Meldonium (Capsules, Solution) Instructions for Use

Instructions
Dosage forms

ATC Code

C01EB22 (Meldonium)

Active Substance

Meldonium (Rec.INN registered by WHO)

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 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 decreased carnitine concentration, gamma-butyrobetaine, which has vasodilating properties, is synthesized more intensively. 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 exertion, 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 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 to form two main metabolites, which are excreted by the kidneys. T_1/2 is 3-6 hours and depends on the dose.

Indications

For oral or 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); decreased performance, physical overexertion (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) – only for parabulbar administration.

ICD codes

Open the list of ICD codes

ICD-10 code	Indication
F10.3	Withdrawal state
H34	Retinal vascular occlusions
H35.0	Background retinopathy and retinal vascular changes
H35.6	Retinal hemorrhage
H36.0	Diabetic retinopathy
H44.8	Other disorders of globe (including hemophthalmos)
I20	Angina pectoris
I21	Acute myocardial infarction
I42	Cardiomyopathy
I50.0	Congestive heart failure
I61	Intracerebral hemorrhage (cerebrovascular accident of hemorrhagic type)
I63	Cerebral infarction
I69	Sequelae of cerebrovascular diseases
Z54.0	Convalescence following surgery
Z73.0	Burn-out
Z73.3	Stress, not elsewhere classified (physical and mental strain)

ICD-11 code	Indication
6C40.4Z	Alcohol withdrawal syndrome, unspecified
8B00.Z	Intracerebral hemorrhage of unspecified site, unspecified
8B11	Cerebral ischemic stroke
8B25.Z	Sequelae of cerebrovascular disease, unspecified
9B3Z	Disorders of the anterior segment of the eyeball, unspecified
9B71.0Z	Diabetic retinopathy, unspecified
9B74.Z	Retinal vascular occlusion, unspecified
9B78.1Z	Background retinopathy and retinal vascular changes, unspecified
9B78.5	Retinal hemorrhage
9C0Z	Diseases of the posterior segment of the eye, unspecified
9E1Z	Diseases of the visual system, unspecified
BA40.Z	Angina pectoris, unspecified
BA41.Z	Acute myocardial infarction, unspecified
BC43.Z	Cardiomyopathy, unspecified
BD10	Congestive heart failure
QB7Y	Other specified convalescence
QD85	Burn-out
QE01	Stress, not elsewhere classified

Dosage Regimen

The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen.

Capsules

Orally, before meals; due to the stimulating effect, it is advisable to use it in the first half of the day.

Increased physical exertion 250 mg 4 times/day. The course of treatment is 10-14 days. If necessary, the treatment is repeated after 2-3 weeks. Athletes are prescribed 500-1000 mg 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.

For cardiovascular diseases (as part of complex therapy)

Stable exertional angina – 250 mg 3 times/day for 3-4 days, then – 250 mg 3 times/day 2 times a week for 1-1.5 months.

Myocardial infarction in the acute period – IV, then orally 500 mg/day, taking the entire dose at once or in 2 divided doses/day.

Chronic heart failure – 500-1000 mg once/day. The course of treatment is 4-6 weeks.

Cardialgia due to dishormonal myocardial dystrophy – 250 mg 2 times/day. The course of treatment is 12 days.

Cerebrovascular accident in the acute period IV, then 500 mg/day, preferably in the first half of the day. The course of treatment is 4-6 weeks.

Alcohol withdrawal syndrome (as part of combined specific therapy) – 500 mg 4 times/day. The course of treatment is 7-10 days.

Solution

Due to the possibility of a stimulating effect, it is recommended to use it in the first half of the day. The dose is set individually depending on the indications and route of administration.

When taken orally, a single dose is 0.25-1 g, the frequency of administration and duration of treatment depend on the indications.

When administered intravenously, the dose is 0.5-1 g once/day, the duration of treatment depends on the indications.

For parabulbar administration, 0.5 ml of the injection solution with a concentration of 500 mg/5 ml is administered for 10 days.

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

The use of the drug 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.

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 antihypertensive 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.

Medical Disclaimer

Brand (or Active Substance), Marketing Authorisation Holder, Dosage Form

Meldonium [Atoll LLC (Russia)]
Capsules 250 mg: from 5 to 150 pcs.
Capsules 500 mg: from 5 to 150 pcs.

Marketing Authorization Holder

Atoll LLC (Russia)

Manufactured By

Ozon, LLC (Russia)

Dosage Forms

Meldonium		Capsules 250 mg: from 5 to 150 pcs.
Meldonium		Capsules 500 mg: from 5 to 150 pcs.

Dosage Form, Packaging, and Composition

Capsules hard gelatin size No. 0, body and cap white, opaque; capsule contents – white or almost white powder or mixture of powder and crystals, with a slight characteristic odor, hygroscopic; compaction of the capsule contents into lumps is allowed.

	1 caps.
Meldonium dihydrate	250 mg

Excipients : microcrystalline cellulose (MCC-102) – 14 mg, potato starch – 8.4 mg, colloidal silicon dioxide – 4.8 mg, magnesium stearate – 2.8 mg.

Capsule body composition titanium dioxide (E171) – 2%, gelatin – up to 100%.
Capsule cap composition titanium dioxide (E171) – 2%, gelatin – up to 100%.

From 5 to 15 pcs. – contour cell packaging (from 1 to 10 pcs.) – cardboard packs.

Capsules hard gelatin size No. 00, body and cap white, opaque; capsule contents – white or almost white powder or mixture of powder and crystals, with a slight characteristic odor, hygroscopic; compaction of the capsule contents into lumps is allowed.

	1 caps.
Meldonium dihydrate	500 mg

Excipients : microcrystalline cellulose (MCC-102) – 28 mg, potato starch – 16.8 mg, colloidal silicon dioxide – 9.6 mg, magnesium stearate – 5.6 mg.

Capsule body composition titanium dioxide (E171) – 2%, gelatin – up to 100%.
Capsule cap composition titanium dioxide (E171) – 2%, gelatin – up to 100%.

From 5 to 15 pcs. – contour cell packaging (from 1 to 10 pcs.) – cardboard packs.

Meldonium [Atoll LLC (Russia)]
Solution for injection 100 mg/1 ml: 5 ml amp. 5, 10, or 20 pcs.

Marketing Authorization Holder

Atoll LLC (Russia)

Manufactured By

Ozon, LLC (Russia)

Dosage Form

Meldonium

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

Dosage Form, Packaging, and Composition

Solution for injection in the form of a transparent, colorless liquid.

	1 ml
Meldonium dihydrate	100 mg

Excipients : water for injections – up to 1 ml.

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

Meldonium [Biosintez, PJSC (Russia)]
Solution for injection 100 mg/ml: 5 ml amp. 5 or 10 pcs.

Marketing Authorization Holder

Biosintez, PJSC (Russia)

Dosage Form

Meldonium

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

Dosage Form, Packaging, and Composition

Solution for injection in the form of a transparent, colorless liquid.

	1 ml
Meldonium dihydrate	100 mg

Excipients : water for injections – up to 1 ml.

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

Meldonium [Biokhimik, JSC (Russia)]
Solution for injection 100 mg/ml: 5 ml amp. 5 or 10 pcs.

Marketing Authorization Holder

Biokhimik, JSC (Russia)

Dosage Form

Meldonium

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

Dosage Form, Packaging, and Composition

Solution for injection colorless or slightly yellowish, transparent.

	1 ml
Meldonium dihydrate	100 mg

Excipients : water for injections – up to 1 ml.

5 ml – ampoules (5) – plastic cell packaging (1) – cardboard packs.
5 ml – ampoules (5) – plastic cell packaging (2) – cardboard packs.
5 ml – ampoules (5) – cardboard packs with partitions.
5 ml – ampoules (10) – cardboard packs with partitions.
5 ml – ampoules (10) – cardboard packs.

Meldonium [Kursk Biofactory - Firm "BIOK", FKP (Russia)]
Solution for injection 100 mg: 5 ml amp. 5 or 10 pcs.

Marketing Authorization Holder

Kursk Biofactory – Firm "BIOK", FKP (Russia)

Dosage Form

Meldonium

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

Dosage Form, Packaging, and Composition

Solution for injection in the form of a transparent, colorless liquid.

	1 ml
Meldonium dihydrate	100 mg,
Which corresponds to the meldonium content	80.2 mg

Excipients : water for injections – up to 1 ml.

5 ml – ampoules (5) – contour cell packaging (1) – cardboard packs.
5 ml – ampoules (5) – contour cell packaging (2) – cardboard packs.
5 ml – ampoules (5) – contour cell packaging (50) – cardboard boxes (for hospitals).
5 ml – ampoules (5) – contour cell packaging (100) – cardboard boxes (for hospitals).

Meldonium [Promomed Rus LLC (Russia)]
Capsules 250 mg: 5, 10, 15, 20, 30, 40, 50, 60, 80, 90, 100, 120, 180, 240, or 300 pcs.

Marketing Authorization Holder

Promomed Rus LLC (Russia)

Manufactured By

Biokhimik, JSC (Russia)

Dosage Form

Meldonium

Capsules 250 mg: 5, 10, 15, 20, 30, 40, 50, 60, 80, 90, 100, 120, 180, 240, or 300 pcs.

Dosage Form, Packaging, and Composition

Capsules hard gelatin, size No. 0, body and cap white, opaque; capsule contents – crystalline powder white or almost white in color, with varying degrees of particle fineness, with a slight odor; hygroscopic; compaction of the capsule contents to the shape of the capsule is allowed.

	1 caps.
Meldonium dihydrate	250 mg

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

Capsule composition titanium dioxide, gelatin.

5 pcs. – contour cell packs (1, 2, 3, 4, 6, 8, 10) – cardboard packs.
10 pcs. – contour cell packs (1, 2, 3, 4, 6, 8, 10) – cardboard packs.
30 pcs. – contour cell packs (1, 2, 3, 4, 6, 8, 10) – cardboard packs.
10 pcs. – polymer containers (1) – cardboard packs.
20 pcs. – polymer containers (1) – cardboard packs.
30 pcs. – polymer containers (1) – cardboard packs.
40 pcs. – polymer containers (1) – cardboard packs.
50 pcs. – polymer containers (1) – cardboard packs.
80 pcs. – polymer containers (1) – cardboard packs.
100 pcs. – polymer containers (1) – cardboard packs.

Meldonium [Pharmstandard-Lexredstva OJSC (Russia)]
Capsules 250 mg: 30 or 60 pcs.

Marketing Authorization Holder

Pharmstandard-Lexredstva OJSC (Russia)

Dosage Form

Meldonium

Capsules 250 mg: 30 or 60 pcs.

Dosage Form, Packaging, and Composition

Capsules hard gelatin, size No. 1, white; capsule contents – white crystalline powder with a characteristic odor; the powder is hygroscopic.

	1 caps.
Meldonium dihydrate	250 mg

Excipients: potato starch – 15.24 mg, colloidal silicon dioxide (aerosil) – 5.4 mg, calcium stearate – 1.36 mg.

Capsule shell composition (body and cap) titanium dioxide (E171) – 2%, gelatin – up to 100%.

10 pcs. – contour cell packs (3) – cardboard packs.
10 pcs. – contour cell packs (6) – cardboard packs.

Meldonium [Pharmstandard-Lexredstva OJSC (Russia)]
Capsules 500 mg: 30 or 60 pcs.

Marketing Authorization Holder

Pharmstandard-Lexredstva OJSC (Russia)

Dosage Form

Meldonium

Capsules 500 mg: 30 or 60 pcs.

Dosage Form, Packaging, and Composition

Capsules hard gelatin, size No. 00, white body, yellow cap; capsule contents – white crystalline powder with a characteristic odor; the powder is hygroscopic.

	1 caps.
Meldonium dihydrate	500 mg

Excipients: potato starch – 30.48 mg, colloidal silicon dioxide (aerosil) – 10.8 mg, calcium stearate – 2.72 mg.

Capsule body composition titanium dioxide (E171) – 2%, gelatin – up to 100%.
Capsule cap composition titanium dioxide (E171) – 1.333%, sunset yellow FCF (E110) – 0.0044%, quinoline yellow (E104) – 0.9197%, gelatin – up to 100%.

10 pcs. – contour cell packs (3) – cardboard packs.
10 pcs. – contour cell packs (6) – cardboard packs.

Meldonium [Pharmstandard-UfaVITA OJSC (Russia)]
Solution for injection 100 mg/1 ml: amp. 5 ml 5 or 10 pcs.

Marketing Authorization Holder

Pharmstandard-UfaVITA OJSC (Russia)

Dosage Form

Meldonium

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

Dosage Form, Packaging, and Composition

Solution for injection clear, colorless.

	1 ml
Meldonium dihydrate (trimethylhydrazinium propionate dihydrate)	100 mg

Excipients: water for injections – up to 1 ml.

5 ml – ampoules of colorless glass (5) – contour cell packs (1) – cardboard packs.
5 ml – ampoules of colorless glass (5) – contour cell packs (2) – cardboard packs.

Meldonium [Pharmfirma Sotex, CJSC (Russia)]
Solution for intravenous, intramuscular, and parabulbar administration 100 mg/1 ml: amp. 5 ml 5 or 10 pcs.

Marketing Authorization Holder

Pharmfirma Sotex, CJSC (Russia)

Dosage Form

Meldonium

Solution for intravenous, intramuscular, and parabulbar administration 100 mg/1 ml: amp. 5 ml 5 or 10 pcs.

Dosage Form, Packaging, and Composition

Solution for intravenous, intramuscular, and parabulbar administration in the form of a clear, colorless liquid.

	1 ml	1 amp.
Meldonium dihydrate	100 mg,	500 mg,
Corresponding to the content of anhydrous meldonium	80.21 mg	401.05 mg

Excipients: water for injections – up to 5 ml.

5 ml – ampoules (5) – contour cell packs (1) – cardboard packs.
5 ml – ampoules (5) – contour cell packs (2) – cardboard packs.

Meldonium [Pharmfirma Sotex, CJSC (Russia)]
Capsules 250 mg: 40 pcs.
Capsules 500 mg: 20 or 60 pcs.

Marketing Authorization Holder

Pharmfirma Sotex, CJSC (Russia)

Manufactured By

Rapharma, JSC (Russia)

Dosage Forms

Meldonium		Capsules 250 mg: 40 pcs.
Meldonium		Capsules 500 mg: 20 or 60 pcs.

Dosage Form, Packaging, and Composition

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

	1 caps.
Meldonium dihydrate	250 mg

Excipients: potato starch, colloidal silicon dioxide, calcium stearate.

Composition of the hard gelatin capsule (body and cap) gelatin, titanium dioxide (E171).

10 pcs. – contour cell packs (4) – cardboard packs.

Capsules hard gelatin, size No. 00, white body and cap; capsule contents – white or almost white crystalline powder with a faint characteristic odor; the powder is hygroscopic.

	1 caps.
Meldonium dihydrate	500 mg

Excipients: potato starch, colloidal silicon dioxide, calcium stearate.

Composition of the hard gelatin capsule (body and cap) gelatin, titanium dioxide (E171).

20 pcs. – polyethylene bottles (1) – cardboard packs.
60 pcs. – polyethylene bottles (1) – cardboard packs.

Meldonium [Ellara, LLC (Russia)]
Solution for intramuscular, intravenous, and parabulbar administration 100 mg/1 ml: 5 ml amp. 5 or 10 pcs.

Marketing Authorization Holder

Ellara, LLC (Russia)

Dosage Form

Meldonium

Solution for intramuscular, intravenous, and parabulbar administration 100 mg/1 ml: 5 ml amp. 5 or 10 pcs.

Dosage Form, Packaging, and Composition

Solution for parabulbar and intravenous administration clear, colorless.

	1 ml
Meldonium dihydrate (trimethylhydrazinium propionate dihydrate)	100 mg

Excipients: water for injections – up to 1 ml.

5 ml – ampoules (5) – plastic cell packs (1) – cardboard packs.
5 ml – ampoules (5) – plastic cell packs (2) – cardboard packs.
5 ml – ampoules (5) – cardboard packs.
5 ml – ampoules (10) – cardboard packs.

Meldonium [YUGPHARM, LLC (Russia)]
Capsules 250 mg: 10, 20, 30, 40, 50, or 60 pcs.

Marketing Authorization Holder

YUGPHARM, LLC (Russia)

Dosage Form

Meldonium

Capsules 250 mg: 10, 20, 30, 40, 50, or 60 pcs.

Dosage Form, Packaging, and Composition

Capsules hard gelatin, No. 0, white body and cap, opaque; capsule contents – white or almost white crystalline powder with a faint characteristic odor; formation of agglomerates is allowed, which are destroyed by light pressure with a glass rod.

	1 caps.
Meldonium dihydrate	250 mg

Excipients: potato starch – 8.4 mg, microcrystalline cellulose (MCC-102) – 14 mg, colloidal silicon dioxide – 4.8 mg, magnesium stearate – 2.8 mg.

Capsule shell composition (body and cap): titanium dioxide – 2% (w/w), gelatin – up to 100%.

10 pcs. – contour cell packs (1) – cardboard packs.
10 pcs. – contour cell packs (2) – cardboard packs.
10 pcs. – contour cell packs (3) – cardboard packs.
10 pcs. – contour cell packs (4) – cardboard packs.
10 pcs. – contour cell packs (5) – cardboard packs.
10 pcs. – contour cell packs (6) – cardboard packs.
20 pcs. – polyethylene terephthalate jars (1) – cardboard packs.
40 pcs. – polyethylene terephthalate jars (1) – cardboard packs.
60 pcs. – polyethylene terephthalate jars (1) – cardboard packs.

Meldonium Avexima [Avexima JSC (Russia)]
Capsules 250 mg: 10, 20, 30, 40, or 60 pcs.
Capsules 500 mg: 10, 20, 30, 40, or 60 pcs.

Marketing Authorization Holder

Avexima JSC (Russia)

Manufactured By

Avexima Siberia LLC (Russia)

Irbit Chemical Pharmaceutical Plant, JSC (Russia)

Dosage Forms

	Meldonium Avexima	Capsules 250 mg: 10, 20, 30, 40, or 60 pcs.
		Capsules 500 mg: 10, 20, 30, 40, or 60 pcs.

Dosage Form, Packaging, and Composition

Capsules hard gelatin, size No. 1, opaque, white or almost white body and cap; capsule contents – a mixture of powder and granules, white or almost white; compaction of the capsule contents into lumps that are easily destroyed by pressure is allowed.

	1 caps.
Meldonium dihydrate	250 mg

Excipients: potato starch, colloidal silicon dioxide, calcium stearate; hard gelatin capsule size No. 1
(body: titanium dioxide, gelatin; cap: titanium dioxide, gelatin).

10 pcs. – contour cell packs (3) – cardboard packs.
10 pcs. – contour cell packs (4) – cardboard packs.
10 pcs. – contour cell packs (6) – cardboard packs.
10 pcs. – polyethylene jars (1) – cardboard packs.
20 pcs. – polyethylene jars (1) – cardboard packs.
30 pcs. – polyethylene jars (1) – cardboard packs.

Capsules hard gelatin, size No. 00, opaque, white or almost white body and cap; capsule contents – a mixture of powder and granules, white or almost white; compaction of the capsule contents into lumps that are easily destroyed by pressure is allowed.

	1 caps.
Meldonium dihydrate	500 mg

Excipients: potato starch, colloidal silicon dioxide, calcium stearate; hard gelatin capsule size No. 00 (body: titanium dioxide, gelatin; cap: titanium dioxide, gelatin).

Meldonium bufus^® [Obnovlenie Pfc, JSC (Russia)]
Solution for injection 100 mg/1 ml: amp. 5 ml 5, 10, 20, or 50 pcs.

Marketing Authorization Holder

Obnovlenie Pfc, JSC (Russia)

Dosage Form

Meldonium bufus^®

Solution for injection 100 mg/1 ml: amp. 5 ml 5, 10, 20, or 50 pcs.

Dosage Form, Packaging, and Composition

Solution for injection clear, colorless.

	1 ml
Meldonium (in the form of dihydrate)	100 mg

Excipients: water for injections.

5 ml – polymer ampoules (5) – cardboard packs.
5 ml – polymer ampoules (10) – cardboard packs.
5 ml – polymer ampoules (20) – cardboard packs.
5 ml – polymer ampoules (50) – cardboard packs.

Meldonium Canon [Canonpharma Production, CJS (Russia)]
Capsules 250 mg: 40 or 60 pcs.

Marketing Authorization Holder

Canonpharma Production, CJS (Russia)

Dosage Form

Meldonium Canon

Capsules 250 mg: 40 or 60 pcs.

Dosage Form, Packaging, and Composition

Capsules hard gelatin No. 1, white body and cap; capsule contents – a mixture of crystalline powder and a compressed mass that spreads when pressed, white or almost white with a faint odor.

	1 caps.
Meldonium dihydrate	250 mg

Excipients: calcium stearate – 2.7 mg, pregelatinized corn starch – 14 mg, colloidal silicon dioxide – 5.3 mg.

Composition of hard gelatin capsule No. 1 – 76 mg, incl. body: gelatin – 44.688 mg, titanium dioxide – 0.912 mg, cap: gelatin – 29.792 mg, titanium dioxide – 0.608 mg.

10 pcs. – contour cell packs (4) – cardboard packs.
10 pcs. – contour cell packs (6) – cardboard packs.

Meldonium Organica [Organika, JSC (Russia)]
Solution for injection 100 mg/1 ml: amp. 5 ml 5 or 10 pcs.

Marketing Authorization Holder

Organika, JSC (Russia)

Dosage Form

Meldonium Organica

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

Dosage Form, Packaging, and Composition

Solution for injection in the form of a clear, colorless liquid.

	1 ml
Meldonium (in the form of dihydrate)	100 mg

Excipients: water for injections.

5 ml – ampoules (5) – contour cell packs (1) – cardboard packs.
5 ml – ampoules (5) – contour cell packs (2) – cardboard packs.

Meldonium Organica [Organika, JSC (Russia)]
Capsules 250 mg: 20, 40, or 60 pcs.

Marketing Authorization Holder

Organika, JSC (Russia)

Dosage Form

Meldonium Organica

Capsules 250 mg: 20, 40, or 60 pcs.

Dosage Form, Packaging, and Composition

Capsules hard gelatin, size No. 1, white/white; capsule contents – white or almost white powder.

	1 caps.
Meldonium dihydrate	250 mg

Excipients: potato starch – 18.125 mg, colloidal silicon dioxide – 5.5 mg, calcium stearate – 1.375 mg.

Capsule shell composition titanium dioxide (E171) – 2%, gelatin – up to 100%.

10 pcs. – contour cell packs (2) – cardboard packs.
10 pcs. – contour cell packs (4) – cardboard packs.
10 pcs. – contour cell packs (6) – cardboard packs.

Meldonium Renewal [Obnovlenie Pfc, JSC (Russia)]
Capsules 250 mg: 28, 30, 40, 56, 60, 90, or 105 pcs.
Capsules 500 mg: 28, 30, 40, 56, 60, 90 or 105 pcs.

Marketing Authorization Holder

Obnovlenie Pfc, JSC (Russia)

Dosage Forms

Meldonium Renewal		Capsules 250 mg: 28, 30, 40, 56, 60, 90, or 105 pcs.
Meldonium Renewal		Capsules 500 mg: 28, 30, 40, 56, 60, 90 or 105 pcs.

Dosage Form, Packaging, and Composition

Capsules hard gelatin size 0 with a white body and cap; the capsule contents are a powder or a mixture of powder and crystals, white or almost white in color; compaction of the capsule contents into lumps is allowed.

	1 caps.
Meldonium	250 mg

Excipients: microcrystalline cellulose, potato starch, colloidal silicon dioxide (aerosil), magnesium stearate.

Capsule body composition: titanium dioxide (E171), gelatin.
Capsule cap composition: titanium dioxide (E171), gelatin.

10 pcs. – contour cell packaging (3) – cardboard packs.
10 pcs. – contour cell packaging (4) – cardboard packs.
10 pcs. – contour cell packaging (6) – cardboard packs.
10 pcs. – contour cell packaging (9) – cardboard packs.
14 pcs. – contour cell packaging (2) – cardboard packs.
14 pcs. – contour cell packaging (4) – cardboard packs.
15 pcs. – contour cell packaging (2) – cardboard packs.
15 pcs. – contour cell packaging (4) – cardboard packs.
15 pcs. – contour cell packaging (6) – cardboard packs.
15 pcs. – contour cell packaging (7) – cardboard packs.

Capsules hard gelatin, size 00, with a white body and cap; the capsule contents are a powder or a mixture of powder and crystals, white or almost white in color; compaction of the capsule contents into lumps is allowed.

	1 caps.
Meldonium	500 mg

Excipients: microcrystalline cellulose, potato starch, colloidal silicon dioxide (aerosil), magnesium stearate.

Capsule body composition: titanium dioxide (E171), gelatin.
Capsule cap composition: titanium dioxide (E171), gelatin.

Meldonium Velpharm [Velpharm, LLC (Russia)]
Capsules 250 mg: 10, 20, 30, 40, 50, or 60 pcs.

Marketing Authorization Holder

Velpharm, LLC (Russia)

Dosage Form

Meldonium Velpharm

Capsules 250 mg: 10, 20, 30, 40, 50, or 60 pcs.

Dosage Form, Packaging, and Composition

Capsules hard gelatin, size 1, white; capsule contents – white or almost white crystalline powder with a faint characteristic odor; the powder is hygroscopic, clumping is allowed.

	1 caps.
Meldonium dihydrate (trimethylhydrazinium propionate dihydrate)	250 mg

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

Composition of the gelatin capsule: titanium dioxide, gelatin.

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 (5) – cardboard packs.
10 pcs. – contour cell packaging (6) – cardboard packs.
10 pcs. – polymer jars (1) – cardboard packs.
20 pcs. – polymer jars (1) – cardboard packs.
30 pcs. – polymer jars (1) – cardboard packs.
40 pcs. – polymer jars (1) – cardboard packs.
50 pcs. – polymer jars (1) – cardboard packs.
60 pcs. – polymer jars (1) – cardboard packs.

Meldonium Velpharm [Velpharm, LLC (Russia)]
Capsules 250 mg: 10, 20, 30, 40, 50, or 60 pcs.

Marketing Authorization Holder

Velpharm, LLC (Russia)

Manufactured By

Velpharm, LLC (Russia)

Velpharm-M, LLC (Russia)

Dosage Form

Meldonium Velpharm

Capsules 250 mg: 10, 20, 30, 40, 50, or 60 pcs.

Dosage Form, Packaging, and Composition

Capsules hard gelatin white size 1; capsule contents – white or almost white crystalline powder with a faint characteristic odor; the powder is hygroscopic, clumping is allowed.

	1 caps.
Meldonium dihydrate (trimethylhydrazinium propionate dihydrate)	250 mg

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

Composition of the gelatin capsule titanium dioxide, gelatin

10 pcs. – contour cell packaging (from 1 to 6 pcs.) – cardboard packs.
10 pcs. – polymer jars (1) – cardboard packs.
20 pcs. – polymer jars (1) – cardboard packs.
30 pcs. – polymer jars (1) – cardboard packs.
40 pcs. – polymer jars (1) – cardboard packs.
50 pcs. – polymer jars (1) – cardboard packs.
60 pcs. – polymer jars (1) – cardboard packs.

Meldonium Velpharm [Velpharm, LLC (Russia)]
Solution for injection 100 mg/1 ml: amp. 5 ml 5 or 10 pcs.

Marketing Authorization Holder

Velpharm, LLC (Russia)

Dosage Form

Meldonium Velpharm

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

Dosage Form, Packaging, and Composition

Solution for injection in the form of a colorless, transparent liquid.

	1 ml
Meldonium dihydrate (trimethylhydrazinium propionate dihydrate)	100 mg

Excipients: water for injections.

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

Meldonium-Binergia [Binergia JSC (Russia)]
Capsules 250 mg: 10, 20, 30, 40, 50, 60 or 100 pcs.

Marketing Authorization Holder

Binergia JSC (Russia)

Manufactured By

PharmVILAR NPO, LLC (Russia)

Dosage Form

Meldonium-Binergia

Capsules 250 mg: 10, 20, 30, 40, 50, 60 or 100 pcs.

Dosage Form, Packaging, and Composition

Capsules hard gelatin, size 1, white body and cap; capsule contents – white or almost white crystalline powder with a faint odor; the powder is hygroscopic, clumping is allowed, and lumps disintegrate when lightly pressed with a glass rod.

	1 caps.
Meldonium dihydrate (calculated as the dihydrate without adsorbed moisture)	250 mg

Excipients: potato starch, colloidal silicon dioxide, calcium stearate.

Composition of the capsule (body and cap): titanium dioxide (E171), gelatin.

Meldonium-Binergia [Binergia JSC (Russia)]
Solution for injection 100 mg/1 ml: amp. 5 ml 5 or 10 pcs.

Marketing Authorization Holder

Binergia JSC (Russia)

Manufactured By

Armavir Biopharmaceutical Plant, FSE (Russia)

Dosage Form

Meldonium-Binergia

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

Dosage Form, Packaging, and Composition

Solution for injection transparent, colorless.

	1 ml
Meldonium dihydrate	100 mg

Excipients: water for injections – up to 1 ml.

5 ml – ampoules (5) – plastic contour packaging (1) – cardboard packs.
5 ml – ampoules (5) – plastic contour packaging (2) – cardboard packs.
5 ml – ampoules (5) – contour cell packaging (1) – cardboard packs.
5 ml – ampoules (5) – contour cell packaging (2) – cardboard packs.

Meldonium-DEKO [Deko Company, LLC (Russia)]
Solution for injection 100 mg/ml: 5 ml amp. 10 pcs.

Marketing Authorization Holder

Deko Company, LLC (Russia)

Dosage Form

Meldonium-DEKO

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

Dosage Form, Packaging, and Composition

Solution for injection in the form of a transparent, colorless liquid.

	1 ml
Meldonium dihydrate	100 mg

Excipients: water for injections – up to 1 ml.

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

Meldonium-Eskom [Mir Chemical and Pharmaceutical Concern, LLC (Russia)]
Solution for injection 500 mg/5 ml: amp. 5, 10, or 20 pcs.

Marketing Authorization Holder

Mir Chemical and Pharmaceutical Concern, LLC (Russia)

Dosage Form

Meldonium-Eskom

Solution for injection 500 mg/5 ml: amp. 5, 10, or 20 pcs.

Dosage Form, Packaging, and Composition

Solution for injection	1 ml	1 amp.
Meldonium dihydrate	100 mg	500 mg

5 ml – ampoules (5) – plastic cell packaging (1) – cardboard packs.
5 ml – ampoules (5) – plastic cell packaging (2) – cardboard packs.
5 ml – ampoules (10) – plastic cell packaging (2) – cardboard packs.
5 ml – ampoules (10) – plastic cell packaging (1) – cardboard packs.

Meldonium-MosPharma [Moscow Pharmaceutical Factory CJS (Russia)]
Capsules 250 mg: 40 or 100 pcs.

Marketing Authorization Holder

Moscow Pharmaceutical Factory CJS (Russia)

Dosage Form

Meldonium-MosPharma

Capsules 250 mg: 40 or 100 pcs.

Dosage Form, Packaging, and Composition

Capsules hard gelatin, size 1, white or almost white body and cap; capsule contents: white crystalline hygroscopic powder with a faint odor.

	1 caps.
Meldonium dihydrate	250 mg

Excipients: potato starch – 13.6 mg, colloidal silicon dioxide – 5.4 mg, calcium stearate – 2.7 mg.

Composition of the hard gelatin capsule titanium dioxide (E171) – 2%, gelatin – up to 100%.

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

Meldonium-SOLOpfarm [Grotex, LLC (Russia)]
Injection solution 100 mg/1 ml: 5 ml amp. 5, 10, 20, 50, or 100 pcs.

Marketing Authorization Holder

Grotex, LLC (Russia)

Dosage Form

Meldonium-SOLOpfarm

Injection solution 100 mg/1 ml: 5 ml amp. 5, 10, 20, 50, or 100 pcs.

Dosage Form, Packaging, and Composition

Solution for injection in the form of a transparent, colorless liquid.

	1 ml
Meldonium dihydrate	100 mg

Excipients: water for injections – up to 1 ml.

5 ml – polyethylene or polypropylene ampoules (5) – cardboard packs.
5 ml – polyethylene or polypropylene ampoules (10) – cardboard packs.
5 ml – polyethylene or polypropylene ampoules (20) – cardboard packs.
5 ml – polyethylene or polypropylene ampoules (50) – cardboard packs.
5 ml – polyethylene or polypropylene ampoules (100) – cardboard packs

Medixlife (Author)

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