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Instruction for use: Lozap

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Dosage form: film coated tablets

Active substance: Losartanum

ATX

C09CA01 Losartan

Pharmacological group

Angiotensin II receptor antagonists (AT1 subtype)

Nosological classification (ICD-10)

I10 Essential (primary) hypertension: hypertension; Arterial hypertension; Arterial hypertension crisis course; Essential Hypertension; Essential hypertension; Essential hypertension; Essential hypertension; Essential hypertension; Primary hypertension; Arterial hypertension, complications of diabetes; The sudden increase in blood pressure; Hypertensive disorders of blood circulation; hypertensive condition; hypertensive crises; arterial Hypertension; malignant Hypertension; Hypertonic disease; hypertensive crises; accelerated hypertension; malignant hypertension; The aggravation of hypertensive disease; Transient hypertension; Isolated systolic hypertension

I15 Secondary hypertension: Arterial hypertension, complications of diabetes; hypertension; The sudden increase in blood pressure; Hypertensive disorders of blood circulation; hypertensive condition; hypertensive crises; hypertension; arterial Hypertension; malignant Hypertension; hypertensive crises; accelerated hypertension; malignant hypertension; The aggravation of hypertensive disease; Transient hypertension; hypertension; Arterial hypertension; Arterial hypertension crisis course; renovascular hypertension; Hypertension symptomatic; Renal hypertension; Renovascular hypertension; renovascular hypertension; Symptomatic hypertension

I15.0 Renovascular Hypertension: Hypertensive Crisis; Renovascular diseases; Malignant hypertension; Isolated systolic hypertension

I50.0 Congestive heart failure: anasarca heart; Decompensated congestive heart failure; Congestive heart failure; Congestive heart failure with high afterload; Congestive chronic heart failure; Cardiomyopathy with severe chronic heart failure; Compensated chronic heart failure; Swelling with circulatory failure; Edema of cardiac origin; Swelling of the heart; Edematous syndrome in diseases of the heart; Edematous syndrome in congestive heart failure; Edematous syndrome in heart failure; Edematous syndrome in heart failure or liver cirrhosis; right ventricular failure; Congestive Heart Failure; Heart failure stagnant; Heart failure with low cardiac output; Heart failure is a chronic; Cardiac edema; Chronic decompensated heart failure; Chronic Congestive Heart Failure; Chronic heart failure; Change of liver function in heart failure

I50.1 Left ventricular failure: Cardiac asthma; Asymptomatic dysfunction of the left ventricle; Asymptomatic left ventricular heart failure; Diastolic dysfunction of the left ventricle; Left ventricular dysfunction; Changes in the left ventricle with myocardial infarction; Left ventricular heart failure; Violation of the function of the left ventricle; Acute left ventricular failure; Acute cardiac left ventricular failure; Cardiac asthma; Heart failure of left ventricular; Changes in the lungs with left ventricular failure; Precordial abnormal pulsation; Lack of left ventricle

I50.9 Heart failure, unspecified: Diastolic rigidity; Diastolic heart failure; Cardiovascular failure; Heart failure with diastolic dysfunction; Cardiovascular failure

I64 Unspecified Stroke as a bleeding or heart attack: Primary stroke; Stroke; Stroke in the course of; microstroke; stroke; The completed stroke

N08.3 Glomerular lesions in diabetes mellitus (E10-14 + with common fourth sign .2): Nephropathy diabetic; Diabetic Nephropathy; Diabetic nephropathy in the background of type 1 diabetes mellitus; Diabetic nephropathy in patients with type I diabetes; Proteinuria in patients with type 2 diabetes mellitus

N18 Chronic Renal Failure: Congestive Renal Failure; Renal failure chronic; Chronic Renal Failure; CRF; Chronic kidney failure in children

N39.1 Persistent proteinuria, unspecified: Severe proteinuria; Proteinuria; Nephrotic-proteinuric syndrome

Composition

Tablets covered with a film coating.

active substance: Losartan potassium 12.5 / 50/100 mg

Excipients

Core: MCC - 52.5 / 80/160 mg; Mannitol - 25/50/100 mg; Crospovidone - 5/10/20 mg; Silicon dioxide colloidal anhydrous - 1/2/4 mg; Talc - 2/4/8 mg; Magnesium stearate - 2/4/8 mg

Film membrane: sepiphilm 752 (white) (hypromellose, MCC, macrogol 2000 stearate, titanium dioxide) - 4.95 / 7.9 / 13.8 mg; Macrogol 6000 - 0.05 (0.1 / 0.2 mg)

Description of dosage form

Tablets 12.5 mg: white or almost white, oblong, biconvex, covered with a film membrane.

Tablets of 50 mg: white or almost white, oblong, biconcave, film-coated, with a risk on both sides.

Tablets of 100 mg: white or almost white, oblong, biconcave, film-coated, with risk on both sides.

Pharmachologic effect

Mode of action - hypotensive.

Pharmacodynamics

Angiotensin II is a potent vasoconstrictor, the main active hormone of RAAS, and the main pathophysiological link in the development of arterial hypertension. Angiotensin II selectively binds to AT receptors found in many tissues (smooth muscle tissues of blood vessels, adrenal glands, kidneys and heart) and performs several important biological functions, including vasoconstriction and aldosterone release.

Angiotensin II also stimulates proliferation of smooth muscle cells. Losartan is a highly effective angiotensin II receptor antagonist (type AT1). Lozartan and its pharmacologically active carboxylated metabolite (E-3174), both in vitro and in vivo. Block all the physiological effects of angiotensin II, regardless of the source or route of synthesis. Losartan selectively binds to AT1 receptors and does not bind, does not block receptors of other hormones and ion channels, which play an important role in the regulation of CCC function. In addition, losartan does not inhibit ACE (kininase II), which contributes to the degradation of bradykinin. Therefore, effects that are not directly related to AT1 receptor blockade, in particular the enhancement of effects associated with bradykinin exposure, or the development of edema, are not relevant to the action of losartan.

Losartan suppresses the increase in SAD and DAD, observed with the introduction of angiotensin II. At the time Cmax reaches losartan in the blood plasma after taking losartan at a dose of 100 mg, the above effect is suppressed by approximately 85%, and after 24 hours after a single and multiple doses - by 26-39%.

During the administration of losartan, the elimination of negative feedback, consisting in the suppression of renin secretion by angiotensin II, leads to an increase in plasma renin activity (ARP). The increase in ARP is accompanied by an increase in the concentration of angiotensin II in the blood plasma. With prolonged (6-week) treatment of patients with arterial hypertension losartan at a dose of 100 mg / day, there was a 2-3-fold increase in the concentration of angiotensin II in blood plasma.

At the time of achieving Cmax losartan, some patients showed an even greater increase in concentration, especially with a short duration of treatment (2 weeks). However, antihypertensive activity and decrease in plasma aldosterone concentration were manifested after 2 and 6 weeks of therapy, which indicates effective blockade of angiotensin II receptors. After cancellation of losartan, ARP and angiotensin II concentration were reduced to the baseline values observed before the drug was started, after 3 days.

Since losartan is a specific antagonist of AT1 receptors of angiotensin II, it does not inhibit ACE (kininase II), an enzyme that inactivates bradykinin.

A study comparing effects of 20 and 100 mg of losartan with ACE inhibitor effects on the reaction to angiotensin I, angiotensin II, and bradykinin showed that losartan blocks the effects of angiotensin I and angiotensin II without affecting the effects of bradykinin, which is due to a specific mechanism Action of losartan. In contrast, the ACE inhibitor blocked the response to angiotensin I and increased the response to bradykinin without affecting the severity of the response to angiotensin II, which demonstrates the pharmacodynamic difference between losartan and ACE inhibitors. The concentration of losartan and its active metabolite in the blood plasma, as well as the antihypertensive effect of losartan increase with increasing dose of the drug. Due to the fact that losartan and its active metabolite are APAII, they both contribute to the antihypertensive effect.

Pharmacokinetics

Suction. When administered orally, losartan is well absorbed and metabolized during primary passage through the liver, resulting in the formation of an active carboxylated metabolite and inactive metabolites. Systemic bioavailability of losartan in tableted form is approximately 33%. The average Cmax of losartan and its active metabolite is reached after 1 hour and 3-4 hours, respectively. When losartan was taken during the usual meal, there was no clinically significant effect on the profile of losartan concentration in the blood plasma.

Distribution. Lozartan and its active metabolite bind to plasma proteins (mainly albumin) by more than 99%. Vd of losartan is 34 liters. Studies in rats have shown that losartan practically does not penetrate the BBB.

Metabolism. Approximately 14% of the dose of losartan administered intravenously or inward is converted to its active metabolite. After ingestion and iv administration of losartan labeled with 14C, the radioactivity of circulating blood plasma is primarily due to the presence of losartan and its active metabolite in it. A low conversion of losartan to its active metabolite was observed in about 1% of the patients studied.

In addition to the active metabolite, biologically inactive metabolites are formed, incl. 2 basic, resulting from the hydroxylation of the butyl side chain, and 1 minor - N-2-tetrazole-glucuronide.

Excretion. The plasma clearance of losartan and its active metabolite is about 600 and 50 ml / min, respectively. The renal clearance of losartan and its active metabolite is approximately 74 and 26 ml / min, respectively. When taking losartan, about 4% of the dose is excreted by the kidneys unchanged and about 6% of the dose - in the form of an active metabolite. Lozartan and its active metabolite have a linear pharmacokinetics when administered in doses up to 200 mg. After oral administration, plasma concentrations of losartan and its active metabolite decrease polyexponentially with a finite T1 / 2 of about 2 and 6-9 hours, respectively. With a single dose of 100 mg, neither losartan nor its active metabolite significantly accumulate in the body. The excretion of losartan and its metabolites occurs with bile and kidneys.

After ingestion of losartan, labeled with 14C, in men about 35% of radioactivity is found in urine and 58% in feces; After iv introduction of losartan, labeled with 14C, in men approximately 43% of radioactivity is found in urine and 50% in feces.

Pharmacokinetics in specific patient groups

Elderly patients. The concentrations of losartan and its active metabolite in blood plasma in elderly male patients with arterial hypertension do not significantly differ from those in young male patients with hypertension.

Floor. Concentrations of losartan in blood plasma were 2 times higher in women with arterial hypertension compared with men with arterial hypertension. The concentrations of active metabolite in men and women did not differ. This apparent pharmacokinetic difference is not clinically significant.

Dysfunction of the liver. When losartan was taken orally by patients with mild and moderate alcoholic cirrhosis, the concentrations of losartan and its active metabolite in blood plasma were respectively 5 and 1.7 times higher than in young healthy male volunteers.

Impaired renal function. Concentrations of losartan in blood plasma in patients with Cl creatinine above 10 ml / min did not differ from those in patients with unchanged renal function. When comparing AUC of losartan in patients with normal renal function and being on hemodialysis, the value of AUC of losartan was approximately 2 times greater in patients on hemodialysis. Plasma concentrations of the active metabolite do not change in patients with impaired renal function or on hemodialysis. Lozartan and its active metabolite can not be removed by hemodialysis.

Indications of the drug Lozap

arterial hypertension;

Chronic heart failure (as part of combination therapy, with intolerance or ineffective therapy with ACE inhibitors);

Reduction in the risk of developing cardiovascular diseases (including stroke) and mortality in patients with hypertension and left ventricular hypertrophy;

Diabetic nephropathy in hypercreatininemia and proteinuria (urine albumin and creatinine ratio> 300 mg / g) in patients with type 2 diabetes and concomitant arterial hypertension (reduction in the progression of diabetic nephropathy to the terminal stage of chronic renal failure).

Contraindications

Hypersensitivity to the components of the drug;

Simultaneous use with aliskiren in patients with diabetes mellitus and patients with renal insufficiency (Cl creatinine less than 60 ml / min);

Severe violations of liver function (more than 9 points on the Child-Pugh scale - no experience of use);

pregnancy;

Lactation period;

Age to 18 years (effectiveness and safety not established).

With caution: arterial hypotension; Heart failure with concomitant severe renal insufficiency; Severe heart failure of IV functional class according to NYHA classification; Heart failure with life-threatening arrhythmias; cardiac ischemia; Cerebrovascular diseases; Hyperkalaemia, age over 75; Use in representatives of the Negroid race; Reduced bcc, violations of water-electrolyte balance, bilateral stenosis of the renal arteries or stenosis of the artery of a single kidney; Renal / hepatic impairment; Condition after kidney transplantation (no experience of application); Aortic and mitral stenosis; Angioedema in history; Primary hyperaldosteronism; Hypertrophic obstructive cardiomyopathy.

Application of pregnancy and breastfeeding

The use of Lozap« in the first trimester of pregnancy is not recommended; In the II and III trimesters - contraindicated.

Epidemiological data on the risk of teratogenicity of ACE inhibitors in the first trimester of pregnancy are not convincing enough, however, the risk for the fetus cannot be entirely ruled out. Despite the fact that controlled epidemiological studies using angiotensin II receptor antagonists have not been conducted, this class of drugs may have similar risks. With the exception of cases when continued treatment with ARAII is considered necessary, patients planning pregnancy should be transferred to other types of antihypertensive therapy, the safety of which is confirmed by the results of clinical studies. When confirming the fact of pregnancy, treatment with Lozap« should be stopped immediately and, if necessary, another treatment should be prescribed.

It is known that the use of ARAII in the II and III trimesters of pregnancy has a toxic effect on the fetal organism (decreased kidney function, development of oligohydramnion, slowing ossification of the skull bones) and newborn (renal failure, arterial hypotension, hyperkalemia). If, for some reason, a woman took Lozap« in the second trimester or later in pregnancy, it is recommended that a fetus ultrasound be performed to monitor kidney function and the condition of the bones of the skull.

Children whose mothers took Lozap« during pregnancy should be closely monitored by the pediatrician because of the risk of developing arterial hypotension.

It is not known whether losartan is excreted in breast milk. Since no information has been received on the use of losartan during breastfeeding, lomazum should be abstinent from the administration of Lozap« to lactating women, preferring alternative treatments with a more studied safety profile, especially when feeding a newborn or premature baby. If it is necessary to use during the lactation period, breastfeeding should be discontinued.

Side effects

Side effects of losartan are usually transient and do not require withdrawal of the drug. When using losartan for the treatment of essential hypertension in controlled trials, among all the side effects, only the incidence of dizziness differed from placebo by more than 1% (4.1 vs. 2.4%).

A dose-dependent orthostatic effect, characteristic of antihypertensive agents, was used in losartan in less than 1% of patients.

The incidence of adverse reactions was determined according to the following gradation (WHO classification): very often ≥1 / 10; Often from ≥1 / 100 to <1/10; Infrequently - from ≥1 / 1000 to <1/100; Rarely - from ≥1 / 10000 to <1/1000; Very rare, including individual messages - from <1/10000; An unknown frequency (if it is impossible to estimate from the available data).

Table

Prevalence of adverse reactions from placebo-controlled clinical trials and post-registration follow-up

Side effect Prevalence of adverse reactions according to indications for use Other
Arterial hypertension Patients with hypertension and left ventricular hypertrophy Chronic heart failure Hypertension and type 2 diabetes mellitus with renal dysfunction Post-registration surveillance
On the part of the blood and lymphatic system
anemia Often Frequency unknown
Thrombocytopenia Frequency unknown
From the immune system
Allergic reactions, anaphylactic rations, Quincke's edema1, vasculitis2 rarely
Disorders of the psyche
depression Frequency unknown
From the nervous system
dizziness Often Often Often Often
drowsiness infrequently
headache infrequently infrequently
sleep disturbance infrequently
Paresthesia rarely
migraine Frequency unknown
Taste disorder Frequency unknown
From the side of the hearing organ and labyrinthine disorders
Vertigo infrequently Often
noise in ears Frequency unknown
From the heart
Heart palpitations infrequently
Angina pectoris infrequently
Fainting rarely
Atrial fibrillation rarely
Acute disturbance of cerebral circulation rarely
From the side of the vessels
(Orthostatic) infrequently Often Often
Marked decrease in blood pressure (including dose-dependent orthostatic effects) 3
On the part of the respiratory system, the thorax and the mediastinum 
dyspnea infrequently
cough infrequently Frequency unknown
From the digestive tract
stomach ache infrequently
Intestinal obstruction infrequently
diarrhea infrequently Frequency unknown
nausea infrequently
Vomiting infrequently
From the liver and biliary tract
Pancreatitis Frequency unknown
hepatitis ­ňńŕţ
Hepatic dysfunction Frequency unknown
From the skin and subcutaneous tissues
hives infrequently Frequency unknown
Itchy skin infrequently Frequency unknown
rash infrequently infrequently Frequency unknown
Photosensitization Frequency unknown
From the musculoskeletal and connective tissue
Myalgia Frequency unknown
arthralgia Frequency unknown
Rhabdomyolysis Frequency unknown
Muscle spasm infrequently
From the side of the kidneys and urinary tract
Impaired renal function Often
Renal insufficiency Often
From the genitals and mammary glands
Erectile dysfunction / impotence Frequency unknown
General disorders and disorders at the site of administration
asthenia infrequently Often infrequently Often
weakness infrequently Often infrequently Often
Edema infrequently Frequency unknown
malaise Frequency unknown
Impact on the results of laboratory and instrumental research
Hyperkalemia Often Infrequently4 Often5
Increased activity ALT6 rarely
Increased concentrations of urea, creatinine and potassium in blood plasma Often
Hyponatremia Frequency unknown
Hypoglycemia Often

1 Including edema of the larynx, vocal folds, face, lips and / or tongue (which leads to impaired airway patency); In some patients, Quincke's edema was noted earlier, in connection with the appointment of other drugs, including ACE inhibitors.

2 Including hemorrhagic vasculitis (Shenlaine-Henoch disease).

3 Especially in patients with hypovolemia, for example, with severe heart failure or receiving diuretics in high doses.

4 Often observed in patients receiving losartan in a dose of 150 instead of 50 mg.

5 In a clinical study conducted with patients with type 2 diabetes and nephropathy, hyperkalemia> 5.5 mmol / L developed in 9.9% of patients receiving losartan in tablets and 3.4% of patients receiving placebo.

6 Usually passes after withdrawal of treatment.

The following additional adverse reactions were more frequent in patients receiving losartan than in patients receiving placebo (exact incidence rates are unknown): back pain, urinary tract infections and influenza-like symptoms.

From the side of the kidneys and urinary tract: as a consequence of inhibition of RAAS in patients at risk, there were violations of kidney function, including acute renal failure. These changes on the part of the kidney function can be reversible in the case of timely withdrawal of treatment.

Interaction

The use of Lozap« with aliskiren in patients with diabetes mellitus is contraindicated. The use of Lozap« with aliskiren should be excluded in patients with renal insufficiency (Cl creatinine <60 ml / min).

Can be administered with other antihypertensive drugs. Mutually enhances the effect of β-adrenoblockers and sympatholytics. The combined use of losartan with diuretics has an additive effect.

Combined use with other drugs that can cause the development of arterial hypotension as an undesirable reaction (eg, tricyclic antidepressants, antipsychotics, baclofen and amifostine), may increase the risk of developing arterial hypotension.

There were no pharmacokinetic interactions of losartan with hydrochlorothiazide, digoxin, warfarin, cimetidine, phenobarbital, ketoconazole, erythromycin.

Losartan is predominantly metabolized by the CYP2C9 isoenzyme of the cytochrome P450 system to form an active metabolite of the carboxylic acid. In a clinical study, it was shown that fluconazole (inhibitor of the isoenzyme CYP2C9) reduces the formation of the active metabolite by approximately 50%. It has been established that the combined use of losartan with rifampicin (an inducer of metabolic enzymes) leads to an increase in the concentration of the active metabolite by 40% in blood plasma. The clinical significance of this effect remains unclear.

With the combined administration of the drug with fluvastatin (a weak inhibitor of the isoenzyme CYP2C9), the change in the concentration of the metabolite was not noted.

The experience of using other drugs acting on RAAS shows that concomitant therapy with potassium-sparing diuretics (spironolactone and its derivative eplerenone, triamterene, amiloride), potassium preparations, salt substitutes containing potassium, and other agents that can increase the potassium content in the blood plasma ( Eg heparin), can lead to the development of hyperkalemia. The antihypertensive effect of the drug may be weakened when combined with NSAIDs, including. Selective inhibitors of COX-2.

As with ACE inhibitors, co-administration of losartan and NSAIDs can lead to an increased risk of impaired renal function, including possible acute renal failure and hyperkalemia, especially in patients with an existing renal impairment. This combination should be taken with caution, especially in elderly patients. Patients receiving co-treatment with losartan and NSAIDs should receive an adequate amount of fluid and be under the supervision of a physician with simultaneous monitoring of renal function indicators.

The administration of concomitant therapy with an ACE inhibitor with ARAII should be limited to exceptional cases according to individual indications and performed against a background of strict monitoring of kidney function. The results of clinical studies showed that in patients with confirmed atherosclerosis, heart failure or diabetes with target organ damage, the double blockade of RAAS is associated with an increased risk of developing arterial hypotension, syncope, hyperkalemia and renal dysfunction (including acute renal failure) compared with Using inhibitors of RAAS alone.

Dosing and Administration

Inside, regardless of food intake. The drug Lozap« can be taken in combination with other antihypertensive drugs.

Arterial hypertension. The standard initial and maintenance dose for most patients is 50 mg of Lozap« once a day. The maximum antihypertensive effect is achieved in 3-6 weeks after the start of therapy. In some patients, to achieve a greater effect, the dose may be increased to a maximum daily dose of 100 mg of Lozap« once a day.

In patients with reduced BCC (for example, when taking large doses of diuretics), the initial dose of Lozap« should be reduced to 25 mg once a day (1/2 tablets at 50 mg, the tablet is at risk).

There is no need to select an initial dosage in patients with renal insufficiency, including patients on dialysis.

Patients with liver disease (more than 9 on the Child-Pugh scale) are recommended to prescribe lower doses of the drug in an anamnesis.

Typically, patients older than 75 years of treatment with Lozap« are advised to start with a dose of 25 mg / day (1/2 table at 50 mg, the tablet is at risk), however, it is not usually necessary to adjust the dosage for prescribing patients to the elderly.

CHF. The initial dose of Lozap« for patients with CHF is 12.5 mg once a day. Typically, the dose titrated with a 7-week interval (ie 12.5, 25, 50, 100 mg / day, and only this indication may increase to a maximum daily dose of 150 mg once a day), depending From individual tolerance.

Reduced risk of associated cardiovascular morbidity and mortality in patients with hypertension and left ventricular hypertrophy. The standard initial dose of Lozap« is 50 mg once a day. In the future, it is recommended to add hydrochlorothiazide at low doses or increase the dose of Lozap« to a maximum daily dose of 100 mg once a day, taking into account the degree of BP reduction.

Kidney protection in patients with type 2 diabetes mellitus and proteinuria. The standard initial dose of Lozap« is 50 mg once a day. In the future, it is recommended to increase the dose of Lozap« to a maximum daily dose of 100 mg once a day, taking into account the degree of BP reduction. The drug Lozap« can be prescribed in combination with other antihypertensive agents (diuretics, BCK α- and β-adrenoblockers, central-acting antihypertensives), insulin and other hypoglycemic agents (sulfonylureas, glitazones and α-glucosidase inhibitors).

Application in pediatrics. Safety and efficacy of the drug in children under 18 years of age have not been established.

Overdose

Symptoms: data on the overdose of losartan in humans are few. Analysis of the pharmacological properties of the drug suggests that the main manifestation of an overdose may be dizziness, tachycardia (bradycardia may result from parasympathetic (vagus) stimulation) and a clinically pronounced decrease in blood pressure, which can lead to loss of consciousness and collapse.

Treatment: with the development of clinically pronounced arterial hypotension, it is necessary to carry out symptomatic treatment and monitor the patient's condition. Lay the patient on his back, raise his legs. If necessary, the BCC should be increased, for example by intravenous administration of a 0.9% solution of sodium chloride. If necessary, sympathomimetic preparations may be prescribed. Elimination of losartan and its active metabolite by hemodialysis is ineffective.

Special instructions

Hypersensitivity. Patients with a history of Quinck's edema (swelling of the face, lips, throat and / or tongue) should be closely monitored.

Arterial hypotension and disturbances of water-electrolyte balance. Arterial hypotension with clinical manifestations, especially after taking the first dose or after increasing the dose, may occur in patients with hypovolemia and / or hyponatremia as a result of taking diuretics in high doses, diets with low table salt, diarrhea, or vomiting.

It is necessary either to correct these conditions before the administration of Lozap«, or to apply initial doses of the drug.

Water-electrolyte disturbances. Water-electrolyte disturbances are characteristic for patients with renal dysfunction in combination with or without diabetes mellitus and require correction. In a clinical study conducted with patients with type 2 diabetes mellitus with nephropathy, the incidence of hyperkalemia in the group receiving losartan was higher than in the placebo group. This indicates the need for constant monitoring of potassium content in the blood plasma and Cl creatinine values-especially patients with heart failure and Cl creatinine from 30 to 50 mL / min are particularly demanding.

The appointment of potassium-sparing diuretics, potassium and potassium-containing substitutes simultaneously with Lozap« is not recommended.

Violation of the function of the liver. Given the pharmacokinetics data suggesting a significant increase in losartan plasma concentration in patients with cirrhosis of the liver, patients with impaired hepatic function (more than 9 on the Child-Pugh scale) are recommended to prescribe the drug in lower doses. The experience of using the drug in patients with severe hepatic insufficiency is absent. In view of this, Lozap« is contraindicated in patients with severe hepatic insufficiency.

Impaired renal function. As a result of inhibition of RAAS against the background of treatment, there have been cases of impaired renal function, including renal failure (in particular, this is characteristic of patients whose kidney function depends on RAAS, for example, in severe heart failure and existing renal failure). As with the appointment of other drugs that affect RAAS, in patients with bilateral stenosis of the renal arteries or stenosis of the artery of a single kidney, there is an increase in the concentrations of urea and creatinine in the blood plasma. These changes may disappear upon cancellation of treatment. Caution should be exercised when administering Lozap« to patients with bilateral stenosis of the renal arteries or stenosis of the artery of a single kidney.

IHD and cerebrovascular disease. As with any antihypertensive drugs, a too sharp decrease in blood pressure in patients with IHD and cerebrovascular diseases can lead to myocardial infarction or ischemic stroke.

Heart failure. In patients with heart failure with or without kidney function, as with other drugs acting on RAAS, there is a risk of severe arterial hypotension and acute renal failure. Virtually no experience with losartan in treating patients with heart failure and concomitant severe renal insufficiency in patients with severe CHF (IV functional class according to the NYHA classification), as well as in patients with heart failure and life-threatening arrhythmias. With this in mind, caution should be exercised when assigning losartan to these patient categories.

Joint use with ACE inhibitors in CHF. When using Lozap« in combination with ACE inhibitors, the risk of side effects may increase, especially renal dysfunction and hyperkalemia (see "Side effects"). In these cases, careful monitoring and monitoring of laboratory indicators is necessary.

Hemodialysis. During hemodialysis, the sensitivity of AD to the action of antagonists of AT1 receptors increases as a result of a decrease in bcc and activation of RAAS. It is necessary to adjust the dose of Lozap« under careful monitoring of blood pressure in patients on hemodialysis.

Kidney transplantation. Data on the use of Lozap« in patients who have recently undergone kidney transplantation are not available.

General anesthesia. In patients receiving ARA II, during general anesthesia and during surgical interventions, arterial hypotension may result from blockade of RAAS. Very rarely there can be cases of severe arterial hypotension, requiring intravenous fluids and / or vasopressor drugs.

Stenosis of the aortic and mitral valve, hypertrophic obstructive cardiomyopathy. Care should be taken when using Lozap«, as well as other vasodilators, in patients with hypertrophic obstructive cardiomyopathy or hemodynamically significant stenosis of the aortic or mitral valve.

Primary hyperaldosteronism. Patients with primary hyperaldosteronism are usually resistant to therapy with antihypertensive drugs that affect RAAS. In this regard, the drug Lozap« is not recommended for such patients.

Elderly patients. Typically, patients older than 75 years of treatment with Lozap« should start with a dose of 25 mg / day.

Other special instructions and precautions. As the clinical experience with the use of ACE inhibitors, losartan and other antagonists of AT1 receptors shows, these drugs less effectively reduce blood pressure in patients of the Negroid race than in representatives of other races, possibly due to low renin activity in patients of this race.

Impact on the ability to manage vehicles and mechanisms. Not studied. When driving vehicles and practicing potentially dangerous activities that require an increased concentration of attention and speed of psychomotor reactions, it should be taken into account that when using the drug, dizziness, drowsiness and fainting can occur.

Release form

Tablets, film-coated, 12.5 mg, 50 mg, 100 mg. By 10 or 15 tables. In a blister of PVC / PVDC / Al or A1 / A1. By 2, 4 or 6 bl. (15 tables) or 3, 6 or 9 bl. (10 tab.) Are placed in a cardboard box.

Manufacturer

Manufacturer and packer (primary packaging). ZENTIVA as, Slovak Republic. 

Packer (secondary (consumer) packaging) and issuing quality control

1. ZENTIVA as, Slovak Republic. 

2. OJSC "Pharmstandard-Leksredstva"

Conditions of supply of pharmacies

On prescription.

Storage conditions of the drug Lozap

In the dark place at a temperature of no higher than 30 ░ C.

Keep out of the reach of children.

The shelf life of the drug Lozap

2 years.

Do not use beyond the expiration date printed on the package.

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