Available in a full range of dosage strengths
Tablets shown are not actual size.
AVAPRO
DOSAGE AND ADMINISTRATION
AVAPRO may be administered with other antihypertensive agents and with or without food.
Hypertension
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.
Nephropathy in Type 2 Diabetic Patients
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).
Volume- and Salt-Depleted Patients
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
DOSAGE AND ADMINISTRATION
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 (eg, pancreatitis), the former much more common
than the latter. (See
ADVERSE REACTIONS (6) in
full Prescribing Information).
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.
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.
Hepatic impairment. No dosage adjustment is necessary in patients with hepatic
impairment.
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-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) in
full Prescribing Information).
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 one 300/25 mg tablet once
daily as needed to control blood pressure (See
CLINICAL STUDIES (14.2) in
full Prescribing Information).
AVALIDE is not recommended as initial therapy in patients with intravascular volume depletion (see
WARNINGS AND PRECAUTIONS (5.2) in
full Prescribing Information).
