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INDICATIONS

Micardis^® (telmisartan) tablets is an angiotensin II receptor blocker (ARB) indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive drugs.

MICARDIS 80 mg is indicated for risk reduction of myocardial infarction, stroke, or death from cardiovascular (CV) causes in patients ≥55 years of age at high risk of developing major CV events who are unable to take ACE inhibitors.

• High risk for CV 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. MICARDIS can be used in addition to other needed treatment (such as antihypertensive, antiplatelet, or lipid-lowering therapy).
• 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 retrying the ACE inhibitor after the cough resolves. Use of telmisartan with an ACE inhibitor is not recommended

IMPORTANT SAFETY INFORMATION

WARNING: AVOID USE IN PREGNANCY
See full prescribing information for complete boxed warning.
When pregnancy is detected, discontinue MICARDIS as soon as possible. Drugs that act directly on the renin-angiotensin system can cause injury and even death to the developing fetus.

MICARDIS is contraindicated in patients with known hypersensitivity (eg, anaphylaxis or angioedema) to telmisartan or any other component of this product.

Symptomatic hypotension may occur in patients with an activated renin-angiotensin system. Correct volume and/or salt depletion in patients before initiating MICARDIS or start treatment under close supervision with a reduced dose.

Patients taking MICARDIS should be told not to use potassium supplements or salt substitutes that contain potassium without consulting their physician. Consider periodic determinations of serum electrolytes to detect possible electrolyte imbalances. Monitor carefully in patients with impaired hepatic or renal function.

In patients with impaired hepatic function, initiate MICARDIS at low doses and titrate slowly.

In patients whose renal function may depend on the activity of the renin-angiotensin-aldosterone system such as patients with severe congestive heart failure or renal dysfunction, treatment with ACE inhibitors and an ARB such as MICARDIS has been associated with oliguria and/or progressive azotemia and, rarely, with acute renal failure and/or death. In patients with renal artery stenosis, increases in serum creatinine or blood urea nitrogen may occur. When adding an ACE inhibitor to an ARB, monitor renal function closely. Use of MICARDIS with ramipril is not recommended.

In clinical trials for hypertension, the most commonly reported adverse events with MICARDIS that were more frequent than with placebo were upper respiratory tract infection, back pain, sinusitis, diarrhea, and pharyngitis.

In a clinical trial for cardiovascular risk reduction, 8.4% of patients treated with telmisartan were discontinued due to adverse events compared to 7.6% treated with placebo. Serious adverse events at least 1% more common on telmisartan than placebo were intermittent claudication and skin ulcer.

Please see full Prescribing Information, including Boxed WARNING, for MICARDIS.