medicament "Dekriz" is used as:

• addition to standard treatment using beta-blockers for the purpose of the reduction of risk of incidence and mortality connected with cardiovascular diseases at stable patients with dysfunction of a left ventricle (fraction of emission of a left ventricle ≤ 40%) and clinical signs of heart failure after recently postponed myocardial infarction;
• addition to standard optimum therapy for the purpose of reduction of risk of the incidence and mortality connected with cardiovascular diseases at adult patients with heart failure of the II class (chronic) on classification by NYHA and dysfunction of a left ventricle (fraction of emission of a left ventricle ≤ 30%).

Structure

1 tablet contains 50 mg of an eplerenon (active ingredient).

Excipients: lactoses monohydrate, cellulose microcrystalline, sodium of a kroskarmelloz, gipromelloz, sodium lauryl sulfate, talc, magnesium stearate.

tablet Cover: gipromelloza, macrogoal 400, polysorbate 80, titan dioxide (E 171), ferrous oxide yellow (E172), ferrous oxide red (E 172).

Contraindication

Hypersensitivity to an eplerenon or to any of excipients.

potassium Level in blood serum> 5 mmol/l at the time of an initiation of treatment.

Renal failure of heavy degree (rated speed of glomerular filtration <30 ml/min. / 1.73м ² ).

Heavy liver failure (class C on a scale of Chayld-Pyyu).

Simultaneous use of kaliysberegayushchy diuretics, medicaments of potassium or powerful CYP3A4 inhibitors (for example an itrakonazola, a ketokonazola, a ritonavira, a nelfinavira, a klaritromitsina, a telitromitsina and a nefazodona) (see the section "Interaction with Other Medicines and Other Types of Interactions").

Simultaneous use of an eplerenon in a triple combination together with APF inhibitor and blockers of receptors of angiotensin.

Route of administration and doses

Tablet of medicament contain doses of 25 mg or 50 mg. The maximum daily dose makes 50 mg a day.

Eplerenon can be accepted both with food, and irrespective of meal (see the section "Pharmacokinetics").

Patients with heart failure after the postponed myocardial infarction. Recommended maintenance dose of an eplerenon makes 50 mg of 1 times a day. Treatment it is necessary to begin with a dose 25 mg of 1 times a day and to gradually increase to a target dose 50 mg of 1 times a day. It is desirable to reach this level of a dose in 4 weeks, considering potassium level in blood serum (see the table below). Treatment eplerenony needs usually to be begun in 3-14 days after an acute myocardial infarction.

Patients with heart failure of the II class (chronic) on classification of NYHA.

Treatment of patients with chronic heart failure of the II class on classification of NYHA should begin with

with a dose 25 mg of 1 times a day and to gradually increase to a target dose 50 mg of 1 times a day. It is desirable to reach this level of a dose in 4 weeks, considering potassium level in blood serum (see the table also the section "Features of Use" is lower).

to Patients at whom potassium level in blood serum exceeds 5 mmol/l should not begin treatment eplerenony (see the section "Contraindications").

potassium Level in serum should be determined by

prior to treatment eplerenony, during the first week of treatment and in a month after an initiation of treatment or dose adjustment. If necessary it is necessary to determine periodically potassium level in blood serum throughout all treatment.

After an initiation of treatment a dose of medicament should be adjusted taking into account potassium concentration in blood serum as it is provided in the table below.

Dose adjustment after an initiation of treatment.

to

Potassium concentration in blood serum (mmol/l)	Action	Dose adjustment
<5.0	Increase	From 25 mg of 1 times in 2 days up to 25 mg of 1 times a day From 25 mg of 1 times a day up to 50 mg of 1 times a day
5.0-5.4	Without changes	Dose is not changed
5.5-5.9	Decrease	From 50 mg of 1 times in day to 25 mg of 1 times in day From 25 mg of 1 times in day to 25 mg of 1 times in 2 days from 25 mg of 1 times in 2 days to temporary cancellation
≥ 6.0	Temporary cancellation	-

in ≥ 6 mmol/l restoration of treatment is possible

After temporary cancellation of an eplerenon because of increase in level of potassium in a dose of 25 mg of 1 times in 2 days after decrease in potassium concentration lower than the level of 5 mmol/l.

Pregnant

Adequate data on use of an eplerenon to pregnant women is not present

Feature of use

. The data received during the researches on animals do not indicate direct or indirect adverse influence on a pregnancy course, development of an embryo and fruit, childbirth and postnatal development. It is necessary to appoint eplerenon to pregnant women with care.

Feeding by a breast. It is unknown whether gets eplerenon into breast milk after oral administration. At the same time, data of preclinical trials confirm existence of an eplerenon and/or its metabolites in milk of rats and normal development of the cubs who were affected by an eplerenon as follows. As the potential of emergence of side effects at the babies who are on breastfeeding is not investigated, it is necessary to make the clinical decision on the feeding termination by a breast or medicament withdrawal depending on importance of medicament for mother.

Children

Data which would give the chance to recommend use of an eplerenon for children, no. Therefore use is not recommended to this age group of patients.

Drivers

did not carry out

Researches of influence of an eplerenon on ability to run motor transport or other mechanisms. Eplerenon does not cause drowsiness or disturbance of cognitive functions, but at control of motor transport or work with other mechanisms it is necessary to take into account a possibility of development of dizziness during medicament treatment.

by

Overdose

Messages about side reactions, connected with overdose of an eplerenon at people, it was not received. It is expected that the most probable manifestations of overdose the person will have an arterial hypotension or a hyperpotassemia. Eplerenon it is impossible to bring out of an organism by means of a hemodialysis. It was shown what eplerenon effectively contacts activated carbon. At development of arterial hypotension it is necessary to begin the supporting treatment. At development of a hyperpotassemia it is necessary to begin treatment according to standards.

Side reactions

are given by

Below side reactions which, perhaps, are connected with use of an eplerenon and which arose during treatment more often than at placebo use, or the serious side reactions arising at treatment more often than at placebo use or those that were described during post-marketing observation.

Side reactions are classified by

by the systems of bodies and for absolute frequency: very often (≥ 1/10), it is frequent (≥ 1/100 - <1/10), infrequently (≥ 1/1000 - <1/100), is rare (≥ 1/10000 - <1/1000), is very rare (<1/10000), it is unknown (it is impossible to establish, based on the available information).

Infection and invasion: infrequently - an infection, pyelonephritis, pharyngitis.

from the system of blood and lymphatic system: infrequently - an eosinophilia.

from an endocrine system: it is rare - a hypothyroidism.

from metabolism and digestion: it is frequent - a hyperpotassemia (see sections of "Contraindication" and "Features of Use"), a hypercholesterolemia; infrequently - a hyponatremia, dehydration, a gipertriglitseridemiya.

from mentality: it is frequent - insomnia.

from nervous system: it is frequent - dizziness, faints, a headache; infrequently - a hypesthesia.

from heart: it is frequent - a left ventricular failure, fibrillation of auricles; infrequently - tachycardia.

from vessels: it is frequent - hypotension; infrequently - thrombosis of arteries of extremities, orthostatic hypotension.

from the respiratory system, bodies of a thorax of mediastinum: it is frequent - cough.

from digestive tract: it is frequent - dyspepsia; infrequently - an abdominal distension.

from skin and hypodermic fabrics: it is frequent - allergic reactions; infrequently - a hyperhidrosis, a Quincke's disease.

from a musculoskeletal system and connective tissues: it is very frequent - muscular spasms, dorsodynias; infrequently - pain in a musculoskeletal system.

from kidneys and urinary tract: it is frequent - a renal failure (see the sections "Features of Use" and "Interaction with Other Medicines and Other Types of Interactions").

from a liver and biliary tract: infrequently - cholecystitis.

from a reproductive system and mammary glands: infrequently - a gynecomastia.

General disorders and disorders in the injection site of drug: it is frequent - an asthenia; infrequently - an indisposition.

Laboratory researches: it is frequent - increase in urea of blood; infrequently - increase in level of creatinine, decrease in number of receptors of an epidermal growth factor, increase in level of glucose of blood.

by

during the research EPHESUS noticed increase in quantity of cases of a stroke at elderly patients (≥ 75 years). However the significant difference between the frequency of cases of a stroke in group of an eplerenon and in group of placebo was not.

Storage conditions.

to Store

in original packing at a temperature not above 25 °C.

to Store

out of children's reach.

Expiration date - 3 years.