Dosage regimen: Adult population: Hypertension: The recommended dose of Diovan is 80 mg or 160 mg film-coated tablet once daily, irrespective of race, age, or gender. The antihypertensive effect is substantially present within 2 weeks and maximal effects are seen after 4 weeks. In patients whose blood pressure is not adequately controlled, the daily dose may be increased to 320 mg, or a diuretic may be added.
Diovan may also be administered with other antihypertensive agents.
Heart failure: The recommended starting dose of Diovan is 40 mg film-coated tablet twice daily. Up-titration to 80 mg and 160 mg twice daily should be done to the highest dose tolerated by the patient. Consideration should be given to reducing the dose of concomitant diuretics. The maximum daily dose administered in clinical trials is 320 mg in divided doses.
Evaluation of patients with heart failure should always include assessment of renal function.
Post-myocardial infarction: Therapy may be initiated as early as 12 hours after a myocardial infarction. After an initial dose of 20 mg twice daily, valsartan therapy should be titrated to 40 mg, 80 mg, and 160 mg film-coated tablet twice daily over the next few weeks. The starting dose is provided by the 40 mg divisible tablet.
The target maximum dose is 160 mg twice daily. In general, it is recommended that patients achieve a dose level of 80 mg twice daily by two weeks after treatment initiation and that the target maximum dose be achieved by three months, based on the patient's tolerability to valsartan during titration. If symptomatic hypotension or renal dysfunction occurs, consideration should be given to a dosage reduction.
Valsartan may be used in patients treated with other post-myocardial infarction therapies, e.g. thrombolytics, acetylsalicylic acid, beta blockers or statins.
Evaluation of post-myocardial infarction patients should always include assessment of renal function.
NOTE for all indications: No dosage adjustment is required for patients with renal impairment or for patients with hepatic insufficiency of non-biliary origin and without cholestasis.
Use in children and adolescents: The safety and efficacy of Diovan have not been established in children and adolescents (below the age of 18 years).
Method of administration: Film-coated tablets: Diovan may be taken independently of a meal and should be administered with water.