AVAPRO and AVALIDE: Hypertension Treatment

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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).

AVALIDE (irbesartan-hydrochlorothiazide) is indicated for the treatment of hypertension.

AVALIDE may be used in patients whose blood pressure is not adequately controlled on monotherapy.

AVALIDE may also be used as initial therapy in patients who are likely to need multiple drugs to achieve their blood pressure goals.

The choice of AVALIDE as initial therapy for hypertension should be based on an assessment of potential benefits and risks and this decision should be shaped by considerations such as baseline blood pressure, target goal, and likelihood of achieving goal compared to monotherapy. [Please see Indications and Usage section of full Prescribing Information.]

IMPORTANT SAFETY INFORMATION

WARNING: USE IN PREGNANCY When pregnancy is detected, discontinue AVAPRO or AVALIDE 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.]

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
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
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
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
In placebo-controlled hypertension studies, the most common adverse experiences reported with AVALIDE that occurred in ≥1% of patients and at a higher incidence vs placebo included fatigue (7% vs 3%), musculoskeletal pain (7% vs 5%), dizziness (8% vs 4%), and nausea/vomiting (3% vs 0%). In a study with AVALIDE used as initial therapy in moderate hypertension, the most common incidences of pre-specified adverse experiences reported that occurred in ≥1% of patients were: dizziness (3.0%, 3.8% and 1.0%), headache (5.5%, 3.8% and 4.8%) and hyperkalemia (1.2%, 0% and 1.0%) in AVALIDE, AVAPRO and HCTZ, respectively. In a study with AVALIDE used as initial therapy in severe hypertension, the most common incidences of pre-specified adverse experiences reported that occurred in ≥1% were: dizziness (3.6% and 4.0%) and headache (4.3% and 6.6%) in AVALIDE and AVAPRO, respectively

Please see full Prescribing Information.

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