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medicalmeds.eu Medicines Angionezina II of receptors antagonist. Lozartan

Lozartan

Препарат Лозартан. РПУП "Академфарм" Республика Беларусь


Producer: RPUP "Akademfarm" Republic of Belarus

Code of automatic telephone exchange: C09CA01

Release form: Firm dosage forms. Tablets.

Indications to use: Arterial hypertension. Prevention of a stroke. Prevention of a myocardial infarction. Chronic heart failure.


General characteristics. Structure:

Active ingredient: 50 mg of a lozartan of potassium.

Excipients: cellulose microcrystallic, calcium гидрофосфатдигидрат, silicon dioxide colloid anhydrous, croscarmellose sodium, talc, magnesium stearate.

Structure of a cover: polyvinyl alcohol, macrogoal 3350, talc, titanium dioxide.

Anti-hypertensive means, reduces the general peripheric resistance of vessels (vascular resistance to a blood flow), reduces an afterload (blood pressure in an aorta due to decrease in peripheric vascular resistance to a blood flow), reduces the arterial pressure (AP). Reduces pressure in a small (pulmonary) circle of blood circulation, warns a delay of sodium and water in an organism. Increases tolerance to an exercise stress at patients with heart failure.




Pharmacological properties:

Pharmacodynamics. Is a synthetic antagonist of receptors of angiotensin II (AT1 type) for oral administration. Angiotensin II – a powerful vasoconstrictor – is the main active hormone a renin-angiotenzinovoy of system and the most important factor of a pathophysiology of arterial hypertension. Angiotensin II contacts the AT1 receptors which are in many fabrics (in unstriated muscles of vessels, in adrenal glands, kidneys and heart) where performs a number of important biological functions, including vasoconstriction and release of Aldosteronum. Angiotensin II also stimulates proliferation of cells of smooth muscles.

Lozartan selectively blocks AT1 receptors. Lozartan and him pharmacological the active metabolite (E-3174) is blocked by all physiologically significant effects of angiotensin II, irrespective of a source or a way of its synthesis. Lozartan has no agonistic effect and does not block the receptors of other hormones or ion channels playing an important role in regulation of function of cardiovascular system. Besides, лозартан does not suppress APF (a kinase of II), the enzyme splitting bradykinin. Therefore, there is no potentiation of the undesirable effects mediated by bradikinin.

At use of a lozartan elimination of negative back reaction of angiotensin II on secretion of a renin leads to increase in activity of a renin in a blood plasma (ARP). Increase in ARP leads to increase in concentration of angiotensin II in a blood plasma. Despite such increase, anti-hypertensive activity and decrease in concentration of Aldosteronum in a blood plasma remain that indicates effective blockade of receptors of angiotensin II. After phase-out of a lozartan indicators of ARP and angiotensin II within 3 days are returned to reference values.

And лозартан, and its main active metabolite have big affinity to AT1 receptors, than to AT2 receptors. The active metabolite is 10-40 times more active, than лозартан (at recalculation on weight).

Pharmacokinetics. Absorption. At intake лозартан well is soaked up and exposed to primary metabolism in a liver (effect of "the first passing") therefore the active carboxyl metabolite and other inactive metabolites are formed. System bioavailability of tablets of a lozartan makes about 33%. Average maximum concentration of a lozartan and its active metabolite are reached in 1 hour and in 3-4 hours respectively.

Distribution. Lozartan and his active metabolite contact proteins of a blood plasma (generally with albumine) more than for 99%. The volume of distribution of a lozartan makes 34 l.

Metabolism. About 14% of a dose of the lozartan entered intravenously or orally turn into its active metabolite. After peroral and intravenous administration of a lozartan, marked 14C, the radioactivity of the circulating blood plasma, as a rule, is connected with existence in it of a lozartan and its active metabolite. Lozartan in the minimum degree will be transformed to an active metabolite approximately at 1% of the inspected persons. In addition to an active metabolite biologically inactive metabolites, including two main metabolites which are formed as a result of a hydroxylation of a butyl side chain and one minor - a N-2-tetrazole-glucuronide are formed.

Removal. The plasma clearance of a lozartan and its active metabolite makes about 600 ml/min. and 50 ml/min., respectively. The renal clearance of a lozartan and its active metabolite makes about 74 ml/min. and 26 ml/min. respectively. At reception of a lozartan inside about 4% of a dose are removed in not changed view with urine, and about 6% of a dose are removed with urine in the form of an active metabolite. Pharmacokinetics of a lozartan and its active metabolite linear at oral administration of a lozartan of potassium in doses to 200 mg.

After intake plasma concentration of a lozartan and its active metabolite decrease polieksponentsialno with a final elimination half-life about 2 hours and 6-9 hours, respectively. At administration of drug in a dose of 100 mg of 1 times a day лозартан, its active metabolite significantly do not collect in a blood plasma.

Removal of a lozartan and its metabolites happens to bile and urine. After intake of a lozartan, marked 14C, about 35% of radioactivity it is found in urine also 58% - in Calais. After intravenous administration of a lozartan, marked 14C, about 43% of radioactivity also 50% - in Calais come to light in urine.

Pharmacokinetics at separate groups of patients. Concentration of a lozartan and its active metabolite in a blood plasma at elderly patients with arterial hypertension significantly do not differ from these indicators at young patients with arterial hypertension.

Concentration of a lozartan in a blood plasma at women with arterial hypertension are twice higher in comparison with the men having arterial hypertension. Concentration of an active metabolite at men and women do not differ.

Patients with alcoholic cirrhosis of easy and moderate severity have a concentration of a lozartan by 5 times, and than an active metabolite - is 1,7 times higher, than at healthy volunteers is a male.

Plasma concentration of a lozartan at patients with the clearance of creatinine (CC) higher than 10 ml/min. do not differ from those at persons with not changed function of kidneys. The area under a curve of concentration (AUC) of a lozartan at the patients who are on a hemodialysis approximately is twice more, than AUC at patients with normal renal function. Plasma concentration of an active metabolite do not change at patients with a renal failure or being on a hemodialysis.

Lozartan and his active metabolite are not brought from an organism by means of a hemodialysis.

Pharmacokinetics at children. The pharmacokinetics of a lozartan was investigated with participation of 50 patients of children's age having arterial hypertension aged from> 1 month to <16 years, after drug use in a dose from about 0,54 to 0,77 mg/kg (average doses) once a day.

Results showed that formation of an active metabolite of a lozartan happens in all age groups. According to the received results, pharmacokinetic parameters of a lozartan after oral administration are approximately identical at newborns and children up to 2 years, children of preschool, school age and teenagers. Pharmacokinetic parameters of a metabolite on age groups differed more. When comparing children of preschool age and teenagers this distinction became statistically significant. Newborns and children up to 2 years had rather high exposure.


Indications to use:

- arterial hypertension;
- decrease in risk of development of a stroke and myocardial infarction in patients with arterial hypertension and a hypertrophy of a left ventricle;
- protection of function of kidneys at patients with a diabetes mellitus 2 types and a proteinuria;
- chronic heart failure (at intolerance or inefficiency of treatment by APF inhibitors).


Route of administration and doses:

Pill is taken inside, washing down with a glass of water, irrespective of meal. Arterial. The standard initial and maintenance dose for most of patients makes 50 mg of 1 times a day. The maximum anti-hypertensive effect is reached in 3-6 weeks from the beginning of therapy. At some patients for achievement of bigger effect the dose can be increased to 100 mg of 1 times a day (morning).

Lozartan-Nan can be applied in combination with other anti-hypertensive means, especially with diuretics (for example, a hydrochlorothiazide).

Patients with arterial hypertension and a diabetes mellitus of the II type with a proteinuria ≥ 0,5 g/day. The standard initial dose of drug makes 50 mg of 1 times a day. The dose can be increased to 100 mg of 1 times a day, depending on the ABP indicators in 1 month after an initiation of treatment. Lozartan-Nan can be appointed in a combination with other anti-hypertensive means (diuretics, blockers of calcium channels, alpha both beta adrenoblockers and drugs of the central action), insulin and other widely used hypoglycemic means (derivatives of sulphonylurea, a glitazonama and inhibitors of glucosidase).

Decrease in risk of development of a stroke in patients with the arterial hypertension and a hypertrophy of a left ventricle confirmed with data of an ECG. The standard initial dose of drug makes 50 mg of 1 times a day. Further it is recommended to add a hydrochlorothiazide in low doses or to increase a dose to 100 mg of 1 times a day taking into account degree of a lowering of arterial pressure (ABP).

Separate groups of patients. The recommended correction of doses cannot be reached according to available forms of a dosage. Therefore, purpose of drug is not recommended to patients for whom lower initial doses are necessary.

Use for patients with a reduced volume of the circulating blood. For treatment of patients with a reduced volume of the circulating blood (for example, at reception of high doses of diuretics), it is necessary to consider a question of use of an initial dose of 25 mg of 1 times a day.

Use for patients with a renal failure and at the patients who are on a hemodialysis. Change of an initial dose is not required from patients with a renal failure and from the patients who are on a hemodialysis.

Use for patients with an abnormal liver function. Patients with liver diseases in the anamnesis are recommended to appoint lower doses of drug. Experience of use of drug for treatment of patients with heavy abnormal liver functions is absent therefore лозартан it is contraindicated to this group of patients.

Use for children and teenagers (6 – 18 years). Data on efficiency and safety of use of a lozartan for children and teenagers at the age of 6-18 years for treatment of arterial hypertension are limited. Also few data on pharmacokinetics at children with arterial hypertension are aged more senior than one month.

For children who can swallow of tablets and whose body weight makes> 20 kg and <50 kg the recommended dose makes 25 mg once a day. In exceptional cases the dose can be increased to maximum - 50 mg once a day. The dose should be adjusted depending on influence on the level of arterial pressure.

At patients with body weight> 50 kg the usual dose makes 50 mg once a day. In exceptional cases the dose can be increased to maximum - 100 mg once a day. Use of the doses exceeding 1,4 mg/kg (or more than 100 mg) in days, at children was not studied.

Use for patients of advanced age. As a rule, patients of advanced age have no need for correction of an initial dose of a lozartan though it is necessary to consider the possibility of use by an initial dose      of 25 mg at patients 75 years are more senior.


Features of use:

Hypersensitivity. Quincke's disease. Patients with a Quincke's disease (a face edema, lips, a throat, and/or language) have to be in the anamnesis under careful observation.

Arterial hypotension and disturbance of water and electrolytic balance. Symptomatic arterial hypotension, especially after reception of the first dose of drug or after increase in a dose, can arise at patients with a reduced intravascular volume and/or deficit of sodium owing to therapy by high doses of diuretics, diets with restriction of consumption of salt, diarrhea or vomiting. These states should be corrected before purpose of a lozartan or to use lower initial dose of drug. The same recommendations concern children aged from 6 up to 18 years.

Disturbances of electrolytic balance. Disturbances of electrolytic balance often meet patients renal failures (with a diabetes mellitus or without it) that it is necessary to take into account. In clinical trials in which patients with a diabetes mellitus of the II type with a nephropathy participated the frequency of emergence of a hyperpotassemia was higher in group, uses of a lozartan, than in the group receiving placebo. Thus, it is necessary to control carefully potassium concentrations in a blood plasma and indicators of clearance of creatinine, especially at patients with heart failure and clearance of creatinine of 30-50 ml/min.

Simultaneous use of kaliysoderzhashchy diuretics, diuretics, additives of potassium and kaliysoderzhashchy substitutes of salt with lozartany is not recommended.

Abnormal liver function. Proceeding from pharmacokinetic data which indicate substantial increase of concentration of a lozartan in a blood plasma at patients with cirrhosis it is necessary to use lower dose of drug at patients with abnormal liver functions in the anamnesis. There is no therapeutic experience of use of a lozartan for patients with heavy abnormal liver functions. Therefore лозартан it is not necessary to apply at patients with heavy abnormal liver functions

Lozartan-Nan is not recommended for treatment of children with abnormal liver functions.

Renal failure. Owing to inhibition a system renin-angiotenzinovoy, at administration of drug renal failures, including a renal failure were noted, (in particular, at patients at whom function of kidneys depends on activity of RAAS, for example, at patients with heavy heart failure or patients with the existing renal failure). As well as at use of other medicines making impact on RAAS it was reported about increase in concentration of urea in blood and creatinine in blood serum at patients with a bilateral stenosis of renal arteries or a stenosis of an artery of the only kidney. These changes of function of kidneys can be reversible after the therapy termination. Lozartan-Nan should be applied with care to treatment of patients with a bilateral stenosis of renal arteries or a stenosis of an artery of the only kidney.

Use for children with renal failures. It is not recommended to use drug for treatment of children with a glomerular filtration rate <30 ml/min. / 1,73 sq.m as data on experience of use in this group of patients are absent.

Throughout treatment lozartany it is regularly necessary to check function of kidneys as its deterioration is possible. Especially it concerns situations when лозартан apply in the presence of other morbid conditions (fever, dehydration) which can influence renal function.

Simultaneous use of a lozartan and APF inhibitors worsens function of kidneys therefore such combination is not recommended.

Transplantation of a kidney. There is no experience of use for the patients who recently transferred transplantation of a kidney.

Primary hyper aldosteronism. Patients with primary hyper aldosteronism in general will not answer therapy with the anti-hypertensive drugs operating by means of inhibition a system renin-angiotenzinovoy. Therefore use of a lozartan is not recommended.

Diseases of coronary arteries and cerebrovascular disease. As well as at use of other anti-hypertensive drugs, the excess lowering of arterial pressure at patients with an ischemic cardiovascular and cerebrovascular disease can lead to development of a myocardial infarction or stroke.

Heart failure. As well as at use of other drugs which influence a renin-angiotenzinovuyu system patients with heart failure with a renal failure or without it, have a risk of development of heavy arterial hypotension and (often acute) renal failure.

There is no sufficient therapeutic experience of use of a lozartan for patients with heart failure and the accompanying heavy renal failure, at patients with heavy heart failure (a class IV on NYHA classification), and also at patients with heart failure and symptomatic, life-threatening cardiac arrhythmia. Therefore лозартан it is necessary to apply with care in this group of patients. It is necessary to apply with care Lozartan-Nan in a combination with beta-blockers.

Stenosis of aortal and mitral valves, subaortic hypertrophic stenosis. As well as at use of other vazodilatator, with special care appoint drug to patients with a stenosis of aortal and mitral valves or a subaortic hypertrophic stenosis.

Special information on excipients. The drug Lozartan-NAN, tablets, coated, 100 mg contains lactose therefore patients are not recommended to appoint drug with intolerance of a galactose, deficit of lactase of Lapp or malabsorption of glucose galactose.
Other cautions and preventions
It is established that APF inhibitors, лозартан and other antagonists of angiotensin are much less effective for a lowering of arterial pressure at patients of negroid race, than at representatives of other races; perhaps, it is caused by the fact that among the patients of negroid race having arterial hypertension persons with the lowered maintenance of a renin prevail.

Use at pregnancy and in the period of a lactation
Pregnancy
Use of a lozartan is not recommended during the first trimester of pregnancy and it is contraindicated in the period of the second and third trimesters of pregnancy. Unless treatment lozartany is vital, the patients planning pregnancy have to be transferred to reception of alternative anti-hypertensive means with the established safety profile for use during pregnancy. At pregnancy confirmation treatment lozartany should be stopped immediately and, if necessary, to pass to alternative treatment.
It is known that use of antagonists of receptors of angiotensin II during the second and third trimesters of pregnancy induces a fetotoksichnost (weakening of function of kidneys, олигогидрамнион, a delay of ossification of bones of a skull) and neonatal toxicity (a renal failure, hypotension, a hyperpotassemia).
If during the second trimester of pregnancy antagonists of receptors of angiotensin II were applied, it is recommended to conduct ultrasonic examination for check of function of kidneys and a condition of bones of a skull.
For newborns whose mothers accepted лозартан, it is necessary to establish medical observation for the purpose of early detection and correction of arterial hypotension.
Feeding by a breast
As information on use of a lozartan during feeding by a breast is absent, it is not recommended to use this drug. Preferably alternative treatment with the established profiles of safety of use during feeding by a breast, especially when feeding newborn or premature children.

Use for children
It is not recommended to apply Lozartan-Nan to treatment of children under 6 years as data on experience of use in this age group are limited.
It is not recommended to use drug for treatment of children with a glomerular filtration rate <30 ml/min. / 1,73 sq.m as data on experience of use in this group of patients are absent.
Lozartan-Nan is also not recommended for use for children with abnormal liver functions.

Influence on ability to drive the car and potentially dangerous mechanisms
Data on influence of a lozartan on ability to manage transport or other technical means are absent. Nevertheless, it is necessary to consider that against the background of anti-hypertensive therapy dizziness or drowsiness, especially in an initiation of treatment or at increase in a dose of drug can arise drug.


Side effects:

During treatment by Lozartan-Nan's drug undesirable effects which are divided according to emergence frequency on can develop: very frequent (> 1/10); frequent (> 1/100 and <1/10); infrequent (> 1/1000 and <1/100); rare (> 1/10000 and <1/1000); very rare (<1/10000, including single messages).

Arterial hypertension. Disturbances from a nervous system: often – dizziness; infrequently – drowsiness, a headache, sleep disorders.

Disturbances from an acoustic organ and labyrinth disturbances: often – вертиго.

Disturbances from heart: infrequently - palpitation, stenocardia, tachycardia.

Disturbances from vessels: infrequently – symptomatic hypotension (especially at patients with a reduced volume of the circulating blood, for example patients with heavy heart failure or at treatment by diuretics in high doses), dozozavisimy orthostatic effect, rash.

Disturbances from respiratory system, bodies of a thorax and a mediastinum: infrequently – cough, a nose congestion, pharyngitis, diseases of bosoms, upper respiratory tract infections.

Disturbances from digestive tract: infrequently – an abdominal pain, a lock, diarrhea, dyspepsia, nausea.

Disturbances from skin and hypodermic fabrics: infrequently – rash.

Disturbances from skeletal and muscular and connecting fabric: infrequently – a dorsodynia, muscular spasms.

The general frustration and disturbances in an injection site: infrequently – an adynamy, increased fatigue, hypostases, thorax pain.

Influence on results of laboratory and tool researches: often – a hyperpotassemia; seldom – increase in activity of alaninaminotranspherase (ALT), usually reversible after drug withdrawal.

Patients with arterial hypertension and a hypertrophy of a left ventricle. Disturbances from a nervous system: often – dizziness.

Disturbances from an acoustic organ and labyrinth disturbances: often – вертиго.

The general frustration and disturbances in an injection site: often – an adynamy, increased fatigue.

Chronic heart failure. Disturbances from blood and lymphatic system: often – anemia.

Disturbances from a nervous system: often – dizziness; infrequently – a headache; seldom – paresthesia.

Disturbances from heart: seldom – a syncope, fibrillation of auricles, a stroke.

Disturbances from vessels: often – hypotension, including orthostatic hypotension.

Disturbances from respiratory system, bodies of a thorax and a mediastinum: infrequently – диспноэ, cough.

Disturbances from digestive tract: infrequently – diarrhea, nausea, vomiting.

Disturbances from skin and hypodermic fabrics: infrequently – urticaria, an itch, rash.

Disturbances from kidneys and urinary tract: often – a renal failure, a renal failure.

The general frustration and disturbances in an injection site: infrequently – an adynamy, increased fatigue.

Influence on results of laboratory and tool researches: often – increase in level of urea in blood, creatinine and potassium in blood serum, infrequently – a hyperpotassemia (it is frequent – at the patients receiving лозартан in a dose of 150 mg instead of 50 mg).

Arterial hypertension and diabetes mellitus of the II type in combination with a disease of kidneys. Disturbances from a nervous system: often – dizziness.

Disturbances from vessels: often – hypotension.

The general frustration and disturbances in an injection site: often – an adynamy, increased fatigue.

Influence on results of laboratory and tool researches: often – a hypoglycemia, гиперкалиемия*.

* During the clinical trials conducted with participation of patients with a diabetes mellitus of the II type in combination with a nephropathy, a hyperpotassemia> 5,5 mmol/l it was revealed at 9,9% of the patients receiving лозартан and at 3,4% receiving placebo.

The following side reactions arose more often at patients who applied лозартан, than patients have groups of placebo.

Disturbances from blood and lymphatic system: frequency is unknown – anemia.

Disturbances from heart: frequency is unknown – a syncope, palpitation.

Disturbances from vessels: frequency is unknown – orthostatic hypotension.

Disturbances from digestive tract: frequency is unknown – diarrhea.

Disturbances from skeletal and muscular system and connecting fabric: frequency is unknown – a dorsodynia.

Disturbances from kidneys and urinary tract: frequency is unknown – infections of urinary tract.

The general frustration and disturbances in an injection site: frequency is unknown – grippopodobny symptoms.

Experience of post-registration use. Disturbances from blood and lymphatic system: frequency is unknown – anemia, thrombocytopenia.

Disturbances from immune system: seldom – hypersensitivity reactions, anaphylactic reactions, a Quincke's disease (including the hypostasis of a throat and glottis causing obstruction of respiratory tracts and/or a face edema, lips, a throat and/or language), At a number of patients the Quincke's disease developed earlier at reception of other medicines, including APF inhibitors; a vasculitis, including Shenleyna-Genokh's purpura.

Disturbances of mentality: frequency is unknown – a depression.

Disturbances from a nervous system: frequency is unknown – migraine, a dysgeusia.

Disturbances from an acoustic organ and labyrinth disturbances: frequency is unknown – a ring in ears.

Disturbances from respiratory system, bodies of a thorax and a mediastinum: frequency is unknown – cough.

Disturbances from digestive tract: frequency is unknown – diarrhea, pancreatitis, vomiting.

Disturbances from a liver and biliary tract: seldom – hepatitis; frequency is unknown – an abnormal liver function.

Disturbances from skin and hypodermic fabrics: frequency is unknown – urticaria, an itch, rash, photosensitivity, an erythrosis.

Disturbances from skeletal and muscular and connecting fabric: frequency is unknown – a mialgiya, an arthralgia, рабдомиолиз.

Disturbances from kidneys and urinary tract: owing to inhibition system renin-angiotensin-aldosteronovoy, it was reported about changes of function of kidneys, including a renal failure, patients have risk groups; these changes of function of kidneys can be reversible after therapy cancellation.

Disturbances from generative organs and a mammary gland: frequency is unknown – erectile dysfunction / impotence.

The general frustration and disturbances in an injection site: frequency is unknown – an indisposition.

Influence on results of laboratory and tool researches: frequency is unknown – a hyponatremia.

Children. The profile of side reactions at children is similar to a profile at adult patients. Data on side reactions at children are limited.


Interaction with other medicines:

Other anti-hypertensive means can strengthen hypotensive effect of a lozartan. Simultaneous use with other drugs capable to lower arterial pressure (tricyclic antidepressants, neuroleptics, Baclofenum, амифостин), can increase risk of developing of hypotension.

Lozartan is metabolized preferential with the participation of system of P450 (CYP) cytochrome 2C9 to active carboxy - an acid metabolite. Flukonazol (CYP2C9 inhibitor) and rifampicin (the inductor of enzymes of metabolism) reduce concentration of an active metabolite in a blood plasma approximately by 50% and 40% respectively. Clinical value of this effect is unknown. At simultaneous use of a lozartan and fluvastatin (weak CYP2C9 inhibitor), distinctions in concentration of drug were not observed.

The accompanying purpose of kaliysberegayushchy diuretics (Spironolactonum, Triamterenum, amiloride), the potassium additives and salts containing potassium can lead to increase in level of potassium in blood serum. Simultaneous use of these means is not recommended

Treatment by Lozartan-Nan's drug can be followed by decrease in excretion and increase in serumal concentration of lithium therefore at simultaneous treatment with drugs of lithium it is necessary to control its serumal concentration.

At co-administration of antagonists of angiotensin II and non-steroidal anti-inflammatory drugs (NPVS), including the selection inhibitors of cyclooxygenase-2 (TsOG-2), acetylsalicylic acid in antiinflammatory doses and non-selective NPVS, weakening of anti-hypertensive action can be observed. Combined use of antagonists of angiotensin II or diuretics and NPVS can increase risk of development of a renal failure, including risk of development of an acute renal failure, and also to lead to increase in content of potassium in blood serum, in particular at patients with the existing renal failures. This combination of drugs has to be appointed with care, in particular to elderly people. Patients have to use enough liquid, also after the beginning of a combination therapy it is necessary to carry out control of function of kidneys, and further to carry out it regularly.

Double blockade the system renin-angiotensin-aldosteronovoy (SRAA) (for example, by addition of APF inhibitor to the antagonist of a receptor of angiotensin II) is associated with the increased risk of development of arterial hypotension, a hyperpotassemia and a renal failure (including development of an acute renal failure) in comparison with monotherapy. Regular control of the ABP, function of kidneys and content of electrolytes in blood at the patients accepting at the same time Lozartan-Nan and other means influencing RAAS is necessary. Use of a lozartan with aliskireny at patients with a diabetes mellitus is contraindicated. It is necessary to avoid simultaneous use of drug of Lozartan-Nan and an aliskiren for patients with a renal failure (a glomerular filtration rate less than 60 ml/min.).


Contraindications:

Hypersensitivity to drug components, pregnancy, the lactation period, children's and teenage age up to 18 years.


Overdose:

Symptoms: the expressed decrease in the ABP, tachycardia, bradycardia.

Treatment: When developing symptomatic arterial hypotension it is necessary to carry out a maintenance therapy. Medical actions depend on time which passed from the moment of administration of drug, type and weight of symptoms. A priority is stabilization of work of cardiovascular system. In case of overdose at use of drug it is inside recommended to accept enough absorbent carbon. After that it is necessary to control carefully vital signs and to adjust them if necessary.

лозартан, its active metabolite are not removed from an organism by means of a hemodialysis.


Storage conditions:

In the place protected from light and moisture, at a temperature not over 25 ºС. To store in the place, unavailable to children. Period of validity 2 years.


Issue conditions:

According to the recipe


Packaging:

Tablets, coated, 100 mg. On 10 or 15 tablets in a blister strip packaging. 3 blister strip packagings on 10 tablets or 2 blister strip packagings on 15 tablets with the instruction on a medical use place in a cardboard pack.



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