Valsartan and Hydrochlorothiazide 160 mg/25 mg film-coated tablets
Each tablet contains 80 mg of valsartan and 12.5 mg of hydrochlorothiazide as the active ingredients.
Excipient(s) with known effect: Each tablet contains 60 mg lactose monohydrate.
Light orange coloured, ovaloid, bevelled edge, biconvex film-coated tablets debossed with 'I' on one side and '61' on other side. The size is 13 mm X 6.5 mm.
Treatment of essential hypertension in adults.
Valsartan and Hydrochlorothiazide fixed-dose combination is indicated in adults whose blood pressure is not adequately controlled on valsartan or hydrochlorothiazide monotherapy.
The recommended dose of Valsartan and Hydrochlorothiazide X mg/Y mg 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/Hydrochlorothiazide 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/Hydrochlorothiazide 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 and Hydrochlorothiazide can be taken with or without food and should be administered with water.
No dose adjustment is required for patients with mild to moderate renal impairment (creatinine clearance ≥30 ml/min). Due to the hydrochlorothiazide component, Valsartan/Hydrochlorothiazide is contraindicated in patients with severe renal impairment.
In patients with mild to moderate hepatic impairment without cholestasis the dose of valsartan should not exceed 80 mg . Valsartan/Hydrochlorothiazide is contraindicated in patients with severe hepatic impairment .
No dose adjustment is required in elderly patients.
Valsartan/Hydrochlorothiazide is not recommended for use in children below the age of 18 years due to a lack of data on safety and efficacy.
- Hypersensitivity to valsartan, hydrochlorothiazide, other sulfonamide-derived medicinal products or to any of the excipients.
- Second and third trimester of pregnancy,
- Severe hepatic impairment, biliary cirrhosis and cholestasis.
- Severe renal impairment (creatinine clearance <30 ml/min), anuria.
- Refractory hypokalaemia, hyponatraemia, hypercalcaemia, and symptomatic hyperuricaemia.