DISOPYRAMIDE PHOSPHATE- disopyramide phosphate capsule
Teva Pharmaceuticals USA Inc
DESCRIPTION
Disopyramide Phosphate is an antiarrhythmic drug available for oral administration in 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:
ClientX$ProductsDisopyramide Phosphate Capsules (070101 and 070102)Submissions2015-08-12 AR -- AJKWorkingINSERTImage FilesDisoPhosCaps-s.jpg
C21 H29 N3 O�H3 PO4 M.W. 437.47
?-[2-(diisopropylamino) ethyl]-?-phenyl-2-pyridineacetamide phosphate
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.
Inactive Ingredients: Capsules: Lactose Monohydrate, Magnesium Stearate and Sodium Starch Glycolate.
Capsule Print and Shell Constituents: Black Iron Oxide, D&C Red #28, D&C Red #33, D&C Yellow #10, D&C Yellow #10 Aluminum Lake, FD&C Blue #1, FD&C Blue #1 Aluminum Lake, FD&C Blue #2 Aluminum Lake, FD&C Red #40 Aluminum Lake, Gelatin, Propylene Glycol, Shellac, Sodium Lauryl Sulfate, Sorbitan Monolaurate and Titanium Dioxide.
CLINICAL PHARMACOLOGY
Mechanisms of Action
Disopyramide Phosphate is a Type 1 antiarrhythmic drug (i.e., similar to procainamide and quinidine). In animal studies, Disopyramide Phosphate 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 no effect on alpha- or beta-adrenergic receptors.
