Medicinal Products

EPLERENONE ARROW 25 mg

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

Coated tablet
box of 90 precut platelets of 1
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 ARROW 25 mg film-coated tablet box of 90 precut platelets of 1

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 eplerenone or 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 (AIAS).

Side Effects Eplerenone Arrow

In two studies (Eplerenone Post-acute Myocardial Infarction Heart Failure Efficacy and Survival Study [EPHESUS] and Eplerenone in Mild Patients Hospitalization and Survival Study in Heart Failure [EMPHASIS-HF]), the overall incidence of adverse events described with eplerenone was similar to that seen with placebo.

The most frequently reported adverse event in the EMPHASIS-HF study is hyperkalemia with an incidence of 8.7% and 4% for eplerenone and placebo, respectively.

Below are the adverse events observed in these two studies (adverse events for which a relationship 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: Frequent:> 1/100, 1/1000, <1/100; indeterminate frequency (can not be estimated based on available data).

Infections and infestations

Frequent: infection.

Uncommon: pyelonephritis, pharyngitis.

Hematologic and lymphatic system disorders

Uncommon: eosinophilia.

Endocrine disorders

Uncommon: hypothyroidism.

Metabolism and nutrition disorders

Frequent: hyperkalemia (see sections Contraindications and Warnings and Precautions for Use ).

Uncommon: hyponatremia, dehydration, hypercholesterolemia, hypertriglyceridemia.

Psychiatric disorders

Uncommon: insomnia.

Nervous system disorders

Common: dizziness, fainting

Uncommon: headache, hypoaesthesia.

Cardiac disorders

Frequent: myocardial infarction.

Uncommon: left heart failure, atrial fibrillation, tachycardia.

Vascular disorders

Common: hypotension

Uncommon: Arterial thrombosis of the limbs, orthostatic hypotension.

Respiratory, thoracic and mediastinal disorders

Frequent: coughing

Gastrointestinal disorders

Common: diarrhea, nausea, constipation

Uncommon: vomiting, flatulence.

Skin and subcutaneous tissue disorders

Common: rash, pruritus.

Uncommon: Hyperhydrosis

Not known: Quincke's edema.

Musculoskeletal and Connective Tissue Disorders

Frequent: muscle spasm, musculoskeletal pain.

Uncommon: back pain.

Renal and urinary disorders

Common: Renal impairment (see Warnings and Precautions and Interactions with other medicinal products and other forms of interactions ) sections.

Hepatobiliary disorders

Uncommon: cholecystitis.

Disorders of reproductive organs and breast

Uncommon: Gynecomastia.

General disorders and administration site conditions

Uncommon: asthenia, malaise.

investigations

Frequent: elevation of urea in the blood.

Uncommon: Increased 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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