active ingredient: eplerenone; 1 tablet contains eplerenone in terms of 100% substance 25 mg or 50mg; excipients: lactose, monohydrate; cellulose microcrystalline; croscarmellose sodium; hypromelosis; sodium lauryl sulfate; talc; magnesium stearate; film shell: hypromelose, macrogol 400; polysorbate 80; titanium dioxide (E 171); iron oxide yellow (E 172); iron oxide red (E 172).
– Additions to the standard treatment with beta blockers to reduce the risk of morbidity and mortality associated with cardiovascular disease in stable patients with left ventricular dysfunction (ejection fraction ≤ 40%) and clinical signs of heart failure after recent myocardial myocardial infarction.
– Addition to standard optimal therapy to reduce the risk of morbidity and mortality associated with cardiovascular diseases in adult patients with heart failure class II (chronic) NYHA classification and left ventricular dysfunction (ejection fraction ≤ 30%).
– Hypersensitivity to eplerenone or to any of the excipients;
– The level of potassium in the blood serum> 5 mmol / L at the start of treatment;
– Severe renal insufficiency (estimated glomerular filtration rate <30 mL / min / 1.73 m2);
– Severe hepatic insufficiency (class C classification Child-Pugh);
– Treatment with potassium-sparing diuretics, kaliyevmisnymy additives or potent inhibitors CYP3A4 (eg itraconazole, ketoconazole, ritonavir, nelfinavir, clarithromycin, telithromycin and nefazodone) (see. Section “Interaction with other medicinal products and other forms of interaction”);
– Simultaneous use of eplerenone in triple combination with ACE inhibitors and angiotensin receptor blockers.
Dosage & Administration
The product exists in doses of 25 mg and 50 mg. The maximum daily dose is 50 mg.
Eplerenone can be taken with food, and regardless of the meal (see. Section “Pharmacokinetics”).
Patients with heart failure after myocardial infarction.
The recommended maintenance dose of eplerenone 50 mg 1 time a day. Treatment should be initiated at a dose of 25 mg 1 time per day and gradually increase to the target dose of 50 mg 1 time a day. It is desirable to achieve the target dose for 4 weeks, given the level of potassium in the blood serum. Treatment usually eplerenone should begin by 3-14 days after acute myocardial infarction.
Patients with heart failure class II (chronic) NYHA classification.
Treatment of patients with chronic heart failure class II NYHA classification should be started at a dose of 25 mg 1 time per day and gradually increase to the target dose of 50 mg 1 time a day. It is desirable to achieve the target dose for 4 weeks, given the level of potassium in the blood serum
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