Label: DISOPYRAMIDE PHOSPHATE capsule

  • NDC Code(s): 51862-095-01, 51862-096-01
  • Packager: Mayne Pharma Commercial LLC
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated July 6, 2023

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  • SPL UNCLASSIFIED SECTION
    Rx Only - Revised: December 2017
  • 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 ...
  • CLINICAL PHARMACOLOGY
    Mechanisms of Action - Disopyramide phosphate is a Type 1 antiarrhythmic drug (i.e., similar to procainamide and quinidine). In - animal studiesdisopyramide decreases the rate of diastolic ...
  • INDICATIONS AND USAGE
    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 ...
  • CONTRAINDICATIONS
    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 ...
  • WARNINGS
    Mortality - In the National Heart, Lung and Blood Institute's Cardiac Arrhythmia Suppression Trial (CAST), a long-term, multi-center, randomized, double-blind study in patients with asymptomatic ...
  • PRECAUTIONS
    General - Atrial Tachyarrhythmias - Patients with atrial flutter or fibrillation should be digitalized prior to disopyramide administration to ensure that drug-induced enhancement of AV ...
  • ADVERSE REACTIONS
    The adverse reactions which were reported in disopyramide phosphate clinical trials encompass observations in 1,500 patients, including 90 patients studied for at least 4 years. The most serious ...
  • OVERDOSAGE
    Symptoms - Deliberate or accidental overdosage of oral disopyramide may be followed by apnea, loss of consciousness, cardiac arrhythmias, and loss of spontaneous respiration. Death has occurred ...
  • 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 ...
  • HOW SUPPLIED
    Disopyramide Phosphate Capsules (equivalent to 100 mg disopyramide base) are opaque orange capsules imprinted with m on one side and 095 on the other. Supplied in bottles of 100. Disopyramide ...
  • SPL UNCLASSIFIED SECTION
    Manufactured by: Mayne Pharma - Greenville, NC 27834 - Revised: December 2017 - 61770
  • PRINCIPAL DISPLAY PANEL - 100 mg Capsule Bottle Label
    NDC 51862-095-01 - Disopyramide - Phosphate - Capsules, USP - 100 mg* Rx Only - 100 Capsules - mayne pharma
  • PRINCIPAL DISPLAY PANEL - 150 mg Capsule Bottle Label
    NDC 51862-096-01 - Disopyramide - Phosphate - Capsules, USP - 150 mg* Rx Only - 100 Capsules - mayne pharma
  • INGREDIENTS AND APPEARANCE
    Product Information