AMIODARONE HYDROCHLORIDE

Disposition Amiodarone exhibits complex disposition characteristics after intravenous administration. Peak serum concentrations after single 5 mg/kg 15-minute intravenous infusions in healthy subjects range between 5 and 41 mg/L. Peak concentrations after 10-minute infusions of 150 mg intravenous amiodarone in patients with ventricular fibrillation (VF) or hemodynamically unstable ventricular tachycardia (VT) range between 7 and 26 mg/L. Due to rapid distribution, serum concentrations decline to...

Apart from studies in patients with VT or VF, described below, there are two other studies of amiodarone showing an antiarrhythmic effect before significant levels of DEA could have accumulated. A placebo-controlled study of intravenous amiodarone (300 mg over 2 hours followed by 1200 mg/day) in post-coronary artery bypass graft patients with supraventricular and 2- to 3-consecutive-beat ventricular arrhythmias showed a reduction in arrhythmias from 12 hours on. A baseline-controlled study using a similar IV regimen in patients with recurrent, refractory VT/VF also showed rapid onset of antiar...

The following adverse reactions are described elsewhere in labeling:

• Hypotension [see Warnings and Precautions (5.1)]
• Hepatic injury [see Warnings and Precautions (5.3)]
• Rhythm disturbances [see Warnings and Precautions (5.4)]
• Pulmonary injury [see Warnings and Precautions (5.5)]
• Thyroid injury [see Warnings and Precautions (5.7)]
• Hypersensitivity [see Warnings and Precautions (5.11)]
• The most common adverse reactions (1% to 2%) leading to discontinuation of intravenous amiodarone ...

Amiodarone is contraindicated in patients with:

• Known hypersensitivity to any of the components of Amiodarone Hydrochloride Injection, USP, 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 peri...

Amiodarone should be administered only by physicians who are experienced in the treatment of life-threatening arrhythmias, who are thoroughly familiar with the risks and benefits of amiodarone therapy, and who have access to facilities adequate for monitoring the effectiveness and side effects of treatment. Because of the long half-life of amiodarone and its metabolite desethylamiodarone, the potential for adverse reactions or interactions, as well as observed adverse effects, can persist follow...

7 DRUG INTERACTIONS Amiodarone is a substrate for CYP3A and CYP2C8, so inhibitors and inducers affect amiodarone exposure ( 7 ) Amiodarone inhibits p-glycoprotein and CYP1A2, CYP2C9, CYP2D6, and CYP3A, increasing exposure to other drugs ( 7 ) 7.1 Pharmacodynamic Interactions Drugs Prolonging the QT Interval Co-administration of drugs prolonging the QT interval (such as class I and III antiarrhythm...