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PRONESTYL (procainamide hydrochloride) is indicated for the treatment of documented ventricular arrhythmias, such as sustained ventricular tachycardia, that, in the judgment of the physician, are life-threatening. Because of the proarrhythmic effects of PRONESTYL (procainamide) , its use with lesser arrhythmias is generally not recommended. Treatment of patients with asymptomatic ventricular premature contractions should be avoided.
Initiation of PRONESTYL (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 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.)
DOSAGE AND ADMINISTRATION
The oral dose and interval of administration should be adjusted for the individual patient, based on clinical assessment of the degree of underlying myocardial diseased, the patient's age, and renal function.
As a general guide, for younger adult patients with normal renal function, an initial total daily oral dose of up to 50 mg/kg of body weight of PRONESTYL (procainamide) Capsules or Tablets may be used, given in divided doses, every three 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. The total daily dose should be administered in divided doses at three, four, or six hour intervals and adjusted according to the patient's response.
To provide approximately 50 mg per kg of body weight per
|88-110||40-50||250 mg q3h to 500 mg q6h|
|132-154||60-70||375 mg q3h to 750 mg q6h|
|176-198||80-90||500 mg q3 hr to 1 g q6h|
|> 220||> 100||625 mg q3h to 1.25 g q6h|
|*Initial dosage schedule guide only, to be adjusted for each patient individually, based on age, cardiorenal function, blood level (if available), and clinical response.|
|PRONESTYL Capsules (Procainamide Hydrochloride Capsules USP)|
|250 mg: two-piece yellow gelatin capsules printed with 758|
|bottles of 100||NDC 0003-0758-50|
|bottles of 1000||NDC 0003-0758-80|
|cartons of 100 Unimatic* unit-dose capsules||NDC 0003-0758-53|
|375 mg: white and orange gelatin capsules printed with 756|
|bottles of 100||NDC 0003-0756-50|
|cartons of 100 Unimatic* unit-dose capsules||NDC 0003-0756-53|
|500 mg: yellow and orange gelatin capsules printed with 757|
|bottles of 100||NDC 0003-0757-50|
|bottles of 1000||NDC 0003-0757-80|
|cartons of 100 Unimatic* unit-dose capsules||NDC 0003-0757-53|
|PRONESTYL Tablets (Procainamide Hydrochloride Tablets USP)|
|250 mg: yellow FILMLOK® tablets debossed with 431|
|bottles of 100||NDC 0003-0431-50|
|375 mg: orange FILMLOK® tablets debossed with 434|
|bottles of 100||NDC 0003-0434-50|
|500 mg: red FILMLOK® tablets debossed with 438|
|bottles of 100||NDC 0003-0438-50|
Store at room temperature; avoid excessive heat (104° F); protect from moisture.
APOTHECON® A Bristol-Myers Squibb Company, Princeton, NJ 08540.
Last reviewed on RxList: 4/8/2009
This monograph has been modified to include the generic and brand name in many instances.
Additional Pronestyl Information
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