INDICATIONS AND USAGE

AVAPRO® (irbesartan) is indicated for the treatment of hypertension, to lower blood pressure. Full Indication
AVALIDE® (irbesartan and hydrochlorothiazide) tablets are indicated for the treatment of hypertension. Full Indication

For US Healthcare Professionals Only

AVAPRO: PROVEN 24-HOUR EFFICACY

AVAPRO is a once-a-day oral angiotensin II receptor blocker (ARB) with demonstrated efficacy in treating mild-to-moderate hypertension.1

When it comes to helping your patients with mild-to-moderate hypertension reach their goals, AVAPRO is a proven therapeutic option that provides effective 24-hour blood pressure control.1

AVALIDE: FOR YOUR PATIENTS WHO NEED ADDED EFFICACY

AVALIDE is a once-a-day combination of irbesartan, an angiotensin II receptor blocker (ARB) and hydrochlorothiazide (HCTZ), indicated for hypertension in patients not adequately controlled with monotherapy.2,3

When it comes to helping your mild-to-moderate hypertensive patients who need added efficacy, AVALIDE is a proven therapeutic option that provides effective, 24-hour blood pressure control.2,3

AVAPRO and AVALIDE Dosage adjustment for specific populations

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No sex-related differences in pharmacokinetics are observed in healthy elderly (age 65–80 years) or in healthy young (age 18–40 years) subjects. In studies of hypertensive patients, there is no sex difference in half-life or accumulation, but somewhat higher plasma concentrations of irbesartan are observed in females (11%–44%). No sex-related dosage adjustment is necessary.5

In elderly subjects (age 65–80 years), irbesartan elimination half-life is not significantly altered, but AUC and Cmax values are about 20% to 50% greater than those of young subjects (age 18–40 years). No dosage adjustment is necessary in the elderly.5

In healthy black subjects, irbesartan AUC values are approximately 25% greater than whites; there is no difference in Cmax values.5

The pharmacokinetics of irbesartan is not altered in patients with renal impairment or in patients on hemodialysis. Irbesartan is not removed by hemodialysis. No dosage adjustment is necessary in patients with mild to severe renal impairment unless a patient with renal impairment is also volume depleted.5

The pharmacokinetics of irbesartan following repeated oral administration are not significantly affected in patients with mild to moderate cirrhosis of the liver. No dosage adjustment is necessary in patients with hepatic insufficiency.5

In vitro studies show significant inhibition of the formation of oxidized irbesartan metabolites with the known cytochrome CYP2C9 substrates/inhibitors sulphenazole, tolbutamide and nifedipine. However, in clinical studies the consequences of concomitant irbesartan on the pharmacodynamics of warfarin were negligible. Based on in vitro data, no interaction would be expected with drugs whose metabolism is dependent upon cytochrome P450 isoenzymes 1A1, 1A2, 2A6, 2B6, 2D6, 2E1, or 3A4.4

In separate studies of patients receiving maintenance doses of warfarin, hydrochlorothiazide, or digoxin, irbesartan administration for 7 days has no effect on the pharmacodynamics of warfarin (prothrombin time) or pharmacokinetics of digoxin. The pharmacokinetics of irbesartan are not affected by coadministration of nifedipine or hydrochlorothiazide.4

No significant drug-drug pharmacokinetic (or pharmacodynamic) interactions have been found in interaction studies with hydrochlorothiazide, digoxin, warfarin, and nifedipine.5

AVAILABLE AUTHORIZED GENERIC

Learn more about the Irbesartan-Authorized Generics

References

1. Fogari R, Ambrosoli S, Corradi L, et al. 24-hour blood pressure control by once-daily administration of irbesartan assessed by ambulatory blood pressure monitoring. J Hypertens. 1997;15:1511-1518.

2. Howe P, Phillips P, Saini R, Kassler-Taub K. The antihypertensive efficacy of the combinations of irbesartan and hydrochlorothiazide assessed by 24-hour ambulatory blood pressure monitoring. Clin Exp Hypertens. 1999;21:1373-1396.

3. Neutel JM, Saunders E, Bakris GL, et al; INCLUSIVE Investigators. The efficacy and safety of low- and high-dose fixed combinations of irbesartan/hydrochlorothiazide in patients with uncontrolled systolic blood pressure on monotherapy: the INCLUSIVE trial. J Clin Hypertens. 2005;7:578-586.

4. AVAPRO [prescribing information]. Bridgewater, NJ: sanofi-aventis; 2018.

5. AVALIDE [prescribing information]. Bridgewater, NJ: sanofi-aventis; 2018.