Medicinal Products

EPLERENONE CRISTERS 50 mg

Generic drug from Inspra
Therapeutic class: Cardiology and angiology
active ingredients: Eplerenone, Eplerenone
laboratory: Cristers

Coated tablet
box of 30
All forms

Indication

Eplerenone is indicated:

· In addition to standard treatments including beta-blockers, to reduce the risk of cardiovascular morbidity and mortality in stable patients with left ventricular dysfunction (LVEF ≤ 40%) and clinical signs of heart failure after recent myocardial infarction ;

· In addition to standard optimal therapy, to reduce the risk of cardiovascular morbidity and mortality in adult patients with New York Heart Association (NYHA) stage II heart failure (chronic) with left ventricular systolic dysfunction (LVEF ≤ 30) %) (see section Pharmacodynamic properties ).

Dosage EPLERENONE CRISTERS 50 mg film-coated tablet box of 30

Eplerenone is indicated:

· In addition to standard treatments including beta-blockers, to reduce the risk of cardiovascular morbidity and mortality in stable patients with left ventricular dysfunction (LVEF ≤ 40%) and clinical signs of heart failure after recent myocardial infarction ;

· In addition to standard optimal therapy, to reduce the risk of cardiovascular morbidity and mortality in adult patients with New York Heart Association (NYHA) stage II heart failure (chronic) with left ventricular systolic dysfunction (LVEF ≤ 30) %) (see section Pharmacodynamic properties ).

Against indications

Hypersensitivity to the active substance or to any of the excipients listed under Composition ;

· Patients with serum potassium> 5.0 mmol / L at initiation of treatment;

· Patients with severe renal impairment (GFR <30 ml per minute per 1.73 m 2 );

· Patients with severe hepatic impairment (Child-Pugh Class C);

· Patients receiving potassium-sparing diuretics, potash supplements or potent CYP3A4 inhibitors (eg itraconazole, ketoconazole, ritonavir, nelfinavir, clarithromycin, telithromycin and nefazodone) (see section Interactions with other drugs and other forms of interaction );

· Combination with a conversion enzyme inhibitor (ACE) and an angiotensin II receptor antagonist (AIAS).

Adverse effects Eplerenone Cristers

In two studies (EPHESUS and EMPHASIS-HF), the overall incidence of adverse events described with eplerenone was similar to that seen with placebo.

Below are the adverse events observed in these two studies (adverse events for which a link with the treatment is suspected and whose incidence is higher than that observed with placebo, or serious adverse events whose incidence is significantly greater than that observed with placebo), ie during post-marketing surveillance. Adverse events are classified by organ system and absolute frequency. Frequencies are defined as follows:

· Very common (≥1 / 10)

· Frequent (≥1 / 100, <1/10)

· Uncommon (≥1 / 1, 000, <1/100)

· Rare (≥1 / 10, 000, <1/1000)

· Very rare (<1 / 10, 000)

· Not known (can not be estimated from the available data).

Table 2: Frequency of Adverse Events in Placebo-Controlled Studies with Eplerenone

MedDRA Organ System Class

Adverse reaction

Infections and infestations

Rare

pyelonephritis, infection, pharyngitis

Blood and lymphatic system disorders

Rare

eosinophilia

Endocrine disorders

Rare

hypothyroidism

Metabolism and nutrition disorders

Frequent

hyperkalemia (see sections Contraindications and Warnings and precautions for use ), hypercholesterolemia

Rare

hyponatremia, dehydration, hypertriglyceridemia

Psychiatric disorders

Frequent

insomnia

Nervous system disorders

Frequent

dizziness, syncope, headache

Rare

hypoaesthesia

Heart conditions

Frequent

myocardial infarction, left heart failure, atrial fibrillation

Rare

tachycardia

Vascular disorders

Frequent

hypotension

Rare

arterial thrombosis of the limbs, orthostatic hypotension

Respiratory, thoracic and mediastinal disorders

Frequent

cough

Gastrointestinal disorders

Frequent

diarrhea, nausea, constipation, vomiting

Rare

flatulence

Skin and subcutaneous tissue disorders

Frequent

rash, pruritus

Rare

hyperhidrosis, angioedema

Musculoskeletal and systemic disorders

Frequent

muscle spasm, back pain

Rare

musculoskeletal pain

Renal and urinary disorders

Frequent

renal impairment (see sections Warnings and precautions for use and Interactions with other medicinal products and other forms of interaction )

Hepatobiliary disorders

Rare

cholecystitis

Disorders of reproductive organs and breast

Rare

gynecomastia

General disorders and administration site conditions

Frequent

asthenia

Rare

discomfort

investigations

Frequent

elevation of urea in the blood, elevation of serum creatinine

Rare

decreased epidermal growth factor receptors, increased blood glucose

In the EPHESUS study, a larger number of cases of stroke were observed in the very elderly group (≥ 75 years). Nevertheless, there was no statistically significant difference between the eplerenone (30) and placebo (22) groups in the occurrence of stroke. In the EMPHASIS-HF study, the number of stroke cases among very old people (≥ 75 years) was 9 in the eplerenone group and 8 in the placebo group.

Reporting of suspected adverse reactions

The reporting of suspected adverse reactions after authorization of the drug is important. It allows continuous monitoring of the benefit / risk ratio of the drug. Health professionals declare any suspected adverse reaction via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and the network of Regional Pharmacovigilance Centers - Website: www.ansm.sante.fr.

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