Losartan kali
Visa No.: VD-35372-21
Product: Losartan STADA 25 mg
API: Losartan kali
Product Category: Cardiovascular & Metabolism
Version approved leaflet: 513/QĐ-QLD_01/09/2021_170BS
INDICATIONS
- Treatment of essential hypertension in adults, children, and adolescents aged 6–18 years.
- Treatment of renal disease in patients with hypertension and type 2 diabetes mellitus with proteinuria ≥ 0.5 g/day.
- Treatment of chronic heart failure in adult patients when treatment with angiotensin-converting enzyme inhibitors (ACEIs) is not appropriate due to intolerance (e.g. cough) or contraindications. Patients with heart failure who are stable on ACEI therapy should not be switched to losartan. These patients have a left ventricular ejection fraction ≤ 40%, are clinically stable, and are receiving an established treatment regimen for chronic heart failure.
- Reduction of the risk of stroke in hypertensive patients with left ventricular hypertrophy.
DOSAGE AND ADMINISTRATION
Dosage:
Hypertension
The usual initial and maintenance dose for most patients is 50 mg once daily. The antihypertensive effect is optimally achieved 3–6 weeks after initiation of treatment. Some patients may obtain additional benefit from increasing the dose to 100 mg once daily (taken in the morning). Losartan may be used in combination with other antihypertensive agents, particularly diuretics (e.g. hydrochlorothiazide).
Children
- Children from 6 months to under 6 years of age: Safety and efficacy in this age group have not been sufficiently established. Therefore, no dosage recommendation can be made for children under 6 years of age.
- Children and adolescents from 6 to 18 years of age who are able to swallow tablets, the recommended doses are as follows:
- Patients weighing 20–50 kg: 25 mg once daily. In exceptional cases, the dose may be increased up to 50 mg once daily. Dose adjustment should be based on clinical response.
- Patients weighing > 50 kg: 50 mg once daily.
In exceptional cases, the dose may be adjusted up to 100 mg once daily.
Doses greater than 1.4 mg/kg/day or exceeding 100 mg/day have not been studied in pediatric patients.
- Use of losartan is not recommended in children with an estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m² or in children with hepatic impairment.
Type 2 diabetes mellitus with hypertension and proteinuria ≥ 0.5 g/day
The usual initial dose is 50 mg once daily. The dose may be increased to 100 mg once daily based on patient response after 1 month of treatment. Losartan may be administered in combination with other antihypertensive agents (diuretics, calcium channel blockers, alpha- or beta-blockers, centrally acting agents), as well as with insulin and other commonly used antidiabetic medicines (sulfonylureas, glitazones, and glucosidase inhibitors).
Heart failure
The recommended initial dose of losartan in patients with heart failure is 12.5 mg once daily. The dose should be titrated weekly according to patient tolerance (12.5 mg/day, 25 mg/day, 50 mg/day, 100 mg/day, up to a maximum of 150 mg/day)
Reduction of the risk of stroke in hypertensive patients with left ventricular hypertrophy
The usual initial dose is 50 mg once daily.
A low dose of hydrochlorothiazide should be added and/or the dose of losartan increased to 100 mg once daily, depending on patient response.
Special populations
Intravascular volume depletion
In patients with intravascular volume depletion (e.g. patients treated with high-dose diuretics), the recommended initial dose is 25 mg once daily.
Renal impairment or haemodialysis
No dose adjustment is required.
Hepatic impairment
Dose reduction is required in patients with hepatic impairment.
There is no experience in patients with severe hepatic impairment; therefore, losartan is contraindicated in these patients.
Elderly patients
In general, no dose adjustment is required in elderly patients. However, a starting dose of 25 mg once daily should be considered in patients over 75 years of age.
Method of administration: Losartan film-coated tablets should be swallowed with a glass of water and may be taken with or without food.
CONTRAINDICATIONS
- Hypersensitivity to any of the excipients of the product.
- Second and third trimesters of pregnancy
- Severe hepatic impairment
- Concomitant use of losartan with aliskiren-containing products in patients with diabetes mellitus or renal impairment (GFR < 60 mL/min/1.73 m²).
WARNINGS AND PRECAUTIONS
Prescription only medicine. Read the instructions before use. Consult a physician or pharmacist if needed. Keep out of reach of children
