Valsartan

Hypertension Treatment of essential hypertension in adults, and hypertension in children and adolescents 6 to 18 years of age. 1). 1).

Sandoz Valsartan (valsartan tablets) is indicated for: • Hypertension o For the treatment of mild to moderate essential hypertension. o Sandoz Valsartan may be administered alone, or concomitantly with thiazide diuretics. o The safety and efficacy of concurrent treatment with valsartan and angiotensin converting enzyme inhibitors have not been established.

• Following Myocardial Infarction o To reduce cardiovascular mortality in clinically stable patients with signs or symptoms of left ventricular dysfunction in conjunction with acute myocardial infarction when the use of an angiotensin-converting enzyme inhibitor (ACEI) is not appropriate.

o The combination of valsartan and an angiotensin-converting enzyme inhibitor (ACEI) has not been shown to result in clinically relevant improvement in cardiovascular outcome over valsartan use alone. Accordingly, such combined use is not recommended.

• Chronic Heart Failure o Sandoz Valsartan can be used in patients with chronic heart failure who have been shown to be intolerant to an angiotensin converting enzyme inhibitor. There is no evidence that valsartan provides added benefits when it is used with ACE inhibitors (See 14 Clinical Trials).

1 INDICATIONS AND USAGE Valsartan tablets are an angiotensin II receptor blocker (ARB) indicated for: • Hypertension , to lower blood pressure in adults and children 1 year and older. 1 Hypertension Valsartan tablets are indicated for the treatment of hypertension, to lower blood pressure in adults and pediatric patients one year of age and older.

Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes, including the class to which valsartan principally belongs.

There are no controlled trials in hypertensive patients demonstrating risk reduction with valsartan tablets. 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.

Treatment of essential hypertension as substitution therapy in adult patients whose blood pressure is adequately controlled on the combination of amlodipine, valsartan and hydrochlorothiazide (HCT), taken either as three single-component formulations or as a dual-component and a single-component formulation.