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Steady-State Serum Amiodarone Concentrations: Relationships with Antiarrhythmic Efficacy and Toxicity

HESCHl H. ROTMENSCH, M.D.; BERNARD BELHASSEN, M.D.; BRIAN N. SWANSON, Ph.D.; DAVID SHOSHANI, M.D.; SCOTT R. SPIELMAN, M.D.; ARNOLD J. GREENSPON, M.D.; ALLAN M. GREENSPAN, M.D.; PETER H. VLASSES, Pharm.D.; and LEONARD N. HOROWITZ, M.D.
[+] Article and Author Information

Presented in part in November 1983 at the 56th Scientific Session of the American Heart Association, Anaheim, California.

▸Requests for reprints should be addressed to Heschi H. Rotmensch, M.D.; Division of Clinical Pharmacology (M-502), Jefferson Medical College, 11th & Walnut Streets; Philadelphia, PA 19107.


Philadelphia, Pennsylvania; and Tel-Aviv, Israel


© 1984 American College of PhysiciansAmerican College of Physicians


Ann Intern Med. 1984;101(4):462-469. doi:10.7326/0003-4819-101-4-462
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The relationship of apparent steady-state serum concentrations of amiodarone and its metabolite, desethylamiodarone, to therapeutic and toxic effects was assessed in 127 patients who had treatment-resistant ventricular or supraventricular arrhythmias or were intolerant to other agents. After at least 2 months (mean, 9.8) of treatment with daily maintenance doses of 200 to 600 mg, arrhythmias were effectively suppressed in 78% of patients. Arrhythmias recurred in 47% of patients with serum amiodarone concentrations of less than 1.0 mg/L, whereas only 14% of patients with higher concentrations had recurrences (p < 0.005). Side effects, most of them mild, occurred in 57%; only 9 patients required discontinuation of drug therapy. The risk of developing adverse reactions was related to serum amiodarone concentrations (p < 0.0001). Adverse reactions were common in patients with serum values exceeding 2.5 mg/L, although pulmonary complications did occur at lower concentrations. Monitoring serum amiodarone concentrations may differentiate failure of drug therapy from suboptimal dosing and reduce the incidence of concentration-related side effects.

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