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Metakartin 1 g/5 ml No. 5 solution d/in.

APPROVED by the Order of the Chairman of the Pharmacy Committee of the Ministry of Health of the Republic of Kazakhstan Instructions for the medical use of the drug Metakartin Trade name Metakartin International nonproprietary name Levocarnitine Dosage form Solution for injection, 1.0 g/5.0 ml Composition 5 ml of the drug contain the active substance - levocarnitine 1.0 g, excipients: acid hydrochloric acid up to pH 6.2-6.6, water for injection up to 5.0 ml. Description Transparent colorless solution. Pharmacotherapeutic group Other drugs for the treatment of gastrointestinal diseases and metabolic disorders. Amino acids and their derivatives. Levocarnitine. ATC code A16AA01 Pharmacological properties Pharmacokinetics After intravenous administration, levocarnitine easily penetrates into all tissues, high concentrations are created in skeletal muscles and myocardium. The maximum concentration in blood plasma is maintained for 9 hours. Does not bind to human plasma proteins and albumin. After parenteral administration, levocarnitine is minimally metabolized. It is excreted by the kidneys, mainly in the form of acyl esters, in an amount directly proportional to the level of levocarnitine in the blood plasma. The half-life is 17.4 hours. Excreted by the kidneys (76% in 24 hours). Pharmacodynamics Metakartin is a drug for the correction of metabolic processes. Levocarnitine is a natural substance related to B vitamins. It participates in metabolic processes as a carrier of fatty acids through cell membranes from the cytoplasm to the mitochondria, where these acids undergo the process of β-oxidation with the formation of large amounts of energy (in the form of ATP). By releasing coenzyme A, levocarnitine increases the flow of metabolites into the Krebs cycle. By the same mechanism, it stimulates the activity of pyruvate dehydrogenase in skeletal muscles and the oxidation of branched amino acids. The drug normalizes protein and fat metabolism, restores the alkaline reserve of the blood, inhibits the formation of ketoacids and anaerobic glycolysis, reduces the degree of lactic acidosis, and also increases physical activity and increases exercise tolerance, while promoting economical consumption of glycogen and increasing its reserves in the liver. Indications for use - primary (genetic) and secondary carnitine deficiency - secondary carnitine deficiency in patients receiving long-term hemodialysis and having the following symptoms: severe persistent muscle spasms, skeletal muscle weakness, myopathies, loss of muscle mass, symptoms of arterial hypotension, anemia, cardiomyopathy, lack of response to treatment or the need for large doses of erythropoietin. Method of administration and dosage Metakartin injection solution is intended for slow intravenous administration (over 2-3 minutes). To determine the optimal dose, it is recommended to monitor therapy by measuring the levels of free and acyl levocarnitine in blood plasma and urine. The level of free levocarnitine in the blood plasma should be 35 - 60 µmol/l. The ratio of acyl levocarnitine to the level of free levocarnitine in the blood plasma should not be higher than 0.35. The dose is calculated depending on age and body weight. For primary and secondary carnitine deficiency, the recommended doses depend on the metabolic disorder and the severity during the treatment period. Metakartin solution for injection, administered intravenously slowly over 2-3 minutes, with the daily dose divided into 3-4 administrations, or as an infusion: intravenously drip, slowly about 3 ml per minute (or no more than 60 drops per minute), at the rate of 30 minutes per 100 ml and 1 hour 20 minutes per 250 ml. Before administration, the required dose of the drug is dissolved in 100 or 250 ml of isotonic sodium chloride solution or 5% glucose solution. Children under 12 years of age (including newborns and infants) In most cases, the recommended dose is 100-200 mg/kg/day. If clinical and biochemical parameters do not improve, the dose may be increased for a short time. High doses up to 400 mg/kg/day may be necessary for acute metabolic decompensation. Adults and children over 12 years of age In case of primary or secondary deficiency of levocarnitine in case of acute decompensation, the drug is prescribed at a dose of 50-100 mg/kg/day. If necessary, it is possible to use the drug in a higher dose, but this is associated with a high risk of adverse reactions. In case of secondary carnitine deficiency during hemodialysis, the drug is administered intravenously slowly (over 2-3 minutes). For children under 12 years of age, the drug is prescribed at a dose of 10-20 mg/kg/day at the end of each hemodialysis procedure (with three hemodialysis procedures per week). Children over 12 years old: 1 g/day and adults: 2 g/day at the end of each hemodialysis procedure. A dose of 2.5 g is prescribed to patients on hemodialysis for more than 1 year. The duration of intravenous treatment is no more than 3 months, this is the period necessary to restore the normal level of levocarnitine in the muscles. The need for a second course of treatment is determined by the level of levocarnitine in the blood plasma, which should be monitored regularly. Side effects - nausea, vomiting, abdominal pain, diarrhea with long-term use of oral levocarnitine; - muscle weakness, cramps in patients with uremia; - allergic reactions (skin itching, skin rash, urticaria, Quincke's edema, anaphylactic shock); - specific body odor. Reducing the dose often reduces or eliminates the patient's drug-induced body odor and gastrointestinal symptoms; - with rapid injection, pain may appear along the vein, which goes away when the speed of injection is reduced. Contraindications: hypersensitivity to levocarnitine or auxiliary components of the drug. In the form of a solution for infusion, Metakartin is contraindicated in patients with hypernatremia and hypervolemia. Infusion solution with glucose solvent is contraindicated in patients with diabetes mellitus. Drug interactions Administration of the drug Metakartin, solution for injection, to patients with diabetes mellitus receiving insulin or oral hypoglycemic drugs may cause hypoglycemia due to increased absorption of glucose. Therefore, in this category of patients, during treatment with the drug, the level of glucose in the blood plasma should be constantly monitored to correct the dosage regimen of hypoglycemic drugs. When used simultaneously, glucocorticosteroids contribute to the accumulation of the drug in tissues (except the liver). Lipoic acid and anabolics enhance the effect of levocarnitine. It is necessary to inform your doctor about the use of any other medications in conjunction with Metakartin. Taking carnitine can increase the content of free valproic acid in the blood serum and thereby potentiate its effect even when taking moderate therapeutic doses. Taking excessive doses of choline may reduce the activity of carnitine. Special instructions The drug is not addictive or addictive, since L - carnitine is a natural component of the body. Tolerance to the drug should be monitored during the first week of treatment and after each dose increase. If you miss a dose, do not take a double dose and continue treatment as usual. Intravenous administration of the drug should be slow (2-3 minutes). Metakartin, solution for injection, should be taken with caution by patients suffering from chronic heart failure, acute renal failure, edema caused by salt retention, as well as patients taking corticosteroid and corticotropic hormonal drugs. Long-term use without supplemental potassium may result in hypokalemia. The drug is used with caution in patients with a history of allergies. Since carnitine improves the absorption of glucose, it is necessary to monitor its level in the blood serum in patients with diabetes mellitus. Intravenous administration of high doses of Metacartin to patients with severe renal impairment or those on dialysis with end-stage renal disease does not lead to the accumulation of the potentially toxic metabolites trimethylamine (TMA) and trimethyl-N-oxide (TMAO), which are usually excreted in the urine. This situation occurs with long-term oral administration in high doses. Pregnancy and lactation Metakartin, an injection solution, is prescribed only in cases of extreme necessity, carefully weighing the benefits to the mother and the potential risk to the fetus or child. Features of the effect of the drug on the ability to drive a vehicle and potentially dangerous mechanisms Persons who notice muscle weakness after using Metakartin, solution for injection, should refrain from driving a car and potentially dangerous mechanisms. Overdose Large doses of levocarnitine can cause diarrhea. Treatment: symptomatic therapy. Release form and packaging 5 ml of the drug is poured into a dark glass ampoule. 5 ampoules are placed in a blister pack made of polyvinyl chloride (PVC) film. 1 blister pack together with instructions for medical use in the state and Russian languages are placed in a cardboard box. Storage conditions Store in a dry place, protected from light, at a temperature not exceeding 25°C. Keep out of the reach of children! Do not freeze! Shelf life 4 years. Do not use after the expiration date. Conditions for dispensing from pharmacies By prescription Manufacturer Mefar Ilach San. A.Sh Address: Istanbul. Ramazanolu Mah. Ensar Jad. No. 20. Kurtkoy Pendik, Türkiye Registration Certificate Holder World Medicine Ilac San. ve Tij. A.Sh. Address: Evren Mah., Jami Yolu Jad. No. 50, Gunashli, Bagcilar, 34192 Istanbul, Turkey Address of the organization that accepts claims from consumers on the quality of products of the Republic of Kazakhstan in the territory of the Republic of Kazakhstan, Almaty, Turksib district, Suyunbay Ave., 222 b Tel/fax: 8 (7272) 529090 www.worldmedicine .kz Address of the organization responsible for post-registration monitoring of the safety of the drug, TROKA-S PHARMA LLP, Almaty, Suyunbay Ave., 222b Cell phone, (24-hour access).

Interaction with other drugs and other types of interactions

An interaction between levocarnitine and coumarin preparations cannot be excluded. In very rare cases, an increase in the international normalized ratio (INR) has been reported with simultaneous use of levocarnitine with coumarin drugs (see Sections “Peculiarities of use”, “Adverse reactions”). In the case of simultaneous use of these drugs, INR monitoring or other coagulation tests should be performed weekly until stabilization and monthly thereafter (see Section “Peculiarities of Application”).

Concomitant use of levocarnitine with drugs that induce hypocarnitinemia and enhance the excretion of carnitine by the kidneys (for example, valproic acid, prodrugs containing pivalonic acid, cephalosporins, cisplatin, carboplatin, ifosfamide) may reduce its level.

Adverse reactions

Adverse reactions (according to clinical studies, literature and post-registration experience) are given by organ system classes in accordance with the MedDRA medical dictionary of regulatory activities and are classified according to the following frequency: very often (≥1/10), often (≥1/100, <10 ), uncommon (≥1/1000, <100), rare (≥1/10000, <100), very rare (<1/10000), frequency unknown (frequency cannot be estimated from available data). Within each frequency group, adverse reactions are listed in descending order of severity.

From the nervous system:

infrequently - headache frequency unknown - convulsions1, dizziness.

From the heart:

frequency unknown - heartbeat.

From the side of blood vessels:

infrequently - arterial hypotension, arterial hypertension.

From the respiratory system, chest and mediastinal organs:

frequency unknown - shortness of breath.

From the digestive tract:

often - nausea, vomiting, diarrhea, abdominal pain; infrequently - dysgeusia, dyspepsia, dry mouth.

For the skin and subcutaneous tissues:

uncommon - abnormal body odor2; frequency unknown - itching, rash.

From the musculoskeletal system and connective tissue:

infrequently - muscle spasms; frequency unknown - myasthenia gravis, muscle tension.

General disorders and disorders at the injection site:

often - chest pain, abnormal sensations, pyrexia.

Study:

uncommon - increased blood pressure; very rarely - increase in INR4.