Indications and Important Safety Information

AVAPRO 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).

AVALIDE is indicated for the treatment of hypertension. This fixed dose combination is not indicated for initial therapy.

• Because of the hydrochlorothiazide component, AVALIDE is contraindicated in patients with anuria or hypersensitivity to sulfonamide-derived drugs
• 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 AVALIDE, 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
• Most common adverse experiences reported in AVALIDE-vs-placebo clinical trials: fatigue (7% vs 3%); musculoskeletal pain (7% vs 5%); dizziness (8% vs 4%); and nausea/vomiting (3% vs 0%)
• Thiazides should be used with caution in patients with severe renal disease and in patients with impaired hepatic function or progressive liver disease, since minor alterations of fluid and electrolyte balance may precipitate hepatic coma
• Hypersensitivity reactions to hydrochlorothiazide may occur in patients with or without a history of allergy or bronchial asthma, but are more likely in patients with such a history
• Thiazide diuretics have been reported to cause exacerbation or activation of systemic lupus erythematosus
• Lithium generally should not be given with thiazides

Please see full Prescribing Information.