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Serum Drug Concentrations in Patients with Ischemic Heart Disease After Administration of a Sustained Release Procainamide Preparation

Division of Cardiology, Department of Medicine, Brookhaven Memorial Hospital Medical Center, Patchogue, NY

Timothy Mirando

Department of Pharmacy, Brookhaven Memorial Hospital Medical Center, Patchogue, NY

Despite widespread marketing of a sustained release preparation of pro cainamide hydrochloride (PROCAN-SR, Parke-Davis), published literature demonstrating its efficacy in maintaining uniform serum drug levels over a 6-hour dosing interval is derived from only normal healthy volunteers.

Thirty-three patients with ischemic heart disease, ages 30-88 years, were administered 1-4g/24 hours (mean dose 34 mg/kg/day) of PROCAN-SR in 4 equally divided doses on a Q6H schedule. After achievement of steady-state equilibrium drug concentration, procainamide and N-acetylprocainamide levels were determined by high-performance liquid chromatography on sera obtained from blood samples drawn 2, 3.5 and 5 hours after an oral dose.

Mean maximal procainamide and N-acetylprocainamide serum concentra tions were 4.6± 1.8 ug/ml and 4.2±2.1 ug/ml respectively. Mean minimal concentrations were 3.5± 1.7 ug/ml and 3.6±2.0 ug/ml respectively. The mean change in drug concentration was small (1.1 ug/ml procainamide and 0.6 ug/ml N-acetylprocainamide) with procainamide and N-acetylprocainamide con centrations varying only by 27 and 15 percent respectively.

These data demonstrate in a population of patients with ischemic heart disease, that Q6H dosing with a sustained release procainamide hydrochloride preparation (PROCAN-SR, Parke-Davis) is associated with only a small ac ceptable variation between maximal and minimal serum procainamide and N-acetylprocainamide concentrations. This preparation should, therefore, offer greater patient convenience and compliance without sacrificing antiar rhythmic efficacy.

Angiology, Vol. 34, No. 1, 32-39 (1983)
DOI: 10.1177/000331978303400104


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