Mildroxyn (Capsules) Instructions for Use

Marketing Authorization Holder

Makiz-Pharma, LLC (Russia)

ATC Code

C01EB (Other drugs for the treatment of heart diseases)

Active Substance

Meldonium (Rec.INN WHO registered)

Dosage Form

Mildroxyn

Capsules 250 mg: 20, 40, or 100 pcs.

Dosage Form, Packaging, and Composition

Capsules are hard gelatin, size No. 1, with a yellow body and a red cap; the capsule contents are a white or almost white crystalline powder with a faint odor, hygroscopic.

Excipients: potato starch, colloidal silicon dioxide (aerosil), calcium stearate.

Capsule shell composition: gelatin, water.

10 pcs. – contour cell packs (2) – cardboard packs.
10 pcs. – contour cell packs (4) – cardboard packs.
10 pcs. – contour cell packs (10) – cardboard packs.
100 pcs. – polymer jars (1) – cardboard packs.

Clinical-Pharmacological Group

A drug that improves tissue metabolism and energy supply

Pharmacotherapeutic Group

Metabolic agent

Pharmacological Action

A drug that improves metabolism and energy supply to tissues. It is a synthetic analogue of gamma-butyrobetaine, inhibits gamma-butyrobetaine hydroxylase, reduces 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. It has cardioprotective properties and normalizes myocardial metabolism.

Under ischemic conditions, it restores the balance between oxygen delivery and consumption processes in cells and prevents disruption of ATP transport; simultaneously, it activates glycolysis (which proceeds without additional oxygen consumption). As a result of the decreased carnitine concentration, gamma-butyrobetaine, which has vasodilating properties, is intensively synthesized.

The mechanism of action of the drug 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 myocardial ischemia, 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 cerebral circulation disorders, it improves blood circulation in the ischemic focus and promotes blood redistribution in favor of the ischemic area.

It is effective in retinal pathology of vascular and dystrophic origin. It also has a tonic effect on the central nervous system. It eliminates functional disorders of the autonomic nervous system in patients with chronic alcoholism during withdrawal syndrome.

Pharmacokinetics

After oral administration, it is rapidly absorbed; bioavailability is 78%. The maximum plasma concentration is reached 1-2 hours after oral administration.

It is metabolized in the body to form two main metabolites, which are excreted by the kidneys. The half-life after oral administration depends on the dose and is 3-6 hours.

Indications

• As part of combination therapy for coronary artery disease (angina pectoris), chronic heart failure, cardialgia against the background of dishormonal myocardial dystrophy;
• Cerebral blood supply disorders (stroke, cerebrovascular insufficiency);
• Alcohol withdrawal syndrome (in combination with specific therapy);
• Postoperative period to accelerate rehabilitation;
• Reduced performance;
• Physical overstrain (including in athletes).

ICD codes

Dosage Regimen

Due to the possible development of a stimulating effect, the drug is recommended to be taken in the first half of the day.

For stable angina pectoris, 250 mg is prescribed 3 times/day for the first 3-4 days, then 2 times a week, 250 mg 3 times/day.

For cardialgia against the background of dishormonal myocardial dystrophy, the drug is prescribed 250 mg 2 times/day (morning and evening). The course of treatment is 12 days.

For chronic cerebral circulation disorders – 0.5-1 g/day, preferably in the first half of the day. The course of treatment is 2-3 weeks.

For chronic alcoholism – 500 mg 4 times/day. The course of treatment is 7-10 days.

For reduced performance and physical overstrain (including in athletes), adults are prescribed 250 mg 4 times/day. The course of treatment is 10-14 days. If necessary, a repeat course is conducted after 2-3 weeks.

Athletes are prescribed 0.5-1 g 2 times/day before training. The duration of the course during the preparatory period is 14-21 days, during the competition period – 10-14 days.

Adverse Reactions

From the cardiovascular system: rarely – tachycardia, decreased blood pressure.

Allergic reactions: rarely – redness, rash, itching, swelling.

Other: rarely – dyspeptic phenomena, agitation.

Contraindications

• Increased intracranial pressure (in case of impaired venous outflow, intracranial tumors);
• Age under 18 years (efficacy and safety not established);
• Hypersensitivity to mildronate.

The drug should be used with caution in liver and/or kidney diseases.

Use in Pregnancy and Lactation

The safety of the drug during pregnancy has not been proven, therefore, the prescription of Mildroxyn during this period is not recommended (to avoid possible adverse effects on the fetus).

It has not been established whether the drug is excreted in breast milk. If it is necessary to prescribe the drug during lactation, breastfeeding should be discontinued.

Use in Hepatic Impairment

The drug should be used with caution in liver diseases.

Use in Renal Impairment

The drug should be used with caution in kidney diseases.

Pediatric Use

The efficacy and safety of the drug in children under 18 years of age have not been established.

Special Precautions

Patients with a history of chronic liver and kidney diseases should exercise caution during long-term use of the drug.

Concomitant use of Mildroxyn with antianginal agents, anticoagulants, antiplatelet agents, antiarrhythmic agents, diuretics, and bronchodilators is possible.

Use in pediatrics

There is insufficient data on the safety and efficacy of Mildroxyn in children.

Effect on the ability to drive vehicles and operate machinery

There are no data on the adverse effect of Mildroxyn on the speed of psychomotor reactions.

Overdose

Cases of Mildroxyn overdose are not known. The drug is low-toxic.

Drug Interactions

With simultaneous use, Mildroxyn enhances the effect of drugs that dilate coronary vessels, some antihypertensive drugs, and cardiac glycosides.

When used concomitantly with nitroglycerin, nifedipine, alpha-blockers, antihypertensive agents, and peripheral vasodilators, the development of moderate tachycardia and arterial hypotension is possible (prescribing such a combination requires caution).

Storage Conditions

List B. The drug should be stored in a dry place, out of reach of children, at a temperature not exceeding 20°C (68°F).

Shelf Life

The shelf life is 3 years.

Dispensing Status

The drug is dispensed 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.