Adenocin (Lyophilisate) Instructions for Use

Marketing Authorization Holder

EGV-Pharma, LLC (Russia)

Manufactured By

Biotechpharm Ge, LLC (Georgia)

ATC Code

C01EX (Other combined drugs for the treatment of heart diseases)

Dosage Form

Adenocin

Lyophilizate for preparation of solution for intravenous and intramuscular administration: amp. 5, 10 and 20 pcs; vial 5, 10 and 20 pcs.

Dosage Form, Packaging, and Composition

Ampoules (5) – cardboard packs.
Ampoules (10) – cardboard packs.
Ampoules (20) – cardboard packs.
Vials (5) – cardboard packs.
Vials (10) – cardboard packs.
Vials (20) – cardboard packs.

Clinical-Pharmacological Group

Cardiotonic with cardioprotective action

Pharmacotherapeutic Group

Cardiotonic agent

Pharmacological Action

Adenocin is a cardiotonic agent with cardioprotective action, capable of arresting the three key links of the systemic inflammatory response syndrome: endotoxemia, tissue hypoxia, and dysfunction of the body’s own protective systems.

Adenocin stimulates ATP synthesis within the cell itself by disinhibiting glycolysis, stimulating the activity of the tricarboxylic acid cycle, and consequently, electron transport to oxygen. As a result, Adenocin eliminates the cell’s energy-deficient state, not only at rest but also under increased cardiac load.

It has a direct stimulating effect on the contractile and relaxation functions of the myocardium and restores calcium ion transport through the cardiomyocyte membrane. Adenocin significantly reduces the severity of congestion in the systemic and pulmonary circulation, reduces end-diastolic pressure, restores or significantly improves central hemodynamic parameters and heart geometry, reduces the degree of pulmonary hypertension and total peripheral vascular resistance.

It reduces myocardial oxygen demand, overcomes myocardial refractoriness to drug therapy even in severe forms of heart failure caused by non-coronary myocardial diseases and cardiosclerosis. The drug has a vasodilatory effect, improves microcirculation and collateral blood supply, and enhances diuresis. It prevents and relieves coronary spasm, reduces heart rate to normal, and stabilizes blood pressure values.

Pharmacokinetics

With intravenous administration, the bioavailability based on the main active ingredient (NAD) averages 85% (70-95%). The time to reach maximum concentration is 10-18 minutes after administration of 2 vials (ampoules) of Adenocin.

The largest portion of the dose is excreted within the first 4.5 hours after administration and is completely eliminated within 8 hours. T_1/2 averages 3.8 hours. It penetrates the blood-brain barrier.

In case of renal impairment (decreased creatinine clearance, 30-60 ml/min), toxic concentrations in the body are not reached. It is excreted primarily by the kidneys.

Indications

Adenocin is indicated for use in the complex therapy of

• chronic heart failure due to non-coronary myocardial diseases (myocarditis, dilated cardiomyopathy, cardiosclerosis), post-infarction cardiosclerosis, chronic coronary artery disease;
• Chronic heart failure after heart surgery and in preparation for heart transplantation, combined and isolated mitral and aortic defects;
• Ischemic cardiomyopathy,
• Cardiopulmonary failure,
• Tachyarrhythmic form of atrial fibrillation,
• Paroxysmal ventricular and supraventricular tachycardia,
• The drug may be used in cases where therapeutic doses of cardiac glycosides lead to the development of glycoside intoxication.

ICD codes

Dosage Regimen

Intravenously and intramuscularly!

Intravenously drip dilute the contents of 1-2 vials (ampoules) of Adenocin in 70-100 ml of 5% dextrose (glucose) or saline (in case of diabetes mellitus) and administer over 1 hour once or 2 times/day.

The maximum daily dose is up to 4 vials (ampoules) in 100 ml of 5% dextrose (glucose) twice/day, the maintenance dose upon stabilization of the condition (reduction of CHF symptoms and improvement of central hemodynamic parameters) is 1-2 vials (ampoules) intramuscularly in 5 ml of water for injection.

Intravenously bolus (very slowly) dilute the contents of 1-2 vials (ampoules) of Adenocin in 15-20 ml of 5% dextrose (glucose) or saline and administer over 15-20 minutes once or 2 times/day. The maximum daily dose is up to 4 vials (ampoules).

Intramuscularly: administer the contents of 1-2 vials (ampoules) of Adenocin, dissolved in 5 ml of water for injection, 1-3 times/day. The maximum daily dose is 8 vials (ampoules).

The course of treatment is 10-40 days depending on the severity of the disease, the severity of chronic heart failure symptoms, and the patient’s response to the therapy.

Repeated courses are recommended no more frequently than every 6 months, for CHF NYHA functional class III-IV every 3 months.

Adverse Reactions

Allergic reactions are possible.

Contraindications

• Pregnancy and lactation period;
• Age under 18 years;
• Hypersensitivity to the drug.

With caution in severe renal failure, creatinine clearance less than 30 ml/min (clinical experience is limited), with simultaneous therapy with cardiac glycosides, cardiotonic agents, antiarrhythmics.

Use in Pregnancy and Lactation

Contraindicated during pregnancy and lactation.

Use in Renal Impairment

With caution: in severe renal failure, creatinine clearance less than 30 ml/min (clinical experience is limited).

Pediatric Use

Contraindicated in children under 18 years of age.

Special Precautions

When used concomitantly with cardiac glycosides and other cardiotonic agents, antiarrhythmic drugs, and in malignant hypertension, monitoring of heart rate, blood pressure, and ECG is necessary.

Overdose

No information available.

Drug Interactions

Simultaneous therapy with nitrates (in various dosage forms), including long-acting ones, as well as anticoagulants, diuretics, oral hypoglycemic agents and/or insulin, “slow” calcium channel blockers, including nimodipine, beta-blockers, angiotensin-converting enzyme inhibitors and other antihypertensive agents, hypolipidemic agents, non-steroidal anti-inflammatory drugs and antibacterial agents of various classes, choline alfoscerate, potassium orotate, potassium chloride, prednisolone, analgesics, antihistamines, nootropics is possible.

Concomitant use with cardiotonic agents (dopamine, dobutamine), as well as antiarrhythmics only for special indications. When used concomitantly with antihypertensive agents, diuretics, their effect may be enhanced.

Storage Conditions

In a dry place, protected from light and out of reach of children, at a temperature from 0°C (32°F) to 10°C (50°F).

Shelf Life

Shelf life – 3 years.

Dispensing Status

By prescription.

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.