Valsartan HCT Stada Dosage/Direction for Use

Posology: The recommended dose of Valsartan HCT is one film-coated tablet once daily. Dose titration with the individual components is recommended. In each case, up-titration of individual components to the next dose should be followed in order to reduce the risk of hypotension and other adverse events.
When clinically appropriate direct change from monotherapy to the fixed combination may be considered in patients whose blood pressure is not adequately controlled on valsartan or hydrochlorothiazide monotherapy, provided the recommended dose titration sequence for the individual components is followed.
The clinical response to Valsartan HCT should be evaluated after initiating therapy and if blood pressure remains uncontrolled, the dose may be increased by increasing either one of the components to a maximum dose of Valsartan HCT 320 mg/25 mg.
The antihypertensive effect is substantially present within 2 weeks.
In most patients, maximal effects are observed within 4 weeks. However, in some patients, 4-8 weeks treatment may be required. This should be taken into account during dose-titration.
Method of administration: Valsartan HCT can be taken with or without food and should be administered with water.
Special populations: Renal impairment: No dose adjustment is required for patients with mild to moderate renal impairment (creatinine clearance ≥30 ml/min). Due to the hydrochlorothiazide component, Valsartan HCT is contraindicated in patients with severe renal impairment (see Contraindications, Precautions and Pharmacology: Pharmacokinetics under Actions).
Hepatic impairment: In patients with mild to moderate hepatic impairment without cholestasis the dose of valsartan should not exceed 80 mg (see Precautions). Valsartan HCT is contraindicated in patients with severe hepatic impairment (see Contraindications, Precautions and Pharmacology: Pharmacokinetics under Actions).
Elderly: No dose adjustment is required in elderly patients.
Paediatric patients: Valsartan HCT is not recommended for use in children below the age of 18 years due to a lack of data on safety and efficacy.