Carcinogenicity: No evidence of carcinogenicity was found in a 2-year study in male rats given Irbesartan in doses of up 500 mg per kg body weight (mg/kg) per day or in female rats given Irbesartan in doses of up to 1000 mg/kg per day or in mice given Irbesartan in doses of up to 1000 mg/kg per day In male and female rats, a 500 mg/kg dose represents 3 and 11 times, respectively, the maximum recommended human daily dose (MRHDD) Of 300 mg of Irbesartan. In female rats, a 1000 mg/kg dose represents approximately 21 times the MRHDD of 300 mg of Irbesartan. For male and female mice a 1000 mg/kg dose represents approximately 3 and 5 times, respectively, the MRHDD of 300 mg of Irbesartan.
Mutagenicity: Irbesartan was not found to be mutagenic in the Ames microbial test, rat hepatocyte DNA repair test, or V 79 mammalian-cell forward gene mutation assay.
Irbesartan was found to be negative for the induction of chromosomal aberrations in the in vivo human lymphocyte assay and in in vivo mouse micronucleus study.
Pediatrics: No information is available on the relationship of age to the effects of Irbesartan in pediatric patients younger than 6 years of age. Safety and efficacy have not been established in patients younger than 6 years of age. Infants exposed in utero to angiotensin II receptor antagonists should be observed closely for hypotension, oliguria, and hyperkalemia. Oliguria should be treated with support of blood pressure and renal perfusion. Dialysis or exchange transfusion may be necessary to reverse hypotension and/or substitute for disordered renal function.
Geriatrics: In subjects 65 to 80 years of age, Irbesartan elimination half-life is not significantly altered, but the area under the plasma concentration-time curve (AUC) and maximum plasma concentration (Cmax) values may be greater by 20 to 50% than those in subjects 18 to 40 years of age. No dosage adjustment is necessary in the elderly may experience greater sensitivity to the effects of Irbesartan.