Indications and Important Safety Information

INDICATIONS

AVAPRO (irbesartan) is indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive agents.

AVAPRO is also indicated for the treatment of diabetic nephropathy with an elevated serum creatinine and proteinuria (>300 mg/day) in patients with type 2 diabetes and hypertension. In this population, AVAPRO reduces the rate of progression of nephropathy as measured by the occurrence of doubling of serum creatinine or end-stage renal disease (need for dialysis or renal transplantation).

IMPORTANT SAFETY INFORMATION

WARNING: USE IN PREGNANCY When pregnancy is detected, discontinue AVAPRO as soon as possible. When used in pregnancy during the second and third trimesters, drugs that act directly on the renin-angiotensin system can cause injury and even death to the developing fetus. [See Warnings and Precautions: Fetal/Neonatal Morbidity and Mortality in the full Prescribing Information.]

In patients with volume or sodium depletion (eg, patients vigorously treated with diuretics or on dialysis), such depletion should be corrected prior to administration of AVAPRO, or a lower initial dose of AVAPRO (75 mg) should be used, to avoid possible symptomatic hypotension
In placebo-controlled hypertension studies, there were no significant differences in adverse events (AEs) between AVAPRO and placebo. Adverse events that occurred in at least 1% of patients treated with AVAPRO and at a higher incidence vs placebo included
diarrhea (3% vs 2%), dyspepsia/heartburn (2% vs 1%), and
fatigue (4% vs 3%)
Additionally, in a study of hypertensive type 2 diabetic patients with renal disease (proteinuria >900 mg/day), the reported AEs for AVAPRO were similar to those seen in hypertension studies, with the exception of an increased incidence of orthostatic symptoms; AVAPRO compared to placebo (both groups received adjunctive antihypertensives): dizziness, (10.2% vs 6.0%); orthostatic dizziness, (5.4% vs 2.7%); and orthostatic hypotension, (5.4% vs 3.2%), respectively. In patients with proteinuria, monitor serum potassium

Please see full Prescribing Information.