March 30, 2017
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Micardis HCT

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Micardis HCT




Indications
Dosage
How Supplied

INDICATIONS

MICARDIS HCT (telmisartan and hydrochlorothiazide) is indicated for the treatment of hypertension, 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 the classes to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with MICARDIS HCT.

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 [see Clinical Studies].

MICARDIS HCT is not indicated for initial therapy for the treatment of hypertension [see DOSAGE AND ADMINISTRATION].

MICARDIS HCT may be used alone or in combination with other antihypertensive agents.

DOSAGE AND ADMINISTRATION

Dosing Information

Initiate a patient whose blood pressure is not adequately controlled with telmisartan monotherapy 80 mg on MICARDIS HCT, 80 mg/12.5 mg once daily. Dose can be titrated up to 160 mg/25 mg after 2 to 4 weeks, if necessary.

Initiate a patient whose blood pressure is not adequately controlled by 25 mg once daily of hydrochlorothiazide, or is controlled but who experiences hypokalemia with this regimen on MICARDIS HCT 80 mg / 12.5 mg once daily. Dose can be titrated up to 160 mg/25 mg after 2 to 4 weeks, if necessary.

Patients titrated to the individual components (telmisartan and hydrochlorothiazide) may instead receive the corresponding dose of MICARDIS HCT.

MICARDIS HCT may be administered with other antihypertensive drugs.

Dose Adjustment For Hepatic Impairment

Initiate patients with biliary obstructive disorders or hepatic insufficiency under close medical supervision using the 40 mg/12.5 mg combination. MICARDIS HCT tablets are not recommended for patients with severe hepatic impairment [see Use in Specific Populations, and CLINICAL PHARMACOLOGY].

Important Administration Instructions

MICARDIS HCT tablets should not be removed from blisters until immediately before administration.

HOW SUPPLIED

Dosage Forms And Strengths

  • 40 mg/12.5 mg, red and white tablets marked with the Boehringer Ingelheim logo and H4
  • 80 mg/12.5 mg, red and white tablets marked with the Boehringer Ingelheim logo and H8
  • 80 mg/25 mg, yellow and white tablets marked with the Boehringer Ingelheim logo and H9

Storage And Handling

MICARDIS HCT is available in three strengths as biconvex two-layered, oblong-shaped, uncoated tablets containing telmisartan and hydrochlorothiazide:

40 mg/12.5 mg tablet: red and white (may contain red specks) marked with the BOEHRINGER INGELHEIM logo and H4; individually blister-sealed in cartons of 30 tablets as 3 x 10 cards (NDC 0597-0043-37)

80 mg/12.5 mg tablet: red and white (may contain red specks) marked with the BOEHRINGER INGELHEIM logo and H8; individually blister-sealed in cartons of 30 tablets as 3 x 10 cards (NDC 0597-0044-37)

80 mg/25 mg tablet: yellow and white (may contain yellow specks) marked with the BOEHRINGER INGELHEIM logo and H9; individually blister-sealed in cartons of 30 tablets as 3 x 10 cards (NDC 0597-0042-37)

Storage

Store at 25°C (77°F); excurs ions permitted to 15°C-30°C (59°F-86°F) [see USP Controlled Room Temperature]. Tablets should not be removed from blisters until immediately before administration.

Distributed by: Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT 06877 USA. Revised: Jan 2016

This monograph has been modified to include the generic and brand name in many instances.

Last reviewed on RxList: 2/6/2017

Indications
Dosage
How Supplied

Micardis HCT - User Reviews

Micardis HCT User Reviews

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