Decris 50
Cardiology

Decris 50

Decris

Decris is a drug that belongs to potassium-sparing diuretics. Recommended as adjunctive therapy in the treatment of dysfunction of the left ventricle of the heart and heart failure. Helps reduce the risk of complications and mortality in adult patients.

Information

Indications for use (instruction): Decris 50

Addition to 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 of the left ventricle ≤ 40%) and clinical signs of heart failure after a recent myocardial infarction .

Addition to standard optimal therapy to reduce the risk of morbidity and mortality associated with cardiovascular disease in adult patients with NYHA class II (chronic) heart failure and left ventricular dysfunction (left ventricular ejection fraction ≤ 30%).

How to use

The maximum daily dose is 50 mg per day.

Eplerenone can be taken with or without food.

Patients with heart failure after myocardial infarction. The recommended maintenance dose of eplerenone is 50 mg once daily. Treatment should begin with a dose of 25 mg once a day and gradually increase to a target dose of 50 mg once a day. It is advisable to achieve this dose level in 4 weeks, given the level of potassium in the blood serum. Treatment with eplerenone usually needs to be started 3–14 days after acute myocardial infarction.

Patients with heart failure class II (chronic) according to the NYHA classification.

The treatment of patients with NYHA class II chronic heart failure should begin with a dose of 25 mg once a day and gradually increase to a target dose of 50 mg once a day. It is advisable to achieve this dose level in 4 weeks, given the level of potassium in the blood serum.

Patients with serum potassium levels exceeding 5 mmol/L should not start treatment with eplerenone.

Serum potassium levels should be determined before starting treatment with eplerenone, during the first week of treatment, and one month after starting treatment or dose adjustment. If necessary, periodically determine the level of potassium in the blood serum throughout the treatment.

Elderly patients.

For elderly patients, there is no need to adjust the initial dose of the drug. Due to the age-related decrease in the intensity of renal function, the risk of developing hyperkalemia in elderly patients increases. The risk also increases in the presence of a concomitant disease, accompanied by an increase in systemic exposure of the drug, in particular impaired liver function of mild to moderate severity. Periodic monitoring of serum potassium levels is recommended.

Impaired renal function.

Patients with mild impaired renal function do not need an initial dose adjustment. It is recommended to periodically monitor the level of potassium in the blood serum and adjust the dose of the drug in accordance with the table above.

Patients with impaired renal function of moderate severity (creatinine clearance 30–60 mg/ml) should start with a dose of 25 mg once every 2 days and adjust the dose depending on the concentration of potassium. Periodic monitoring of serum potassium levels is recommended.

There is no experience with the use of the drug in patients with creatinine clearance <50 ml/min and heart failure after myocardial infarction. Eplerenone should be used with caution to treat such patients.

The use of doses exceeding 25 mg per day was studied in patients with creatinine clearance <50 ml/min.

Eplerenone is contraindicated in patients with severe kidney damage (creatinine clearance <30 ml/min). Eplerenone is not removed from the body by dialysis.

Impaired liver function.

Patients with mild or moderate hepatic impairment do not need to adjust the initial dose, but as a result of increasing the systemic exposure level of eplerenone in this category of patients, especially in elderly patients, it is recommended that frequent and regular monitoring of serum potassium concentration is performed.

Combined use.

In the case of simultaneous use with mild or moderate CYP3A4 inhibitors (for example, amiodarone, diltiazem and verapamil), treatment with eplerenone can be started with an initial dose of 25 mg once a day. The dose of the drug should not exceed 25 mg once a day.

Children.

There is no information that would make it possible to recommend the use of eplerenone in children. Therefore, the use of this age group of patients is not recommended.

Read more about the application in the instructions.

Contraindications

Hypersensitivity to eplerenone or to any of the excipients.

Serum potassium levels > 5 mmol/L at the start of treatment.

Severe renal failure (estimated glomerular filtration rate <30 ml/min / 1.73 m2).

Severe hepatic insufficiency (class C on the Child – Pugh scale).

Concomitant use of potassium-sparing diuretics, potassium preparations, or potent CYP3A4 inhibitors (e.g., itraconazole, ketoconazole, ritonavir, nelfinavir, clarithromycin, telithromycin, and nefazodone).

The simultaneous use of eplerenone in a triple combination with an ACE inhibitor and angiotensin receptor blockers.

Composition

Active ingredient: 1 tablet contains 50 mg of eplerenone.

Excipients: lactose, microcrystalline cellulose, croscarmellose sodium, hypromellose, sodium lauryl sulfate, talc, magnesium stearate.

Tablet shell: hypromellose, macrogol 400, polysorbate 80, titanium dioxide (E 171), iron oxide yellow (E172), iron oxide red (E172).

Release form

10 tablets in a blister, 3 blisters in a cardboard bundle.

Storage conditions

Store in the original packaging at a temperature not exceeding 25 °C. Keep out of the reach of children.

Manufacturer

Adamed Pharma S.A., ul. Marshal J. Pilsudski, 5, 95-200, Pabianice, Poland.

Sanitary and hygienic conclusion

No.464 dated 02.22.2019

Registration Certificate UA/13553/01/02

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