Pulmonary, Hepatic And Cardiac Toxicity

Amiodarone hydrochloride is intended for use only in patients with the indicated life-threatening arrhythmias because its use is accompanied by substantial toxicity [see INDICATIONS AND USAGE (1)].

Amiodarone hydrochloride tablets can cause pulmonary toxicity (hypersensitivity pneumonitis or interstitial/alveolar pneumonitis) that has resulted in clinically manifest disease at rates as high as 17% in some series of patients. Pulmonary toxicity has been fatal about 10% of the time. Obtain a baseline chest X-ray and pulmonary-function tests, including diffusion capacity, when amiodarone hydrochloride tablets therapy is initiated. Repeat history, physical exam, and chest X-ray every 3 to 6 months [see WARNINGS AND PRECAUTIONS 5.2)].

Amiodarone hydrochloride can cause hepatoxicity, which can be fatal. Obtain baseline and periodic liver transaminases and discontinue or reduce dose if the increase exceeds three times normal, or doubles in a patient with an elevated baseline. Discontinue amiodarone hydrochloride tablets if the patient experiences signs or symptoms of clinical liver injury [see WARNINGS AND PRECAUTIONS (5.3)].

Amiodarone hydrochloride can exacerbate arrhythmias. Initiate amiodarone hydrochloride tablets in a clinical setting where continuous electrocardiograms and cardiac resuscitation are available [see WARNINGS AND PRECAUTIONS (5.4)].