SARANTO 50 FILM-COATED TABLETS 50MG [SIN16366P]

Product Info

SARANTO 50 FILM-COATED TABLETS 50MG

[SIN16366P]

Therapeutic indications

Hypertension

Losartan Potassium is indicated for the treatment of hypertension.

Hypertensive Patients with Left Ventricular Hypertrophy

Losartan Potassium is indicated for the reduction in the risk of stroke in hypertensive patients with left ventricular hypertrophy (see RACE).

Renal Protection in Type 2 Diabetic Patients with Proteinuria

Losartan Potassium is indicated to delay the progression of renal disease as measured by a reduction in the incidence of doubling of serum creatinine and end stage renal disease (need for dialysis or renal transplantation), and to reduce proteinuria.

Dosage and administration

Losartan tablets may be administered with or without food.

Losartan Potassium may be administered with other antihypertensive agents.

Hypertension

The usual starting and maintenance dose is 50 mg once daily for most patients. The maximal antihypertensive effect is attained 3–6 weeks after initiation of therapy. Some patients may receive an additional benefit by increasing the dose to 100 mg once daily.

Losartan may be administered with other antihypertensive agents, especially with diuretics (e.g. hydrochlorothiazide).

For patients with intravascular volume-depletion (e.g., those treated with high-dose diuretics), a starting dose of 25 mg once daily should be considered (see PRECAUTIONS – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

No initial dosage adjustment is necessary for elderly patients up to 75 years of age, or for patients with mild renal impairment. For patients above 75 years of age, patients with moderate to severe renal impairment and patients on dialysis, a lower starting dose of 25mg is recommended. A lower dose should be considered for patients with a history of hepatic impairment (see PRECAUTIONS – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Reduction in the risk of stroke in hypertensive patients with left ventricular hypertrophy

The usual starting dose is 50 mg of losartan once daily. A low dose of hydrochlorothiazide should be added and/or the dose of losartan should be increased to 100 mg once daily based on blood pressure response.

Renal Protection in Type 2 Diabetic Patients with Proteinuria

The usual starting dose is 50 mg once daily. The dose may be increased to 100 mg once daily based on blood pressure response. Losartan Potassium may be administered with other antihypertensive agents (e.g., diuretics, calcium channel blockers, alpha- or beta-blockers, and centrally acting agents) as well as with insulin and other commonly used hypoglycemic agents (e.g., sulfonylureas, glitazones and glucosidase inhibitors).

Paediatric Use

Safety and effectiveness in children have not been established.

Neonates with a history of in utero exposure to Losartan Potassium:

If oliguria or hypotension occur, direct attention toward support of blood pressure and renal perfusion. Exchange transfusions or dialysis may be required as a means of reversing hypotension and/or substituting for disordered renal function.

Use in Elderly

In clinical studies there was no age-related difference in the efficacy or safety profile of losartan.

Presently there is limited clinical experience in patients above 75 years of age; a lower starting dose of 25 mg once daily is recommended.

Race

Based on the LIFE (Losartan Intervention For Endpoint reduction in hypertension) study, the benefits of Losartan Potassium on cardiovascular morbidity and mortality compared to atenolol do not apply to Black patients with hypertension and left ventricular hypertrophy although both treatment regimens effectively lowered blood pressure in Black patients. In the overall LIFE study population (n=9193), treatment with Losartan Potassium resulted in a 13.0% risk reduction (p=0.021) as compared to atenolol for patients reaching the primary composite endpoint of the combined incidence of cardiovascular death, stroke, and myocardial infarction. In this study, Losartan Potassium decreased the risk of cardiovascular morbidity and mortality compared to atenolol in non-Black, hypertensive patients with left ventricular hypertrophy (n=8660) as measured by the primary endpoint of the combined incidence of cardiovascular death, stroke, and myocardial infarction (p=0.003). In this study, however, Black patients treated with atenolol were at lower risk of experiencing the primary composite endpoint compared with Black patients treated with Losartan Potassium (p=0.03). In the subgroup of Black patients (n=533; 6% of the LIFE study patients), there were 29 primary endpoints among 263 patients on atenolol (11%, 25.9 per 1000 patient-years) and 46 primary endpoints among 270 patients (17%, 41.8 per 1000 patient-years) on Losartan Potassium.

Contraindications

Losartan Potassium is contraindicated in patients who are hypersensitive to any component of this product. The concomitant use of losartan with aliskiren-containing products is contraindicated in patients with diabetes mellitus or renal impairment (GFR < 60 ml/min/1.73 m²).