Irbesartan Prescribing Information
• Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus
Irbesartan Tablets is an angiotensin II receptor blocker (ARB) indicated for:
• Treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. (1.1)
• Treatment of diabetic nephropathy in hypertensive patients with type 2 diabetes, an elevated serum creatinine, and proteinuria. (1.2)
Ind ication | D o s e |
| Hypertension (2.2) | 150 to 300 mg once daily |
| Diabetic Nephropathy (2.3) | 300 mg once daily |
Irbesartan Tablets USP 75 mg are available as white to off white, oval shaped, biconvex, uncoated tablet, debossed with “L131” on one side and “75” on other side.
Irbesartan Tablets USP 150 mg are available as white to off white, oval shaped, biconvex, uncoated tablet, debossed with “L132” on one side and “150” on other side.
Irbesartan Tablets USP 300 mg are available as white to off white, oval shaped, biconvex, uncoated tablet, debossed with “L133” on one side and “300” on other side.
• Lactation: Potential for adverse effects in infants. (8.2)
Irbesartan Tablets are contraindicated in patients who are hypersensitive to any component of this product.
Do not coadminister aliskiren with Irbesartan Tablets in patients with diabetes.