General Considerations

The side effects 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. [See Adverse Reactions (6).]

Maximum antihypertensive effects are attained within 2 to 4 weeks after a change in dose.

AVALIDE may be administered with or without food.

AVALIDE may be administered with other antihypertensive agents.

Add-On Therapy

In patients not controlled on monotherapy with irbesartan or hydrochlorothiazide, the recommended doses of AVALIDE, in order of increasing mean effect, are (irbesartan and 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 Studies (14.2).]

Replacement Therapy

AVALIDE may be substituted for the titrated components.

Initial Therapy

The usual starting dose is AVALIDE 150/12.5 mg once daily. The dosage can be increased after 1 to 2 weeks of therapy to a maximum of 300/25 mg once daily as needed to control blood pressure [see Clinical Studies (14.2)]. AVALIDE is not recommended as initial therapy in patients with intravascular volume depletion [see Warnings and Precautions (5.2)].