AVAPRO

AVAPRO may be administered with other antihypertensive agents and with or without food.
The recommended initial dose of AVAPRO is 150 mg once daily. Patients requiring further reduction in blood pressure should be titrated to 300 mg once daily.

A low dose of a diuretic may be added, if blood pressure is not controlled by AVAPRO alone. Hydrochlorothiazide has been shown to have an additive effect (see CLINICAL PHARMACOLOGY: Clinical Studies in full Prescribing Information). 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.

No dosage adjustment is necessary in elderly patients, or in patients with hepatic impairment or mild to severe renal impairment.
The recommended target maintenance dose is 300 mg once daily. There are no data on the clinical effects of lower doses of AVAPRO on diabetic nephropathy (see CLINICAL PHARMACOLOGY: Clinical Studies in full Prescribing Information).
A lower initial dose of AVAPRO (irbesartan) (75 mg) is recommended in patients with depletion of intravascular volume or salt (eg, patients treated vigorously with diuretics or on hemodialysis) (see WARNINGS: Hypotension in Volume- or Salt-Depleted Patients in full Prescribing Information).

AVALIDE

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 (eg, patients treated vigorously with diuretics or on hemodialysis) (see WARNINGS: Hypotension in Volume- or Salt-depleted Patients in full Prescribing Information). 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 in full Prescribing Information) 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 (eg, 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 (irbesartan-hydrochlorothiazide) Tablets may be administered with other antihypertensive agents.

AVALIDE may be administered with or without food.

The combination may be substituted for the titrated components.
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 in full Prescribing Information). 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.
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.
No dosage adjustment is necessary in patients with hepatic impairment.