Valsar Plus Dosage/Direction for Use

The recommended dose of Valsartan + Amlodipine (as besilate) 80 mg/5 mg Film-coated tablet (Valsar Plus) is one tablet per day. Valsartan + Amlodipine (as besilate) 80 mg/5 mg Film-coated tablet (Valsar Plus) may be administered in patients whose blood pressure is not adequately controlled with amlodipine 5 mg or valsartan 80 mg alone. Individual dose titration with the components (i.e. amlodipine and valsartan) is recommended before changing to the fixed dose combination. When clinically appropriate, direct change from monotherapy to the fixed-dose combination may be considered. For convenience, patients receiving valsartan and amlodipine from separate tablets/capsules may be switched to Valsartan + Amlodipine (as besilate) 80 mg/5 mg Film-coated tablet (Valsar Plus) containing the same component doses or as prescribed by the physician.
Renal Impairment: Valsartan + Amlodipine (as besilate) 80 mg/5 mg Film-coated tablet (Valsar Plus) is contraindicated in patients with severe renal impairment. No dosage adjustment is required for patients with mild to moderate renal impairment. Monitoring of potassium levels and creatinine is advised in moderate renal impairment. The concomitant use of Valsartan + Amlodipine (as besilate) 80 mg/5 mg Film-coated tablet (Valsar Plus) with aliskiren is contraindicated in patients with renal impairment (GFR <60 mL/min/1.73 m²).
Diabetes Mellitus: The concomitant use of Valsartan + Amlodipine (as besilate) 80 mg/5 mg Film-coated tablet (Valsar Plus) with aliskiren is contraindicated in patients with diabetes mellitus.
Hepatic Impairment: Valsartan + Amlodipine (as besilate) 80 mg/5 mg Film-coated tablet (Valsar Plus) is contraindicated in patients with severe hepatic impairment. Caution should be exercised when administering Valsartan + Amlodipine (as besilate) 80 mg/5 mg Film-coated tablet (Valsar Plus) to patients with hepatic impairment or biliary obstructive disorders. In patients with mild to moderate hepatic impairment without cholestasis, the maximum recommended dose is 80 mg valsartan. Amlodipine dosage recommendations have not been established in patients with mild to moderate hepatic impairment.
Elderly (Age 65 years or over): In elderly patients, caution is required when increasing the dosage.
Pediatric Population: The safety and efficacy of Valsartan + Amlodipine (as besilate) 80 mg/5 mg Film-coated tablet (Valsar Plus) in children aged below 18 years have not been established. No data are available.