NORPACE- disopyramide phosphate capsule, gelatin coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

disopyramide phosphate (UNII: N6BOM1935W) (disopyramide - UNII:GFO928U8MQ)

Available from:

Carilion Materials Management

INN (International Name):

disopyramide phosphate

Composition:

disopyramide 100 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Norpace and Norpace 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 and Norpace CR, their use with lesser arrhythmias is generally not recommended. Treatment of patients with asymptomatic ventricular premature contractions should be avoided. Initiation of Norpace or Norpace CR treatment, as with other antiarrhythmic agents used to treat life-threatening arrhythmias, should be carried out in the hospital. Norpace 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. Norpace and Norpace CR are contraindicated in the presence of cardiogenic shock, preexisting second- or third-degree AV block (if no pacemaker is present), congenital Q-T prolongation, or known hypersensitivity to the drug.

Product summary:

NDC:68151-0526-3 in a PACKAGE of 1 CAPSULE, GELATIN COATEDS Store at 25°C (77°F); excursions permitted to 15–30°C (59–86°F). [See USP Controlled Room Temperature.]

Authorization status:

New Drug Application

Summary of Product characteristics

NORPACE- DISOPYRAMIDE PHOSPHATE CAPSULE, GELATIN COATED
CARILION MATERIALS MANAGEMENT
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NORPACE DISOPYRAMIDE PHOSPHATE CAPSULES NORPACE CR DISOPYRAMIDE
PHOSPHATE EXTENDED-
RELEASE CAPSULES
DESCRIPTION
Norpace (disopyramide phosphate) is an antiarrhythmic drug available
for oral administration in
immediate-release and controlled-release capsules containing 100 mg or
150 mg of disopyramide base,
present as the phosphate. The base content of the phosphate salt is
77.6%. The structural formula of
Norpace is:
Norpace is freely soluble in water, and the free base (pKa 10.4) has
an aqueous solubility of 1 mg/ml.
The chloroform:water partition coefficient of the base is 3.1 at pH
7.2.
Norpace is a racemic mixture of and isomers. This drug is not
chemically related to other
antiarrhythmic drugs. _d-l-_
Norpace CR (controlled-release) capsules are designed to afford a
gradual and consistent release of
disopyramide. Thus, for maintenance therapy, Norpace CR provides the
benefit of less-frequent dosing
(every 12 hours) as compared with the every-6-hour dosage schedule of
immediate-release Norpace
capsules.
Inactive ingredients of Norpace include corn starch, edible ink, FD&C
Red No. 3, FD&C Yellow No.
6, gelatin, lactose, talc, and titanium dioxide; the 150-mg capsule
also contains FD&C Blue No. 1.
Inactive ingredients of Norpace CR include corn starch, D&C Yellow No.
10, edible ink,
ethylcellulose, FD&C Blue No. 1, gelatin, shellac, sucrose, talc, and
titanium dioxide; the 150-mg
capsule also contains FD&C Red No. 3 and FD&C Yellow No. 6.
CLINICAL PHARMACOLOGY
®
®
MECHANISMS OF ACTION
Norpace (disopyramide phosphate) is a Type 1 antiarrhythmic drug
(i.e., similar to procainamide and
quinidine). Norpace decreases the rate of diastolic depolarization
(phase 4) in cells with augmented
automaticity, decreases the upstroke velocity (phase 0) and increases
the action potential duration of
normal cardiac cells, decreases the disparity in refractoriness
between infarcted and adjacent normally
perfused myocardium, and has