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 Nifedipine Extended-Release 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. Nifedipine Extended-Release 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) Nifedipine Extended-Release 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 Nifedipine Extended-Release Tablets Are Indicated For The Treatment Of Hypertension To Lower Blood Pressure. Lowering Blood Pressure Reduces The Risk Of Fatal And Nonfatal Cardiovascular Events, Primarily Strokes And Myocardial Infarctions. These Benefits Have Been Seen In Controlled Trials Of Antihypertensive Drugs From A Wide Variety Of Pharmacologic Classes Including Nifedipine Extended-Release Tablets. Control Of High Blood Pressure Should Be Part Of Comprehensive Cardiovascular Risk Management, Including, As Appropriate, Lipid Control, Diabetes Management, Antithrombotic Therapy, Smoking Cessation, Exercise, And Limited Sodium Intake. Many Patients Will Require More Than One Drug To Achieve Blood Pressure Goals. For Specific Advice On Goals And Management, See Published Guidelines, Such As Those Of The National High Blood Pressure Education Program’s Joint National Committee On Prevention, Detection, Evaluation, And Treatment Of High Blood Pressure (jnc). Numerous Antihypertensive Drugs, From A Variety Of Pharmacologic Classes And With Different Mechanisms Of Action, Have Been Shown In Randomized Controlled Trials To Reduce Cardiovascular Morbidity And Mortality, And It Can Be Concluded That It Is Blood Pressure Reduction, And Not Some Other Pharmacologic Property Of The Drugs, That Is Largely Responsible For Those Benefits. The Largest And Most Consistent Cardiovascular Outcome Benefit Has Been A Reduction In The Risk Of Stroke, But Reductions In Myocardial Infarction And Cardiovascular Mortality Also Have Been Seen Regularly. Elevated Systolic Or Diastolic Pressure Causes Increased Cardiovascular Risk, And The Absolute Risk Increase Per Mmhg Is Greater At Higher Blood Pressures, So That Even Modest Reductions Of Severe Hypertension Can Provide Substantial Benefit. Relative Risk Reduction From Blood Pressure Reduction Is Similar Across Populations With Varying Absolute Risk, So The Absolute Benefit Is Greater In Patients Who Are At Higher Risk Independent Of Their Hypertension (for Example, Patients With Diabetes Or Hyperlipidemia), And Such Patients Would Be Expected To Benefit From More Aggressive Treatment To Lower Blood Pressure Goal. Some Antihypertensive Drugs Have Smaller Blood Pressure Effects (as Monotherapy) In Black Patients, And Many Antihypertensive Drugs Have Additional Approved Indications And Effects (e.g., On Angina, Heart Failure, Or Diabetic Kidney Disease). These Considerations May Guide Selection Of Therapy. Nifedipine Extended-Release Tablets May Be Used Alone Or In Combination With Other Antihypertensive Agents.

All Formulated Excipients (12 Total)

Name Structure Kind Function Status
1. Silicon Dioxide SILICON DIOXIDE Unresolved AC-Anticaking agent , MISC-Miscellaneous , STAB-Stabilizer GRAS-Generally recognized as safe.
2. Ethylcelluloses ETHYLCELLULOSES Unresolved
3. Hydroxyethyl Cellulose HYDROXYETHYL CELLULOSE Unresolved
4. Hypromelloses HYPROMELLOSES Unresolved
5. 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.
6. Methacrylic Acid - Methyl Methacrylate Copolymer (1:1) METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1) Unresolved
7. Methacrylic Acid - Methyl Methacrylate Copolymer (1:2) METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:2) Unresolved
8. Cellulose, Microcrystalline CELLULOSE, MICROCRYSTALLINE Unresolved
9. Polyethylene Glycols POLYETHYLENE GLYCOLS Unresolved
10. Ferric Oxide Red FERRIC OXIDE RED Molecular
11. 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.
12. Talc TALC Unresolved DYE-Dye GRAS-Generally recognized as safe.

Active Ingredients ( 1 Total)

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