Index of drugs

Treatment of primary hypertension in adults and in children and adolescents aged 6 - 18 years. Treatment of kidney disease in patients with hypertension and type 2 diabetes mellitus with proteinuria ≥0.5 g / day as a component of antihypertensive therapy. Treatment of chronic heart failure (in patients ≥60 years) when treatment with ACE inhibitors is not suitable due to non-compliance, especially coughing or contraindication; in patients with heart failure whose condition has been stabilized with the use of an ACE inhibitor, treatment should not be changed to losartan; ejection fraction of the left ventricle in patients should be ≤40% and their condition should be stabilized during treatment of chronic heart failure. Reduction of stroke risk in adult patients with hypertension and left ventricular hypertrophy confirmed by ECG.

1 tabl powl. contains 50 mg of potassium losartan.

Angiotensin II receptor antagonist (AT type₁). Both potassium Losartan and its pharmacologically active metabolite (carboxylic acid) selectively bind to the AT receptor₁ blocking the effects of angiotensin II, regardless of the source or route of its synthesis; they do not bind or block other hormone receptors or ion channels important for regulation in the circulatory system. Losartan is also not an inhibitor of kininase II (an enzyme that breaks down bradykinin), so it does not increase the effects of bradykinin-dependent effects. Following oral administration, losartan is well absorbed from the gastrointestinal tract and undergoes the first-pass effect of the liver. It is metabolized to the active carboxylic acid metabolite and inactive metabolites. Bioavailability is about 33%. The maximum concentration of losartan in the blood occurs after about 1 hour and its active metabolite after 3-4 hours. Losartan and its metabolites are excreted in urine (35%) and faeces (58%). T_0,5 is about 2 h for Losartan, about 6-9 h for the active metabolite.

Hypersensitivity to the components of the preparation. Severe liver dysfunction. II and III trimester of pregnancy. Breastfeeding period.

Patients with angioedema in an interview should remain under close observation. In patients with circulating and / or sodium-depleted blood volume due to intensive diuretic therapy, dietary salt restriction, diarrhea or vomiting, symptomatic hypotension may occur, particularly after the first dose and after increasing the dose. Such deficiencies should be corrected before administration of the preparation or a lower starting dose. In patients with renal dysfunction with or without diabetes, electrolyte imbalance often needs to be compensated. Use with caution in adult patients with impaired hepatic function. As a consequence of renin-angiotensin-aldosterone system inhibition, renal dysfunction with renal insufficiency has been observed (especially in patients whose renal function depends on the activity of the renin-angiotensin-aldosterone system, such as those with severe heart failure or pre-existing renal dysfunction ). Caution should be used in patients with bilateral renal artery stenosis or stenosis of the artery that supplies blood to the only kidney. Due to the lack of data, the use of losartan is not recommended in children with glomerular filtration rate <30 ml / min / 1.73 m². There are no experiences in patients after a recent kidney transplantation. Patients with primary hyperaldosteronism usually do not respond to antihypertensive drugs acting by inhibiting the activity of the renin-angiotensin system - the use of the preparation in this group of patients is not recommended. Excessive reduction in blood pressure in patients with ischemic heart disease and cerebrovascular disease may result in myocardial infarction or stroke.In patients with heart failure with or without renal impairment, there is - as with other agents acting on the renin-angiotensin system - a risk of severe hypotension and (often acute) renal failure. The lack of sufficient therapeutic experience in the use of losartan in patients with heart failure and concomitant severe renal impairment, in patients with severe heart failure (NYHA stage IV), as well as in patients with heart failure and symptomatic, life-threatening cardiac arrhythmias - losartan should be use with caution in these patient groups. Particularly cautiously use in patients with aortic or mitral stenosis or hypertrophic cardiomyopathy with narrowing of the outflow pathway. Due to the lactose content, the preparation should not be used in patients with rare hereditary galactose intolerance, lactase deficiency (Lapp type) or malabsorption of glucose-galactose. Angiotensin II receptor antagonists are less effective in the treatment of hypertension in the black population. Due to the lack of data, the use of losartan in children under 6 years is not recommended and in children with glomerular filtration rate <30 ml / min / 1.73 m². The use of losartan in children with impaired hepatic function is also not recommended.

It is not recommended during the first trimester of pregnancy. In the II and III trimester of pregnancy and during breastfeeding, the use of the preparation is contraindicated. Administration of the preparation during the second and third trimester of pregnancy results in toxic effects on the fetus (deterioration of fetal renal function, oligohydramnios, delayed ossification of the skull) and the newborn (renal failure, hypotension, hyperkalemia). If the exposure to losartan occurred from the second trimester of pregnancy, ultrasound examination of the kidneys and skull is recommended. Newborns whose mothers have taken losartan should be observed for hypotension.

Common: dizziness, weakness, fatigue, hypotension, hypoglycaemia or hyperkalemia. Uncommon: drowsiness, headache, sleep disturbances, palpitations, angina pectoris, orthostatic hypotension, rash, abdominal pain, constipation, swelling, shortness of breath, diarrhea, nausea, vomiting, urticaria, pruritus, rash. Rare: paraesthesia, cerebrovascular accident, fainting, atrial fibrillation, anaphylactic reactions, angioneurotic edema, vasculitis (including Schönlein-Henoch purpura), hepatitis, transient ALT elevations. In addition, anemia, palpitations, back pain, urinary tract infections, flu-like symptoms, thrombocytopenia, migraine, cough, liver dysfunction, muscle pain, arthralgia have been observed. Renal impairment has been observed, including renal failure in at-risk patients. In patients with heart failure, increases in urea, creatinine and potassium in the blood were observed.

Orally.Hypertension. Adults: The usual starting and maintenance dose for most patients is 50 mg once a day. The maximum antihypertensive effect is obtained within 3-6 weeks from the start of treatment. In some patients, it may be beneficial to increase the dose to 100 mg once a day (in the morning). The preparation can be used in combination with other antihypertensive agents, especially diuretics (eg hydrochlorothiazide). Children: There are limited data on the efficacy and safety of losartan in the treatment of hypertension in children and adolescents from 6 to 16 years of age. Limited pharmacokinetic data are available for hypertensive children over 1 month. For patients (≥6 years) with a body weight> 20 kg to <50 kg who can swallow tablets, the recommended dose is 25 mg once a day. In exceptional cases, the dose may be increased up to a maximum of 50 mg once a day. Dosage should be adjusted based on changes in blood pressure. For patients weighing> 50 kg, the usual dose is 50 mg once a day. In exceptional cases, the dose may be increased up to a maximum of 100 mg once a day. No studies have been conducted in children at doses above 1.4 mg / kg. (or more than 100 mg) daily.Patients with hypertension and type 2 diabetes mellitus with proteinuria ≥0.5 g / day. The usual starting dose is 50 mg once a day.After the first month from the start of treatment, depending on the value of your blood pressure, the dose can be increased to 100 mg once a day. The preparation can be used simultaneously with other antihypertensive drugs (eg diuretics, Calcium channel blockers, α- or β-blockers and centrally acting drugs), as well as with insulin and other commonly used hypoglycemic agents (eg sulphonylurea, glitazones) and glucosidase inhibitors).Heart failure. The usual starting dose is 12.5 mg once a day. The dose should be increased gradually at one-week intervals (ie 12.5 mg / day, 25 mg / day, 50 mg / day) until a usual maintenance dose of 50 mg is achieved once daily, if it is tolerated by the patient.Reduction of the risk of stroke in patients with hypertension and left ventricular hypertrophy confirmed by ECG. The usual starting dose is 50 mg once a day. Depending on the change in blood pressure, you can add hydrochlorothiazide low dose and (or) increase the dose of losartan to 100 mg once a day.
For patients with reduced circulating blood volume (eg, treated with high diuretics), a starting dose of 25 mg once a day should be considered. Adaptation of the initial dosage in patients with impaired renal function and hemodialyzed patients is not necessary. A lower dose should be considered in patients with impaired hepatic function. Although consideration should be given to initiating treatment with a 25 mg dose in patients over 75 years of age, dosage adjustment is not usually necessary in the elderly.
The tablets can be taken with or without a meal, with a glass of water.