Avapro

[Irbesartan]

Irbesartan was not mutagenic in a battery of in vitro tests (Ames microbial test, rat hepatocyte DNA repair test, V79 mammalian-cell forward gene-mutation assay). Irbesartan was negative in several tests for induction of chromosomal aberrations (in vitro-human lymphocyte assay; in vivo-mouse micronucleus study).

Irbesartan had no adverse effects on fertility or mating of male or female rats at oral doses 650 mg/kg/day, the highest dose providing a systemic exposure to irbesartan (AUC0-24h, bound plus unbound) about 5 times that found in humans receiving the maximum recommended dose of 300 mg/day.

Pregnancy

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Pregnancy Categories C (first trimester) and D (second and third trimesters).

See WARNINGS: Fetal/Neonatal Morbidity and Mortality.

Nursing Mothers

It is not known whether irbesartan is excreted in human milk, but irbesartan or some metabolite of irbesartan is secreted at low concentration in the milk of lactating rats. Because of the potential for adverse effects on the nursing infant, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established.Pharmacokinetic parameters in pediatric subjects (age 6-16, n=21) were comparable to adults. At doses up to 150 mg daily for 4 weeks AVAPRO (irbesartan) was well tolerated in hypertensive children and adolescents (see CLINICAL PHARMACOLOGY: Special Populations). Blood pressure reductions were comparable to adults receiving 150 mg daily; however, greater sensitivity in some patients cannot be ruled out (see DOSAGE AND ADMINISTRATION: Pediatric Patients). AVAPRO has not been studied in pediatric patients less than 6 years old.

Geriatric Use

Of 4925 subjects receiving AVAPRO (irbesartan) in controlled clinical studies of hypertension, 911 (18.5%) were 65 years and over, while 150 (3.0%) were 75 years and over. No overall differences in effectiveness or safety were observed between these subjects and younger subjects, but greater sensitivity of some older individuals cannot be ruled out. (See Pharmacokinetics, Special Populations , and Clinical Studies.)

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