Instructions Agvantar complex capsules No. 20
Composition
active ingredient: levocarnitine;
1 ml of solution contains 200 mg of levocarnitine;
excipients: methylparaben (E 218), propylparaben (E 216), sucrose, sorbitol (E 420), banana flavoring, purified water.
Dosage form
Solution for oral use.
Main physicochemical properties: transparent, slightly yellowish solution, thick consistency with a specific odor.
Pharmacotherapeutic group
Amino acids and their derivatives. ATC code A16A A01.
Pharmacological properties
Pharmacodynamics.
Levocarnitine (L-carnitine) is a vitamin-like substance that is synthesized in the liver, kidneys and brain tissue under natural conditions from the amino acids lysine and methionine with the participation of iron and ascorbic acid, in the blood plasma it is found in free form and in the form of acylcarnitine esters. Levocarnitine is the main cofactor of fatty acid metabolism in the heart, liver and skeletal muscles, plays the role of the main carrier of long-chain fatty acids in the mitochondria, where their beta-oxidation to acetyl-CoA occurs with the subsequent formation of ATP. It promotes the removal of metabolites and toxic substances from the cytoplasm, improves metabolic processes, increases performance, accelerates growth, causes an increase in muscle mass and a decrease in the amount of fat in adipocytes, contributes to the normalization of basic metabolism in hyperthyroidism. Reduces symptoms of physical and mental overstrain, has neuro-, hepato- and cardioprotective effects, helps reduce myocardial ischemia and limit the infarction zone, reduces blood cholesterol levels, stimulates cellular immunity, increases concentration. Levocarnitine eliminates functional disorders of the nervous system in patients with chronic alcoholism with withdrawal syndrome. During intense physical exertion and sports, carnitine increases endurance, increases the threshold of muscle pain sensitivity, optimizes the work of skeletal muscles and heart muscle.
Pharmacokinetics.
After oral administration, the drug is rapidly absorbed from the digestive tract. The maximum concentration in the blood plasma is reached 3 hours after administration, the therapeutic concentration is maintained for 9 hours. The drug is metabolized to form acyl esters, which are excreted by the kidneys. The half-life when taken orally, depending on the dose, is 3-6 hours.
Indication
Primary (congenital) carnitine deficiency.
Secondary carnitine deficiency.
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
Do not exceed the recommended doses of the drug. If side effects occur, the drug should be discontinued. When prescribing Agvantar solution to patients with diabetes, it should be taken into account that the drug contains sucrose.
Long-term oral administration of high doses of levocarnitine is not recommended in patients with severe renal impairment or end-stage renal disease (ESRD) because it may lead to accumulation in the blood of potentially toxic metabolites, trimethylamine (TMA) and trimethylamine-M-oxide (TMAO), due to insufficient renal excretion. This accumulation leads to increased urinary TMA.
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Contains 2 g of sucrose per dose (5 ml). Use with caution in patients with diabetes.
The energy value of 1 g of sorbitol is 2.6 kcal.
May be harmful to teeth.
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 potential risk to the fetus.
If it is necessary to use Agvantar, breastfeeding should be discontinued for the period of therapy with this drug.
Ability to influence reaction speed when driving vehicles or other mechanisms
No effect.
Method of administration and doses
The doctor sets the doses and duration of treatment individually depending on the age and nosological form of the disease. Agvantar should be taken orally 30 minutes before meals. To dose the drug, use a dosing syringe or measuring cup. Adults should be prescribed the drug in an initial dose of 1 g per day (5 ml), gradually increasing the dose, depending on the patient's condition and tolerability. The usual dose of Agvantar for adults is 1-3 g (5-15 ml) per day, divided into 1-3 doses. The maximum daily dose for adults is 6 g (30 ml).
Children should be prescribed Agvantar starting at a dose of 50 mg/kg per day. The usual dose for children is 50-100 mg/kg per day (see table).
Table
| Children (age) | Single dose | Number of receptions per day |
Newborns | 100 mg (0.5 ml) | 2-3 | | Up to 1 year | 100-200 mg (0.5-1 ml) | 2-3 |
| 1-3 years | 200-400 mg (1-2 ml) | 3 |
| 4-6 years | 400-600 mg (2-3 ml) | 3 |
| 7-11 years old | 500-800 mg (2.5-4 ml) | 3 |
| From 12 years old | 800-1000 mg (4-5 ml) | 3 |
The maximum daily dose is 3 g. 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.
Agvantar can be used in children (full-term and premature newborns) from the first day of life.
Overdose
There is no data on overdose of the drug.
Adverse reactions
Gastrointestinal: dyspeptic disorders, epigastric pain, nausea, vomiting, diarrhea.
On the part of the immune system: sometimes with individual intolerance it can cause allergic reactions (possibly of a delayed type).
Other: body odor.
Cases of seizures have been described in patients with and without prior seizure activity. In patients with prior seizure activity, the frequency and/or severity of seizures increased.
The presence of sorbitol (E 420) in the composition of the drug may have a mild laxative effect.
Treatment is symptomatic.
Expiration date
2 years.
Storage conditions
Store at a temperature not exceeding 25 °C.
Keep out of reach of children.
Packaging
30 ml or 100 ml in a polyethylene terephthalate container and a cardboard box together with a dosing syringe and/or measuring cup.
Vacation category
Without a prescription.
Producer
Chanel Medical.
Location of the manufacturer and address of its place of business.
Dublin Road, Loughrea, Co. Galway, Ireland.
Applicant.
LLC "Ersel Pharma Ukraine".
Location of the applicant.
Ukraine, 21030, Vinnytsia, Yunosti Ave., 20/73.
