AVAPRO^®(irbesartan) / AVALIDE^®(irbesartan and hydrochlorothiazide)

Contraindications

AVAPRO and AVALIDE are contraindicated in patients with hypersensitivity to any component of this product.

AVALIDE is contraindicated in patients with hypersensitivity to any component of this product, anuria or hypersensitivity to sulfonamide-derived drugs.

Do not coadminister aliskiren with AVAPRO or AVALIDE in patients with diabetes.

Warnings and Precautions

Fetal Toxicity: AVAPRO or AVALIDE can cause fetal harm to a pregnant woman. Reduces fetal renal function and increases fetal and neonatal morbidity and death. Potential neonatal adverse effects include skull hypoplasia, anuria, hypotension, renal failure and death. Discontinue as soon as possible when pregnancy is detected.

Hypotension in Volume or Salt-Depleted Patients: Symptomatic hypotension may occur in patients with intravascular volume or salt depletion (e.g., in patients treated with high doses of diuretics or in patients on diuretics). Correct volume or salt depletion prior to administration of AVAPRO or AVALIDE or use a lower starting dose. If hypotension occurs, the patient should be placed in the supine position and, if necessary, given an intravenous infusion of normal saline.

Hypersensitivity Reaction: 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 taking AVALIDE.

Systemic Lupus Erythematosus: For patients taking AVALIDE, thiazide diuretics have been reported to cause exacerbation or activation of systemic lupus erythematosus.

Electrolyte and Metabolic Imbalances: Coadministration of AVALIDE with potassium-sparing diuretics, potassium supplements, potassium-containing salt substitutes or drugs that raise serum potassium levels may result in hyperkalemia, sometimes severe. Monitor serum potassium in such patients. Hydrochlorothiazide can cause hypokalemia and hyponatremia. Monitor serum electrolytes periodically. Hyperuricemia may occur or frank gout may be precipitated in certain patients. Hydrochlorothiazide may alter glucose tolerance and raise serum levels of cholesterol and triglycerides. Antihypertensive effects of the drug may be enhanced in post-sympathectomy patients. Thiazides may decrease urinary calcium excretion or cause intermittent and slight elevation of serum calcium in the absence of known disorders of calcium metabolism. Thiazides should be discontinued before carrying out tests for parathyroid function.

Hepatic Impairment: For patients taking AVALIDE with impaired hepatic function or progressive liver disease, thiazides should be used with caution since minor alterations of fluid and electrolyte balance may precipitate hepatic coma.

Impaired Renal Function: Patients whose renal function may depend on the activity of the renin-angiotensin-aldosterone system (e.g., patients with severe congestive heart failure), treatment with ACE inhibitors has been associated with oliguria and/or progressive azotemia and (rarely) with acute renal failure and/or death. Thiazides should be used with caution in severe renal disease and may precipitate azotemia in patients with renal disease. Cumulative effects of the drug may develop in patients with impaired renal function. Monitor renal function periodically in these patients. Consider withholding or discontinuing therapy in patients who develop a clinically significant decrease in renal function on AVAPRO or AVALIDE.

Acute Angle-Closure Glaucoma, Acute Myopia, and Choroidal Effusion: For patients taking AVALIDE, hydrochlorothiazide, can cause an idiosyncratic reaction resulting in acute angle closure glaucoma and elevated intraocular pressure with or without a noticeable acute myopic shift and/or choroidal effusions. Cases of acute angle-closure glaucoma have been reported. Symptoms include acute onset of decreased visual acuity or ocular pain and typically occur within hours to weeks of drug initiation. Untreated acute angle-closure glaucoma may result in permanent vision loss. Discontinue drug intake as rapidly as possible. Prompt medical or surgical treatments may need to be considered if the intraocular pressure remains uncontrolled.

Adverse Reactions

The most common adverse reactions for AVAPRO from clinical studies of nephropathy in type 2 diabetic patients were hyperkalemia, dizziness, orthostatic dizziness, and orthostatic hypotension.

The most common adverse reactions for AVALIDE are dizziness, fatigue, and musculoskeletal pain.

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