Application Nr Approved Date Route Status External Links
NDA020850 2000-04-04 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Micardis Is An Angiotensin Ii Receptor Blocker (arb) Indicated For: Treatment Of Hypertension (1.1) Cardiovascular (cv) Risk Reduction In Patients Unable To Take Ace Inhibitors (1.2) 1.1 Hypertension Micardis Is Indicated For The Treatment Of Hypertension. It May Be Used Alone Or In Combination With Other Antihypertensive Agents [see Clinical Studies (14.1)] . 1.2 Cardiovascular Risk Reduction Micardis Is Indicated For Reduction Of The Risk Of Myocardial Infarction, Stroke, Or Death From Cardiovascular Causes In Patients 55 Years Of Age Or Older At High Risk Of Developing Major Cardiovascular Events Who Are Unable To Take Ace Inhibitors. High Risk For Cardiovascular Events Can Be Evidenced By A History Of Coronary Artery Disease, Peripheral Arterial Disease, Stroke, Transient Ischemic Attack, Or High-Risk Diabetes (insulin-Dependent Or Non-Insulin Dependent) With Evidence Of End-Organ Damage [see Clinical Studies (14.2)] . Micardis Can Be Used In Addition To Other Needed Treatment (such As Antihypertensive, Antiplatelet Or Lipid-Lowering Therapy) [see Clinical Studies (14.2)] . Studies Of Telmisartan In This Setting Do Not Exclude That It May Not Preserve A Meaningful Fraction Of The Effect Of The Ace Inhibitor To Which It Was Compared. Consider Using The Ace Inhibitor First, And, If It Is Stopped For Cough Only, Consider Re-Trying The Ace Inhibitor After The Cough Resolves. Use Of Telmisartan With An Ace Inhibitor Is Not Recommended [see Warnings And Precautions (5.6)] .

All Formulated Excipients (4 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. Meglumine MEGLUMINE Molecular
3. Povidones POVIDONES Unresolved
4. Sorbitol SORBITOL Molecular MISC-Miscellaneous GRAS-Generally recognized as safe.

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Telmisartan TELMISARTAN ZINC1530886

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