Index of drugs

Treatment of essential hypertension. Treatment of kidney disease in patients with hypertension and type 2 diabetes mellitus with proteinuria ≥0.5 g / day in combination with other antihypertensive agents. Treatment of chronic heart failure if the ACE inhibitor can not be used due to pharmaceutical incompatibilities or contraindications; in patients with heart failure whose condition has stabilized under the influence of an ACE inhibitor, do not change this medicine to losartan; left ventricle ejection fraction should be ≤40%; the clinical condition should be stabilized during the treatment of chronic heart failure.

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 hepatic failure. Pregnancy and breastfeeding.

Patients with angioedema in an interview should be under close medical supervision. Particularly cautiously use in patients with bilateral renal artery stenosis or stenosis of the artery supplying the only kidney. Caution in patients with hypovolaemia and / or sodium depletion as a result of intense diuretic therapy, dietary salt restriction, diarrhea or vomiting - risk of symptomatic hypotension (fluidity and sodium deficiency or a lower starting dose should be compensated before starting losartan therapy). In patients treated with losartan (especially in patients whose normal renal function depends on the proper functioning of the renin-angiotensin-aldosterone system, i.e. patients with severe heart failure or renal dysfunction), renal dysfunction, including renal failure, has been observed. Use with caution in patients with ischemic heart disease, cerebrovascular disease, aortic valve stenosis and mitral valve, hypertrophic cardiomyopathy with narrowing of the outflow tract or liver dysfunction. In patients with heart failure, with or without renal insufficiency there is a risk of severe hypotension and renal failure. There are no clinical data on the use of losartan in patients with heart failure and concomitant acute renal failure, in patients with severe heart failure (NYHA class IV) and in patients with heart failure and life-threatening cardiac arrhythmias. Angiotensin II antagonists are less effective in lowering blood pressure in black people. The use of losartan in patients with primary aldosteronism is not recommended. There are no clinical data on the use of losartan in kidney transplant patients. Due to the lack of experience with the use of the drug in children under 18 years of age, it should not be administered in this age group.

The preparation is contraindicated in pregnancy and breast-feeding.Drugs acting directly on the renin-angiotensin system used in the second and third trimester of pregnancy may cause fetal or neonatal disorders (hypotension, renal dysfunction, oliguria and / or anuria, oligohydramnios, skull hypoplasia, intrauterine growth retardation), and even death. There have also been cases of lung depletion, craniofacial abnormalities and limb contractures.

Common (≥1 / 100, <1/10): dizziness, hypoglycaemia, hyperkalemia. Uncommon (≥1 / 1000, <1/100): drowsiness, headache, sleep disturbances, palpitations, angina, hypotension (including orthostatic hypotension), rash, abdominal pain, constipation, weakness, fatigue, edema, shortness of breath , diarrhea, nausea, vomiting, urticaria, pruritus, rash. Rare (≥1 / 10,000, <1/1000): paresthesia, syncope, atrial fibrillation, cerebrovascular events, hypersensitivity reactions (angioneurotic edema, vasculitis, including Schönlein-Henoch purpura), hepatitis. In addition: anemia, back pain, urinary tract infections, flu-like symptoms, thrombocytopenia, migraine, cough, diarrhea, liver dysfunction, muscle and joint pain, in patients at risk - renal dysfunction (including renal failure), increase in ALT , hyperkalemia (especially in patients with type 2 diabetes mellitus and nephropathy), increased urea and creatinine in the blood.

Hypertension. Adults: the initial and maintenance dose is usually 50 mg once a day. The maximum antihypertensive effect occurs 3-6 weeks after the start of treatment. In some patients, it may be beneficial to increase the dose to 50 mg 2 times a day (morning and evening) or 100 mg once a day (in the morning). Losartan can be used in combination with other antihypertensive agents, especially diuretics (such as hydrochlorothiazide).Heart failure: the starting dose is usually 12.5 mg once a day; the dose should be increased gradually at weekly intervals (eg 12.5 mg per day, 25 mg per day, 50 mg per day) to the usual maintenance dose of 50 mg once a day, depending on the clinical condition of the patient. For the treatment of heart failure, losartan is usually used in combination with a diuretic, digitalis and / or β-blocker.Kidney disease in patients with hypertension and type 2 diabetes mellitus with proteinuria ≥0.5 g / day, in combination with other antihypertensive agents: the usual starting dose is 50 mg once a day. The dose can then be increased to 100 mg once a day depending on the blood pressure measured one month after the start of treatment. The preparation can be used simultaneously with other antihypertensive drugs (eg diuretics, Calcium antagonists, α- or β-blockers and preparations active on the o.u.n.), insulin and other commonly used hypoglycaemic preparations (eg, sulfonylureas, glitazones and glucosidase inhibitors).
In patients with a reduced volume of intravascular fluid (eg, treated with high doses of diuretic drugs), it is recommended to start treatment with a dose of 25 mg once a day. In patients with a history of liver dysfunction, lower doses of losartan should be considered. In patients> 75 years, consideration should be given to starting treatment with a 25 mg dose.
The tablets can be taken with or without food, with a glass of water.