Product manufactured by Redpharm Drug, Inc.

Application Nr Approved Date Route Status External Links
ANDA072781 1993-07-30 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications And Usage I. Vasospastic Angina Nifedipine Is Indicated For The Management Of Vasospastic Angina Confirmed By Any Of The Following Criteria: 1) Classical Pattern Of Angina At Rest Accompanied By St Segment Elevation, 2) Angina Or Coronary Artery Spasm Provoked By Ergonovine, Or 3) Angiographically Demonstrated Coronary Artery Spasm. In Those Patients Who Have Had Angiography, The Presence Of Significant Fixed Obstructive Disease Is Not Incompatible With The Diagnosis Of Vasospastic Angina, Provided That The Above Criteria Are Satisfied. Nifedipine May Also Be Used Where The Clinical Presentation Suggests A Possible Vasospastic Component But Where Vasospasm Has Not Been Confirmed, E.g., Where Pain Has A Variable Threshold On Exertion Or When Angina Is Refractory To Nitrates And/or Adequate Doses Of Beta Blockers. Ii. Chronic Stable Angina (classical Effort-Associated Angina) Nifedipine Is Indicated For The Management Of Chronic Stable Angina (effort-Associated Angina) Without Evidence Of Vasospasm In Patients Who Remain Symptomatic Despite Adequate Doses Of Beta Blockers And/or Organic Nitrates Or Who Cannot Tolerate Those Agents. In Chronic Stable Angina (effort-Associated Angina) Nifedipine Has Been Effective In Controlled Trials Of Up To Eight Weeks Duration In Reducing Angina Frequency And Increasing Exercise Tolerance, But Confirmation Of Sustained Effectiveness And Evaluation Of Long-Term Safety In These Patients Are Incomplete. Controlled Studies In Small Numbers Of Patients Suggest Concomitant Use Of Nifedipine And Betablocking Agents May Be Beneficial In Patients With Chronic Stable Angina, But Available Information Is Not Sufficient To Predict With Confidence The Effects Of Concurrent Treatment, Especially In Patients With Compromised Left Ventricular Function Or Cardiac Conduction Abnormalities. When Introducing Such Concomitant Therapy, Care Must Be Taken To Monitor Blood Pressure Closely Since Severe Hypotension Can Occur From The Combined Effects Of The Drugs. (see Warnings).

All Formulated Excipients (7 Total)

Name Structure Kind Function Status
1. Gelatin GELATIN Unresolved
2. Glycerin GLYCERIN Molecular MISC-Miscellaneous FS-Substances permitted as optional ingredient in a standardized food.
3. Isobutyl Alcohol ISOBUTYL ALCOHOL Molecular
4. Polyethylene Glycols POLYETHYLENE GLYCOLS Unresolved
5. Ferric Oxide Red FERRIC OXIDE RED Molecular
6. Shellac SHELLAC Unresolved
7. Sorbitol SORBITOL Molecular MISC-Miscellaneous GRAS-Generally recognized as safe.

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Nifedipine NIFEDIPINE ZINC85205448