Tablets "Inspra ^® " are applied at the following indications:

• addition to standard treatment using β-blockers for the purpose of the reduction of risk of incidence and lethality 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 lethality 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

Active ingredient - eplerenon (one tablet contains 50 mg of an eplerenon).

Excipients: lactose, monohydrate; microcrystalline cellulose; sodium of a kroskarmelloz; gipromelloza; sodium lauryl sulfate; talc; magnesium stearate; Opadry yellow YS-1-12524-A.

Contraindication

• hypersensitivity to active ingredient or to any of the excipients specified in the section "Structure";
• to patients with potassium level in blood serum> 5 mmol/l at the time of an initiation of treatment;
• to patients with a renal failure of heavy degree (rated speed of glomerular filtration <30 ml/minute / 1.73 m ² );
• to patients with a liver failure of heavy degree (class C on classification of Chayld-Pyyu);
• to the patients accepting kaliysokhranyayushchy diuretics or powerful CYP inhibitors 3A4 (for example itrakonazol, ketokonazol, ritonavir, nelfinavir, klaritromitsin, telitromitsin and nefazodon);
• simultaneous use of an eplerenon in a triple combination together with APF inhibitor and blockers of receptors of angiotensin.

Route of administration

Maximum daily dose makes 50 mg a day.

Eplerenon can be applied both with food, and irrespective of meal.

Patients with heart failure after the postponed myocardial infarction. The 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. Treatment eplerenony is usually begun in 3-14 days after an acute myocardial infarction.

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.

to Patients at whom potassium level in blood serum exceeds 5 mmol/l should not begin treatment eplerenony.

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

After an initiation of treatment a dose of medicament should be adjusted taking into account potassium concentration in blood serum.

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

whether gets eplerenon into breast milk after oral administration. As the potential of emergence of side effects at babies who are on breastfeeding, is not investigated, it is necessary to solve, to stop feeding by a breast or to stop medicament use, considering importance of medicament for mother.

Safety and efficiency of use of an eplerenon is not established to children by

.

Drivers

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 during control of motor transport or other mechanisms it is necessary to take into account a possibility of development of dizziness in connection with treatment.

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. In case of 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 effects

during two researches (EPHESUS and EMPHASIS-HF) it was shown that the general frequency of development of side reactions at use of an eplerenon and placebo was identical.

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

from metabolism and digestion: often (≥ 1/100 - <1/10) - a hyperpotassemia.

from mentality: often (≥ 1/100 - <1/10) - insomnia.

from nervous system: often (≥ 1/100 - <1/10) - faints, dizziness, a headache.

from heart: often (≥ 1/100 - <1/10) - a left ventricular failure, fibrillation of auricles.

from vessels: often (≥ 1/100 - <1/10) - hypotension.

from the respiratory system, bodies of a thorax and mediastinum: often (≥ 1/100 - <1/10) - cough.

from digestive tract: often (≥ 1/100 - <1/10) - diarrhea, nausea, a constipation, vomiting.

from skin and hypodermic fabrics: often (≥ 1/100 - <1/10) - rashes, an itching.

from a musculoskeletal system and connective tissues: often (≥ 1/100 - <1/10) - muscular spasms, dorsodynias.

from kidneys and urinary tract: often (≥ 1/100 - <1/10) - a renal failure.

to Store

out of children's reach. Special storage conditions are not required.

Expiration date - 3 years.