Renial (eplerenone) coated tablets 50 mg. №30

Description

Renial (eplerenone) coated tablets 50 mg. №30

Composition 

active ingredient: eplerenone;

1 tablet contains eplerenone in terms of 100% substance 25 mg or 50 mg;

excipients: lactose, monohydrate; cellulose microcrystalline; croscarmellose sodium; hypromelosis; sodium lauryl sulfate; talc; magnesium stearate; film shell: hypromelose, macrogol 400; polysorbate 80; titanium dioxide (E 171); iron oxide yellow (E 172); iron oxide red (E 172).

Dosage form

Film-coated tablets.

Basic physical and chemical properties: beige-colored tablets, round in shape with a biconvex surface, with the inscription “25” or “50” on one side of the tablet.

Pharmacological group

Potassium-sparing diuretics. Aldosterone antagonists. Eplerenone.
ATX code C03D A04.

Pharmacological properties

It is a potassium-sparing diuretic. The drug prevents the binding of the key hormone of the renin-angiotensin-aldosterone system – aldosterone, which is involved in the regulation of blood pressure, the pathophysiology of cardiovascular diseases.

Indications

Renial tablets is used as an adjunct to the standard optimal treatment:

• to reduce the risk of complications, mortality in patients with stable left ventricular dysfunction (with left ventricular ejection fraction less than 40%), clinical signs of heart failure after myocardial infarction;
• to reduce the risk of complications and mortality in adults with chronic heart failure (NYHA II) with left ventricular dysfunction (ejection fraction less than 30%).

Contraindications:

• with allergy to eplerenone, intolerance to excipients;
• with a plasma potassium level of more than 5 mmol / l at the time of initiation of therapy;
• with severe renal failure (with an estimated glomerular filtration rate of less than 30 ml / minute / 1.73 m2);
• with liver failure (class C on the Child-Pugh scale);
• while taking potassium preparations, potassium-sparing diuretics, powerful inhibitors of CYP 3A4 (ritonavir, itraconazole, ketoconazole, nelfinavir, telithromycin, clarithromycin, nefazodone).

Application during pregnancy and lactation

Renial tablets is not used during breastfeeding. For the treatment of pregnant women, it is used with caution.

Method of administration and dosage

The drug can be taken with food or with or without food.
For patients after myocardial infarction with the development of heart failure, a maintenance dose of 50 mg once a day is recommended. Treatment begins with a dose of 25 mg / day, which is gradually (preferably over four weeks) increased to the target of 50 mg / day, taking into account the level of potassium in the plasma. Typically, treatment begins 3-14 days after an acute heart attack.
Patients with chronic heart failure (NYHA II) start treatment with a dose of 25 mg once a day, gradually increasing it to the target – 50 mg / day.
The maximum dose is 50 mg / day.

Overdose

Probable manifestations: hyperkalemia, arterial hypotension.
Treatment: the appointment of activated carbon, supportive therapy.

Side effects:

• Infections / invasions: pharyngitis, pyelonephritis.
• Hematologic disorders: eosinophilia.
• Endocrine disorders: hypothyroidism.
• Metabolic disorders: hyperkalemia, dehydration, hypercholesterolemia, hyponatremia, hypertriglyceridemia.
• Mental disorders: insomnia.
• Neurological disorders: dizziness, headache, fainting, hypesthesia.
• Cardiovascular disorders: thrombosis of limb arteries, left ventricular failure, atrial fibrillation, tachycardia, orthostatic hypotension, arterial hypotension.
• Respiratory disorders: cough.
• Digestive disorders: dyspepsia, bloating.
• Dermatological disorders: hyperhidrosis, allergic reactions, angioedema.
• Musculoskeletal disorders: muscle spasms, back pain, pain in the musculoskeletal system.
• Urinary disorders: impaired renal function.
• Hepatobiliary Disorders: Cholecystitis.
• Genitourinary disorders: gynecomastia.
• General disorders: asthenia, malaise.
• Changes in laboratory parameters: hyperuricemia, hypercreatininemia, decreased EGFR levels, hyperglycemia.