PRONESTYL-SR SUMMARY
PRONESTYL-SR® TABLETS
Procainamide Hydrochloride
Extended-Release Tablets USP
PRONESTYL (procainamide hydrochloride), a Group 1A cardiac antiarrhythmic drug, is p-amino-N-[2-(diethylamino)ethyl]-benzamide monohydrochloride, molecular weight 271.
PRONESTYL-SR Tablets (Procainamide Hydrochloride Extended-Release Tablets) are indicated for the treatment of documented ventricular arrhythmias, such as sustained ventricular tachycardia, that, in the judgement of the physician, are life-threatening. Because of the proarrhythmic effects of PRONESTYL-SR, its use with lesser arrhythmias is generally not recommended. Treatment of patients with asymptomatic ventricular premature contractions should be avoided.
Initiation of PRONESTYL-SR treatment, as with other antiarrhythmic agents used to treat life-threatening arrhythmias, should be carried out in the hospital.
Antiarrhythmic drugs have not been shown to enhance survival in patients with ventricular arrhythmias.
Because procainamide has the potential to produce serious hematological disorders (0.5 percent) particularly leukopenia or agranulocytosis (sometimes fatal), its use should be reserved for patients in whom, in the opinion of the physician, the benefits of treatment clearly outweigh the risks. (See WARNINGS and Boxed WARNING.)
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