These highlights do not include all the information needed to use MICARDIS safely and effectively. See full prescribing information for MICARDIS.
MICARDIS ® (telmisartan) Tablets
Initial U.S. Approval: 1998
WARNING: FETAL TOXICITY
See full prescribing information for complete boxed warning.
-
When pregnancy is detected, discontinue MICARDIS as soon as possible (5.1)
-
Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus (5.1)
RECENT MAJOR CHANGES
|
Warnings and Precautions |
|
|
|
Dual Blockade of the Renin-Angiotensin-Aldosterone System (5.6) |
12/2014 |
INDICATIONS AND USAGE
MICARDIS is an angiotensin II receptor blocker (ARB) indicated for:
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Treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. (1.1)
-
Cardiovascular (CV) risk reduction in patients unable to take ACE inhibitors (1.2)
DOSAGE AND ADMINISTRATION
-
May be administered with or without food (2.1)
-
When used for cardiovascular risk reduction, monitoring of blood pressure is recommended, and if appropriate, adjustment of medications that lower blood pressure may be necessary (2.2)
|
Indication |
Starting Dose |
Dose Range |
|
Hypertension (2.1) |
40 mg once
daily |
40 to 80 mg once
daily |
Cardiovascular
Risk Reduction (2.2) |
80 mg once
daily |
80 mg once
daily |
DOSAGE FORMS AND STRENGTHS
-
Tablets: 20 mg, 40 mg, 80 mg (3)
CONTRAINDICATIONS
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Known hypersensitivity (e.g., anaphylaxis or angioedema) to telmisartan or any other component of this product (4)
-
Do not co-administer aliskiren with MICARDIS in patients with diabetes (4)
WARNINGS AND PRECAUTIONS
-
Avoid fetal or neonatal exposure (5.1)
-
Hypotension: Correct any volume or salt depletion before initiating therapy. Observe for signs and symptoms of hypotension (5.2)
-
Monitor carefully in patients with impaired hepatic (5.4) or renal function (5.5)
-
Avoid concomitant use of an ACE inhibitor and angiotensin receptor blocker (5.6)
ADVERSE REACTIONS
-
Hypertension: The most common adverse events (≥1%) reported in hypertension trials are back pain, sinusitis, and diarrhea (6.1)
-
Cardiovascular risk reduction: The serious adverse events (≥1%) reported in cardiovascular risk reduction trials were intermittent claudication and skin ulcer (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact Boehringer Ingelheim Pharmaceuticals, Inc. at (800) S542-6257 or (800) 459-9906 TTY, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
DRUG INTERACTIONS
-
NSAIDS: Increased risk of renal impairment and loss of anti-hypertensive effect (7)
-
Do not co-administer aliskiren with MICARDIS in patients with diabetes (7)
USE IN SPECIFIC POPULATIONS
-
Nursing Mothers: Choose to discontinue nursing or drug (8.3)
-
Geriatric Patients: No overall difference in efficacy or safety vs younger patients, but greater sensitivity of some older individuals cannot be ruled out (8.5)
See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.
Revised: 12/2014
