Alotrem®Neo-injection

INSTRUCTIONS FOR MEDICAL USE

ALOTREM NEO

Trade name of the drug: Alotrem® Neo

Active substance (INN): Levocarnitine/L-carnitine

Dosage form: Solution for injection.

Contents:

5 ml of solution (1 ampoule) contains:

Active ingredient: L-carnitine-1000 mg.

Excipients: Hydrochloric acid (to create the required pH), water for injection.

Description: colorless to light yellow transparent solution.

Pharmacotherapeutic group: agents for correction of metabolic processes.

ATX code: A16AA01

Pharmacological properties

The drug for the correction of metabolic processes. L-carnitine – a natural substance, related to the B vitamins. Participates in metabolic processes as a carrier of long-chain fatty acids (including palmitic) through cell membranes from the cytoplasm to the mitochondria, where these acids are oxidized (beta-oxidation process) to form a large amount of metabolic energy (in the form of ATP).

The drug improves metabolism and energy supply of tissues; corrector of metabolic processes, stimulator of energy metabolism.

The drug replenishes blood alkaline reserve, restores autoregulation of cerebral hemodynamics and increases blood supply to the affected area, accelerates reparative processes in the lesion and has an anabolic effect. It has a neurotrophic effect, inhibits the development of apoptosis, limits the lesion area and restores the structure of nervous tissue. The drug has an anabolic and lipolytic effect. Normalizes protein and fat metabolism, reduces excess body weight, reduces muscle fat, increases resistance to exercise, increases motor activity.

The product increases the secretion and enzymatic activity of gastric and intestinal juices, improves digestion.

The drug normalizes elevated basal metabolism in hyperthyroidism, being a partial antagonist of thyroxine.

Pharmacokinetics

During parenteral administration, the drug penetrates well into all tissues, high concentrations are formed in skeletal muscle and myocardium. It is excreted by kidneys mainly as acyl esters, free carnitine is reabsorbed.

Indications for use

  • Secondary carnitine deficiency in patients with end-stage renal failure who have undergone hemodialysis, because free carnitine (which is usually reabsorbed by the kidneys) is eliminated and the acyl esters (released by the healthy kidneys) are stored;
  • in carnitine deficiency in preterm infants on total parenteral nutrition. Injection of nutrients into the vein eliminates their initial passage through the intestinal wall and the liver. As a result, there is an excess of lipids in the blood plasma, which depresses the rate of all biochemical reactions (in particular, the utilization of methyl groups of methionine is impaired);
  • carnitine deficiency in patients with dramatically increased carnitine consumption (including hypoxia, diphtheria, taking valproic acid drugs);
  • Anorexia, lack of weight gain and stunting in children;
  • Cardiomyopathy (myocardial utilization of fatty acids as an energy source is very intensive, so the need for carnitine increases, after its administration an increase in muscle contractility, prevention of further muscle degeneration, normalization of the ECG is noted);
  • Skeletal muscle weakness and myopathy;
  • distress syndrome in premature infants;
  • organic acidemia.

This pathology results from congenital or genetic abnormalities of normal organic acid metabolism. In such patients, acyl CoA metabolites, such as propionyl-CoA, accumulate in cells, turn into acyl esters of carnitine and are removed from cells with it, leading to its intracellular deficiency. Propionic acid residue in the liver inhibits oxidative phosphorylation, thus impairing its function;

  • in the treatment of diseases that require the use of anabolic (nonsteroidal) agents. The drug is used in the treatment of acute hypoxic conditions (acute cerebral hypoxia, ischemic stroke, transient ischemic attack), skin diseases, chronic gastritis, and chronic pancreatitis with decreased secretory function.

The drug is prescribed in acute, subacute and recovery periods of cerebrovascular disorders. It is used for discirculatory encephalopathy and various traumatic and toxic lesions of the brain, in the recovery period after surgical interventions. The drug is indicated for ischemic heart disease (stenocardia, acute myocardial infarction, postinfarction states), hypoperfusion due to cardiogenic shock and other myocardial metabolic disorders.

The drug is used as part of complex therapy:

  • intensive physical activity and psycho-emotional stress: to increase working capacity, endurance, reduce fatigue, including, in elderly people;
  • During rehabilitation after diseases, surgeries and injuries, including for acceleration of tissue regeneration;

Directions for use and dosages

The drug is administered intramuscularly, intravenously slowly (2-3 minutes) or by infusion.

Adults and children over 12 years of age.

The daily dose is usually 1-3 g in 3-4 injections. The initial dose is 1 g/day and after examination of the patient the dose may be increased to 3 g/day depending on the condition.

In primary or secondary carnitine deficiency in acute decompensation, the drug is prescribed in a dose of 50-100 mg/kg/day in 3-4 injections. If necessary, the drug may be administered in a higher dose.

In carnitine deficiency secondary deficiency in patients with terminal stage of chronic renal failure, receiving hemodialysis the drug is prescribed in dose 20 mg/kg/day at the end of each hemodialysis procedure (in three hemodialysis procedures during a week).

The duration of the IV treatment is not more than 3 months and the period required to restore normal levels of levocarnitine in muscles.

The need for repeated treatment is determined by the plasma content of levocarnitine, which should be monitored regularly.

PathologySchemeCourse duration
Acute disturbances of cerebral circulation1 g/day i/v 0.5 g/day i/v3 days 7 days After 10-12 days repeated courses of 3-5 days are possible
Subacute and recovery period after cerebral circulatory disorders, discirculatory encephalopathy and other brain lesions0.5-1 g/day intravenously (drops, streams) or intramuscularly ( 2-3 times a day) without dilution3-7 days If necessary, in 12-14 days a second course is prescribed
Acute myocardial infarction, acute heart failure3-5 g/day divided into 2 to 3 dosesIn the first 2-3 days, with subsequent reduction of the dose by half.
Cardiogenic shock3-5 g/day divided into 2 to 3 dosesUntil the patient comes out of shock

Children under 12 years of age.

In case of primary or secondary carnitine deficiency in acute decompensation the drug is prescribed in a dose of 50-100 mg/kg/day in 3-4 injections.

In carnitine deficiency secondary deficiency in patients with terminal stage of chronic kidney failure who are hemodialysis patients this preparation is prescribed in dose 10-20 mg/kg/day at the end of each hemodialysis procedure (3 hemodialysis procedures during a week). The duration of treatment with the drug when administered intravenously is not more than 3 months. Usually a repeated course of therapy is prescribed.

Side effects

Allergic reactions, muscle weakness (in patients with uremia), pain in the epigastric region are possible.

During rapid injection, pain along the vein is possible; it will disappear if the injection speed is reduced.

Contraindications

Hypersensitivity to the drug components.

Caution: The drug should be used in case of diabetes mellitus and during pregnancy and lactation (breast-feeding) only if absolutely necessary.

Drug interactions

Before prescribing the drug, it should be found out which drugs the patient is taking. The drug may be combined with various anabolic agents; with drugs with antioxidant and/or antihypoxant activity. Excessive doses of choline inhibit levocarnitine synthesis and activity. Glucocorticosteroids promote accumulation of levocarnitine in tissues (except liver). Anabolic agents enhance the effect of carnitine.

Special indications

It is recommended to monitor therapy by measuring free and acyl levocarnitine concentrations in plasma and urine to determine an adequate dose of the drug. Levocarnitine is not addictive because it is an endogenous substance of the human body. Administration of the drug to patients with diabetes mellitus receiving insulin or oral hypoglycemic agents may cause hypoglycemia. Therefore, in this category of patients during treatment with the drug, blood glucose content should be constantly monitored for immediate correction of hypoglycemic drugs dosing regimen.

Effect on the ability to drive motor transport and operate machinery.

The drug does not affect the ability to drive vehicles and other potentially dangerous activities.

Overdose

There are no data concerning toxicity in case of overdose of levocarnitine. Tolerability of the drug should be controlled during the first week of treatment and after each increase in the dose taken.

Symptoms: diarrhea.

Treatment: carry out symptomatic therapy.

Form of production

Solution for injection 1000 mg/5 ml in ampules of 5 ml, #5, #10.

Storage Conditions

Store in a dry place, protected from light, at a temperature not exceeding 25°C. Keep out of reach of children!

Shelf life

3 years. Do not use after the expiration date.

Conditions for dispensing from pharmacies

Released by a doctor’s prescription.

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