Hyvan

Strengths

Hyvan 80/12.5, Hyvan 160/12.5, Hyvan 160/25

Dosage Form

Film Coated Tablets

Composition

Hyvan 80/12.5
Each film coated tablet contains:
Valsartan 80 mg
Hydrochlorothiazide 12.5 mg

Hyvan 160/12.5
Each film coated tablet contains:
Valsartan 160 mg
Hydrochlorothiazide 12.5 mg

Hyvan 160/25
Each film coated tablet contains:
Valsartan 160 mg
Hydrochlorothiazide 25 mg

Packaging

Hyvan 80/12.5: 30 film coated tablets
Hyvan 160/12.5: 30 film coated tablets
Hyvan 160/25: 30 film coated tablets

Indications

Hyvan is indicated for the treatment of essential hypertension. This fixed-dose combination is indicated in patients whose blood pressure is not adequately controlled on valsartan or hydrochlorothiazide monotherapy.

Dosage and Administration

General Considerations:
The usual starting dose of valsartan and hydrochlorothiazide tablets is 160 mg/12.5 mg once daily. The dosage can be increased after 1 to 2 weeks of therapy to a maximum of one 320 mg/25 mg tablet once daily as needed to control blood pressure. Maximum antihypertensive effects are attained within 2 to 4 weeks after a change in dose.
Add-On Therapy:
A patient whose blood pressure is not adequately controlled with valsartan (or another ARB) alone or hydrochlorothiazide alone may be switched to combination therapy with valsartan and hydrochlorothiazide tablets.
The clinical response to valsartan and hydrochlorothiazide tablets should be subsequently evaluated and if blood pressure remains uncontrolled after 3 to 4 weeks of therapy, the dose may be titrated up to a maximum of 320 mg/25 mg.
Initial Therapy:
Valsartan and hydrochlorothiazide tablets are not recommended as initial therapy in patients with intravascular volume depletion.
Valsartan and hydrochlorothiazide tablets may be administered with other antihypertensive agents.
Renal Impairment:
No dose adjustment is required for patients with mild to moderate renal impairment (Glomerular Filtration Rate ≥ 30 ml/min). Due to the presence of hydrochlorothiazide, valsartan/ hydrochlorothiazide is contraindicated in patients with severe renal impairment (Glomerular Filtration Rate< 30 ml/min) and anuria. Concomitant use of valsartan with aliskiren is contraindicated in patients with renal impairment (Glomerular Filtration Rate< 60 mL/min/1.73 m2).
Concomitant use of valsartan with aliskiren is contraindicated in patients with diabetes mellitus.
Hepatic Impairment:
In patients with mild to moderate hepatic impairment without cholestasis the dose of valsartan should not exceed 80 mg. No adjustment of the hydrochlorothiazide dose is required for patients with mild to moderate hepatic impairment. Due to the presence of valsartan, valsartan/ hydrochlorothiazide is contraindicated in patients with severe hepatic impairment or with biliary cirrhosis and cholestasis.
Elderly: No dose adjustment is required in elderly patients.
Pediatric 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.