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 procainamide, its use with lesser arrhythmias is generally not recommened. Treatment of patients with asymptomatic ventricular premature contractions should be avoided.

Initiation of procainamide 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 leucopenia 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 risk. (See WARNINGS and

DESCRIPTION

The oral dose and interval of administration should be adjusted for the individual patient, based on clinical assessment of the degree of underlying myocardial disease, the patient's age, and renal function.

As a general guide, for younger patients with normal renal function, an initial total daily oral dose of up to 50 mg/kg of body weight of procainamide hydrochloride extended-release tablets may be used, given in divided doses, every six hours, to maintain therapeutic blood levels. For older patients especially those over 50 years of age, or for patients with renal, hepatic or cardiac insufficiency, lesser amounts or longer intervals may produce adequate blood levels, and decrease the probability of occurrence of dose related adverse reactions.

* Initial dosage schedule guide only, to be adjusted for each patient individually, based on age, cardiorenal function, blood level (if available), and clinical response

Procainamide Hydrochloride Extended-release Tablet, USP, 500 mg (pink, capsule-shaped scored, film-coated, debossed "COPLEY" on one side and debossed "188" on the other side) is supplied as follows: Bottles of 100 and Bottles of 500.

Procainamide Hydrochloride Extended-release Tablet, USP, 750 mg (light orange to tan, capsule-shaped, scored, film-coated, debossed "COPLEY" on one side and debossed "114" on the other side) is supplied as follows: Bottles of 100 and Bottles of 500.

Procainamide Hydrochloride Extended-release Tablets USP, 1000 mg (red, modified capsule-shaped film-coated unscored and debossed "COPLEY 117" on one side and scored and plain on the other side) is supplied as follows: Bottles of 100.

Storage Conditions

Protect from moisture.

Store at controlled room temperature 15-30° C (59-86° F).

CAUTION: Federal law prohibits dispensing without prescription.

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