Application Nr Approved Date Route Status External Links
ANDA090617 2012-08-01 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications & Usage Section 1.1 Hypertension Metoprolol Succinate Extended-Release Tablets Are Indicated For The Treatment Of Hypertension, To Lower Blood Pressure. Lowering Blood Pressure Lowers The Risk Of Fatal And Non-Fatal 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 Metoprolol. 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 1 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 (eg, On Angina, Heart Failure, Or Diabetic Kidney Disease). These Considerations May Guide Selection Of Therapy. Metoprolol Succinate Extended-Release Tablets May Be Administered With Other Antihypertensive Agents. 1.2 Angina Pectoris Metoprolol Succinate Extended-Release Tablets Are Indicated In The Long-Term Treatment Of Angina Pectoris, To Reduce Angina Attacks And To Improve Exercise Tolerance. 1.3 Heart Failure Metoprolol Succinate Extended-Release Tablets Are Indicated For The Treatment Of Stable, Symptomatic (nyha Class Ii Or Iii) Heart Failure Of Ischemic, Hypertensive, Or Cardiomyopathic Origin. It Was Studied In Patients Already Receiving Ace Inhibitors, Diuretics, And, In The Majority Of Cases, Digitalis. In This Population, Metoprolol Succinate Extended-Release Tablets Decreased The Rate Of Mortality Plus Hospitalization, Largely Through A Reduction In Cardiovascular Mortality And Hospitalizations For Heart Failure.

All Formulated Excipients (10 Total)

Name Structure Kind Function Status
1. Acetyltributyl Citrate ACETYLTRIBUTYL CITRATE Molecular
2. Silicon Dioxide SILICON DIOXIDE Unresolved AC-Anticaking agent , MISC-Miscellaneous , STAB-Stabilizer GRAS-Generally recognized as safe.
3. Croscarmellose Sodium CROSCARMELLOSE SODIUM Unresolved
4. Ethylcelluloses ETHYLCELLULOSES Unresolved
5. Hypromelloses HYPROMELLOSES Unresolved
6. Methylene Chloride METHYLENE CHLORIDE Molecular MISC-Miscellaneous , SOLV-Solvent REG-Food additives for which a petition has been filed and a regulation issued.
7. Cellulose, Microcrystalline CELLULOSE, MICROCRYSTALLINE Unresolved
8. Polyethylene Glycol 6000 POLYETHYLENE GLYCOL 6000 Unresolved
9. Prosolv PROSOLV Unresolved
10. Sodium Stearyl Fumarate SODIUM STEARYL FUMARATE Molecular MISC-Miscellaneous , STAB-Stabilizer REG-Food additives for which a petition has been filed and a regulation issued.

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Metoprolol Succinate METOPROLOL SUCCINATE ZINC1530717