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Lorista Losartan Composition:
active substance: losartan; 1 film-coated tablet contains 50 mg of losartan potassium;
excipients: celactose (contains lactose and powdered cellulose), corn starch, corn starch, microcrystalline cellulose, colloidal silicon dioxide, magnesium stearate, hypromellose, talc, propylene glycol, titanium dioxide (E 171).
Indications
Treatment of essential hypertension in adults and children aged 6 years and over;
Treatment of renal disease in adult patients with hypertension and type 2 diabetes mellitus with proteinuria ≥ 0.5 g/day as part of antihypertensive therapy;
Treatment of chronic heart failure (in patients aged 60 years and over) when the use of angiotensin-converting enzyme (ACE) inhibitors is considered impossible due to incompatibility, especially in the presence of cough, or is contraindicated. Patients with heart failure whose condition has been stabilized on an ACE inhibitor should not be switched to losartan. The patient should have a left ventricular ejection fraction ≤ 40%, be clinically stable, and be on the established treatment regimen for chronic heart failure;
reducing the risk of stroke in adult patients with arterial hypertension and left ventricular hypertrophy, as documented by ECG.
Method of administration and dosage
Losartan tablets should be taken with a glass of water.
The use of the drug does not depend on food intake.
Arterial hypertension
Usually the initial and maintenance dose for most patients is 50 mg of the drug 1 time per day (1 tablet of Lorista 50 mg). The maximum antihypertensive effect is achieved 3-6 weeks after the start of treatment. For some patients, it may be more beneficial to increase the dose of the drug to 100 mg 1 time per day (in the morning).
Lorista® can be used in combination with other antihypertensive drugs, especially diuretics (for example, hydrochlorothiazide).
Patients with arterial hypertension and type 2 diabetes mellitus with proteinuria ≥ 0.5 g/day
Usually the initial dose is 50 mg (1 tablet of Lorista) 1 time per day. The dose may be increased to 100 mg once daily depending on blood pressure response 1 month after initiation of treatment. Lorista® may be used with other antihypertensive agents (e.g. diuretics, calcium channel blockers, α- or β-receptor blockers and centrally acting agents) as well as with insulin and other commonly used hypoglycaemic agents (e.g. sulphonylureas, glitazones and glucosidase inhibitors).
Heart failure
The usual starting dose of Lorista in patients with chronic heart failure is 12.5 mg once daily. The dose is usually titrated at weekly intervals (i.e. 12.5 mg daily, 25 mg daily, 50 mg daily) to the usual maintenance dose of 50 mg (1 tablet of Lorista) once daily, depending on individual tolerability.
Reduction of the risk of stroke in patients with arterial hypertension and left ventricular hypertrophy, documented by ECG
Usually the initial dose is 50 mg of losartan (1 tablet of Lorista 50 mg) 1 time per day. Depending on the changes in blood pressure, low-dose hydrochlorothiazide should be added to the treatment and/or the dose of Lorista should be increased to 100 mg 1 time per day.
Specific patient groups
Use in patients with reduced circulating blood volume
In patients with reduced circulating blood volume (for example, due to treatment with high doses of diuretics), therapy should be started with a dose of 25 mg 1 time per day.
Use in patients with renal impairment and patients undergoing hemodialysis
When prescribing Lorista to patients with renal impairment and patients undergoing hemodialysis, no initial dose adjustment is required.
Use in patients with hepatic impairment
For patients with a history of hepatic impairment, a lower dose should be considered. There is no experience in treating patients with severe hepatic impairment, therefore losartan is contraindicated in this group of patients.
Use in children
Efficacy and safety data on the use of losartan in children aged 6-18 years for the treatment of arterial hypertension are limited. There are also limited pharmacokinetic data in children with arterial hypertension from 1 month of age. For children who can swallow tablets and whose body weight is more than 20 kg and less than 50 kg, the recommended dose is 25 mg once a day. In exceptional cases, the dose may be increased to a maximum of 50 mg once a day. The dose should be adjusted depending on the effect on blood pressure. In patients weighing more than 50 kg, the usual single dose is 50 mg once daily. In exceptional cases, the dose may be increased to a maximum of 100 mg once daily. Doses exceeding 1.4 mg/kg (or more than 100 mg) per day have not been studied in children.
Losartan is not recommended for use in children under 6 years of age, as data on the use of the drug in this group of patients are insufficient.
The drug is not recommended for use in children with a glomerular filtration rate < 30 ml/min/1.73 m2, as there are no relevant data on use.
Losartan is also not recommended for use in children with impaired liver function.
Use in elderly patients
As a rule, no adjustment of the initial dose is required for elderly patients, although consideration should be given to the possibility of prescribing the drug at an initial dose of 25 mg in patients over 75 years of age.
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