence from controlled trials that the use of amiodarone hydrochloride tablets favorably affects survival. pacerone® (amiodarone hydrochloride) tablets should be used only by physicians familiar with and with access to (directly or through referral) the use of all available modalities for treating recurrent life-threatening ventricular arrhythmias, and who have access to appropriate monitoring facilities, includin

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

a a h pharmaceuticals ltd - amiodarone hydrochloride - oral tablet - 100mg