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Norpace

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Norpace

Indications
Dosage
How Supplied

INDICATIONS

Norpace (disopyramide phosphate) and Norpace (disopyramide phosphate) CR are 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 Norpace (disopyramide phosphate) and Norpace (disopyramide phosphate) CR, their use with lesser arrhythmias is generally not recommended. Treatment of patients with asymptomatic ventricular premature contractions should be avoided.

Initiation of Norpace (disopyramide phosphate) or Norpace (disopyramide phosphate) CR treatment, as with other antiarrhythmic agents used to treat life-threatening arrhythmias, should be carried out in the hospital. Norpace (disopyramide phosphate) CR should not be used initially if rapid establishment of disopyramide plasma levels is desired.

Antiarrhythmic drugs have not been shown to enhance survival in patients with ventricular arrhythmias.

DOSAGE AND ADMINISTRATION

The dosage of Norpace (disopyramide phosphate) or Norpace (disopyramide phosphate) CR must be individualized for each patient on the basis of response and tolerance. The usual adult dosage of Norpace (disopyramide phosphate) or Norpace (disopyramide phosphate) CR is 400 to 800 mg per day given in divided doses. The recommended dosage for most adults is 600 mg/day given in divided doses (either 150 mg every 6 hours for immediate-release Nor-pace or 300 mg every 12 hours for Norpace (disopyramide phosphate) CR). For patients whose body weight is less than 110 pounds (50 kg), the recommended dosage is 400 mg/day given in divided doses (either 100 mg every 6 hours for immediate-release Norpace (disopyramide phosphate) or 200 mg every 12 hours for Norpace (disopyramide phosphate) CR). In the event of increased anticholinergic side effects, plasma levels of disopyramide should be monitored and the dose of the drug adjusted accordingly. A reduction of the dose by one third, from the recommended 600 mg/day to 400 mg/day, would be reasonable, without changing the dosing interval.

For patients with cardiomyopathy or possible cardiac decompensation, a loading dose, as discussed below, should not be given, and initial dosage should be limited to 100 mg of immediate-release Norpace (disopyramide phosphate) every 6 to 8 hours. Subsequent dosage adjustments should be made gradually, with close monitoring for the possible development of hypotension and/or congestive heart failure (see WARNINGS).

For patients with moderate renal insufficiency (cre-atinine clearance greater than 40 ml/min) or hepat-ic insufficiency, the recommended dosage is 400 mg/day given in divided doses (either 100 mg every 6 hours for immediate-release Norpace (disopyramide phosphate) or 200 mg every 12 hours for Norpace (disopyramide phosphate) CR).

For patients with severe renal insufficiency (Ccr 40 ml/min or less), the recommended dosage regimen of immediate-release Norpace (disopyramide phosphate) is 100 mg at intervals shown in the table below, with or without an initial loading dose of 150 mg.

IMMEDIATE-RELEASE NORPACE (disopyramide phosphate) DOSAGE INTERVAL FOR PATIENTS WITH RENAL INSUFFICIENCY

Creatinine clearance (ml/min) 40-30 30-15 less than 15
Approximate maintenance-dosing interval q 8 hr q 12 hr q 24 hr

The above dosing schedules are for Norpace (disopyramide phosphate) immediate-release capsules; Norpace (disopyramide phosphate) CR is not recommended for patients with severe renal insufficiency.

For patients in whom rapid control of ventricular arrhythmia is essential, an initial loading dose of 300 mg of immediate-release Norpace (disopyramide phosphate) (200 mg for patients whose body weight is less than 110 pounds) is recommended, followed by the appropriate maintenance dosage. Therapeutic effects are usually attained 30 minutes to 3 hours after administration of a 300-mg loading dose. If there is no response or evidence of toxicity within 6 hours of the loading dose, 200 mg of immediate-release Nor-pace every 6 hours may be prescribed instead of the usual 150 mg. If there is no response to this dosage within 48 hours, either Norpace (disopyramide phosphate) should then be discontinued or the physician should consider hospitalizing the patient for careful monitoring while subsequent immediate-release Norpace (disopyramide phosphate) doses of 250 mg or 300 mg every 6 hours are given. A limited number of patients with severe refractory ventricular tachycardia have tolerated daily doses of Norpace (disopyramide phosphate) up to 1600 mg per day (400 mg every 6 hours), resulting in disopyramide plasma levels up to 9 mcg/ml. If such treatment is warranted, it is essential that patients be hospitalized for close evaluation and continuous monitoring.

Norpace (disopyramide phosphate) CR should not be used initially if rapid establishment of disopyramide plasma levels is desired.

Transferring to Norpace (disopyramide phosphate) or Norpace (disopyramide phosphate) CR.

The following dosage schedule based on theoretical considerations rather than experimental data is suggested for transferring patients with normal renal function from either quinidine sulfate or procaina-mide therapy (Type 1 antiarrhythmic agents) to Norpace (disopyramide phosphate) or Norpace (disopyramide phosphate) CR therapy:

Norpace (disopyramide phosphate) or Norpace (disopyramide phosphate) CR should be started using the regular maintenance schedule without a loading dose 6 to 12 hours after the last dose of quinidine sulfate or 3 to 6 hours after the last dose of pro-cainamide.

In patients in whom withdrawal of quinidine sulfate or procainamide is likely to produce life-threatening arrhythmias, the physician should consider hospitalization of the patient. When transferring a patient from immediate-release Norpace (disopyramide phosphate) to Norpace (disopyramide phosphate) CR, the maintenance schedule of Norpace (disopyramide phosphate) CR may be started 6 hours after the last dose of immediate-release Norpace (disopyramide phosphate) .

Pediatric Dosage

Controlled clinical studies have not been conducted in pediatric patients; however, the following suggested dosage table is based on published clinical experience.

Total daily dosage should be divided and equal doses administered orally every 6 hours or at intervals according to individual patient needs. Disopyr-amide plasma levels and therapeutic response must be monitored closely. Patients should be hospitalized during the initial treatment period, and dose titration should start at the lower end of the ranges provided below.

SUGGESTED TOTAL DAILY DOSAGE*

Age (years) Disopyramide
(mg/kg body weight/day)
Under 1 10 to 30
1 to 4 10 to 20
4 to 12 10 to 15
12 to 18 6 to 15
*Dosage is expressed in milligrams of disopyramide base. Since Norpace (disopyramide phosphate) 100-mg capsules contain 100 mg of disopyramide base, the pharmacist can readily prepare a 1-mg/ml to 10-mg/ml liquid suspension by adding the entire contents of Norpace capsules to cherry syrup. (Prepare cherry syrup as follows: cherry juice, 475 mL; sucrose 800 g; alcohol, 20 mL; purified water, a sufficient quantity to make 1000 mL.) The resulting suspension, when refrigerated, is stable for one month and should be thoroughly shaken before the measurement of each dose. The suspension should be dispensed in an amber glass bottle with a child-resistant closure.

Norpace (disopyramide phosphate) CR capsules should not be used to prepare the above suspension.

HOW SUPPLIED

Norpace (disopyramide phosphate) is supplied in hard gelatin capsules containing either 100 mg or 150 mg of disopyramide base, present as the phosphate.

Norpace (disopyramide phosphate) 100-mg capsules are white and orange, with markings SEARLE, 2752, NORPACE (disopyramide phosphate) , and 100 MG.

NDC Number Size
0025-2752-31 bottle of 100
0025-2752-52 bottle of 1,000

 Norpace (disopyramide phosphate) 150-mg capsules are brown and orange, with markings SEARLE, 2762, NORPACE (disopyramide phosphate) , and 150 MG.

NDC Number Size
0025-2762-31 bottle of 100
0025-2762-52 bottle of 1,000

Norpace CR (disopyramide phosphate) Controlled-Release is supplied as specially prepared controlled-release beads in hard gelatin capsules containing either 100 mg or 150 mg of disopyramide base, present as the phosphate.

Norpace (disopyramide phosphate) CR 100-mg capsules are white and light green, with markings SEARLE, 2732, NORPACE (disopyramide phosphate) CR, and 100 mg.

NDC Number Size
0025-2732-31 bottle of 100
0025-2732-51 bottle of 500
0025-2732-34 carton of 100 unit dose

Norpace (disopyramide phosphate) CR 150-mg capsules are brown and light green, with markings SEARLE, 2742, NORPACE (disopyramide phosphate) CR, and 150 mg.

NDC Number Size
0025-2742-31 bottle of 100
0025-2742-51 bottle of 500
0025-2742-34 carton of 100 unit dose

Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F). [See USP Controlled Room Temperature.]

Revised: September 2001. G.D. Searle LLC, A subsidiary of Pharmacia Corporation, Chicago, IL 60680, USA. FDA revision date: 5/17/2000

Last reviewed on RxList: 7/17/2008
This monograph has been modified to include the generic and brand name in many instances.

Indications
Dosage
How Supplied
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