Dosage Regimen: General target population: A patient whose blood pressure is not adequately controlled on monotherapy may be switched to combination therapy with VALGEN-AM. The recommended dose is one tablet per day. 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 may be switched to VALGEN-AM containing the same component doses.
For initial therapy the usual starting dose is Amlodipine and Valsartan tablets 5 mg/80 mg once daily. The dosage can be increased after 1 to 2 weeks of therapy to a maximum of 10 mg/320 mg per day as needed to control blood pressure. VALGEN-AM is not recommended as initial therapy in patients with intravascular volume depletion (Note: VALGEN-AM 5 mg + 80 mg is not available in Malaysia).
The maximum dose is 10 mg/320 mg per day.
Both amlodipine and valsartan monotherapy can be taken with or without food. It is recommended to take VALGEN-AM with some water.
The products are not able to deliver all approved dose regimen for the combination of amlodipine and valsartan tablet. Other approved dosage forms and strengths of the combination of amlodipine and valsartan tablet should be used in such cases.
Special populations: Geriatric patients (aged 65 years or above): Since both components of the combination are equally well tolerated when used at similar doses in elderly (aged 65 years or above) or younger patients, no dose adjustment of the starting dose is required. Starting with the lowest available dose of amlodipine should be considered. The lowest strength of VALGEN-AM contains 5 mg of amlodipine.
Pediatric patients (below 18 years): VALGEN-AM is not recommended for use in patients aged below 18 years due to a lack of data on safety and efficacy.
Renal impairment: No dosage adjustment is required for patients with mild to moderate renal impairment. Caution is required if severe renal impairment occur.
Hepatic impairment: Liver function should be monitored in patients with mild to moderate hepatic impairment. The daily dose of VALGEN-AM should not exceed 5/80 mg in patients with mild to moderate hepatic impairment without cholestasis. VALGEN-AM is contraindicated in severe hepatic impairment. Starting with the lowest available dose of amlodipine should be considered. The lowest strength of VALGEN-AM contains 5 mg of amlodipine.
Method of Administration: For oral use.