AVALIDE (irbesartan-hydrochlorothiazide) Tablets is indicated for the treatment of hypertension. This fixed dose combination is not indicated for initial therapy (see DOSAGE AND ADMINISTRATION).

The recommended initial dose of irbesartan is 150 mg once daily. Patients requiring further reduction in blood pressure should be titrated to 300 mg once daily.

A lower initial dose of irbesartan (75 mg) is recommended in patients with depletion of intravascular volume (e.g., patients treated vigorously with diuretics or on hemodialysis) (see WARNINGS: Hypotension in Volume- or Salt-depleted Patients). Patients not adequately treated by the maximum dose of 300 mg once daily are unlikely to derive additional benefit from a higher dose or twice-daily dosing.

Hydrochlorothiazide is effective in doses of 12.5 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 irbesartan are generally rare and apparently independent of dose; those of hydrochlorothiazide are a mixture of dose-dependent (primarily hypokalemia) and dose-independent phenomena (e.g., pancreatitis), the former much more common than the latter. Therapy with any combination of irbesartan and hydrochlorothiazide will be associated with both sets of dose-independent side effects.

AVALIDE may be administered with other antihypertensive agents.

Replacement Therapy

The combination may be substituted for the titrated components.

Dose Titration by Clinical Effect

A patient whose blood pressure is inadequately controlled by irbesartan or hydrochlorothiazide alone may be switched to once daily AVALIDE. Recommended doses of AVALIDE, in order of increasing mean effect, are (irbesartan-hydrochlorothiazide) 150/12.5 mg, 300/12.5 mg, and 300/25 mg. The largest incremental effect will likely be in the transition from monotherapy to 150/12.5 mg. (See CLINICAL PHARMACOLOGY: Clinical Studies.) It takes 2–4 weeks for the blood pressure to stabilize after a change in the dose of AVALIDE.

The usual dose of AVALIDE is one tablet once daily. The maximal antihypertensive effect is attained about 2–4 weeks after initiation of therapy.

Use in Patients with Renal Impairment

The usual regimens of therapy with AVALIDE 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 AVALIDE is not recommended.

Patients with Hepatic Impairment

No dosage adjustment is necessary in patients with hepatic impairment.

AVALIDE® (irbesartan-hydrochlorothiazide) 150/12.5 mg and 300/12.5 mg tablets are peach, biconvex, and oval with a heart debossed on one side and “2775” or “2776” on the reverse side. The 300/25 mg film-coated tablet is pink, biconvex, and oval with a heart debossed on one side and “2788” on the reverse side. AVALIDE® Tablets are supplied as follows:

Storage

Store at 25°C (77°F); excursions permitted to 15°C - 30°C (59°F - 86°F) [see USP Controlled Room Temperature].

Distributed by: Bristol-Myers Squibb Sanofi-Synthelabo Partnership., New York, NY 10016
Revised October 2005. FDA rev date: 4/21/2006

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