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Losartan

Losartan
Film-coated tablets 50 mg 
ATC  C09CA01

Prescription Only Medicine

Medicines reimbursed by the Health Insurance Fund

POSOLOGY AND METHOD OF ADMINISTRATION

Method of administration: Losartan film-coated tablets should be swallowed with a glass of water. May be administered with or without food.

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

Hypertensive Type Ⅱ Diabetic Patients With Proteinuria ≥ 0.5 g/day

The usual starting dose is 50 mg once daily. The dose may be increased to 100 mg once daily based on blood pressure response from one month onwards after initiation of therapy. Losartan 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).

Heart Failure

The usual initial dose of losartan in patients with heart failure is 12.5 mg once daily. The dose should generally be titrated at weekly intervals (i.e. 12.5 mg daily, 25 mg daily, 50 mg daily, 100 mg daily, up to a maximum dose of 150 mg once daily) as tolerated by the patient

Reduction in the Risk of Stroke in Hypertensive Patients with Left Ventricular Hypertrophy Documented by ECG

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.

Special populations

Patients With Intravascular Volume Depletion

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.

Patients With Renal Impairment and in Haemodialysis Patients

No initial dosage adjustment is necessary for patients with renal impairment and in haemodialysis patients.

Patients With a History of Hepatic Impairment

A lower dose should be considered for patients with a history of hepatic impairment. There is no therapeutic experience in patients with severe hepatic impairment. Therefore, losartan is contraindicated in patients with severe hepatic impairment.

Paediatric population

6 Months – Less than 6 Years

The safety and efficacy of children aged 6 months to less than 6 years have not been established. Currently available data are described but no recommendation on a posology can be made.

6-18 Years

For patients who can swallow tablets, the recommended dose is 25 mg once daily in patients >20 to 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. Doses above 1.4 mg/kg (or in excess of 100 mg) daily have not been studied in paediatric patients.

Losartan is not recommended for use in children under 6 years old, as limited data are available in these patient groups. It is not recommended in children with glomerular filtration rate < 30 ml/min/1.73 m², as no data are available. Losartan is also not recommended in children with hepatic impairment.

Use in the Elderly: Although consideration should be given to initiating therapy with 25 mg in patients over 75 years of age, dosage adjustment is not usually necessary for the elderly.

Medicine’s information on this web page is only a short description of its characteristics. Do not take them as recommendations for self-treatment of your health condition.

You must inform your physician and pharmacist and follow their recommendations before you use the medicine for treatment. Always read carefully the patient information leaflet.

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Description

COMPOSITION

Each film-coated tablet contains 50 mg losartan potassium, excipients.

THERAPEUTIC INDICATIONS

– Treatment of essential hypertension in adults and in children and adolescents 6 – 18 years of age.
– Treatment of renal disease in adult patients with hypertension and type 2 diabetes mellitus with proteinuria ≥ 0.5 g/day as part of antihypertensive treatment.
– Treatment of chronic heart failure in adult patients when treatment with angiotensin-converting enzyme (ACE) inhibitors is not considered suitable due to incompatibility, especially cough, or contraindication. Patients with heart failure who have been stabilised with an ACE inhibitor should not be switched to losartan. The patients should have a left ventricular ejection fraction ≤ 40% and should be clinically stable and on an established treatment regimen for chronic heart failure.
– Reduction in the risk of stroke in adult hypertensive patients with left ventricular hypertrophy documented by electrocardiography.

CONTRAINDICATIONS

• Hypersensitivity to losartan potassium or to any of the excipients.
• 2nd and 3rd trimester of pregnancy.
• Severe hepatic impairment.
• 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).

PACKAGING

Box with 30 film-coated tablets of 50 mg (3 blisters x 10 tablets)

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