Dosage regimen: General target population: A patient whose blood pressure is not adequately controlled on monotherapy may be switched to combination therapy with Exforge. The recommended dose is one tablet per day (the 3 strengths are listed under DESCRIPTION). 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 Exforge containing the same component doses.
For initial therapy the usual starting dose is Exforge 5mg/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. Exforge is not recommended as initial therapy in patients with intravascular volume depletion (see Precautions).
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 Exforge with some water.
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 Exforge contains 5 mg of amlodipine (see PHARMACOLOGY under Actions).
Pediatric patients (below 18 years): Exforge 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 Exforge should not exceed 5/80mg in patients with mild to moderate hepatic impairment without cholestasis. Exforge is contraindicated in severe hepatic impairment. Starting with the lowest available dose of amlodipine should be considered. The lowest strength of Exforge contains 5 mg of amlodipine.