Medicinal Products

EPLERENONE MYLAN 25 mg

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

Coated tablet
box of 90
All forms

Indication

Eplerenone is indicated:

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

· To reduce the risk of cardiovascular mortality and morbidity, in addition to optimal standard therapy, in NYHA Class II adult patients - heart failure (chronic) and left ventricular systolic dysfunction (LVEF ≤ 30%) (see section 5.1). .

Dosage EPLERENONE MYLAN 25 mg film-coated tablet box of 90

Eplerenone is indicated:

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

· To reduce the risk of cardiovascular mortality and morbidity, in addition to optimal standard therapy, in NYHA Class II adult patients - heart failure (chronic) and 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 at initiation of treatment;

· Patients with severe renal impairment (eGFR <30 ml / min 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 such as itraconazole, ketoconazole, ritonavir, nelfinavir, clarithromycin, telithromycin and nefazodone (see section Interactions with other drugs) drugs and other forms of interaction );

Combination of an angiotensin converting enzyme (ACE) inhibitor and an angiotensin receptor antagonist (ARB) with eplerenone.

Adverse effects Eplerenone Mylan

In two studies (E p er eno Pos t - Acu te M y oca rdi al I nfarc ti on H e art Fa ilure E f fi ca cy and Su rvi val S t udy [EP HESUS] and the '' '' '' '' '' '' '' '' '' '' '' '' '' '' '' '' '' '' '' '' '' '' '' '' '' '' '' '' '' '' '' '' '' '' '' '' '' '' '' '' '' '' '' '' '' '' '' '' '' '' '' '' '' '' '' '' '' '' '' '' '' '' '' '' '' '' '' '' '' '' '' '' '' '' '' '. dence gl a ob 'é é v v v v v v.......................................... The event was held in the context of the EMP HASIS -H Fé was the hypèlka li é mea with a t un p e n io n ce p e n 8%, 7% and 4% for the er ero and the bo bo.

Below are adverse events for which a relationship with the treatment is suspected and whose incidence is greater than that observed with placebo, or which are considered to be serious with a significantly higher incidence than with placebo, or observed during post-marketing surveillance. Adverse events are classified by organ systems and absolute frequencies. Frequencies are defined as follows:

Frequent (1/100 to <1/10).

Uncommon (1/1000 to <1/100).

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

MedDRA classes of organ systems

Junk event

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 ventricular failure, fibrillation

auricular, tachycardia

Vascular disorders

Frequent

hypotension

Rare

arterial thrombosis of a limb, 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

increased sweating

Not known frequency

angioedema

Musculoskeletal and systemic disorders

Frequent

muscle spasms, 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 creatinine in the blood, decreased epidermal growth factor receptors, increased blood glucose

In the EPHESUS study, cases of stroke were numerically higher in the group of very elderly patients (³ 75 years). There was no statistically significant difference in the occurrence of cerebrovascular accidents in the eplerenone group (30) compared to the placebo group (22). In the EMPHASIS-HF study, the number of strokes in the very elderly group (³ 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.

Popular Posts

Category Medicinal Products, Next Article