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To view the MICARDIS® (telmisartan) Prescribing Information, including
the boxed WARNING, click the link below.
MICARDIS® Prescribing Information
To view the MICARDIS® HCT (telmisartan and hydrochlorothiazide) Prescribing
Information, including boxed WARNING, click the link below.
MICARDIS® HCT Prescribing Information
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MICARDIS® (telmisartan) Tablets is indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive agents.
MICARDIS® HCT (telmisartan/hydrochlorothiazide) Tablets is indicated for the treatment of hypertension. MICARDIS® HCT is not indicated for initial therapy.
MICARDIS® and MICARDIS® HCT are contraindicated in patients who are hypersensitive to any component of these products. MICARDIS® HCT is contraindicated in patients with anuria or hypersensitivity to other sulfonamide-derived drugs.
No overall differences in effectiveness and safety of telmisartan/hydrochlorothiazide were observed in elderly patients compared to younger patients, but greater sensitivity of some older individuals cannot be ruled out.
MICARDIS® HCT is not recommended for patients with severe renal or hepatic impairment.
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USE IN PREGNANCY
When used in pregnancy during the second and third trimesters, drugs that act directly on the renin-angiotensin system can cause injury and even death to the developing fetus.
When pregnancy is detected, MICARDIS® and MICARDIS® HCT Tablets should be discontinued as soon as possible (see WARNINGS, Fetal/Neonatal Morbidity and Mortality).
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In patients with an activated renin-angiotensin system, such as volume- and/or salt-depleted patients (e.g., those receiving high doses of diuretics), symptomatic hypotension may occur after initiation of MICARDIS® or MICARDIS® HCT therapy. This condition should be corrected prior to administration of MICARDIS® or MICARDIS® HCT, and treatment should start under close medical supervision. Patients with biliary obstructive disorders or hepatic insufficiency should have treatment started under close medical supervision.
The most common adverse events occurring with MICARDIS® Tablets monotherapy at a rate of ?1% and greater than placebo, respectively, were: upper respiratory tract infection (URTI) (7%, 6%), back pain (3%, 1%), sinusitis (3%, 2%), diarrhea (3%, 2%), and pharyngitis (1%, 0%).
Thiazide diuretics should be used with caution in patients with impaired hepatic function or progressive liver disease, since minor alterations of fluid and electrolyte balance may precipitate hepatic coma. Hypersensitivity reactions to hydrochlorothiazide may occur in patients with or without a history of allergy or bronchial asthma, but are more likely in patients with such a history. Thiazide diuretics have been reported to cause exacerbation or activation of systemic lupus erythematosus. Lithium generally should not be given with thiazides.
The most common adverse events occurring in ?2% of patients taking MICARDIS® HCT vs placebo, respectively, were: dizziness (5%, 1%), diarrhea (3%, 0%), fatigue (3%, 1%), nausea (2%, 0%), influenza-like symptoms (2%, 1%), sinusitis (4%, 3%), and URTI (8%, 7%).
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