Dosage regimen: The recommended dose is one tablet per day (the 5 strengths are listed in DESCRIPTION).
A patient whose blood pressure is not adequately controlled on dual therapy may be directly switched to single pill combination therapy.
For convenience, patients receiving valsartan, amlodipine and HCTZ from separate tablets may be switched to the tablet strength containing the same component doses. A patient who experiences dose limiting adverse reactions on any dual combination of the components may be switched to the tablet strength containing a lower dose of that component to achieve similar blood pressure reductions.
Dosage may be increased after two weeks. The maximum antihypertensive effect is reached within two weeks after a change in dose. The maximum recommended dose is 10/320/25 mg.
Special populations: Geriatrics patients (aged 65 years and 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): Not recommended for use in patients aged below 18 years due to a lack of data on safety and efficacy.
Renal impairment: Contraindicated in patients with anuria due to the hydrochlorothiazide component (see CONTRAINDICATIONS). Use with caution in patients with severe kidney disease (GFR <30 mL/min) (see PRECAUTIONS and also PHARMACOLOGY under ACTIONS). Thiazide diuretics are ineffective as monotherapy in severe renal impairment (GFR <30 mL/min) but may be useful in these patients, when used with due caution in combination with a loop diuretic even in patients with GFR <30 mL/min. No dosage adjustment is required for patients with mild to moderate renal impairment.
Hepatic impairment: Due to the valsartan, hydrochlorothiazide and amlodipine components, particular caution should be exercised when administering in patients with hepatic impairment or biliary obstructive disorders. Starting with the lowest available dose of amlodipine should be considered. The lowest strength of Exforge HCT contains 5 mg of amlodipine. (See PRECAUTIONS and also PHARMACOLOGY under ACTIONS).
Method of administration: Can be taken with or without food. It is recommended to take the tablet with some water.
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