MICARDIS HCT (telmisartan/hydrochlorothiazide) is indicated for the treatment of hypertension. This fixed dose combination is not indicated for initial therapy (see DOSAGE AND ADMINISTRATION).

The usual starting dose of telmisartan is 40 mg once a day; blood pressure response is dose related over the range of 20-80 mg. Patients with depletion of intravascular volume should have the condition corrected or telmisartan tablets should be initiated under close medical supervision (see WARNINGS, Hypotension in Volume Depleted Patients). Patients with biliary obstructive disorders or hepatic insufficiency should have treatment started under close medical supervision (see PRECAUTIONS).

Hydrochlorothiazide is effective in doses of 12.5 mg to 50 mg once daily.

To minimize dose-independent side effects, it is usually appropriate to begin combination therapy only after a patient has failed to achieve the desired effect with monotherapy. The side effects (see WARNINGS) of telmisartan are generally rare and apparently independent of dose; those of hydrochlorothiazide are a mixture of dose-dependent phenomena (primarily hypokalemia) and dose-independent phenomena (e.g., pancreatitis), the former much more common than the latter. Therapy with any combination of telmisartan and hydrochlorothiazide will be associated with both sets of dose-independent side effects.

MICARDIS HCT (telmisartan/hydrochlorothiazide) tablets may be administered with other antihypertensive agents.

MICARDIS HCT tablets may be administered with or without food.

Replacement Therapy

The combination may be substituted for the titrated components.

Dose Titration by Clinical Effect

MICARDIS HCT is available as tablets containing either telmisartan 40 mg and hydrochlorothiazide 12.5 mg, or telmisartan 80 mg and hydrochlorothiazide 12.5 mg or 25 mg. A patient whose blood pressure is not adequately controlled with telmisartan monotherapy 80 mg (see above) may be switched to MICARDIS HCT, telmisartan 80 mg/hydrochlorothiazide 12.5 mg once daily, and finally titrated up to 160/25 mg, if necessary.

A patient whose blood pressure is inadequately controlled by 25 mg once daily of hydrochlorothiazide may be switched to MICARDIS HCT (telmisartan 80 mg/hydrochlorothiazide 12.5 mg or telmisartan 80 mg/hydrochlorothiazide 25 mg) once daily. The clinical response to MICARDIS HCT should be subsequently evaluated and if blood pressure remains uncontrolled after 2-4 weeks of therapy, the dose may be titrated up to 160/25 mg, if necessary. Those patients controlled by 25 mg hydrochlorothiazide but who experience hypokalemia with this regimen, may be switched to MICARDIS HCT (telmisartan 80 mg/hydrochlorothiazide 12.5 mg) once daily, reducing the dose of hydrochlorothiazide without reducing the overall expected antihypertensive response.

Patients with Renal Impairment

The usual regimens of therapy with MICARDIS HCT may be followed as long as the patient's creatinine clearance is > 30 mL/min. In patients with more severe renal impairment, loop diuretics are preferred to thiazides, so MICARDIS HCT is not recommended.

Patients with Hepatic Impairment

MICARDIS HCT is not recommended for patients with severe hepatic impairment. Patients with biliary obstructive disorders or hepatic insufficiency should have treatment started under close medical supervision using the 40/12.5 mg combination (see PRECAUTIONS).

MICARDIS HCT (telmisartan/hydrochlorothiazide) is available in three strengths as biconvex two-layered, oblong-shaped, uncoated tablets in three combinations of 40 mg/12.5 mg, 80 mg/12.5 mg and 80 mg/25 mg telmisartan and hydrochlorothiazide, respectively. The hydrochlorothiazide layer is red in the 40 mg/12.5 mg and 80 mg/12.5 mg tablets, and yellow in the 80 mg/25 mg tablets, and all are unmarked. The telmisartan layer for all three strengths is white, but may contain red specks in the 40 mg/12.5 mg and 80 mg/12.5 mg tablets and yellow specks in the 80 mg/25 mg tablets. The telmisartan layer is marked with the BOEHRINGER INGELHEIM logo and H4 for the 40 mg/12.5 mg dose strength, H8 for the 80 mg/12.5 mg dose strength and H9 for the 80 mg/25 mg dose strength.

Tablets are provided as follows:

MICARDIS HCT tablets 40 mg/12.5 mg are individually blister-sealed in cartons of 30 tablets as 3 x 10 cards (NDC 0597-0043-37).

MICARDIS HCT tablets 80 mg/12.5 mg are individually blister-sealed in cartons of 30 tablets as 3 x 10 cards (NDC 0597-0044-37).

MICARDIS HCT tablets 80 mg/25 mg are individually blister-sealed in cartons of 30 tablets as 3 x 10 cards (NDC 0597-0042-37).

Storage

Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-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. Licensed from: Boehringer Ingelheim International GmbH, Ingelheim, Germany. Revised: June 2, 2006. FDA revision date: 2/27/2007

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