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Avapro (Irbesartan) - Indications and Dosage

 
 



INDICATIONS AND USAGE

Hypertension

AVAPRO (irbesartan) is indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive agents.

Nephropathy in Type 2 Diabetic Patients

AVAPRO is indicated for the treatment of diabetic nephropathy with an elevated serum creatinine and proteinuria (>300 mg/day) in patients with type 2 diabetes and hypertension. In this population, AVAPRO reduces the rate of progression of nephropathy as measured by the occurrence of doubling of serum creatinine or end-stage renal disease (need for dialysis or renal transplantation) (see CLINICAL PHARMACOLOGY: Clinical Studies).

DOSAGE AND ADMINISTRATION

AVAPRO may be administered with other antihypertensive agents and with or without food.

Hypertension

The recommended initial dose of AVAPRO (irbesartan) 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). 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).

Volume- and Salt-Depleted Patients

A lower initial dose of AVAPRO (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).

HOW SUPPLIED

AVAPRO® (irbesartan) is available as white to off-white biconvex oval tablets, debossed with a heart shape on one side and a portion of the NDC code on the other. Unit-of-use bottles contain 30, 90, or 500 tablets and blister packs contain 100 tablets, as follows:

  75 mg 150 mg 300 mg
Debossing277127722773
Bottle of 300087-2771-310087-2772-310087-2773-31
Bottle of 900087-2771-320087-2772-320087-2773-32
Bottle of 500 0087-2772-150087-2773-15
Blister of 100 0087-2772-35 

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

1192328A3
1192327A3
Rev April 2007

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