Elcar^® (Granules, Solution) Instructions for Use

ATC Code

A16AA01 (Levocarnitine)

Active Substance

Levocarnitine (Rec.INN registered by WHO)

Clinical-Pharmacological Group

A drug that improves tissue metabolism and energy supply

Pharmacotherapeutic Group

Other agents for the treatment of gastrointestinal diseases and metabolic disorders; amino acids and their derivatives

Pharmacological Action

Pharmacodynamics

L-carnitine is a natural substance related to B vitamins. It participates in metabolic processes as a transporter of long-chain fatty acids (including palmitic acid) through cell membranes from the cytoplasm into the mitochondria, where these acids undergo beta-oxidation to produce ATP 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 lactic acidosis, promotes economical use of glycogen, and increases its reserves in the liver and muscles.

It has anabolic and lipolytic effects. It normalizes increased basal metabolism in hyperthyroidism, being a peripheral (indirect) antagonist of the action of thyroid hormones, and not a direct inhibitor of thyroid function.

It improves metabolism and energy supply to tissues.

Pharmacokinetics

Absorption and Distribution

After oral administration, it is well absorbed in the intestine, C_max is reached after 3 hours. The therapeutic concentration is maintained for 9 hours. It penetrates well into the liver and myocardium, and more slowly into the muscles.

Metabolism and Excretion

It is excreted by the kidneys, mainly in the form of acyl esters.

Indications

As part of complex therapy

• 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, 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 (including 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 and newborn infants who have suffered birth trauma or asphyxia;
• For 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 at risk;
• For growth retardation and underweight in children and adolescents under 16 years of age.

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

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

ICD codes

Dosage Regimen

Granules

Take orally, 30 minutes before meals. The single dose of 1000 mg (1 g) of carnitine must be dissolved in 100-200 ml of water at room temperature (15-25°C (59-77°F)) and taken immediately after preparation.

For intense and prolonged physical exertion, psychoemotional stress, 1-2 g is prescribed 3 times/day.

For nervous anorexia, as well as during the rehabilitation period after past illnesses and surgical interventions, injuries, including to accelerate tissue regeneration – 1 g 3 times/day. The course of treatment is for 1-2 months.

For diseases accompanied by carnitine deficiency or its increased loss (myopathies, cardiomyopathies, mitochondrial diseases, hereditary diseases with concomitant mitochondrial insufficiency), up to 50-100 mg/kg of body weight is prescribed with a frequency of administration of 2-3 times/day up to 7 g/day. The course of treatment is for 3-4 months.

In sports medicine and during intense training – from 1 g 3 times/day to 2 g 2-3 times/day (daily dose 3-6 g); in case of use for therapeutic purposes – 70-100 mg/kg/day. The course of administration is 3-4 weeks in the pre-competition period. During the training process – up to 6-8 weeks.

Solution

The drug is taken orally, 30 minutes before meals, additionally diluted with liquid.

Elcar^® is used as part of complex therapy.

For prolonged physical and psychoemotional stress, the drug is prescribed at a dose of 750 mg (1/2 measuring spoon or 2.5 ml) 3 times/day to 2.25 g (1.5 measuring spoons or 7.5 ml) 2-3 times/day.

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

In complex therapy of chronic gastritis and chronic pancreatitis with reduced secretory function, the drug is prescribed at 375 mg (1/4 measuring spoon or 1.25 ml) 2 times/day. The course of treatment is for 1-1.5 months.

For treatment of skin diseases – 750 mg (1/2 measuring spoon or 2.5 ml). The course of treatment is for 2-4 weeks.

For mild hyperthyroidism, the drug is prescribed at 250 mg (13 drops) 2-3 times/day. The course of treatment is 20 days. The course of treatment is repeated after a 1-2 month break or used for 3 months without a break.

For brain lesions of vascular, toxic, and traumatic origin – 750 mg (1/2 measuring spoon or 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), the drug is prescribed at a dose of up to 50-100 mg/kg (2-5 drops/kg) of body weight. Frequency of administration – 2-3 times/day. The course of treatment is for 3-4 months.

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

For children aged under 3 years, the dose is determined by the attending physician. For children aged 3 to 6 years – in a single dose of 100 mg (5 drops) 2-3 times/day, daily dose – 200-300 mg (11-16 drops). The course of treatment is 1 month. For children aged 6 to 12 years, a single dose of 200-300 mg (11-16 drops) 2-3 times/day is prescribed, daily dose – 400-900 mg (22-48 drops). The course of treatment is at least 1 month.

For growth retardation – 250 mg (13 drops) 2-3 times/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 intense training, 2.5 g 1-3 times/day (daily dose 2.5-7.5 g) is prescribed; 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.

Use in Pregnancy and Lactation

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

Pediatric Use

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

Special Precautions

Use in pediatrics

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

Effect on ability to drive vehicles and machinery

The drug does not affect the performance of potentially hazardous activities requiring special attention and speed of psychomotor reactions (driving vehicles, working with moving machinery, 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

With simultaneous use, glucocorticosteroids promote the accumulation of levocarnitine in tissues (except the liver).

Anabolic agents enhance the effect of the drug.

Storage Conditions

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

Shelf Life

The shelf life is 3 years. Do not use after the expiration date.

After opening, the bottle should be stored at a temperature from 2°C (35.6°F) to 8°C (46.4°F) 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.