Instructions Steatel oral solution 1 g/10 ml bottle 10 ml No. 10
Composition
active ingredient: levocarnitine;
1 ml of solution contains 100 mg of levocarnitine;
excipients: malic acid, methylparaben (E 218), propylparaben (E 216), sodium saccharin, orange flavoring, purified water.
Dosage form
Oral solution.
Main physicochemical properties: clear liquid from colorless to yellowish.
Pharmacotherapeutic group
Amino acids and their derivatives. ATC code A16A A01.
Pharmacological properties
Pharmacodynamics
Levocarnitine is a natural substance essential for energy metabolism. Levocarnitine facilitates the entry of long-chain fatty acids into the mitochondria of cells, thus providing a substrate for oxidation and energy production. Fatty acids are used as a substrate for energy production in all tissues except the brain. Primary systemic carnitine deficiency is characterized by low concentrations of levocarnitine in blood plasma, erythrocytes and/or tissues. It is not clear which symptoms are caused by carnitine deficiency and which by organic acidemia; it is expected that carnitine may alleviate the symptoms of both pathologies. Carnitine improves the elimination of excess organic and fatty acids in patients with disorders of fatty acid metabolism and/or with specific organic acidopathies that cause the accumulation of acyl-CoA in the body.
Secondary deficiency is observed in connection with alimentary deficiency of carnitine, its incomplete synthesis in the body or with exceptionally high endogenous needs of the body for carnitine, including in seriously ill, weakened and postoperative patients. A significant decrease in the level of carnitine in the myocardium is manifested in patients with dilated cardiomyopathy and ischemic heart disease. The total level of carnitine in the myocardium decreased to 42% in heart failure. It has been proven that carnitine deficiency causes a decrease in myocardial contractility, heart rhythm disturbances.
The development of hepatic steatosis is associated with carnitine deficiency, which leads to mitochondrial dysfunction. Levocarnitine helps improve energy metabolism and reduces fatty infiltration of the liver.
Carnitine deficiency may be a consequence of congenital metabolic disorders. Carnitine may reduce metabolic disorders in patients with congenital pathologies that cause the accumulation of toxic organic acids. This effect has been demonstrated for the following conditions: glutaric aciduria II, methylmalonic aciduria, propionic acidemia, and medium-chain fatty acid acyl-CoA dehydrogenase deficiency. 7,8-autointoxication in such patients occurs due to the accumulation of acyl-CoA compounds, which disrupt intermediate metabolism. Further hydrolysis of acyl-CoA compounds to free acids causes acidosis, which can be life-threatening. Levocarnitine neutralizes acyl-CoA compounds, forming acylcarnitine, which is rapidly excreted from the body. Carnitine is effective in alcohol or drug intoxication, as well as in intoxication caused by xenobiotics.
Carnitine deficiency is detected biochemically by a very low concentration of free carnitine in the blood plasma, less than 20 μmol/l a week after taking the drug, and may be manifested simultaneously by low concentrations in tissues and/or urine. In addition, this condition may be associated with a ratio of plasma concentrations of acylcarnitine/levocarnitine exceeding 0.4 or with abnormally high concentrations of acylcarnitine in the urine. In premature infants and newborns, secondary deficiency is manifested as a concentration of levocarnitine in the blood plasma below the age-appropriate dose. The effectiveness of carnitine has been shown in peripheral neuropathy, including diabetic and alcoholic, in patients with obesity and atherogenic dyslipidemia. Levocarnitine increases the sensitivity of cells to the action of insulin.
Levocarnitine did not bind to plasma proteins or albumin when tested at any concentrations in animals or humans.
Pharmacokinetics
From 58% to 65% of levocarnitine is excreted in the urine and feces within 5-11 days. The maximum concentration of carnitine in the blood serum was noted 2.0-4.5 hours after taking the drug. The main metabolites identified were trimethylamine-N-oxide, mainly in the urine (from 8% to 49% of the administered dose), and [3H]-γ-butyrobetaine, mainly in the feces (from 0.44% to 45% of the administered dose). Urinary excretion of unchanged levocarnitine is from 4% to 8% of the administered dose. Fecal excretion of levocarnitine is less than 1% of the administered dose.
Indication
Primary (congenital) carnitine deficiency; secondary carnitine deficiency; cardiomyopathy.
Contraindication
Hypersensitivity to the components of the drug.
Interaction with other medicinal products and other types of interactions
Simultaneous use of glucocorticoids leads to the accumulation of levocarnitine in body tissues (except the liver). Other anabolic agents enhance the effect of the drug.
Application features
Administration of levocarnitine to diabetic patients receiving insulin or oral hypoglycemic treatment may cause hypoglycemia. In such patients, plasma glucose levels should be monitored regularly to adjust the hypoglycemic treatment regimen. Prolonged oral administration of high doses of levocarnitine to patients with severe renal impairment or end-stage renal disease (ESRD) is not recommended, as it may lead to accumulation in the blood of potentially toxic metabolites, trimethylamine (TMA) and trimethylamine-N-oxide (TMAO), due to insufficient renal excretion. Such accumulation leads to an increase in urinary TMA.
Do not exceed the recommended dose of the drug. If side effects occur, the drug should be discontinued.
Ability to influence reaction speed when driving vehicles or other mechanisms
Does not affect.
Use during pregnancy or breastfeeding
The drug has not been reported to have teratogenic or embryotoxic effects, but due to the lack of adequate controlled clinical studies, the drug can be used in pregnant women only if the expected benefit to the mother outweighs the possible risk to the fetus.
If it is necessary to use Steatel, breastfeeding should be discontinued for the period of treatment with the drug.
Method of administration and doses
The dose and duration of treatment are determined by the doctor individually depending on the age and nosological form of the disease. Steatel should be taken orally 30 minutes before meals. Use a dosing syringe or measuring cup to dose the drug. Adults should be prescribed the drug in an initial dose of 1 g per day (10 ml), gradually increasing the dose depending on the patient's condition and tolerance. The usual dose of the drug for adults is 1-3 g (10-30 ml) per day, divided into 1-3 doses. The maximum daily dose for adults is 6 g (60 ml).
The average course of treatment for adults and children is 1-3 months. If necessary, the course of treatment can be repeated. In case of primary and secondary carnitine deficiency, the drug should be taken continuously or until the cause of the latter is eliminated.
Children. The drug should be used in children (full-term and premature newborns) from the first day of life.
Children should be given Steatel starting at a dose of 50 mg/kg/day. The usual dose for children is 50-100 mg/kg/day (see table).
Table
| Age | Single dose | Number of receptions per day |
| Newborns | 100 mg (1 ml) | 2-3 |
| Children under 1 year of age | 100-200 mg (1-2ml) | 2-3 |
| Children 1-3 years old | 200-400 mg (2-4 ml) | 3 |
| Children 4-6 years old | 200-400 mg (2-4 ml) | 3 |
| Children 7-11 years old | 500-800 mg (5-8 ml) | 3 |
| Children from 12 years old | 800-1000 mg (8-10 ml) | 3 |
The maximum daily dose for children is 3 g (30 ml).
Overdose
There have been no reports of toxicity from overdose of levocarnitine. Large doses of the drug may cause diarrhea.
In case of overdose, provide symptomatic treatment.
Adverse reactions
With prolonged use of L-carnitine orally, various minor gastrointestinal disorders have been reported: reversible nausea and vomiting, flatulence, diarrhea. Only with the use of L-carnitine in patients with uremia have cases of myasthenia gravis been described.
Sensitivity to the drug should be carefully assessed during the first week of drug use and after each dose increase.
Cases of seizures have been described in patients with and without existing seizure activity who received oral or intravenous levocarnitine.
Expiration date
3 years.
Storage conditions
Store at a temperature not exceeding 25 °C in a place protected from light. Keep out of the reach of children.
Packaging
10 ml in a bottle, 10 bottles in a cardboard box.
Vacation category
Without a prescription.
Producer
Help, SA
Location of the manufacturer and its business address
Pedini Ioanninon, Ioannina, 45500, Greece./Pedini Ioanninon, Ioannina, 45500, Greece.
