Steatel oral solution

• primary (congenital) insufficiency of carnitine;
• secondary insufficiency of carnitine;
• cardiomyopathy.

Doses and duration of treatment are determined individually by the doctor, depending on the age and nosological form of the disease. Steatelle should be taken internally 30 minutes before eating. To dispense the drug use a dosing syringe or measuring cup. Adult drug should be administered at an initial dose of 1 g per day (10 ml), gradually increasing the dose depending on the patient's condition and tolerability. 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 the case of primary and secondary carnitine insufficiency, the drug should be taken continuously or until the cause of the latter has been eliminated.

Children. The drug should be used for children (preterm and preterm infants) from the first day of life.

To appoint Steatel children starting at a dose of 50 mg/kg per day. The usual doses for children are 50–100 mg/kg per day.

The maximum daily dose for children is 3 g (30 ml).

Hypersensitivity to the drug components.

Special precautions

Administration of levocarnitine to patients with diabetes mellitus receiving insulin or oral hypoglycemic treatment may cause hypoglycemia. In such patients, plasma glucose levels should be monitored continuously to adjust the hypoglycemic treatment regimen. Prolonged oral administration of high doses of levocarnitine in patients with severe renal impairment or end-stage renal disease (ESRD) is not recommended, as it can lead to accumulation of potentially toxic metabolites, trimethylamine (TMA) trimethylamine-N-oxide (TMAO), in the blood due to insufficient renal excretion. This accumulation leads to an increase in TMA in the urine.

Do not exceed the recommended doses of the drug. If side effects occur, the drug should be discontinued.

Interaction with other drugs and other types of interactions

Concomitant use of glucocorticoids leads to the accumulation of levocarnitine in body tissues (except for the liver). Other anabolic agents enhance the effect of the drug.

Features of application

Use during pregnancy or lactation

Teratogenic and embryotoxic effects of the drug have not been reported, but due to the lack of adequate controlled clinical trials, the drug should be used in pregnant women only when the expected benefit to the mother exceeds 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.

Ability to influence the reaction rate when driving vehicles or using other mechanisms

No effect.

Overdose

There have been no reports of levocarnitine toxicity in overdose. Large doses of the drug may cause diarrhea. In case of an overdose, provide symptomatic treatment.

Adverse reactions

With prolonged oral administration of L-carnitine, various minor gastrointestinal disorders have been reported: reversible nausea and vomiting, flatulence, diarrhea. Only when L-carnitine is used in patients with uremia, cases of mild myasthenia gravis have been described. Sensitivity to the drug should be carefully assessed during the first week of use and after each dose increase. Cases of seizures have been described in patients with and without seizure activity who received levocarnitine orally or intravenously.

Active ingredient: levocarnitine;

1 ml of solution contains 100 mg of levocarnitine.

Excipients: malic acid, methylparaben (E 218), propylparaben (E 216), saccharin sodium, orange flavoring, water purified.

10 ml in a vial, 10 vials in a cardboard pack.

Do not store above 25 °C in light. Keep out of the reach of children.

Help, S.A., Pedini Ioanninon, Ioannina, 45500, Greece.

UA/12945/01/01