Steatel (levocarnitine) solution for injections 1 g/5 ml. ampoules 5 ml. №5

Description

Steatel (levocarnitine) solution for injections 1 g/5 ml. ampoules 5 ml. №5

Composition

active substance: levocarnitine;

1 ml of solution contains 200 mg of levocarnitine;

Excipients: dilute hydrochloric acid, water for injections.

Dosage form

Solution for injection.

Basic physical and chemical properties: clear liquid from colorless to yellowish color.

Pharmacotherapeutic group

Amino acids and their derivatives.
ATX code A16A A01.

Pharmacological properties

Levocarnitine is present as a natural component in animal tissues, microorganisms and plants. In humans, physiological needs for carnitine are supplemented by the consumption of foods containing carnitine (primarily meat products) and by endogenous synthesis in the liver from trimethyllysine. Only the L-isomer is biologically active, levocarnitine plays an important role in lipid metabolism, as well as in the metabolism of ketone bodies. Levocarnitine is required for the transport of long-chain fatty acids in the mitochondria for their subsequent beta-oxidation. By releasing coenzyme A from thioethers, levocarnitine also enhances carbohydrate oxidation in the Krebs cycle, stimulates the activity of a key glycolysis enzyme, pyruvate dehydrogenase, and in skeletal muscle, branching chain oxidation. Thus, levocarnitine is directly or indirectly involved in most energy processes, its presence is required for the oxidation of fatty acids, amino acids, carbohydrates and ketone bodies.

The highest levels of levocarnitine are found in muscle tissue, myocardium and liver. Levocarnitine plays an important role in cardiac metabolism, as the oxidation of fatty acids depends on the availability of sufficient amounts of this substance. Experimental studies have shown that under certain conditions, such as stress, acute ischemia, myocarditis, it is possible to reduce the level of levocarnitine in myocardial tissue. A large number of animal studies have confirmed the positive effects of levocarnitine in various induced cardiac disorders: acute and chronic ischemia, cardiac decompensation, heart failure due to myocarditis, drug cardiotoxicity (taxanes, adriamycin, etc.).

Indication

Primary and secondary carnitine deficiency in adults and children, including newborns and infants.

Secondary carnitine deficiency in patients undergoing hemodialysis.

Suspicion of secondary carnitine deficiency in hemodialysis patients in the following cases:

• severe and persistent muscle spasms and / or hypotensive episodes during dialysis;
• energy shortage, which leads to a significant negative impact on quality of life;
• muscle weakness and / or myopathy;
• cardiopathy;
• anemia that does not respond to erythropoietin treatment or requires high doses of erythropoietin;
• loss of muscle mass.

Contraindication

Hypersensitivity to the components of the drug Steatel.

Use during pregnancy or breastfeeding

Teratogenic effects in preclinical studies of the drug Steatel were not detected.

Given the serious consequences of carnitine deficiency for pregnant women, the risk of discontinuation of treatment with the drug for the mother is considered greater than the theoretical risk to the fetus (if treatment is continued).

Levocarnitine is a common component of breast milk.

Method of application and dosage

The drug Steatel is administered intravenously slowly for 2-3 minutes.

Use in congenital metabolic disorders.

During therapy, it is advisable to monitor the level of carnitine and acyl-carnitine in both blood plasma and urine.

The required dose depends on the specifics of congenital metabolic disorders and the severity of the disease.

In case of acute decompensation, the recommended dose may be up to 100 mg / kg per day for 3-4 injections. If necessary, higher doses can be used, although side effects, including diarrhea, may be exacerbated.

Secondary carnitine deficiency in patients undergoing hemodialysis.

Plasma carnitine levels should be monitored prior to initiating therapy.

Secondary carnitine deficiency is diagnosed when the ratio of acyl carnitine to free carnitine in blood plasma is more than 0.4 and / or when the concentration of free carnitine is less than 20 μmol / l.

A dose of 2 g should be administered intravenously at the end of each dialysis session. The overall response should be determined by monitoring plasma acyl carnitine and free carnitine levels and assessing the patient’s condition. Normalization of carnitine levels in muscle tissue and cardiomyocytes occurs approximately 3 months after reaching normal plasma carnitine levels. If you stop taking carnitine, its level will definitely start to fall again. The need for a repeat saturating course of treatment is determined by quantifying carnitine in blood plasma at regular intervals and by monitoring the patient’s condition.

Hemodialysis is a supportive therapy

After a saturating course of intravenous levocarnitine, a maintenance dose of 1 g of the drug per day orally is used. On the day of dialysis, the drug is administered intravenously at a dose of 1 g immediately after the end of the next session.

Children

The drug Steatel is used in children from the first day of life, including premature.

Overdose

There were no reports of levocarnitine toxicity in overdose. Large doses of the drug can cause diarrhea. Levocarnitine is easily removed from blood plasma by dialysis.

Treatment: take measures to remove the drug from the digestive tract in case of oral administration, conduct symptomatic and supportive therapy. No life-threatening cases of overdose have been reported.

Side effects

Various moderate gastrointestinal disorders have been observed with long-term oral administration of levocarnitine, including transient nausea and vomiting, abdominal pain, and diarrhea. Dose reduction often reduces or eliminates gastrointestinal symptoms. The tolerability of the drug should be carefully monitored during the first week of administration and after any increase in dose. Intravenous use of the drug is usually well tolerated.