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.
For initial therapy, the usual starting dose is Co-Diovan 160/12.5 mg once daily. The dosage can be increased after 1 to 2 weeks of therapy to a maximum of one 320/25 mg tablet once daily as needed to control blood pressure. Co-Diovan is not recommended as initial therapy in patients with intravascular volume depletion (see Precautions).
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 (Glomerular Filtration Rate (GFR) ≥30 mL/min). Due to the hydrochlorothiazide component, Co-Diovan is contraindicated in patients with anuria (see Contraindications) and should be used with caution in patients with severe renal impairment (GFR <30 mL/min) (see Precautions and 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.
Hepatic impairment: No dosage adjustment is required in patients with mild to moderate hepatic impairment. Due to the hydrochlorothiazide component, Co-Diovan should be used with particular caution 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 Precautions).
Pediatric patients (below 18 years): The safety and efficacy of Co-Diovan have not been established in children below the age of 18 years.
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