USA - engelska - NLM (National Library of Medicine)

general injectables and vaccines, inc. - amiodarone hydrochloride (unii: 976728sy6z) (amiodarone - unii:n3rq532iut) - amiodarone hydrochloride 50 mg in 1 ml

USA - engelska - NLM (National Library of Medicine)

remedyrepack inc. - amiodarone hydrochloride (unii: 976728sy6z) (amiodarone - unii:n3rq532iut) - amiodarone hydrochloride 50 mg in 1 ml

USA - engelska - NLM (National Library of Medicine)

hospira, inc. - amiodarone hydrochloride (unii: 976728sy6z) (amiodarone - unii:n3rq532iut) - amiodarone hydrochloride 50 mg in 1 ml

USA - engelska - NLM (National Library of Medicine)

mckesson contract packaging - amiodarone hydrochloride (unii: 976728sy6z) (amiodarone - unii:n3rq532iut) - amiodarone hydrochloride 200 mg

USA - engelska - 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 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. 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-(5.8)]. in addition to causing infrequent congenital goiter/hypothyroidism and hyperthyroidism, amiodarone has caused a variety of adverse effects in animals. in a reproductive study in which amiodarone was given intravenously to rabbits at dosages of 5, 10, or 25 mg/kg per day (about 0.1, 0.3, and 0.7 times the maximum recommended human dose [mrhd] on a body surface area basis), maternal deaths occurred in all groups, including controls. embryotoxicity (as manifested by fewer full-term fetuses and increased resorptions with concomitantly lower litter weights) occurred at dosages of 10 mg/kg and above. no evidence of embryotoxicity was observed at 5 mg/kg and no teratogenicity was observed at any dosages. in a teratology study in which amiodarone was administered by continuous iv infusion to rats at dosages of 25, 50, or 100 mg/kg per day (about 0.4, 0.7, and 1.4 times the mrhd when compared on a body surface area basis), maternal toxicity (as evidenced by reduced weight gain and food consumption) and embryotoxicity (as evidenced by increased resorptions, decreased live litter size, reduced body weights, and retarded sternum and metacarpal ossification) were observed in the 100 mg/kg group. use amiodarone during pregnancy only if the potential benefit to the mother justifies the risk to the fetus. 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 breastfeeding 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 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.

USA - engelska - NLM (National Library of Medicine)

avera mckennan hospital - amiodarone hydrochloride (unii: 976728sy6z) (amiodarone - unii:n3rq532iut) - amiodarone hydrochloride 200 mg

USA - engelska - NLM (National Library of Medicine)

physicians total care, inc. - amiodarone hydrochloride (unii: 976728sy6z) (amiodarone - unii:n3rq532iut) - amiodarone hydrochloride 200 mg - because of its life-threatening side effects and the substantial management difficulties associated with amiodarone use (see "warnings" below), pacerone® (amiodarone hcl) 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 hcl tablets favorably affects survival. pacerone® (amiodarone hcl) 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, including in-hospital and amb

USA - engelska - NLM (National Library of Medicine)

teva pharmaceuticals usa, inc. - amiodarone hydrochloride (unii: 976728sy6z) (amiodarone - unii:n3rq532iut) - amiodarone hydrochloride 200 mg

USA - engelska - NLM (National Library of Medicine)

bryant ranch prepack - amiodarone hydrochloride (unii: 976728sy6z) (amiodarone - unii:n3rq532iut) - amiodarone hydrochloride 200 mg

USA - engelska - NLM (National Library of Medicine)

remedyrepack inc. - amiodarone hydrochloride (unii: 976728sy6z) (amiodarone - unii:n3rq532iut) - amiodarone hydrochloride 200 mg