Valsartan 80 mg / 160 mg tablets may not be suitable to deliver all dosage regimens of valsartan; and therefore other suitable available approved dosage forms and/or strengths of valsartan should be used in such cases.
The general dosage recommendations of valsartan are given as follows.
Hypertension: Adult Hypertension: The recommended starting dose of valsartan is 80 mg or 160 mg once daily when used as monotherapy in patients who are not volume-depleted. Patients requiring greater reductions may be started at the higher dose. Valsartan may be used over a dose range of 80 mg to 320 mg daily, administered once a day.
The antihypertensive effect is substantially present within 2 weeks and maximal reduction is generally attained after 4 weeks. If additional antihypertensive effect is required over the starting dose range, the dose may be increased to a maximum of 320 mg or a diuretic may be added. Addition of a diuretic has a greater effect than dose increases beyond 80 mg.
No initial dosage adjustment is required for elderly patients, for patients with mild or moderate renal impairment. Care should be exercised with dosing of valsartan in patients with severe renal impairment. Valsartan is contraindicated in patients with severe hepatic impairment; biliary cirrhosis and cholestasis (see CONTRAINDICATIONS). In patients with mild to moderate hepatic impairment without cholestasis, it should be used with caution and the dose of valsartan should not exceed 80 mg.
Valsartan may be administered with other antihypertensive agents. Valsartan may be administered with or without food.
Pediatric Hypertension (6 to 18 years of age): For children who can swallow tablets, the usual recommended starting dose is 1.3 mg/kg once daily (up to 40 mg total). The dosage should be adjusted according to blood pressure response. Doses higher than 2.7 mg/kg (up to 160 mg) once daily have not been reported in pediatric patients 6 to 16 years old.
For children who cannot swallow tablets, or children for whom the calculated dosage (mg/kg) does not correspond to the available strengths of valsartan tablets, may be prescribed other alternative suitable available formulation (e.g. suspension) of valsartan.
No data are available in pediatric patients either undergoing dialysis or with a glomerular filtration rate <30 ml/min/1.73 m2 (see PRECAUTIONS).
Valsartan is not recommended for patients <6 years old.
Heart Failure: The recommended starting dose of valsartan is 40 mg twice daily. Up titration to 80 mg and 160 mg twice daily should be done to the highest dose, as 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.
Valsartan may be administered with other heart failure therapies. However, the triple combination of an ACE inhibitor, a beta blocker and valsartan is not recommended.
Evaluation of patients with heart failure should always include assessment of renal function.
Post-Myocardial Infarction: Valsartan may be initiated as early as 12 hours after a myocardial infarction. The recommended starting dose of valsartan is 20 mg twice daily. Patients may be up-titrated within 7 days to 40 mg twice daily, with subsequent titrations to a target maintenance dose of 160 mg twice daily, as tolerated by the patient. If symptomatic hypotension or renal dysfunction occurs, consideration should be given to a dosage reduction. Valsartan may be given with other standard post-myocardial infarction treatment, including thrombolytics, aspirin, beta-blockers, statins and diuretics. The combination with ACE inhibitors is not recommended.
Evaluation of post-myocardial infarction patients should always include assessment of renal function.
Method of Administration: Valsartan tablet may be taken independently of a meal and should be administered with water.
Special Populations: Renal Impairment: (see PRECAUTIONS).
Hepatic Impairment: (see PRECAUTIONS).
Elderly: No initial dose adjustment is required in elderly patients.
Pediatrics: (see PRECAUTIONS).