AVAPRO may be administered with other antihypertensive agents and with or without food and is indicated for:

Hypertension:

• Treatment of hypertension.The recommended initial dose of AVAPRO is 150 mg once daily. The dosage can be increased to a maximum dose of 300 mg once daily as needed to control blood pressure.

Nephropathy in Type 2 Diabetic Patients:

• Treatment of diabetic nephropathy in patients with type 2 diabetes and hypertension, an elevated serum creatinine, and proteinuria (>300 mg/day). 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).

Do not co-administer aliskiren with AVAPRO in patients with diabetes. Avoid use of aliskiren with AVAPRO in patients with renal impairment (GFR <60 mL/min).

In patients with an activated renin-angiotensin system, such as volume or salt-depleted patients (e.g. those being treated with high doses of diuretics), symptomatic hypotension may occur after initialization of treatment with AVAPRO. Correct volume or salt depletion prior to administration of AVAPRO or use a lower starting dose.

Changes in renal function including acute renal failure can be caused by drugs that inhibit the renin-angiotensin system. Patients whose renal function may depend in part on the activity of the renin-angiotensin system (e.g., patients with renal artery stenosis, chronic kidney disease, severe heart failure, or volume depletion) may be at particular risk of developing acute renal failure or death on AVAPRO.

In patients who are elderly, volume-depleted (including those on diuretic therapy), or with compromised renal function, co-administration of NSAIDs, including selective COX-2 inhibitors, with angiotensin II receptor antagonists (including irbesartan) may result in deterioration of renal function, including possible acute renal failure.

Dual blockade of the RAS with angiotensin receptor blockers, ACE inhibitors, or aliskiren is associated with increased risks of hypotension, hyperkalemia, and changes in renal function (including acute renal failure) compared to monotherapy.

Most patients receiving the combination of two RAS inhibitors do not obtain any additional benefit compared to monotherapy. In general, avoid combined use of RAS inhibitors. Closely monitor blood pressure, renal function and electrolytes in patients on AVAPRO and other agents that affect the RAS.

Co-administration of AVAPRO with other drugs that raise serum potassium levels may result in hyperkalemia, sometimes severe.

Increases in serum lithium concentrations and lithium toxicity have been reported with concomitant use of irbesartan and lithium. Monitor lithium levels in patients receiving irbesartan and lithium.

AVAPRO can cause fetal harm when administered to a pregnant woman. Use of drugs that act on the  renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death. Resulting oligohydramnios can be associated with  fetal lung hypoplasia and skeletal deformations. Potential neonatal adverse effects include skull hypoplasia, anuria, hypotension, renal failure, and death. When pregnancy is detected, discontinue AVAPRO as soon as possible.

It is not known whether irbesartan is excreted in human milk, but irbesartan or some metabolite of irbesartan is secreted at low concentration in the milk of lactating rats. Because of the potential for adverse effects on the nursing infant, discontinue nursing or discontinue AVAPRO.

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• Adult dosage greater than 300 mg once daily. GoToSource

• Use in patients under 6 years of age. GoToSource

• Improve anti-inflammatory response of atorvastatin and aspirin in patients with coronary heart disease. GoToSource

• Slow progression of aortic-root dilation in patients with marfan syndrome. GoToSource

• Chronic obstructive pulmonary disease. GoToSource

Fetal toxicity. GoToSource

Increased risk of lung cancer. GoToSource

Fatigue, diarrhea, cough, heartburn, tachycardia (rapid heart rate), anxiety and upper respiratory infection. GoToSource

Angioedema (swelling in the deep layers of skin) and hypotensive shock. GoToSource

Sprue-like enteropathy (gastrointestinal disorder), liver injury and cholestasis (flow of bile from liver is reduced or blocked). GoToSource

Phosphate nephropathy following oral sodium phosphate bowel purgative. GoToSource

Lawsuits filed for cancer and liver damage from NDMA contamination.