Dosage regimen: The recommended dose is one tablet per day (the 3 strengths are previously listed in DESCRIPTION).
A patient whose blood pressure is not adequately controlled on dual therapy may be directly switched to combination therapy with Exforge HCT.
For convenience, patients receiving valsartan, amlodipine and HCTZ from separate tablets may be switched to Exforge HCT containing the same component doses. A patient who experiences dose limiting adverse reactions on any dual combination of the components of Exforge HCT may be switched to Exforge HCT containing a lower dose of that component to achieve similar blood pressure reductions.
Dosage may be increased after two weeks. The maximum antihypertensive effect of Exforge HCT is reached within two weeks after a change in dose. The maximum recommended dose of Exforge HCT is 10/320/25 mg.
Special populations: Geriatric patients (aged 65 years or above): No dose adjustment of the starting dose is required for elderly patients aged 65 years or above. Starting with the lowest available dose of amlodipine should be considered. The lowest strength of Exforge HCT contains 5 mg of amlodipine. (See PHARMACOLOGY under Actions).
Pediatric patients (below 18 years): Exforge HCT is not recommended for use in patients aged below 18 years due to a lack of data on safety and efficacy.
Renal impairment: Exforge HCT is contraindicated in severe renal impairment (creatinine clearance <30mL/min) (see CONTRAINDICATIONS). No dosage adjustment is required for patients with mild to moderate renal impairment (see PRECAUTIONS). Monitoring of creatinine and potassium levels is advised for patients with moderate renal impairment.
Hepatic impairment: Exforge HCT is contraindicated in severe hepatic impairment, biliary cirrhosis or cholestasis and in patients undergoing dialysis (see CONTRAINDICATIONS). In patients with mild to moderate hepatic impairment without cholestasis the maximum recommended dose is 80 mg valsartan, and therefore, Exforge HCT is not suitable in this group of patients (see PRECAUTIONS). Starting with the lowest available dose of amlodipine should be considered. The lowest strength of Exforge HCT contains 5 mg of amlodipine.
Method of administration: Exforge HCT can be taken with or without food. It is recommended to take Exforge HCT with some water.