Medatern (Capsules) Instructions for Use

Marketing Authorization Holder

Ozon, LLC (Russia)

ATC Code

C01EB22 (Meldonium)

Active Substance

Meldonium (Rec.INN registered by WHO)

Dosage Form

Medatern

Capsules 250 mg: 5, 10, 15, 20, 30, 40, 50, 60, 90, 100, 120, or 300 pcs.

Dosage Form, Packaging, and Composition

Capsules hard gelatin, size No. 0, white, opaque; the capsule contents are a white or almost white crystalline powder with varying degrees of particle fineness, with a faint odor, hygroscopic; compaction of the capsule contents to the shape of the capsule is allowed.

Excipients: microcrystalline cellulose – 10 mg, potato starch – 12.5 mg, colloidal silicon dioxide – 4.8 mg, magnesium stearate – 2.7 mg.

Capsule shell composition titanium dioxide, gelatin.

5 pcs. – contour cell packaging (1) – cardboard packs.
5 pcs. – contour cell packaging (2) – cardboard packs.
5 pcs. – contour cell packaging (3) – cardboard packs.
5 pcs. – contour cell packaging (4) – cardboard packs.
5 pcs. – contour cell packaging (6) – cardboard packs.
5 pcs. – contour cell packaging (10) – cardboard packs.
10 pcs. – contour cell packaging (1) – cardboard packs.
10 pcs. – contour cell packaging (2) – cardboard packs.
10 pcs. – contour cell packaging (3) – cardboard packs.
10 pcs. – contour cell packaging (4) – cardboard packs.
10 pcs. – contour cell packaging (10) – cardboard packs.
10 pcs. – polymer containers (1) – cardboard packs.
20 pcs. – polymer containers (1) – cardboard packs.
30 pcs. – contour cell packaging (1) – cardboard packs.
30 pcs. – contour cell packaging (2) – cardboard packs.
30 pcs. – contour cell packaging (3) – cardboard packs.
30 pcs. – contour cell packaging (4) – cardboard packs.
30 pcs. – contour cell packaging (6) – cardboard packs.
30 pcs. – contour cell packaging (10) – cardboard packs.
30 pcs. – polymer containers (1) – cardboard packs.
40 pcs. – polymer containers (1) – cardboard packs.
50 pcs. – polymer containers (1) – cardboard packs.
100 pcs. – polymer containers (1) – 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 analogue 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 in cells of activated forms of non-oxidized fatty acids – derivatives of acylcarnitine and acylcoenzyme A.

Under ischemic conditions, it restores the balance of oxygen delivery and its consumption 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 variety 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 activity, and reduces the frequency of angina attacks. In acute and chronic ischemic cerebrovascular disorders, it improves blood circulation in the ischemic focus and promotes the redistribution of blood in favor of the ischemic area. It is effective in vascular and dystrophic pathology of the fundus. It has a tonic effect on the central nervous system 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

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).

ICD codes

Dosage Regimen

Administer in the first half of the day due to the potential for a stimulating effect.

Set the dose individually based on the specific indication and clinical presentation.

For oral administration, the single dose is 250 mg to 1 g (one to four 250 mg capsules).

For coronary artery disease and chronic heart failure, take 500 mg to 1 g once daily or divide into two doses. The usual course duration is 4 to 6 weeks.

For cerebrovascular disorders, use a dose of 500 mg to 1 g daily. The treatment course can be repeated 2-3 times per year as indicated.

For reduced performance or physical overstrain, including in athletes, administer 500 mg twice daily. The typical course is 10 to 14 days, with the possibility of repetition if necessary.

In the postoperative period to accelerate rehabilitation, use 250 mg four times daily for a duration of up to 10 days.

For withdrawal syndrome in chronic alcoholism, the standard dose is 500 mg taken four times daily. The usual course of therapy is 7 to 10 days.

The maximum daily dose should generally not exceed 2 grams.

Adjust the regimen for patients with hepatic or renal impairment, especially during long-term therapy.

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 during pregnancy and lactation (breastfeeding) is contraindicated.

Use in Hepatic Impairment

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

Use in Renal Impairment

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

Pediatric Use

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

Meldonium in capsule form is contraindicated for use in children and adolescents under 18 years of age; in syrup form – in children under 12 years of age.

Geriatric Use

Use with caution in elderly patients.

Special Precautions

Use with caution in liver and/or kidney diseases, especially for a long 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-adrenoblockers, 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.