CO-DIOVAN 80/12.5 TABLET

NOVARTIS (SINGAPORE) PTE LTD

NOVARTIS (SINGAPORE) PTE LTD

Therapeutic

Prescription Only

TABLET, FILM COATED

**DOSAGE REGIMEN AND ADMINISTRATION** **Dosage regimen** The recommended dose of Co-Diovan is 1 coated tablet per day. When clinically appropriate either 80 mg valsartan and 12.5 mg hydrochlorothiazide or 160 mg valsartan and 12.5 mg hydrochlorothiazide or 320 mg valsartan and 12.5 mg hydrochlorothiazide may be used. When necessary 160 mg valsartan and 25 mg hydrochlorothiazide or 320 mg valsartan and 25 mg hydrochlorothiazide may be used. The maximum daily dose is 320 mg/25 mg. The maximum antihypertensive effect is seen within 2 to 4 weeks. **Renal impairment** No dosage adjustment is required for patients with mild to moderate renal impairment (creatinine clearance>30 mL/min). Due to the hydrochlorothiazide component, Co-Diovan is contraindicated in patients with anuria and severe renal impairment (creatinine clearance <30mL/min) (see section WARNINGS AND PRECAUTIONS, CONTRAINDICATIONS and CLINICAL PHARMACOLOGY subsection PHARMACOKINETICS – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). **Hepatic impairment** No dosage adjustment is required in patients with mild to moderate hepatic impairment. Due to the hydrochlorothiazide component, Co-Diovan is contraindicated in patients with severe hepatic impairment. Due to the valsartan component, Co-Diovan should be used with particular caution in patients with biliary obstructive disorders (see sections CONTRAINDICATIONS and WARNINGS AND PRECAUTIONS – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). **Pediatric patients (below 18 years)** The safety and efficacy of Co-Diovan have not been established in children below the age of 18 years.