Almiba
Ukraine
Table of Contents
INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT ALMIBA (ALMIBA)
Composition:
Active substance: levocarnitine;
1 ml of solution contains levocarnitine 100 mg;
Excipients: malic acid, sodium methylparaben (E 219), sodium propylparaben (E 217), sodium saccharin, cherry flavor, water for injections.
Pharmaceutical form. Oral solution.
Main physicochemical properties: colorless or slightly yellowish transparent solution with a characteristic odor, free from visible particles.
Pharmacotherapeutic group. Other agents affecting the digestive system and metabolic processes. Amino acids and their derivatives. ATC code A16A A01.
Pharmacological Properties
Pharmacodynamics
Levocarnitine (L-carnitine) is a vitamin-like substance naturally synthesized in the liver, kidneys, and brain tissue from the amino acids lysine and methionine with the participation of iron and ascorbic acid. In blood plasma, it exists in free form and as acylcarnitine esters. Levocarnitine is the principal cofactor in fatty acid metabolism in the heart, liver, and skeletal muscles. It acts as the main transporter of long-chain fatty acids into mitochondria, where their beta-oxidation to acetyl-CoA occurs, followed by ATP production. It facilitates the removal of metabolites and toxic substances from the cytoplasm, improves metabolic processes, enhances physical performance, accelerates growth, promotes an increase in muscle mass and reduction of fat content in adipocytes, and helps normalize basal metabolism in hyperthyroidism. It reduces symptoms of physical and mental overexertion, exerts neuroprotective, hepatoprotective, and cardioprotective effects, contributes to reducing myocardial ischemia and limiting the infarction zone, lowers blood cholesterol levels, stimulates cellular immunity, and improves concentration. Levocarnitine eliminates functional disorders of the nervous system in patients with chronic alcoholism during withdrawal syndrome. During intense physical exertion and sports activities, carnitine increases endurance, raises the pain sensitivity threshold in muscles, and optimizes the function of skeletal and cardiac muscles.
Pharmacokinetics
After oral administration, the drug is rapidly absorbed from the gastrointestinal tract. Maximum plasma concentration is reached within 3 hours after intake, and therapeutic concentration is maintained for 9 hours. The drug is metabolized, forming acyl esters, which are excreted by the kidneys. The elimination half-life after oral administration depends on the dose and ranges from 3 to 6 hours.
Clinical characteristics.
Indications.
Primary (congenital) carnitine deficiency.
Secondary carnitine deficiency.
Cardiomyopathy.
Contraindications.
Hypersensitivity to the components of the drug.
Special safety precautions.
Administration of levocarnitine to diabetic patients receiving insulin or oral hypoglycemic therapy may cause hypoglycemia. Such patients require continuous monitoring of plasma glucose levels to adjust their hypoglycemic therapy regimen. Prolonged oral administration of high doses of levocarnitine to patients with severe renal function impairment or end-stage renal disease (ESRD) is not recommended, as it may lead to accumulation in blood of potentially toxic metabolites, trimethylamine (TMA) and trimethylamine-N-oxide (TMAO), due to insufficient renal excretion. This accumulation leads to increased TMA excretion in urine. Prolonged use without potassium supplementation may cause hypokalemia; therefore, electrolyte balance should be monitored during treatment.
The recommended doses of the drug should not be exceeded. If adverse effects occur, the drug must be discontinued.
Interaction with other medicinal products and other forms of interaction.
Concomitant use of glucocorticoids leads to accumulation of levocarnitine in body tissues (except liver). Lipoic acid and anabolic agents enhance the effect of the drug.
Special applications.
Use during pregnancy or breastfeeding.
No teratogenic or embryotoxic effects of the drug have been reported. However, due to the lack of adequate controlled clinical studies, the use of the drug during pregnancy is possible only when the expected benefit to the mother outweighs the potential risk to the fetus.
If Almibi use is necessary, breastfeeding should be discontinued during treatment.
Ability to affect reaction rate while driving or operating machinery.
Does not affect.
Dosage and Administration.
The dosage and duration of treatment are determined individually by a physician, depending on the patient's age and the nosological form of the disease. Almibu is taken orally, 30 minutes before meals. For accurate dosing, use the provided dosing syringe or measuring cup.
For adults, the initial dose is 1 g (10 mL) per day. The dose may be gradually increased depending on the patient's condition and tolerability. The usual daily dose of Almibu for adults is 1–3 g (10–30 mL), divided into 1–3 doses. The maximum daily dose for adults is 6 g (60 mL).
For children, Almibu should be initiated at a dose of 50 mg/kg per day. The usual dosage for children is 50–100 mg/kg per day (see table).
Table
| Age |
Single dose |
Number of doses per day |
| Newborns |
100 mg (1 ml) |
2 - 3 |
| Children under 1 year |
100 - 200 mg (1 - 2 ml) |
2 - 3 |
| Children 1 - 3 years |
200 - 400 mg (2 - 4 ml) |
3 |
| Children 4 - 6 years |
400 - 600 mg (4 - 6 ml) |
3 |
| Children 7 - 11 years |
500 - 800 mg (5 - 8 ml) |
3 |
| Children from 12 years |
800 - 1000 mg (8 - 10 ml) |
3 |
The maximum daily dose for children is 3 g. The average treatment course for adults and children is 1 - 3 months. If necessary, the treatment course may be repeated. In cases of primary and secondary carnitine deficiency, the drug should be taken continuously or until the cause of the deficiency is eliminated.
Children.
The drug may be administered to children (full-term and preterm newborns) from the first day of life.
Overdose.
There have been no reports of levocarnitine toxicity in cases of overdose. Large doses of the drug may cause diarrhea. Levocarnitine is readily removed from blood plasma by dialysis.
Treatment: perform measures to remove the drug from the gastrointestinal tract (gastric lavage); carry out symptomatic and supportive therapy.
Side effects.
Allergic reactions, dyspeptic disorders, epigastric pain, and nausea may occasionally occur in individuals with hypersensitivity. With prolonged oral administration of L-carnitine, various mild gastrointestinal disturbances have been reported: nausea and vomiting, flatulence, diarrhea. Cases of mild myasthenia have been described only in patients with uremia receiving L-carnitine.
Sensitivity to the drug must be carefully monitored during the first week of treatment and after each dose increase.
Seizure episodes have been reported in patients receiving levocarnitine orally or intravenously, both in those with and without pre-existing seizure activity.
In patients with prior seizure activity, an increase in frequency and/or severity of seizures has been observed.
Reducing the dose often diminishes or completely eliminates drug-induced body odor and gastrointestinal disturbances. Sensitivity to the drug must be carefully monitored during the first week of levocarnitine administration and after each dose increase.
Shelf life. 3 years.
Storage conditions. Store in the original packaging at a temperature not exceeding 25 °C, protected from light. Keep out of reach of children.
Packaging.
10 ml in a vial. 10 vials per cardboard box.
Prescription status.
Over-the-counter.
Manufacturer.
Anfarm Ellas S.A.
Manufacturer's address and location of operations.
61st km National Road Athens-Lamia, Schimatari Viotias, 32009, Greece.
Marketing authorization holder.
Grand Medical Group AG.
Address of the marketing authorization holder.
Kornmarkt 10, CH-6004, Lucerne, Switzerland.