Disopyramide Phosphate ER (Page 4 of 4)

DOSAGE AND ADMINISTRATION

The dosage of disopyramide (as the phosphate) must be individualized for each patient on the basis of response and tolerance. The usual adult dosage of disopyramide is 400 to 800 mg (calculated as the disopyramide base) per day given in divided doses. The recommended dosage for most adults is 600 mg/day given in divided doses (300 mg every 12 hours for the extended-release product). For patients whose body weight is less than 110 pounds (50 kg), the recommended dosage is 400 mg/day given in divided doses (200 mg every 12 hours for the extended-release product). In the event of increased anticholingeric 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 should not be given, and initial dosage should be limited to 100 mg of immediate-release 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 (creatinine clearance greater than 40 mL/min) or hepatic insufficiency, the recommended dosage is 400 mg/day given in divided doses (200 mg every 12 hours for the extended-release product).

Disopyramide Phosphate Extended-release Capsules, USP are not recommended for patients with severe renal insufficiency.

Disopyramide Phosphate Extended-release Capsules, USP should not be used initially if rapid establishment of disopyramide plasma levels is desired.

Transferring to Disopyramide Phosphate Extended-release Capsules, USP

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 procainamide therapy (Type 1 antiarrhythmic agents) to Disopyramide Phosphate Extended-release Capsules, USP therapy.

Disopyramide Phosphate Extended-release Capsules, USP 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 test dose of procainamide.

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 disopyramide to extended-release disopyramide, the maintenance schedule of Disopyramide Phosphate Extended-release Capsules, USP may be started 6 hours after the last dose of immediate-release disopyramide phosphate capsules.

Pediatric dosage

There is no adequate data to recommend use of Disopyramide Phosphate Extended-release Capsules, USP in pediatric patients.

Disopyramide Phosphate Extended-release Capsules, USP should not be used to prepare extemporaneous suspensions.

HOW SUPPLIED

Disopyramide Phosphate Extended-release Capsules, USP 150 mg are purple and orange hard gelatin capsules imprinted “ETHEX” and “002” in black ink containing 150 mg of disopyramide (as the phosphate) in extended-release beads.

NDC Number Size

58177-002-04 Bottle of 100

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

Manufactured by
KV Pharmaceutical Co. for
ETHEX Corporation
St. Louis, MO 63043-2413

DISOPYRAMIDE PHOSPHATE ER disopyramide phosphate capsule, extended release

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:58177-002 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Disopyramide Phosphate (Disopyramide) Disopyramide 150 mg

Inactive Ingredients Ingredient Name Strength aluminum hydrate black iron oxide calcium stearate D&C Red No. 28 D&C Yellow No. 10 dibutyl sebacate ethylcellulose FD&C Blue No. 1 FD&C Red No. 40 gelatin lecithin pharmaceutical glaze povidone simethicone starch sucrose talc titanium dioxide

Product Characteristics Color purple (purple) , orange (orange) Score no score Shape CAPSULE (capsule) Size 19mm Flavor Imprint Code ETHEX;002 Contains Coating false Symbol true

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:58177-002-04 100 CAPSULE, EXTENDED RELEASE (100 CAPSULE) in 1 BOTTLE None

Labeler — ETHEX

Revised: 02/2007 ETHEX