Posology: The recommended dose of Co-Diovan 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 Co-Diovan 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 Co-Diovan 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: Co-Diovan can be taken with or without food and should be administered with water.
Special populations: Patients with Renal impairment: No dose adjustment is required for patients with mild to moderate renal impairment (Glomerular Filtration Rate (GFR) ≥ 30 ml/min). Due to the hydrochlorothiazide component, Co-Diovan is contraindicated in patients with severe renal impairment (GFR <30 mL/min) and anuria (see Contraindications, Precautions and Pharmacology: Pharmacokinetics under Actions).
Patients with Hepatic impairment: In patients with mild to moderate hepatic impairment without cholestasis the dose of valsartan should not exceed 80 mg (see Precautions). No adjustment of the hydrochlorothiazide dose is required for patients with mild to moderate hepatic impairment. Due to the valsartan component, Co-Diovan is contraindicated in patients with severe hepatic impairment or with biliary cirrhosis and cholestasis (see Contraindications, Precautions and Pharmacology: Pharmacokinetics under Actions).
Older people: No dose adjustment is required in elderly patients.
Paediatric patients: Co-Diovan is not recommended for use in children below the age of 18 years due to a lack of data on safety and efficacy.