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Carnitine (Solution, Concentrate) Instructions for Use

ATC Code

A16AA01 (Levocarnitine)

Active Substance

Carnitine (Rec.INN registered by WHO)

Clinical-Pharmacological Group

A drug that improves tissue metabolism and energy supply

Pharmacotherapeutic Group

Metabolic agent

Pharmacological Action

A means for the correction of metabolic processes. It has an anabolic, antihypoxic, and antithyroid effect, activates fat metabolism, stimulates regeneration, and increases appetite.

Carnitine is a natural substance related to B vitamins. It is a co-factor of metabolic processes that maintain the activity of coenzyme A. It reduces the basal metabolic rate and slows down the breakdown of protein and carbohydrate molecules.

It promotes the penetration through mitochondrial membranes and the breakdown of long-chain fatty acids with the formation of acetyl-CoA (necessary for ensuring the activity of pyruvate carboxylase in the process of gluconeogenesis, the formation of ketone bodies, the synthesis of choline and its esters, oxidative phosphorylation, and the formation of ATP).

It mobilizes fat (due to the presence of 3 labile methyl groups) from fat depots. By competitively displacing glucose, it activates the fatty acid metabolic shunt, the activity of which is not limited by oxygen (unlike aerobic glycolysis), which is why the drug is effective in conditions of acute hypoxia (including cerebral hypoxia) and other critical conditions.

It has a neurotrophic effect, inhibits apoptosis, limits the area of damage, and restores the structure of nervous tissue. It normalizes protein and fat metabolism, and the increased basal metabolism in thyrotoxicosis (being a partial antagonist of thyroxine). It restores the alkaline reserve of the blood.

It reduces the formation of keto acids, increases tissue resistance to the influence of toxic breakdown products, activates anaerobic glycolysis, and stimulates and accelerates reparative processes.

It increases the threshold of resistance to physical exertion, reduces the degree of lactate acidosis, and restores working capacity after prolonged physical exertion. At the same time, it promotes economical consumption of glycogen and increases its reserves in the liver and muscles.

It does not affect the blood coagulation system.

Pharmacokinetics

After intravenous administration, it is almost completely eliminated from the blood within 3 hours. It easily penetrates the liver and myocardium, and more slowly into the muscles. It is excreted by the kidneys mainly in the form of acyl esters.

Indications

As part of complex therapy: ischemic stroke (in the acute, recovery periods), transient cerebrovascular accident, dyscirculatory encephalopathy, traumatic and toxic brain lesions.

Primary and secondary carnitine deficiency.

As a cardioprotector during treatment with cytostatics, especially those of the anthracycline series.

ICD codes

ICD-10 code Indication
E61.8 Deficiency of other specified nutrient elements
G45 Transient cerebral ischemic attacks [TIAs] and related syndromes
G92 Toxic encephalopathy
G93.4 Unspecified encephalopathy
I63 Cerebral infarction
I69 Sequelae of cerebrovascular diseases
T90 Sequelae of injuries of head
Y43.3 Other antineoplastic drugs
ICD-11 code Indication
5B5K.3 Iodine deficiency
5B5K.4 Fluorine deficiency
5B5K.5 Sodium chloride deficiency
5B7Z Malnutrition, unspecified
8B10.Z Transient ischemic attack, unspecified
8B11 Cerebral ischemic stroke
8B25.Z Sequelae of cerebrovascular disease, unspecified
8D43.0Y Other specified toxic encephalopathy
8D43.0Z Toxic encephalopathy, unspecified
8E47 Encephalopathy, not elsewhere classified
8E4A.0 Paraneoplastic or autoimmune disorders of the central nervous system, including brain and spinal cord
8E63 Post-cardiopulmonary bypass encephalopathy
NA0Z Head injury, unspecified
PL00 Drugs, medicaments or biological substances causing injury or harm in therapeutic use

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.

Administer intravenously by slow drip infusion only. Do not administer by rapid intravenous injection.

For adult patients, the typical daily dose is 0.5-1 g. Adjust the exact dosage based on the specific indication and individual patient response.

For the treatment of primary carnitine deficiency, administer a dose of 50 mg/kg/day. Titrate the dose based on clinical response and tolerance, with a maximum dose of 300 mg/kg/day.

When used as a cardioprotector during anthracycline-based chemotherapy, administer a single dose of 1-2 g/m² prior to the cytostatic infusion.

For pediatric patients with growth retardation, base the dose on body weight. The typical dose is 50-100 mg/kg/day.

Determine the duration of treatment individually based on the underlying condition and therapeutic goals. For acute conditions, the course may be shorter; for chronic deficiencies, long-term therapy may be required.

Dilute the required dose in a suitable volume of 0.9% Sodium Chloride or 5% Dextrose solution prior to administration. Inspect the final solution for particulate matter or discoloration; discard if present.

Monitor patients for signs of efficacy and potential adverse reactions, particularly during dose titration and long-term use.

Adverse Reactions

Possible allergic reactions, muscle weakness in patients with uremia.

Contraindications

Hypersensitivity to carnitine.

Use in Pregnancy and Lactation

No specific studies on the safety of use during pregnancy and lactation have been conducted. If it is necessary to use in this category of patients, the expected benefit of therapy for the mother should be weighed against the potential risk to the fetus or breastfed infant.

Pediatric Use

Can be used for growth retardation in children.

Special Precautions

Can be used for anorexia, hypotrophy, growth retardation in children.

Drug Interactions

Corticosteroids promote the accumulation of carnitine in tissues (except the liver).

Other anabolic agents enhance the effect of carnitine.

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

Marketing Authorization Holder

Belmedpreparaty, JSC (Republic of Belarus)

Dosage Form

Bottle Rx Icon Carnitine Concentrate for solution for infusion 500 mg/5 ml: amp. 5 or 10 pcs.

Dosage Form, Packaging, and Composition

Concentrate for solution for infusion 1 ml 1 amp.
Carnitine hydrochloride 100 mg 500 mg

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

Marketing Authorization Holder

Experimental Production of MBP RK NPC (Russia)

Dosage Form

Bottle Rx Icon Carnitine chloride Injection Solution 10% (500 mg/5 ml): amp. 5 or 10 pcs.

Dosage Form, Packaging, and Composition

Injection Solution 10% 1 ml 1 amp.
Carnitine 100 mg 500 mg

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

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