FORMULATION

Each film-coated tablet contains:

Losartan Potassium………………………….. 25 / 50 mg

DESCRIPTION:

Losartan is an angiotensin II receptor antagonist with

antihypertensive activity due mainly to selective blockade of AT1 receptors

and the consequent reduced pressor effect of angiotensin II.

INDICATIONS:

It is used in the management of hypertension and may have a role in patients who develop cough with ACE inhibitors. It has also been tried in heart failure and in myocardial infarction.

DOSAGE AND ADMINISTRATION:

Losartan is given by mouth as the potassium salt.

In hypertension the usual dose is 50 mg once daily. The maximum effect is achieved in about 3 to 6 weeks after initiating treatment. The dose may be increased, if necessary, to 100 mg daily in one or two divided doses. An initial dose of 25 mg once daily is suggested for the elderly over 75 years-of-age, and for patients with moderate to severe renal impairment (creatinine clearance less than 20 mL per minute), or intravascular fluid depletion. A reduced dose should also be considered for patients with hepatic impairment.

ADVERSE REACTIONS:

Adverse effects of losartan have been reported to be usually mild and transient, and include dizziness and dose-related orthostatic hypotension. Hypotension may occur particularly in patients with volume depletion (for example those who have received high-dose diuretics). Impaired renal function and, rarely, rash, angioedema, and raised alanine aminotransferase may occur. Hyperkalaemia and myalgia have been reported. Losartan appears less likely than ACE inhibitors to cause cough.

PRECAUTIONS:

Losartan is contraindicated in pregnancy and breast feeding. It should be used with caution in patients with renal artery stenosis.

Reduced doses may be required in patients with renal impairment and should be considered in patients with hepatic impairment. Patients with volume depletion (for example those who have received high-dose diuretic therapy) may experience hypotension, which may be minimized by initiating treatment with a low dose of losartan. Since hyperkalaemia may occur, serum-potassium concentrations should be monitored, especially in the elderly and patients with renal impairment, and the concomitant use of potassium-sparing diuretics should be avoided.

PHARMACOKINETICS:

Losartan is readily absorbed from the

gastrointestinal tract following oral administration, with an oral bioavailability

of about 33%. It undergoes first-pass metabolism to form an active

carboxylic acid metabolite E-3174 (EXP-3174), which has greater

pharmacological activity than losartan, and some inactive metabolites. Peak

plasma concentrations of losartan and E-3174 occur about 1 hour and 3 to 4

hours, respectively, after an oral dose. Both losartan and E-3174 are more

than 98% bound to plasma proteins. Losartan is excreted in the urine, and in

the faeces via bile, as unchanged drug and metabolites. Following oral

dosing about 35% of the dose is excreted in the urine and about 60% in the

faeces. The terminal elimination half-lives of losartan and E-3174 are about

1.5 to 2.5 hours and 3 to 9 hours, respectively.

STORAGE CONDITION:

Store at temperatures not exceeding 30°C.

AVAILABILITY:

Blister pack of 10’s tablets (Box of 50’s).

CAUTION:

Foods, Drugs, Devices and Cosmetics Act prohibits dispensing

without prescription.

MANUFACTURED BY:

KUSUM HEALTHCARE PRIVATE LIMITED

SP 289(A) RIICO Indl. Area, Chopanki

(Bhiwadi), Distt- Alwar, Rajasthan, INDIA

IMPORTED & DISTRIBUTED BY:

S.M.H.P. MARKETING & CONSULTANCY

G/F Manor Bldg. 2629, Taft Avenue,

Malate, Manila, PHILIPPINES