Medicinal Products

EPLERENONE PFIZER 50 mg

Generic drug from Inspra
Therapeutic class: Cardiology and angiology
active ingredients: Eplerenone, Eplerenone
laboratory: Pfizer Pfe France

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 treatment, to reduce the risk of cardiovascular morbidity and mortality in adult patients with NYHA II (chronic) heart failure with left ventricular systolic dysfunction (LVEF ≤ 30%) (see section 5.1). ).

Dosage EPLERENONE PFIZER 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 treatment, to reduce the risk of cardiovascular morbidity and mortality in adult patients with NYHA II (chronic) heart failure with left ventricular systolic dysfunction (LVEF ≤ 30%) (see section 5.1). ).

Against indications

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

· Patients with serum potassium> 5.0 mmol / L when initiating 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, potassium supplements or potent CYP3A4 inhibitors (eg itraconazole, ketoconazole, ritonavir, nelfinavir, clarithromycin, telithromycin and nefazodone) (see section 4.2) . other drugs and other forms of interaction ),

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

Side effects Eplerenone Pfizer

In two studies (Eplerenone Post-acute Myocardial Infarction Heart Failure Efficiency and Survival Study [EPHESUS] and Eplerenone in Mild Patients Hospitalization and Survival Study in Heart Failure [EMPHASIS-HF]), the overall incidence of adverse effects described with eplerenone was similar to that seen with placebo. The most commonly reported adverse event in the EMPHASIS-HF study is hyperkalemia with an incidence of 8.7% and 4% for eplerenone and placebo, respectively.

The following are the observed adverse reactions for which a link with the treatment is suspected and whose incidence is greater than that observed with placebo, or serious adverse events whose incidence is significantly greater than that observed with placebo, either during post-marketing surveillance. Adverse effects 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).

MedDRA Organ System Class

Adverse reaction

Infections and infestations

Frequent

infection

Rare

pyelonephritis, 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 )

Rare

hyponatremia, dehydration, hypercholesterolemia, hypertriglyceridemia

Psychiatric disorders

Rare

insomnia

Nervous system disorders

Frequent

dizziness, syncope

Rare

headache, hypoaesthesia

Heart conditions

Frequent

myocardial infarction

Rare

left heart failure, atrial fibrillation, 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

Rare

vomiting, flatulence

Skin and subcutaneous tissue disorders

Frequent

rash, pruritus

Rare

hyperhidrosis

Not known frequency

Quincke's edema

Musculoskeletal and systemic disorders

Frequent

muscle spasm, musculoskeletal pain

Rare

back 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

Rare

asthenia, malaise

investigations

Frequent

elevation of urea in the blood

Rare

increased serum creatinine, 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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