LOSARTAN+HCT MEVON TABLET 50/12.5MG [SIN13777P]

Product Info

LOSARTAN+HCT MEVON TABLET 50/12.5MG

[SIN13777P]

THERAPEUTIC INDICATIONS
Hypertension
Losartan + HCT Mevon film-coated tablets are indicated for the treatment of hypertension, for patients in whom combination therapy is appropriate.

Hypertensive patients with left ventricular hypertrophy
Losartan + HCT Mevon film-coated tablets is a combination of losartan 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).

DOSAGE AND ADMINISTRATION
Losartan + HCT Mevon film-coated tablets may be administered with other antihypertensive agents.
Losartan + HCT Mevon film-coated tablets may be administered with or without food.

Hypertension
The usual starting and maintenance dose is one tablet of Losartan + HCT Mevon 50/12.5mg film-coated tablets (losartan potassium 50 mg/hydrochlorothiazide 12.5 mg) once daily. For patients who do not respond adequately to Losartan + HCT Mevon 50/12.5mg film-coated tablets, the dosage may be increased to one tablet of Losartan + HCT Mevon 100/25mg film- coated tablets (losartan potassium 100 mg/hydrochlorothiazide 25 mg) once daily or two tablets of Losartan + HCT Mevon 50/12.5mg film-coated tablets (losartan potassium 50 mg/hydrochlorothiazide 12.5mg) once daily. In general, the antihypertensive effect is attained within three weeks after initiation of therapy.

Losartan + HCT Mevon film-coated tablets should not be initiated in patients who are intravascularly volume-depleted (e.g. those treated with high-dose diuretics).

Losartan + HCT Mevon film-coated tablets 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 Losartan + HCT Mevon 50/12.5mg film-coated tablets is necessary for elderly patients. Losartan + HCT Mevon 100/25mg film-coated tablets 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 100mg and hydrochlorothiazide 12.5 mg once daily. If necessary, the dose should be increased to losartan 100 mg and hydrochlorothiazide 25 mg once daily. Losartan + HCT Mevon film-coated tablets are suitable alternative formulations in patients who would otherwise be treated concomitantly with losartan plus hydrochlorothiazide.

CONTRAINDICATIONS
Losartan + HCT Mevon film-coated tablets is contraindicated in:

• patients who are hypersensitive to any component of this product.

• patients who are hypersensitive to other sulfonamide-derived drugs.

• patients with anuria.

The concomitant use of Losartan + HCT Mevon film-coated tablets with aliskiren-containing products is contraindicated in patients with diabetes mellitus or renal impairment (GFR < 60 ml/min/1.73m²) (see Interactions – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).