Valsartan

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

DIOVAN-HCT® (valsartan and hydrochlorothiazide tablets) is indicated for: • the treatment of mild to moderate essential hypertension in patients for whom combination therapy is appropriate. DIOVAN-HCT is not indicated for initial therapy (see 4 DOSAGE AND ADMINISTRATION).

Patients should be titrated on individual drugs. If the fixed combination represents the dose and dosing frequency determined by this titration, the use of DIOVAN-HCT may be more convenient in the management of patients. If during maintenance therapy dosage adjustment is necessary it is advisable to use the individual drugs.

1 Pediatrics (< 18 years of age): The safety and efficacy of DIOVAN-HCT in children and adolescents (below the age of 18 years) have not been established and use in this age group is not recommended. 2 Geriatrics (> 65 years of age): No overall age-related differences were seen in the adverse effect profile but greater sensitivity in some older individuals cannot be ruled out and appropriate caution is recommended.

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