Expiration date: 06/2025

International nonproprietary name: levocarnitine

Chemical name:

(3R)-3-hydroxy-4-(trimethylammonio)butanoate

Dosage form:

effervescent granules for preparation of solution for oral administration.

Composition:

1 sachet contains:

active substance: levocarnitine 1000,0 mg;

excipients: citric acid anhydrous 2750,0 mg, sodium carbonate anhydrous 1100,0 mg, lemon flavor 100,0 mg, Acesulfame potassium 35,0 mg, silicon dioxide colloidal anhydrous 15,0 mg.

Description:

white or white granules with a yellowish tint with a weak lemon smell; after dissolution of granules the colourless or with a yellowish tint slightly opalescent solution with a weak lemon smell is formed.

Pharmacotherapeutic group:

metabolic agent

Code ATX: A16AA01

Pharmacodynamics

L-carnitine is a natural substance, related b vitamins Involved in the metabolic processes as a carrier of long chain fatty acids (palmitic, etc.) from the cytoplasm into the mitochondria, where these acids undergo the process of ?-oxidation with the formation of adenosine triphosphate and acetyl-COA.

Improves protein and fat metabolism, increases secretion and enzymatic activity of gastric and intestinal juices, improves food absorption, reduces overweight and reduces fat content in muscles. Increases resistance to physical activity, inhibits the formation of keto acids and anaerobic glycolysis, reduces the degree of lactic acidosis, promotes economical consumption of glycogen and increases its reserves in the liver and muscles.

It has an anabolic and lipolytic effect. Normalizes increased basal metabolism in hyperthyroidism: it is a peripheral (indirect) antagonist of thyroid hormones, and not a direct inhibitor of thyroid function.

It improves metabolism and energy supply of tissues.

Pharmacokinetics

It is well absorbed in the intestine, the plasma concentration reaches a maximum in 3 hours and remains in the therapeutic range for 9 hours. Easily penetrates the liver, myocardium, slower – in the muscles. It is excreted by the kidneys, mainly in the form of acyl esters.

Indications for use

The drug is used as part of complex therapy in adults:

· with intensive and prolonged physical activity, psycho-emotional stress: to improve performance, endurance, reduce fatigue, including in the elderly;

· during rehabilitation after diseases and surgical interventions, injuries, including to accelerate tissue regeneration;

· with anorexia nervosa;

· in diseases accompanied by a lack of carnitine or its increased loss (myopathy, cardiomyopathy, mitochondrial diseases, hereditary diseases with concomitant mitochondrial insufficiency): to make up for its deficiency in the complex therapy;

· in sports medicine and in intensive training (during the training process in the development of aerobic performance): to improve speed and strength performance and coordination of movements, to increase muscle mass and reduction of body fat, to prevent post-training syndrome (acceleration of recovery processes after exercise), with traumatic injuries to accelerate muscle regeneration.

Contraindications

Individual intolerance to the components of the drug, age up to 18 years.

Use during pregnancy and breastfeeding

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

Dosage and administration

The drug is used as part of complex therapy in adults.

Inside 30 minutes before meals. The contents of the bag is dissolved in 100-200 ml of water at room temperature (15-25 °C) and taken immediately after preparation.

1 sachet contains 1000 mg (1 g) of levocarnitine.

With intensive and prolonged physical activity, psycho-emotional stress: 1-2 g (1-2 bags) 3 times a day.

With anorexia nervosa, as well as during rehabilitation after illness and surgery, injuries, including to accelerate tissue regeneration: 1 g (1 bag) 3 times a day. The course of treatment – for 1-2 months.

In diseases accompanied by a lack of carnitine or its increased loss (myopathy, cardiomyopathy, mitochondrial diseases, hereditary diseases with concomitant mitochondrial insufficiency): up to 50-100 mg/kg body weight with a frequency of 2-3 times a day to 7 g (7 bags) per day. The course of treatment – for 3-4 months.

In sports medicine and intensive training: from 1 g (1 bag) 3 times a day to 2 g (2 bags) 2-3 times a day (daily dose 3-6 g); in the case of use for therapeutic purposes – 70-100 mg/kg/day (5-7 g/day). Course of administration: 3-4 weeks in the pre-competition period. During the training process – up to 6-8 weeks.

Side effect

Adverse reactions that may occur during the use of the drug are classified as very rare (<1/10000 appointments):

disorders of the nervous system: very rare – myasthenic disorders (in patients with uremia);

disorders of the gastrointestinal tract: very rare – gastralgia, dyspepsia;

disorders of the skin and subcutaneous tissues: very rare – rash, allergic dermatitis.

If any of the adverse reactions listed in the instructions are aggravated, or You notice any other adverse reactions not listed in the instructions, inform your doctor.

Overdose

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

Treatment: gastric lavage, administration of activated charcoal.

Interaction

Glucocorticosteroids contribute to the accumulation of the drug in the tissues (except the liver), other anabolics enhance the effect.

The effect of the drug for medical use on the ability to drive vehicles, mechanisms

The drug does not affect the performance of potentially dangerous activities that require special attention and rapid reactions (driving and other vehicles, working with moving mechanisms, the work of the dispatcher and operator, etc.).

Form release

Effervescent granules for preparation of solution for oral administration 1000 mg.

5 g granules are placed in a heat-sealable bag of multilayer material (paper/polyethylene/aluminum/polyethylene).

On 10 or 30 individual or fastened in pairs bags together with the instruction on application place in a pack from a cardboard.

Storage conditions

Store in a dry, dark place at a temperature not exceeding 25 °C.

Keep out of reach of children.

Shelf life

3 years.

Do not use after the expiration date.