Losartan tablets p / o 100 mg, No. 30 Prana

Arterial hypertension. Reducing the risk of associated cardiovascular morbidity and mortality in patients with arterial hypertension and left ventricular hypertrophy, manifested by a combined decrease in the incidence of cardiovascular mortality, stroke and myocardial infarction. Kidney protection in patients with type 2 diabetes mellitus with proteinuria - slowing the progression of renal failure, manifested by a decrease in the incidence of hypercreatininemia, the incidence of end-stage chronic renal failure requiring hemodialysis or kidney transplantation, mortality rates, and a decrease in proteinuria. Chronic heart failure (as part of combination therapy, with intolerance or ineffectiveness of therapy with ACE inhibitors).

The average oral dose is 50 mg 1 time / day. If necessary, the dose can be reduced to 25 mg / day or increased to 100 mg / day, in the latter case, it can be used 2 times / day.

Film-coated tablets of white or almost white color, round, biconvex, two layers are visible on the fracture - a white or almost white core and a film membrane.

1 tablet

losartan potassium 100 mg

Excipients: lactose monohydrate 190.1 mg, microcrystalline cellulose 57 mg, povidone 13.3 mg, magnesium stearate 3.8 mg, croscarmellose sodium 15.8 mg.

Pregnancy, lactation, children and adolescents under 18 years of age, hypersensitivity to losartan.

pharmachologic effect

Antihypertensive agent.

It is a non-peptide angiotensin II receptor blocker. Possesses high selectivity and affinity for AT1 receptors (with the participation of which the main effects of angiotensin II are realized). By blocking these receptors, losartan prevents and eliminates the vasoconstrictor effect of angiotensin II, its stimulating effect on the secretion of aldosterone by the adrenal glands and some other effects of angiotensin II. It is characterized by a long-term effect (24 hours or more), which is due to the formation of its active metabolite. Pharmacokinetics After oral administration, losartan is rapidly absorbed from the gastrointestinal tract. Bioavailability is about 33%. It is metabolized during the 'first pass' through the liver with the formation of a carboxyl metabolite, which has a more pronounced pharmacological activity than losartan, and a number of inactive metabolites.Cmax in the blood plasma of losartan and the active metabolite is achieved after 1 hour and 3-4 hours, respectively. The plasma protein binding of losartan and the active metabolite is high - more than 98%. T1 / 2 of losartan and the active metabolite in the final phase is about 1.5-2.5 hours and 3-9 hours, respectively. Losartan is excreted in the urine and feces (bile) unchanged and in the form of metabolites. About 35% is excreted in the urine and about 60% in the feces.

Indications of active substances of the drug Losartan

Arterial hypertension. Reducing the risk of associated cardiovascular morbidity and mortality in patients with arterial hypertension and left ventricular hypertrophy, manifested by a combined decrease in the incidence of cardiovascular mortality, stroke and myocardial infarction. Kidney protection in patients with type 2 diabetes mellitus with proteinuria - slowing the progression of renal failure, manifested by a decrease in the incidence of hypercreatininemia, the incidence of end-stage chronic renal failure requiring hemodialysis or kidney transplantation, mortality rates, and a decrease in proteinuria. Chronic heart failure (as part of combination therapy, with intolerance or ineffectiveness of therapy with ACE inhibitors).

Dosage regimen

The average oral dose is 50 mg 1 time / day. If necessary, the dose can be reduced to 25 mg / day or increased to 100 mg / day, in the latter case, it can be used 2 times / day.

Side effect

From the side of the cardiovascular system: dizziness, orthostatic hypotension. From the side of metabolism: hyperkalemia. Allergic reactions: angioedema (including swelling of the face, lips, pharynx and / or tongue), urticaria. From the digestive system: diarrhea, increased ALT activity. From the side of the central nervous system: headache. Dermatological reactions: itching. Others: impaired renal function, myalgia.

Contraindications for use

Pregnancy, lactation, children and adolescents under 18 years of age, hypersensitivity to losartan.

Application during pregnancy and lactation

Contraindicated for use during pregnancy and lactation.

Application for violations of liver function

In patients with a history of liver disease, losartan should be used in low doses. With cirrhosis of the liver, the concentration of losartan in the blood plasma increases significantly.

Application for impaired renal function

In case of impaired renal function, a dose reduction of losartan may be required.

Application in children

The safety and efficacy of losartan in children have not been established.

Use in elderly patients

In elderly patients during the period of treatment, the level of potassium in the blood should be regularly monitored.

special instructions

It should be used with caution in case of arterial hypotension, a decrease in BCC, disturbances in water and electrolyte balance, bilateral stenosis of the renal arteries or stenosis of an artery of a single kidney, with renal / hepatic insufficiency Patients who have a fluid and / or sodium deficiency should be corrected before starting treatment water and electrolyte disturbances or use a lower initial dose. In patients with dehydration (for example, receiving high-dose diuretic treatment), symptomatic arterial hypotension may occur at the beginning of treatment with losartan. In case of impaired renal function, a dose reduction of losartan may be required. In patients with a history of liver disease, losartan should be used in low doses. With cirrhosis of the liver, the concentration of losartan in the blood plasma increases significantly.During the period of treatment, the level of potassium in the blood should be regularly monitored, especially in elderly patients with impaired renal function. The simultaneous use of losartan with potassium-sparing diuretics should be avoided. The safety and efficacy of losartan in children have not been established.

Drug interactions

With simultaneous use with diuretics in high doses, arterial hypotension is possible. With simultaneous use with potassium preparations, potassium-sparing diuretics, the risk of developing hyperkalemia increases. With simultaneous use with indomethacin, it is possible to reduce the effectiveness of losartan. There is a report on the development of lithium intoxication with simultaneous use with lithium carbonate. With simultaneous use with orlistat, the antihypertensive effect of losartan decreases, which can lead to a significant increase in blood pressure, the development of a hypertensive crisis. With simultaneous use with rifampicin, the clearance of losartan increases and its effectiveness decreases.