FORMULATION:
Each film-coated tablet contains:
Losartan potassium ..............................................................50 mg
Amlodipine (as Besilate) ........................................................5 mg

INDICATIONS:
Losartan potassium/Amlodipine besilate is indicated for the treatment of hypertension, angina pectoris & mild to moderate hypertension, alone or in combination with other antihypertensives.

DOSAGE AND ADMINISTRATION:
The usual starting and maintenance dose is one tablet once daily for most patients. The dose may be increase to 2 tablets once daily. A lower dose should be considered for patients with a history of hepatic impairment. Or as prescribed by the Physician.

PHARMACOLOGICAL CLASSIFICATION:
VasodiIators, hypotensive medicines.

PHARMACOKINETICS:
Absorption: Amlodipine: Plasma levels peak 6-12 hr after oral administration; absolute bioavailability is estimated to be 64-90%. Losartan: Well absorbed; undergoes substantial 1st pass metabolism by CYP450 enzymes; systemic
bioavailability is about 33%; about 14% of an oral dose is converted to active metabolites.
Distribution: Amlodipine: 93% bound to plasma proteins. Losartan and its active metabolites: Highly bound to plasma proteins, mainly albumin.
Metabolism: Amlodipine: About 90% converted to inactive metabolites hepatically. Losartan is metabolised to an active carboxylic acid metabolite E-3174 (EXP-3174), which has greater pharmacological activity than losartan; some inactive metabolites are also formed.
Excretion: Amlodipine: 10% of parent compound and 60% of the metabolites are removed in the urine; elimination from the plasma is biphasic with terminal half-life of about 30-50 hr. Losartan and its active metabolites: Biliary excretion; terminal half-life: About 2 hr (Losartan) and 6-9 hr (metabolites).

CONTRAINDICATIONS:
Losartan potassium/Amlodipine besilate during pregnancy and lactation is contraindicated Safety and efficacy has not been established in children. Hypersensitivity to any of the ingredients & dihydropyridines.