Irbesartan

Irbesartan is indicated in adults for the treatment of essential hypertension. 1).

and 14 CLINICAL TRIALS). The dosage may be increased after 2 - 4 weeks of therapy to a maximum of 300/25 mg once daily. Sandoz Irbesartan HCT is not recommended as initial therapy in patients with intravascular volume depletion (see 7 WARNINGS AND PRECAUTIONS, Cardiovascular).

DOSE ADJUSTMENT IN SPECIAL POPULATION Diuretic Treated Patients In patients receiving diuretics, irbesartan therapy should be initiated with caution, since these patients may be volume-depleted and thus more likely to experience hypotension following initiation of additional antihypertensive therapy.

Whenever possible, all diuretics should be discontinued 2 - 3 days prior to the administration of irbesartan to reduce the likelihood of hypotension (see 7 WARNINGS AND PRECAUTIONS, Cardiovascular, and 9 DRUG INTERACTIONS). If this is not possible because of the Sandoz Irbesartan HCT (Irbesartan and hydrochlorothiazide) Page 7 of 54 Protected B / Protégé B patient’s condition, irbesartan should be administered with caution and the blood pressure monitored closely.

1 INDICATIONS AND USAGE Irbesartan tablets are 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 ) Treatment of diabetic nephropathy in hypertensive patients with type 2 diabetes, an elevated serum creatinine, and proteinuria. 1 Hypertension Irbesartan tablets are indicated for the treatment of hypertension, to lower blood pressure.

Lowering blood pressure lowers the risk of fatal and non-fatal cardiovascular (CV) events, primarily strokes and myocardial infarction. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including this drug.

Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake.

Ifirmasta is indicated in adults for the treatment of essential hypertension. 1).