Cartan oral solution 1 g/10 ml ampoule 10 ml No. 10




Oral solution "Kartal" is used for the following indications:
Treatment of primary and secondary carnitine deficiency; secondary carnitine deficiency in patients undergoing hemodialysis; suspected secondary carnitine deficiency in patients undergoing hemodialysis in the following cases: severe persistent muscle spasms and/or hypotensive episodes during dialysis; energy deficiency leading 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.Composition
The active substance is levocarnitine (1 ml of solution contains 100 mg of levocarnitine).
Excipients: sorbitol solution 70%, methylparaben (E 218), sodium saccharin, sodium, orange flavoring, hydrochloric acid, water for injections.
Contraindication
Hypersensitivity to the active substance or other components of the drug.
Method of application
The dose and duration of treatment are determined by the doctor individually depending on age, body weight and nosological form of the disease. Take orally 30 minutes before meals. For dosing, use a dosing syringe or measuring cup. Before use, it is recommended to dilute the drug in a glass of water. During therapy, it is advisable to monitor the level of free carnitine and acyl-carnitine both in blood plasma and in urine.
Primary and secondary carnitine deficiency
The dosage required depends on the specific inborn error of metabolism and the severity of the condition being treated. In general, the recommended oral dose is 100 to 200 mg/kg/day in 2-4 divided doses; in less severe conditions, the dose may be lower (50-100 μg/kg/day). If clinical and biochemical signs do not improve, the dose may be increased for a short period. In acute metabolic disorders, higher doses (up to 400 mg/kg/day) or administration of levocarnitine at a daily dose of 100 mg/kg may be required.
Secondary carnitine deficiency in patients undergoing hemodialysis. If significant clinical results have been achieved after the first course of administration, maintenance therapy can be used using 1 g per day by oral administration. On the day of dialysis, oral administration of the drug is carried out after the procedure.
Children
The drug is used in children from the first day of life, including premature babies. Children are prescribed the drug 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).
It is recommended to dissolve the drug in a glass of water before use.
Application features
Pregnant women
No teratogenic effects were observed in studies of the drug. When using the highest tested dose of 600 mg/kg body weight in animals, a statistically insignificant increase in the frequency of post-implantation fetal death in early pregnancy was noted. The significance of these results for humans is unknown.
Taking into account the serious consequences of carnitine deficiency for a pregnant woman, the risk of interrupting treatment with Kartal for the mother is considered greater than the theoretical risk to the fetus if treatment is continued.
Levocarnitine is a common component of human breast milk.
Overdose
There have been no reports of toxicity from overdose of levocarnitine. Large doses may cause diarrhea. Levocarnitine is readily removed from plasma by dialysis.
Treatment: gastric lavage, symptomatic and supportive therapy. No life-threatening cases of overdose have been reported.
Side effects
Various mild gastrointestinal disturbances have been observed with long-term oral levocarnitine administration, including transient nausea and vomiting, abdominal pain, and diarrhea. Reduction of the dose often reduces or eliminates gastrointestinal symptoms. Careful monitoring of tolerability is necessary during the first week of administration and after any increase in dose.
Storage conditions
Store in the original packaging at a temperature not exceeding 25 °C, out of the reach of children and protected from light.
Shelf life - 4 years.
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