Application Nr Approved Date Route Status External Links
NDA018655 None Oral None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications And Usage 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.

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Disopyramide Phosphate DISOPYRAMIDE PHOSPHATE ZINC1530617

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