Nifedical Xl

Product manufactured by Cardinal Health

Application Nr Approved Date Route Status External Links
ANDA075289 2001-02-06 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications And Usage I. Vasospastic Angina Nifedical Xl® Tablets Are 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. Nifedical Xl® Tablets 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 In Unstable Angina Where Electrocardiographic Findings Are Compatible With Intermittent Vasospasm, Or When Angina Is Refractory To Nitrates And/or Adequate Doses Of Beta-Blockers. Ii. Chronic Stable Angina (classical Effort-Associated Angina) Nifedical Xl® Tablets Are 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 Is Incomplete. Controlled Studies In Small Numbers Of Patients Suggest Concomitant Use Of Nifedipine And Beta-Blocking 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). Iii. Hypertension Nifedical Xl® Tablets Are Indicated For The Treatment Of Hypertension. It May Be Used Alone Or In Combination With Other Antihypertensive Agents.

All Formulated Excipients (12 Total)

Name Structure Kind Function Status
1. Anhydrous Lactose ANHYDROUS LACTOSE Molecular
2. Silicon Dioxide SILICON DIOXIDE Unresolved AC-Anticaking agent , MISC-Miscellaneous , STAB-Stabilizer GRAS-Generally recognized as safe.
3. Ethylcelluloses ETHYLCELLULOSES Unresolved
4. Hydroxyethyl Cellulose HYDROXYETHYL CELLULOSE Unresolved
5. Hypromelloses HYPROMELLOSES Unresolved
6. Magnesium Stearate MAGNESIUM STEARATE Molecular AF-Antifoaming (or defoaming) agent , MISC-Miscellaneous REG-Food additives for which a petition has been filed and a regulation issued.
7. Methacrylic Acid - Methyl Methacrylate Copolymer (1:1) METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1) Unresolved
8. Methacrylic Acid - Methyl Methacrylate Copolymer (1:2) METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:2) Unresolved
9. Cellulose, Microcrystalline CELLULOSE, MICROCRYSTALLINE Unresolved
10. Polyethylene Glycols POLYETHYLENE GLYCOLS Unresolved
11. Ferric Oxide Red FERRIC OXIDE RED Molecular
12. Sodium Lauryl Sulfate SODIUM LAURYL SULFATE Molecular AF-Antifoaming (or defoaming) agent , CTG-Component or coating , EMUL-Emulsifier , SANI-Sanitizing agent , SDA-Solubilizing & dispersing agent REG-Food additives for which a petition has been filed and a regulation issued.

Active Ingredients ( 1 Total)

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

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