Application Nr Approved Date Route Status External Links
NDA021392 2003-02-06 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Diltiazem Hydrochloride Extended-Release Tablet Is A Nondihydropyridine Calcium Channel Blocker Indicated For •treatment Of Hypertension, To Lower Blood Pressure. Lowering Blood Pressure Reduces The Risk Of Fatal And Nonfatal Cardiovascular Events, Primarily Strokes And Myocardial Infarctions. It Can Be Used Alone Or In Combination With Other Antihypertensives (1.1) •improving Exercise Tolerance In Patients With Chronic Stable Angina (1.2) 1.1 Hypertension Diltiazem Hydrochloride Extended-Release Tablet 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 This Drug. 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 A 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. Diltiazem Hydrochloride Extended-Release Tablets May Be Used Alone Or In Combination With Other Antihypertensive Medications. 1.2 Angina Diltiazem Hydrochloride Extended-Release Tablets Are Indicated To Improve Exercise Tolerance In Patients With Chronic Stable Angina.

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. Croscarmellose Sodium CROSCARMELLOSE SODIUM Unresolved
3. Hypromelloses HYPROMELLOSES Unresolved
4. 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.
5. Cellulose, Microcrystalline CELLULOSE, MICROCRYSTALLINE Unresolved
6. Microcrystalline Wax MICROCRYSTALLINE WAX Unresolved
7. Polydextrose POLYDEXTROSE Unresolved MISC-Miscellaneous REG-Food additives for which a petition has been filed and a regulation issued.
8. Polyethylene Glycols POLYETHYLENE GLYCOLS Unresolved
9. Povidones POVIDONES Unresolved
10. Simethicone SIMETHICONE Unresolved
11. Sucrose Stearate SUCROSE STEARATE Molecular
12. Talc TALC Unresolved DYE-Dye GRAS-Generally recognized as safe.

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Diltiazem Hydrochloride DILTIAZEM HYDROCHLORIDE ZINC621893

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