DISOPYRAMIDE PHOSPHATE capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

DISOPYRAMIDE PHOSPHATE (UNII: N6BOM1935W) (DISOPYRAMIDE - UNII:GFO928U8MQ)

Available from:

Golden State Medical Supply, Inc.

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Disopyramide phosphate capsules 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 disopyramide, its use with lesser arrhythmias is generally not recommended. Treatment of patients with asymptomatic ventricular premature contractions should be avoided. Initiation of disopyramide 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. Disopyramide phosphate capsules 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:

Disopyramide Phosphate Capsules (equivalent to 100 mg disopyramide base) are opaque orange capsules imprinted DAN 5560 supplied in bottles of 100. Disopyramide Phosphate Capsules (equivalent to 150 mg disopyramide base) are opaque brown capsules imprinted DAN 5561 supplied in bottles of 100. Dispense in a well-closed container with child-resistant closure. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

DISOPYRAMIDE PHOSPHATE- DISOPYRAMIDE PHOSPHATE CAPSULE
GOLDEN STATE MEDICAL SUPPLY, INC.
----------
DISOPYRAMIDE PHOSPHATE CAPSULES, USP
RX ONLY
DESCRIPTION
Disopyramide phosphate is an antiarrhythmic drug available for oral
administration in immediate-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
disopyramide phosphate is:
C
H
N
O·H
PO
M.W. 437.47
(±)-α-[2-(Diisopropylamino)ethyl]-α-phenyl-2-pyridineacetamide
phosphate (1:1).
Disopyramide phosphate 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.
Disopyramide phosphate is a racemic mixture of _d-_ and _l-_isomers.
This drug is not chemically related to
other antiarrhythmic drugs.
Disopyramide phosphate capsules (equivalent to 100 mg Disopyramide
Base) and Disopyramide
phosphate capsules (equivalent to 150 mg Disopyramide Base) contain
the following inactive
ingredients: magnesium stearate, microcrystalline cellulose and sodium
lauryl sulfate. The capsule
shells contain gelatin, methylparaben, propylparaben, silicon dioxide,
sodium lauryl sulfate and titanium
dioxide.
The 100 mg capsule shell also contains D&C Red No. 28, D&C Yellow No.
10, FD&C Blue No. 1 and
FD&C Red No. 40.
The 150 mg capsule shell also contains black iron oxide and red iron
oxide.
CLINICAL PHARMACOLOGY
MECHANISMS OF ACTION
Disopyramide phosphate is a Type 1 antiarrhythmic drug (i.e., similar
to procainamide and quinidine). _In_
_animal studies_ disopyramide decreases the rate of diastolic
depolarization (phase 4) in cells with
augmented automaticity, decreases the upstroke velocity (phase 0) and
increases the action potential
21
29
3
3
4
duration of normal cardiac cells, decreases the disparity in
refractoriness between infarcted and
adjacent normally perfused myocardium, and has no effect on alpha- or
beta-adrenergic receptors.
ELECTROPHYS IOLOGY
In