Lozap - angiotensin II receptor antagonist; antihypertensive drug.
Release form and composition
Lozap is produced in the form of tablets, film-coated white or almost white, biconvex, oblong (10 pieces in blisters, in a cardboard bundle 3, 6 or 9 blisters).
The active ingredient of the drug is potassium losartan. 1 tablet contains 12.5 mg, 50 mg or 100 mg.
Auxiliary components: crospovidone, mannitol, anhydrous colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, talc.
The composition of the film shell: macrogol 6000 and sepifilm 752 white (macrogol 2000 stearate, microcrystalline cellulose, titanium dioxide, hypromellose).
Indications for use
The drug is used to treat the following diseases:
- Arterial hypertension;
- Diabetic nephropathy with proteinuria and hypercreatininemia (urine albumin and creatinine ratio more than 300 mg / g) in patients with type 2 diabetes with concomitant arterial hypertension (the goal of therapy is to reduce the progression of diabetic nephropathy to terminal chronic renal failure);
- Chronic heart failure (as part of combination therapy, in case of intolerance or failure of therapy with angiotensin-converting enzyme inhibitors).
Lozap is also prescribed to reduce the risk of developing diseases of the cardiovascular system (including stroke) and mortality in patients with left ventricular hypertrophy and arterial hypertension.
- Age up to 18 years;
- Hypersensitivity to the drug.
In the following cases, Lozap is used with caution:
- Decrease in the volume of the circulating blood;
- Violations of water and electrolyte balance;
- Bilateral renal artery stenosis or single kidney artery stenosis;
- Renal / hepatic failure.
Dosing and Administration
Lozap should be taken 1 time per day, regardless of the meal.
The average daily dose for hypertension is 50 mg. In some cases, to achieve a greater therapeutic effect, the doctor may increase it to 100 mg in 1-2 doses.
Treatment of chronic deficiency begin with a daily dose of 12.5 mg. In the future, it is increased once a week - first to 25 mg, then, if necessary, to an average maintenance dose of 50 mg.
Patients receiving diuretics in high doses, at the beginning of treatment is prescribed 25 mg / day.
When prescribing a drug to reduce the risk of cardiovascular diseases and mortality, the initial dose is 50 mg / day. If necessary, further it is increased to 100 mg in 1-2 doses and / or hydrochlorothiazide is added in a low dose.
Treatment of patients with concomitant type 2 diabetes mellitus, accompanied by proteinuria, begins with a daily dose of 50 mg. If necessary, taking into account the degree of reduction in blood pressure, it is increased to 100 mg in 1-2 doses.
People over the age of 75, during the procedure of hemodialysis, as well as patients with a history of liver disease and dehydration, the recommended dose at the beginning of treatment is 25 mg (1/2 tablet 50 mg) per day.
According to controlled studies, when using Lozap to treat essential hypertension, the incidence of dizziness differed from placebo among side effects.
Side effects occurring in more than 1% of patients:
- General reactions: fatigue, asthenia, peripheral edema, pain in the chest;
- Cardiovascular system: tachycardia;
- Digestive system: abdominal pain, dyspeptic symptoms, diarrhea, nausea;
- Musculoskeletal system: pain in the legs and back, cramps of the gastrocnemius muscles;
- Central nervous system: dizziness, headache, insomnia;
- Respiratory system: nasal congestion, sinusitis, pharyngitis, cough, bronchitis, infections of the upper respiratory tract.
The described adverse events are transient in nature and do not require discontinuation of the drug.
Side effects occurring in less than 1% of patients:
- Cardiovascular system: vasculitis, epistaxis, dose-dependent orthostatic hypotension, arrhythmias, angina pectoris, bradycardia, myocardial infarction;
- Digestive system: toothache, dry oral mucosa, vomiting, flatulence, constipation, gastritis, anorexia, abnormal liver function, hepatitis; very rarely - hyperbilirubinemia, a moderate increase in the activity of transaminases AST and ALT;
- Hematopoietic system: sometimes - eosinophilia, thrombocytopenia, Shenlein-Genoch purpura, anemia;
- Central and peripheral nervous system: memory disorders, drowsiness, peripheral neuropathy, sleep disturbance, tremor, hypoesthesia, paresthesia, syncope, ataxia, migraine, anxiety, depression;
- Urinary system: impaired renal function, urinary tract infection, urgency to urinate; sometimes - an increase in the level of residual nitrogen and urea or serum creatinine;
- Musculoskeletal system: pain in the shoulder and knee, arthritis, arthralgia, fibromyalgia;
- The reproductive system: decreased libido, impotence;
- Metabolism: often - hyperkalemia, gout;
- Sense organs: a violation of taste and vision, conjunctivitis, tinnitus;
- Dermatological reactions: photosensitivity, ecchymosis, increased sweating, erythema, alopecia, dry skin;
- Allergic reactions: itching, skin rash, urticaria, angioedema.
Symptoms of overdose: marked reduction in blood pressure and tachycardia. Bradycardia is possible due to parasympathetic stimulation. In the case of receiving an excessive dose of Lozap, forced diuresis is performed and symptomatic therapy is prescribed.
Before the appointment of Lozap, it is necessary to correct dehydration. If this is not possible, treatment should begin with a lower dose.
Drugs that affect the renin-angiotensin-aldosterone system (RAAS) may increase serum creatinine and urea levels in patients with bilateral renal artery stenosis or single kidney artery stenosis.
The whole period of treatment should regularly monitor the concentration of potassium in the blood, especially in patients with impaired renal function and the elderly.
Data on the use of losartan during pregnancy is not. However, it has been reliably established that drugs that act directly on the RAAS, when taken in the second and third trimesters, can cause developmental defects and even death of the fetus. For this reason, if a pregnancy occurs, Lozap should be canceled immediately.
Negative impact on the reaction rate and ability to concentrate the attention of the drug does not have.
If necessary, Lozap can be administered simultaneously with other antihypertensive drugs. When used in combination with diuretics, an additive effect is observed. Mutual enhancement of the action of sympatholitics and beta-blockers is noted.
Fluconazole and rifampicin are reported to reduce the concentration of the active metabolite of losartan in the blood plasma. The clinical significance of this interaction is not yet known.
Pharmacokinetic interaction of losartan with warfarin, digoxin, cimetidine, erythromycin, phenobarbital, hydrochlorothiazide and ketoconazole was not observed.
Non-steroidal anti-inflammatory drugs may reduce the effect of diuretics and other antihypertensive drugs.
With the simultaneous use of potassium-sparing diuretics, potassium preparations or salts containing potassium, the risk of hyperkalemia increases.
When used in combination with lithium preparations, an increase in plasma concentration of lithium is possible, therefore such a combination can be prescribed only after a thorough assessment of the benefits and risks. During treatment, plasma concentrations of lithium should be monitored.
Terms and conditions of storage
Keep out of reach of children at temperature not exceeding 30 ° C.
Shelf life - 2 years.