Lozap pills 100mg №90

Dosage form

Coated tablets

Composition

In 1 tablet, film coated, contains: Losartan potassium 100 mg.

Excipients: microcrystalline cellulose, mannitol, croscarmellose sodium, anhydrous colloidal silicon dioxide, talc, Magnesium stearate.

Film shell: sepifilm 752 (white) (hypromellose, microcrystalline cellulose, macrogol 2000 stearate, titanium hydroxide), macrogol 6000.

Packaging

In the blister of 10 tablets. In a carton box 9 blisters.

Mechanism of action

Lozap - losartan is a specific angiotensin II receptor antagonist (subtype AT 1). He inhibits kinase II - an enzyme that catalyzes the reaction of converting angiotensin I to angiotensin II.

Reduces the OPSS, the concentration in the blood of adrenaline and aldosterone, blood pressure, pressure in the pulmonary circulation; reduces afterload, has a diuretic effect. Interferes with the development of myocardial hypertrophy, increases exercise tolerance in patients with heart failure.

Losartan does not inhibit angiotensin-converting enzyme (ACE) -kininase II and, accordingly, does not prevent the destruction of bradykinin, so side effects indirectly associated with bradykinin (for example, angioedema) occur quite rarely.

After a single oral administration, the hypotensive effect (the systolic and diastolic blood pressure decreases) reaches its maximum after 6 hours, then gradually decreases within 24 hours.

The maximal hypotensive effect develops through the BB weeks after the start of the drug.

In patients with arterial hypertension without concomitant diabetes mellitus with proteinuria (more than 2 g / day), the use of the drug significantly reduces proteinuria, the excretion of albumin and immunoglobulins G.

Stabilizes the level of urea in the blood plasma. Does not affect the autonomic reflexes, and does not have a long-term effect on the concentration of norepinephrine in the blood plasma. Losartan in a dose of up to 150 mg per day does not affect the level of triglycerides, total cholesterol and high density lipoprotein cholesterol (HDL) in the serum of patients with arterial hypertension. At the same dose, losartan does not affect fasting blood glucose levels.

Indications and usage

- Arterial hypertension.
- Chronic heart failure (as part of combination therapy, with intolerance or failure of therapy with ACE inhibitors).
- To reduce the risk of cardiovascular diseases (including stroke) and mortality in patients with arterial hypertension and left ventricular hypertrophy.
- Diabetic nephropathy in hypercreatininemia and proteinuria (the ratio of urine albumin to creatinine is more than 300 mg / g) in patients with type 2 diabetes and concomitant arterial hypertension (decrease in the progression of diabetic nephropathy to terminal chronic renal failure).

Contraindications

- Hypersensitivity to the drug.
- Pregnancy.
- Lactation period.
- Age up to 18 years (efficacy and safety have not been established).

- Arterial hypotension.
- Reduced blood volume.
- Violations of water and electrolyte balance.
- Bilateral renal artery stenosis.
- Stenosis of the artery of the only kidney.
- Renal failure.
- Liver failure.

Pregnancy and Breastfeeding

There are no data on the use of Lozap during pregnancy. However, it is known that drugs acting directly on the renin-angiotensin system, when applied in the second and third trimesters of pregnancy, can cause a defect of development or even death of a developing fetus. Therefore, when a pregnancy occurs, Lozapa should be stopped immediately.

When prescribing during lactation, a decision should be made either to discontinue breastfeeding or to discontinue treatment with the drug.

Dosage and administration

The drug is taken orally, regardless of the meal. Frequency of admission - 1 time per day.

In 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 1 time per day.

In heart failure, the initial dose for patients is 12.5 mg 1 time per day. As a rule, the dose increases with a weekly interval (i.e.12.5 mg / day, 25 mg / day, 50 mg / day) to an average maintenance dose of 50 mg 1 time / day, depending on the patient's tolerance to the drug.

Patients receiving diuretics in high doses, the initial dose of the drug should be reduced to 25 mg 1 time / day. It is not required to adjust the dose to elderly patients.

To reduce the 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, hydrochlorothiazide may be added in low doses and / or the dose of the drug may be increased to 100 mg per day in one or two doses. Patients with concomitant type 2 diabetes mellitus with proteinuria: the drug is prescribed in an initial dose of 50 mg once a day with a further dose increase to 100 mg / day (taking into account the degree of blood pressure reduction) in one or two doses.

In case of diabetes mellitus type 2 with proteinuria, the initial dose of the drug is 50 mg 1 time per day with a further dose increase to 100 mg / day (taking into account the degree of blood pressure reduction) in 1 or 2 doses.

Patients with liver disease in history, dehydration, during the hemodialysis procedure, as well as patients over 75 years old are recommended a lower initial dose of the drug - 25 mg 1 time per day.

Adverse reactions

Marked (*) side effects, the incidence of which is comparable to placebo.
The relationship of side effects occurring with a frequency of less than 1% of cases using losartan has not been proven.
In most cases, Lozap is well tolerated, side effects are transient in nature and do not require discontinuation of the drug.
From the nervous system and sensory organs: 1% or more - dizziness, asthenia, fatigue, headache, insomnia; less than 1% - anxiety, sleep disturbance, drowsiness, memory disorder, peripheral neuropathy, paresthesia, hypoesthesia, migraine, tremor, ataxia, depression, syncope, tinnitus, impaired taste, vision change, conjunctivitis.
Respiratory: 1% or more - nasal congestion, cough, infections of the upper respiratory tract (fever, sore throat, sinusopathy *, sinusitis, pharyngitis); less than 1% - dyspnea, bronchitis, rhinitis.
On the part of the digestive tract: 1% or more - nausea, diarrhea, dyspeptic symptoms, abdominal pain; less than 1% - anorexia, dry mouth, toothache, vomiting, flatulence, gastritis, constipation.
Musculoskeletal system: 1% or more - cramps, myalgia *, pain in the back, chest, legs; less than 1% - arthralgia, pain in the shoulder, knee, arthritis, fibromyalgia.
Cardiovascular: orthostatic hypotension (dose-dependent), palpitations, tachy- or bradycardia, arrhythmia, angina pectoris, anemia.
From the genitourinary system: less than 1% - imperative urge to urinate, urinary tract infections, renal dysfunction, weakening of libido, impotence.
From the skin: less than 1% - dry skin, erythema, blood flow, photosensitivity, increased sweating, alopecia.
Allergic reactions: less than 1% - urticaria, rash, itching, angioedema, incl. face, lips, pharynx and / or tongue.
Other: hyperkalemia (serum potassium> 5.5 mmol / l).

Special notes

It is necessary to carry out the correction of dehydration before the appointment of Lozap or begin treatment with the use of the drug at a lower dose.

Drugs that affect the renin-angiotensin system may increase blood urea and serum creatinine in patients with bilateral renal stenosis or arterial stenosis of a single kidney.

During the period of treatment should regularly monitor the concentration of potassium in the blood, especially in elderly patients, with impaired renal function.

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 diseases, it should be given in lower doses.

Losartan does not affect the ability to drive or operate machinery.

May be administered with other antihypertensives. Mutually enhances the effect of beta-blockers and sympatholytic. The combined use of losartan with diuretics has an additive effect.

Pharmacokinetic interactions of losartan with hydrochlorothiazide, Digoxin, Warfarin, cimetidine, phenobarbital, Ketoconazole and Erythromycin were not observed. Rifampicin and Fluconazole reportedly decrease the level of the active metabolite in the blood plasma.The clinical significance of these interactions is not yet known. As with the use of other agents that inhibit angiotensin II or its action, the combined use of losartan with potassium-saving diuretics (for example, spironolactone, triamterene, amiloride), potassium preparations and salts containing potassium, increases the risk of hyperkalemia.

Non-steroidal anti-inflammatory drugs (NSAIDs), including selective cyclooxygenase-2 inhibitors (C0G-2), may reduce the effect of diuretics and other antihypertensive drugs.

The combined use of angiotensin II receptor antagonists and lithium may increase the plasma concentration of lithium. Given this, it is necessary to weigh the benefits and the risk of losartan combined with lithium salts. If it is necessary to use the drugs together, it is necessary to regularly monitor the concentration of lithium in the blood plasma.

Symptoms: pronounced decrease in blood pressure, tachycardia; Bradycardia may appear due to parasympathetic (vagal) stimulation.
Treatment: forced diuresis, symptomatic therapy, hemodialysis is not effective.

Store at a temperature not higher than 30 ° C.

2 years.