Losartan

Indication

Losartan is used to treat hypertension in adults and in children and adolescents 6 - 18 years of age; to protect the kidney in hypertensive type 2 diabetic patients along with impaired kidney function proven by blood tests, with proteinuria ≥0.5 g per day; to treat chronic heart failure when treatme...read more

Dosage and Administration

For patients with intravascular volume depletion (e.g. those treated with high-dose diuretics), a starting dose of25 mg once daily should be considered. It may be used alone or in combination with other antihypertensive agents. It may be administered with or without food. Losartan is not recommended...read more

Adult patients with High Blood Pressure:

Usual initial dose is 50 mg once daily. The maximum antihypertensive effect is achieved 3 to 6 weeks after initiation of therapy. In some patients, the dose may later be increased to 100 mg once daily (in the morning).

Children aged 6 to 18 years old:

The recommended dose in patients who weigh between 20 and 50 kg is 25 mg once daily. In exceptional cases, dose can be increased to a maximum of 50 mg once daily. In patients> 50 kg, the usual dose is 50 mg once daily. In exceptional cases, the dose can be adjusted to a max­imum of 100 mg once daily...read more

Hypertensive type 2 diabetes:

Usual initial dose is 50 mg once daily. The dose may later be increased to 100 mg once daily depending on blood pressure response from one month onwards after initiation of therapy.

Patients with heart failure:

Usual initial dose is 12.5 mg once daily. In general, the dose should be increased gradually on a weekly basis (i.e. 12.5 mg daily during the first week, 25 mg daily during the second week, 50 mg daily during the third week, 100 mg daily during the fourth week, 150 mg daily during the fifth week) up...read more

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

Usual initial dose is 50 mg 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.

Composition

Each film-coated tablet contains:

Losartan Potassium B.P ... 25 mg/ 50 mg.

Description

Losartan Potassium is described chemically as potassium 5-[4 [[2-butyl-4-chloro-5-(hydroxymethyl)- l H-imidazol-1-yl]methyl]biphenyl-2-yl]tetrazol-l-ide. The empirical formula is C22H22CIKN6O and its molecular weight is 461.0.

Clinical Pharmacology

Losartan is a synthetic oral angiotensin-11 receptor (type AT I) antagonist. Angiotensin II, a potent vasoconstrictor, is the primary active hormone of the renin-angiotensin system and an important determinant of the pathophysiology of hypertension. Angiotensin II binds to the AT! receptor present i...read more

Pharmacokinetics

Losartan is well absorbed following oral administration, and a meal slows absorption of losartan and decreases its Cmax but has only minor effects on losartan AUC or on the AUC of the metabolite (about I 0% decreased). It undergoes substantial first-pass metabolism, forming an active carboxylic acid...read more

Contraindication

Losartan is contraindicated in patients with a history of hypersensitivity to losartan, severe hepatic impairment, 2nd and 3rd trimester of pregnancy, lactation and coad­ministration with aliskiren in patients with diabetes or renal impairment (GFR < 60 mL/min/l.73m2).

Precaution

It is used with caution in patients with a history of angioedema (swelling of face, lips, throat and/or tongue); severe vomiting or diarrhea associated with severe volume and/or salt depletion of the body; patient with renal artery stenosis or recent kidney transplant; liver impairment (low dose sho...read more

Adverse Effects

Swelling of face, lips, mouth, throat and/or tongue, dizziness, low blood pressure, vertigo, fatigue, orthostatic hypotension, hypoglycemia, hyperkalaemia, anaemia, increase in blood urea, serum creatine and serum potassium in patient with heart failure, headache, dizziness, insomnia, cough, upper r...read more

Drug Interaction

Non-Steroidal Anti-Inflammatory Drugs (NSAIDs): may antagonize the antihypertensive effect of Losartan and increase risk of worsening of renal function, including possible acute renal failure. These effects are usually reversible. Monitor renal function periodically in patients receiving losartan an...read more

Medicines which retain potassium or increase potassium levels (e.g. potassium supplements, potassium sparing diuretics such as amiloride, triamterene, spironolactone or heparin): may lead to increase in serum potassium. Lithium: reduce lithium excretion and reversible increases in serum lithium conc...read more

Phenobarbital: may lead to reduction of about 20% in the AUC of losartan and that of its active metabolite.

Other antihypertensive agents: may increase the hypot­ensive action of losartan.

Medicines which induce hypotension as adverse effect (e.g. tricyclic antidepressants, antipsychotics, baclofen, amifostine): may increase the risk of hypotension.

ACEI or aliskiren: concomitant use may dually block the renin-angiotensin-aldosterone system resulting in higher frequency of hypotension, syncope, hyperkalaemia and changes in renal function.

Storage

Store below 30°C in cool, dry place. Protect from light and moisture. Keep out of reach and sight of children.

Presentation

10 x 10's Blisters.