Hyzaar® Plus 100/12.5mg Tablet

II. INDICATIONS

Hypertension

HYZAAR® / HYZAAR® PLUS / HYZAAR® FORTE is indicated for the treatment of hypertension, for patients in whom combination therapy is appropriate.

Hypertensive Patients with Left Ventricular Hypertrophy

HYZAAR® / HYZAAR® PLUS / HYZAAR® FORTE is a combination of losartan (COZAAR) and hydrochlorothiazide. In patients with hypertension and left ventricular hypertrophy, losartan, often in combination with hydrochlorothiazide, reduces the risk of stroke in hypertensive patients with left ventricular hypertrophy (see RACE – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

IV. CONTRAINDICATIONS

HYZAAR® / HYZAAR® PLUS / HYZAAR® FORTE is contraindicated in:

• patients who are hypersensitive to any component of this product.
• patients with anuria.
• patients who are hypersensitive to other sulfonamide-derived drugs.

The concomitant use of HYZAAR® / HYZAAR® PLUS / HYZAAR® FORTE with aliskiren-containing products is contraindicated in patients with diabetes mellitus or renal impairment (GFR <60 mL/min/1.73 m2) (see DRUG INTERACTIONS – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

III. DOSAGE AND ADMINISTRATION

HYZAAR® / HYZAAR® PLUS / HYZAAR® FORTE may be administered with other antihypertensive agents.

HYZAAR® / HYZAAR® PLUS / HYZAAR® FORTE may be administered with or without food.

Hypertension

The usual starting and maintenance dose is one tablet of HYZAAR® (losartan potassium 50 mg/hydrochlorothiazide 12.5 mg) once daily. For patients who do not respond adequately to HYZAAR®, the dosage may be increased to one tablet of HYZAAR® FORTE (losartan potassium 100 mg/hydrochlorothiazide 25 mg) once daily or two tablets of HYZAAR® once daily. The maximum dose is one tablet of HYZAAR® FORTE or two tablets of HYZAAR® once daily. In general, the antihypertensive effect is attained within three weeks after initiation of therapy. HYZAAR® PLUS (losartan potassium 100 mg/hydrochlorothiazide 12.5 mg) is available for those patients titrated to 100 mg of COZAAR who require additional blood pressure control.

HYZAAR® / HYZAAR® PLUS / HYZAAR® FORTE should not be initiated in patients who are intravascularly volume-depleted (e.g., those treated with high-dose diuretics).

HYZAAR® / HYZAAR® PLUS / HYZAAR® FORTE is not recommended for patients with severe renal impairment (creatinine clearance ≤30 mL/min) or for patients with hepatic impairment.

No initial dosage adjustment for HYZAAR® is necessary for elderly patients. HYZAAR® FORTE / HYZAAR® PLUS should not be used as the initial dose in elderly patients.

Reduction in the Risk of Stroke in Hypertensive Patients with Left Ventricular Hypertrophy

The usual starting dose is 50 mg of losartan once daily. If goal blood pressure is not reached with losartan 50 mg, therapy should be titrated using a combination of losartan and a low dose of hydrochlorothiazide (12.5 mg) and, if needed, the dose should then be increased to losartan 100 mg and hydrochlorothiazide 12.5 mg once daily. If necessary, the dose should be increased to losartan 100 mg and hydrochlorothiazide 25 mg once daily. HYZAAR®, HYZAAR® PLUS and HYZAAR® FORTE are suitable alternative formulations in patients who would otherwise be treated concomitantly with losartan plus hydrochlorothiazide.