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  • Irbesartan was negative in several tests for induction of chromosomal aberrations in vitro-human lymphocyte assay; in vivo-mouse micronucleus study.
  • In multiple dose studies in hypertensive patients, there were no clinically important effects on fasting triglycerides, total cholesterol, HDL -cholesterol, or fasting glucose concentrations.
  • If oliguria occurs, support blood pressure and renal perfusion.
  • Radioactivity was present in the rat and rabbit fetus during late gestation and in rat milk following oral doses of radiolabeled irbesartan.
  • Because of the potential for adverse effects on the nursing infant, discontinue nursing or discontinue irbesartan tablets.
  • Pediatric Use In infants with histories of in utero exposure to an angiotensin II receptor antagonist observe for hypotension, oliguria, and hyperkalemia.

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