Levocarnil^® (Solution) Instructions for Use

Marketing Authorization Holder

Evalar, CJSC (Russia)

Contact Information

EVALAR CJSC (Russia)

ATC Code

A16AA01 (Levocarnitine)

Active Substance

Levocarnitine (Rec.INN registered by WHO)

Dosage Form

Levocarnil®

Oral solution 300 mg/ml: 100 ml bottle

Dosage Form, Packaging, and Composition

Oral solution transparent, colorless or almost colorless, with a specific odor.

Excipients: citric acid monohydrate – 1.2 mg, methylparaben – 0.5 mg, propylparaben – 0.2 mg, purified water – up to 1 ml.

100 ml – dark glass bottles (1) with a dropper cap – cardboard packs.

A measuring cup may be included in the cardboard pack.

Clinical-Pharmacological Group

A drug that improves tissue metabolism and energy supply

Pharmacotherapeutic Group

Metabolic agent

Pharmacological Action

L-carnitine is a natural substance related to B vitamins.

It participates in metabolic processes as a transporter of long-chain fatty acids (palmitic acid, etc.) from the cytoplasm into the mitochondria, where these acids undergo beta-oxidation to form adenosine triphosphate and acetyl-CoA.

It improves protein and fat metabolism, increases the secretion and enzymatic activity of gastric and intestinal juices, improves food absorption, reduces excess body weight and decreases fat content in muscles.

It increases resistance to physical exertion, suppresses the formation of keto acids and anaerobic glycolysis, reduces the degree of lactate acidosis, promotes economical use of glycogen and increases its reserves in the liver and muscles.

It has an anabolic and lipolytic effect.

It normalizes increased basal metabolism in hyperthyroidism: it is a peripheral (indirect) antagonist of thyroid hormone action, not a direct inhibitor of thyroid function.

It improves metabolism and energy supply to tissues.

Pharmacokinetics

It is well absorbed in the intestine, C_max in blood plasma reaches a maximum after 3 hours and remains in the therapeutic range for 9 hours.

It easily penetrates the liver, 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 in adults

• Intense physical and psychoemotional stress: to increase performance, endurance, reduce fatigue, including in the elderly;
• During the rehabilitation period after past illnesses and surgical interventions, injuries, including to accelerate tissue regeneration;
• Complex therapy of chronic gastritis and chronic pancreatitis with reduced secretory function;
• Complex therapy of skin diseases (psoriasis, seborrheic eczema, focal scleroderma and discoid lupus erythematosus);
• Mild hyperthyroidism;
• Neurological manifestations in vascular, toxic and traumatic brain lesions;
• Nervous anorexia syndrome;
• Diseases accompanied by carnitine deficiency or its increased loss (myopathies, cardiomyopathies, mitochondrial diseases, hereditary diseases with concomitant mitochondrial insufficiency) – to replenish its deficiency as part of complex therapy.

In pediatric practice (treatment of children under 3 years of age under medical supervision):

• For nursing premature infants, newborns who have suffered birth trauma or asphyxia; children with sluggish sucking reflex and low weight gain; reduced muscle tone, with insufficient development of motor and mental functions, as well as for the prevention of these disorders in children from “risk groups”; for growth retardation and underweight in children and adolescents under 16 years of age.

In adults in sports medicine and during intensive training (during the training process when developing aerobic performance):

• To improve speed-strength indicators and movement coordination, to increase muscle mass and reduce body fat mass, to prevent post-training syndrome (accelerating recovery processes after physical exertion), for traumatic injuries to accelerate muscle regeneration.

ICD codes

Dosage Regimen

Orally 30 minutes before meals, additionally diluted with liquid. For convenient dosing, a pipette or medical syringe can be used.

The drug is used as part of complex therapy.

For prolonged physical and psychoemotional stress from 0.75 g (2.5 ml) 3 times a day to 2.25 g (7.5 ml) 2-3 times a day.

For nervous anorexia, as well as during the rehabilitation period after past illnesses, surgical interventions and injuries 1.5 g (5 ml) 2 times a day. The course of treatment is for 1-2 months.

In complex therapy of chronic gastritis and chronic pancreatitis with reduced secretory function 0.375 g (1.25 ml) 2 times a day. The course of treatment is for 1-1.5 months.

For treatment of skin diseases 0.75 g (2.5 ml). The course of treatment is for 2-4 weeks.

For mild hyperthyroidism 0.25 g (13 drops) 2-3 times a day. The course of treatment is 20 days. The course of treatment is repeated after a 1-2 month break or prescribed for 3 months without a break.

For vascular, toxic and traumatic brain lesions 0.75 g (2.5 ml)/day. The course of treatment is for 3-5 days. If necessary, a repeat course is prescribed after 12-14 days.

For diseases accompanied by carnitine deficiency (primary and secondary carnitine deficiency) up to 50-100 mg/kg (2-5 drops/kg) of body weight with a frequency of administration 2-3 times a day. The course of treatment is for 3-4 months.

For children, it is prescribed as an additive to sweet dishes (jelly, compote, juices).

Children under 3 years the dose is determined by the attending physician.

Children from 3 to 6 years – in a single dose of 0.1 g (5 drops) 2-3 times a day, in a daily dose of 0.2-0.3 g (11-16 drops). The course of treatment is 1 month.

Children from 6 to 12 years are prescribed in a single dose of 0.2-0.3 g (11-16 drops) 2-3 times a day, in a daily dose of 0.4-0.9 g (22-48 drops). The course of treatment is at least 1 month.

For growth retardation 0.25 g (13 drops) 2-3 times a day. The course of treatment is 20 days. The course of treatment is repeated after a 1-2 month break or prescribed for 3 months without a break.

In sports medicine and during intensive training 2.5 g (8.33 ml) 1-3 times a day (daily dose 2.5-7.5 g); in case of use for therapeutic purposes – 70-100 mg/kg/day (5-7.5 g/day). Courses of administration: 3-4 weeks in the pre-competition period. During the training process – up to 6-8 weeks.

Adverse Reactions

Possible allergic reactions, gastralgia, dyspepsia, myasthenia (in patients with uremia).

Contraindications

• Individual intolerance to the components of the drug.

Use in Pregnancy and Lactation

Due to the lack of studies, use during pregnancy and breastfeeding is not recommended.

Pediatric Use

Treatment of children under 3 years of age should be carried out under medical supervision.

Special Precautions

Treatment of children under 3 years of age should be carried out under medical supervision.

Effect on the ability to drive vehicles and mechanisms

The drug does not affect the performance of potentially hazardous activities requiring special attention and quick reactions (driving a car and other vehicles, working with moving mechanisms, work of a dispatcher and operator, etc.).

Overdose

Symptoms dyspeptic disorders, myasthenic disorders (in patients with uremia).

Treatment gastric lavage, intake of activated charcoal.

Drug Interactions

Glucocorticosteroids promote the accumulation of the drug in tissues (except the liver), other anabolic agents enhance the effect.

Storage Conditions

The drug should be stored out of the reach of children at a temperature not exceeding 25°C (77°F).

Shelf Life

Shelf life – 3 years. Do not use after the expiration date.

After opening, store in the refrigerator for 2 months.

Dispensing Status

The drug is dispensed without a 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.