Miljen (Solution) Instructions for Use

Marketing Authorization Holder

LIFE SCIENCES OHFK, LLC (Russia)

Manufactured By

Ferment Firm, LLC (Russia)

ATC Code

C01EB (Other drugs for the treatment of heart diseases)

Active Substance

Meldonium (Rec.INN registered by WHO)

Dosage Form

Miljen

Solution for injection 100 mg/ml: 5 ml amp. 5 or 10 pcs.

Dosage Form, Packaging, and Composition

Solution for injection as a transparent colorless liquid.

Excipients: water for injections – up to 1 ml.

5 ml – ampoules (5) – cardboard packs.
5 ml – ampoules (10) – cardboard packs.

Clinical-Pharmacological Group

A drug that improves tissue metabolism and energy supply

Pharmacotherapeutic Group

Metabolic agent

Pharmacological Action

A metabolic-improving agent, an analog of gamma-butyrobetaine. It inhibits gamma-butyrobetaine hydroxylase, suppresses the synthesis of carnitine and the transport of long-chain fatty acids across cell membranes, and prevents the accumulation of activated forms of non-oxidized fatty acids – derivatives of acylcarnitine and acylcoenzyme A in cells.

Under ischemic conditions, it restores the balance of oxygen delivery and consumption processes in cells, prevents disruption of ATP transport; simultaneously, it activates glycolysis, which proceeds without additional oxygen consumption. As a result of the decrease in carnitine concentration, gamma-butyrobetaine, which has vasodilating properties, is intensively synthesized. The mechanism of action determines the diversity of its pharmacological effects: increased performance, reduction of symptoms of mental and physical overstrain, activation of tissue and humoral immunity, cardioprotective action.

In case of acute ischemic myocardial damage, it slows down the formation of the necrotic zone and shortens the rehabilitation period. In heart failure, it increases myocardial contractility, increases tolerance to physical load, and reduces the frequency of angina attacks. In acute and chronic ischemic cerebrovascular disorders, it improves blood circulation in the ischemic focus and promotes blood redistribution in favor of the ischemic area. It is effective in vascular and dystrophic pathology of the ocular fundus. It has a tonic effect on the CNS and eliminates functional disorders of the nervous system in patients with chronic alcoholism during withdrawal syndrome.

Pharmacokinetics

After oral administration, it is rapidly absorbed from the gastrointestinal tract. The bioavailability is about 78%. C_max in plasma is reached 1-2 hours after administration. It is biotransformed in the body with the formation of two main metabolites, which are excreted by the kidneys. T_1/2 is 3-6 hours and depends on the dose.

Indications

For intravenous administration: as part of complex therapy for coronary artery disease (angina pectoris, myocardial infarction), chronic heart failure, dishormonal cardiomyopathy; as part of complex therapy for acute and chronic cerebrovascular disorders (strokes and cerebrovascular insufficiency); reduced performance, physical overstrain (including in athletes), postoperative period to accelerate rehabilitation; withdrawal syndrome in chronic alcoholism (in combination with specific therapy for alcoholism).

For parabulbar administration: acute circulatory disorders in the retina, hemophthalmos and retinal hemorrhages of various etiologies, thrombosis of the central retinal vein and its branches, retinopathies of various etiologies (including diabetic and hypertensive).

ICD codes

Dosage Regimen

Administer the solution intravenously or via parabulbar injection according to the specific indication.

For intravenous administration, use a dose of 500 mg to 1 gram (5-10 ml) once daily.

Adjust the treatment duration based on the underlying condition and clinical response.

For cardiovascular diseases (angina pectoris, myocardial infarction, chronic heart failure), the typical course is 4 to 6 weeks.

For cerebrovascular disorders, the treatment course is typically 4 to 6 weeks, with the possibility of repeated courses.

For reduced performance or physical overstrain, the usual course is 10 to 14 days; repeat if necessary after a 2-3 week interval.

For withdrawal syndrome in chronic alcoholism, the standard course is 7 to 10 days.

For parabulbar administration, inject 0.5 ml of the 100 mg/ml solution retrobulbarly.

The standard course for ophthalmic conditions is 10 days.

Do not administer for more than 1.5 months continuously.

Adverse Reactions

From the cardiovascular system rarely – tachycardia, changes in blood pressure.

From the central nervous system rarely – psychomotor agitation.

From the digestive system rarely – dyspeptic symptoms.

Allergic reactions rarely – skin itching, redness, rash, edema.

Contraindications

Increased intracranial pressure (including in cases of impaired venous outflow, intracranial tumors), pregnancy, lactation period (breastfeeding), children and adolescents under 18 years of age, hypersensitivity to meldonium.

Use in Pregnancy and Lactation

Use is contraindicated during pregnancy and breastfeeding.

Use in Hepatic Impairment

Use with caution in liver diseases, especially for a long period of time.

Use in Renal Impairment

Use with caution in kidney diseases, especially for a long period of time.

Pediatric Use

In children and adolescents under 18 years of age, the efficacy and safety of meldonium have not been established.

Special Precautions

Use with caution in liver and/or kidney diseases, especially for a long period of time.

Long-term experience in treating acute myocardial infarction and unstable angina in cardiology departments shows that Meldonium is not a first-line agent for acute coronary syndrome.

Drug Interactions

When used concomitantly, Meldonium enhances the effect of antianginal agents, some hypotensive drugs, and cardiac glycosides.

With simultaneous use of meldonium with nitroglycerin, nifedipine, alpha-blockers, antihypertensive agents, and peripheral vasodilators, the development of moderate tachycardia and arterial hypotension is possible (caution is required with these combinations).

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

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.