Composition
of film-coated tablets.
1 film coated tablet contains:
Active ingredient
Losartan Potassium 50 mg
Auxiliary substances
Core
Microcrystalline cellulose,
mannitol,
crospovidone,
colloidal anhydrous silicon dioxide,
talc,
magnesium stearate.
Film shell
Sepifilm 752 (white) (hypromellose, microcrystalline cellulose, macrogol 2000 stearate, titanium dioxide), macrogol 6000.
Indications
- Arterial hypertension;
- Chronic heart failure (as part of combination therapy, with intolerance or ineffectiveness of therapy with ACE inhibitors);
- Reducing the risk of developing cardiovascular diseases (including stroke) and mortality in patients with arterial hypertension and left ventricular hypertrophy;
- Diabetic nephropathy with hypercreatininemia and proteinuria (urinary albumin to creatinine ratio greater than 300 mg / g) in patients with type 2 diabetes mellitus and concomitant arterial hypertension (reduced progression of diabetic nephropathy to end-stage chronic renal failure).
Contraindications
- Hypersensitivity to the components of the drug;
- Pregnancy and lactation;
- Age up to 18 years (efficacy and safety have not been established).
With caution: Â hypotension, reduced circulating blood volume, impaired water and electrolyte balance, bilateral renal artery stenosis or stenosis of the artery of a single kidney, renal / hepatic insufficiency.
Interaction
It can be prescribed with other antihypertensive agents. Mutually enhances the effect of beta-blockers and sympatholytics. Concomitant use of losartan with diuretics has an additive effect. There were no pharmacokinetic interactions of losartan with hydrochlorothiazide, digoxin, warfarin, cimetidine, phenobarbital, ketoconazole, or erythromycin. Rifampicin and fluconazole have been reported to reduce plasma levels of the active metabolite.
The clinical significance of these interactions is still unknown. As with other agents that inhibit angiotensin II or its action, the combined use of losartan with potassium-sparing diuretics (for example, spironolactone, triamterene, amiloride), potassium preparations and salts containing potassium increases the risk of hyperkalemia. Nonsteroidal anti-inflammatory drugs (NSAIDs), including selective cyclooxygenase-2 (COX-2) inhibitors, may reduce the effect of diuretics and other antihypertensive agents.
With the combined use of angiotensin II receptor antagonists and lithium, an increase in the concentration of lithium in blood plasma is possible. Given this, it is necessary to weigh the benefits and risks of concomitant use of losartan with lithium salts. If it is necessary to use drugs together, it is necessary to regularly monitor the concentration of lithium in the blood plasma.
How to take, course of use and dosage
The drug LOZAP® is taken orally, regardless of food intake, the frequency of use is 1 time per day.
With arterial hypertension, the average daily dose is 50 mg. In some cases, to achieve a greater therapeutic effect, the dose is increased to 100 mg in two doses or once a day. The initial dose for patients with chronic heart failure is 12.5 mg once a day (1 tablet of LOZAP® 12.5 mg). As a rule, the dose is increased at weekly intervals (i. e. 12.5 mg / day,25 mg / day and 50 mg / day) to an average maintenance dose of 50 mg once a day, depending on the patient’s tolerance of the drug.
When prescribing the drug to patients receiving high-dose diuretics, the initial dose of LOZAP® should be reduced to 25 mg (? LOZAP® 50 mg tablets) once a day.
No dose adjustment is required in elderly patients.
Reduced risk of cardiovascular diseases (including stroke) and mortality in patients with arterial hypertension and left ventricular hypertrophy:  the initial dose of the drug is 50 mg per day once. In the future, low-dose hydrochlorothiazide may be added and / or the dose of LOZAP® may be increased to 100 mg per day in one or two doses.
Patients with concomitant type 2 diabetes mellitus with proteinuria:  LOZAP® is prescribed at an initial dose of 50 mg once a day with a further increase in the dose to 100 mg / day (taking into account the degree of reduction in blood pressure) in one or two doses. Patients with a history of liver disease, dehydration, during hemodialysis, as well as patients over 75 years of age are recommended to take a lower initial dose of the drug – 25 mg (? LOZAP® 50 mg tablets) once a day.
Overdose
Symptoms: Â marked decrease in blood pressure, tachycardia, due to parasympathetic (vagal) stimulation, bradycardia may develop.
Treatment: Â forced diuresis, symptomatic therapy; hemodialysis is not effective.
Special instructions
It is necessary to correct dehydration before prescribing LOZAP® or start treatment with a lower dose of the drug.
Drugs that affect the renin-angiotensin system may increase blood urea and serum creatinine concentrations in patients with bilateral renal stenosis or single-kidney artery stenosis. In patients with cirrhosis of the liver, the concentration of losartan in the blood plasma increases significantly, and therefore, if there is a history of liver disease, it should be prescribed in lower doses.
During treatment, the concentration of potassium in the blood should be regularly monitored, especially in elderly patients with impaired renal function. Effects on the ability to concentrate: losartan does not affect the ability to drive a car or work with mechanisms.
Form of production
Lozap tablets, film-coated in white or almost white color, oblong, biconvex.
Active ingredient
Losartan
Conditions of release from pharmacies
By prescription
Dosage form
Tablets
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