Angiocardil^® (Solution) Instructions for Use

Marketing Authorization Holder

Novosibkhimpharm, JSC (Russia)

ATC Code

C01EB22 (Meldonium)

Active Substance

Meldonium (Rec.INN registered by WHO)

Dosage Form

Angiocardil®

Solution for injection 100 mg/1 ml: amp. 5 ml or 10 ml 5, 10, or 20 pcs.

Dosage Form, Packaging, and Composition

Solution for injection as a colorless, transparent liquid.

Excipients: water for injections – up to 1 ml.

5 ml – glass ampoules (10) – cardboard boxes.
5 ml – glass ampoules (5) – contour cell packaging (1) – cardboard packs.
5 ml – glass ampoules (5) – contour cell packaging (2) – cardboard packs.
5 ml – glass ampoules (10) – contour cell packaging (1) – cardboard packs.
5 ml – glass ampoules (10) – contour cell packaging (2) – cardboard packs.
10 ml – glass ampoules (10) – cardboard boxes.
10 ml – glass ampoules (5) – contour cell packaging (1) – cardboard packs.
10 ml – glass ampoules (5) – contour cell packaging (2) – cardboard packs.
10 ml – glass ampoules (10) – contour cell packaging (1) – cardboard packs.
10 ml – glass ampoules (10) – contour cell packaging (2) – cardboard packs.

Clinical-Pharmacological Group

A drug that improves tissue metabolism and energy supply

Pharmacotherapeutic Group

Drugs for the treatment of heart diseases; other drugs for the treatment of heart diseases

Pharmacological Action

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

Under ischemic conditions, it restores the balance between 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 synthesized more actively. 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 pathologies of the ocular 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

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 Angiocardil^®intravenously or via parabulbar injection, depending on the indication.

For intravenous administration, use a dose of 0.5-1 g (5-10 ml of the 100 mg/ml solution) once daily.

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

In ischemic heart disease and chronic heart failure, the typical course is part of a comprehensive treatment plan.

For cerebrovascular disorders, administer for the period determined by the severity of the condition.

To address reduced performance or physical overstrain, including in athletes, use a course of 10-14 days.

In the postoperative period, administer to accelerate rehabilitation as directed.

For withdrawal syndrome in chronic alcoholism, use in combination with specific therapy.

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

Use the 500 mg/5 ml ampoule concentration for this route.

The standard course for ophthalmic indications is 10 days.

Do not exceed the recommended dosage or duration without medical supervision.

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, swelling.

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 15°C (59°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.