Application Nr Approved Date Route Status External Links
NDA022401 2009-10-16 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Twynsta (telmisartan/amlodipine) Tablets Are Indicated For The Treatment Of Hypertension, Alone Or With Other Antihypertensive Agents 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 Angiotensin Ii Receptor Blockers And Dihydropyridine Calcium Channel Blockers. There Are No Controlled Trials Demonstrating Risk Reduction With Twynsta. 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. Twynsta Tablets May Also Be Used As Initial Therapy In Patients Who Are Likely To Need Multiple Drugs To Achieve Their Blood Pressure Goals. Base The Choice Of Twynsta Tablets As Initial Therapy For Hypertension On An Assessment Of Potential Benefits And Risks Including Whether The Patient Is Likely To Tolerate The Starting Dose Of Twynsta Tablets. Patients With Moderate Or Severe Hypertension Are At Relatively High Risk For Cardiovascular Events (such As Strokes, Heart Attacks, And Heart Failure), Kidney Failure, And Vision Problems, So Prompt Treatment Is Clinically Relevant. Consider The Patient's Baseline Blood Pressure, The Target Goal, And The Incremental Likelihood Of Achieving Goal With A Combination Compared With Monotherapy When Deciding Whether To Use Twynsta Tablets As Initial Therapy. Individual Blood Pressure Goals May Vary Based Upon The Patient’s Risk. Data From An 8-Week, Placebo-Controlled, Multidose, Factorial Trial Provide Estimates Of The Probability Of Reaching A Blood Pressure Goal With Twynsta Compared To Telmisartan Or Amlodipine Monotherapy And Placebo [see Clinical Studies (14.1)] . The Figures Below Provide Estimates Of The Likelihood Of Achieving Systolic And Diastolic Blood Pressure Control With Twynsta 80/10 Mg Tablets, Based Upon Baseline Systolic Or Diastolic Blood Pressure. The Curve Of Each Treatment Group Was Estimated By Logistic Regression Modeling. The Estimated Likelihood At The Right Tail Of Each Curve Is Less Reliable Due To Small Numbers Of Subjects With High Baseline Blood Pressures. Figure 1a: Probability Of Achieving Systolic Blood Pressure <140 Mmhg At Week 8 Figure 1b: Probability Of Achieving Systolic Blood Pressure <130 Mmhg At Week 8 Figure 2a: Probability Of Achieving Diastolic Blood Pressure <90 Mmhg At Week 8 Figure 2b: Probability Of Achieving Diastolic Blood Pressure <80 Mmhg At Week 8 The Figures Above Provide An Approximation Of The Likelihood Of Reaching A Targeted Blood Pressure Goal At 8 Weeks. For Example, A Patient With A Baseline Blood Pressure Of 160/110 Mmhg Has About A 16% Likelihood Of Achieving A Goal Of <140 Mmhg (systolic) And 16% Likelihood Of Achieving <90 Mmhg (diastolic) On Placebo. The Likelihood Of Achieving These Same Goals On Telmisartan Is About 46% (systolic) And 26% (diastolic). The Likelihood Of Achieving These Same Goals On Amlodipine Is About 69% (systolic) And 22% (diastolic). These Likelihoods Rise To 79% For Systolic And 55% For Diastolic With Twynsta. Twynsta Is An Angiotensin Ii Receptor Blocker (arb) And A Dihydropyridine Calcium Channel Blocker (dhp-Ccb) Combination Product Indicated For The Treatment Of Hypertension Alone Or With Other Antihypertensive Agents To Lower Blood Pressure. Lowering Blood Pressure Reduces The Risk Of Fatal And Nonfatal Cardiovascular Events, Primarily Strokes And Myocardial Infarctions. (1) Twynsta Tablets Are Indicated As Initial Therapy In Patients Likely To Need Multiple Antihypertensive Agents To Achieve Their Blood Pressure Goals (1) Figure 1a Figure 1b Figure 2a Figure 2b

All Formulated Excipients (9 Total)

Name Structure Kind Function Status
1. Sodium Hydroxide SODIUM HYDROXIDE Unresolved BC-Boiler compound , B&N-Buffer & neutralizing agent , MISC-Miscellaneous REG-Food additives for which a petition has been filed and a regulation issued.
2. Povidones POVIDONES Unresolved
3. Meglumine MEGLUMINE Molecular
4. Sorbitol SORBITOL Molecular MISC-Miscellaneous GRAS-Generally recognized as safe.
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. Cellulose, Microcrystalline CELLULOSE, MICROCRYSTALLINE Unresolved
7. Starch, Corn STARCH, CORN Unresolved
8. Silicon Dioxide SILICON DIOXIDE Unresolved AC-Anticaking agent , MISC-Miscellaneous , STAB-Stabilizer GRAS-Generally recognized as safe.
9. Ferrosoferric Oxide FERROSOFERRIC OXIDE Molecular

Active Ingredients ( 2 Total)

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