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active ingredient: eplerenone;
1 tablet contains 25 mg eplerenone (calculated as 100% anhydrous substance);
excipients: lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, hypromelose, sodium lauryl sulfate, talc, magnesium stearate; film coating: Opadry yellow 15 B220000 (hypromelose, polysorbate 80, macrogol (PEG 400), titanium dioxide (E 171), iron oxide yellow (E 172)).
Addition to standard treatment with β-blockers to reduce the risk of cardiovascular morbidity and mortality in stable patients with left ventricular dysfunction (left ventricular ejection fraction ≤ 40%) and clinical signs of heart failure after a recent myocardial infarction . Adjunct to standard optimal therapy to reduce the risk of cardiovascular morbidity and mortality in adult patients with NYHA class II (chronic) heart failure and left ventricular dysfunction (left ventricular ejection fraction ≤ 30%).
Dosage & Administration
The drug can be used regardless of the meal.
Heart failure after myocardial infarction
Therapy is usually started within 3-14 days after an acute myocardial infarction.
The recommended maintenance dose is 50 mg 1 time per day. Treatment should be initiated at a dose of 25 mg 1 time a day followed by titration of the dose for 4 weeks until the target dose of 50 mg 1 time per day under the control of the level of potassium in the blood plasma, as shown in the table.
Chronic heart failure (II FC by NYHA)
Treatment should be initiated at a dose of 25 mg 1 time per day and titrated to the target dose of 50 mg 1 time a day for 4 weeks, taking into account the level of potassium in the blood plasma
Hypersensitivity to eplerenone or any other components of the drug;
clinically significant hyperkalemia or associated state (the potassium level in blood plasma> 5 mmol / L (mEq / L)) at the start of treatment;
severe renal insufficiency (creatinine clearance <30 mL / min);
severe hepatic insufficiency (class C Child-Pugh);
simultaneous use with other potassium-sparing diuretics, potassium supplements, or as powerful inhibitors of CYP 3A4, as ketoconazole, itraconazole, ritonavir, nelfinavir, clarithromycin, telithromycin, nefazodone;
triple combination with ACE inhibitors, angiotensin receptor blockers (ARBs) and eplerenone;
AG in conjunction with:
– Type II diabetes mellitus with microalbuminuria;
– Increased level of plasma creatinine> 2 mg / dL (177 mmol / l) in men and 1.8 mg / dL (159 mmol / L) – females.
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