Avapro

[Irbesartan]

Special Populations

Pediatric

The pharmacokinetics of irbesartan were studied in hypertensive children (age 6-12, n=9) and adolescents (age 13-16, n=12) following single and multiple daily doses of 2 mg/kg (maximum dose of 150 mg per day) for 4 weeks. Accumulation with repeated doses was limited (18%) in both age groups. Clearance rates, AUC values, and Cmax values were comparable to adults receiving 150 mg daily. Irbesartan pharmacokinetics have not been investigated in patients <6 years of age.

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Gender

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

Geriatric

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

Race

In healthy black subjects, irbesartan AUC values were approximately 25% greater than whites; there were no differences in Cmax values.

Renal Insufficiency:

The pharmacokinetics of irbesartan were 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. (See WARNINGS: Hypotension in Volume- or Salt-depleted Patients and DOSAGE AND ADMINISTRATION.)

Hepatic Insufficiency:

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

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