Elcar® oral solution

Registration number: . ЛСР-006143/10.

Trade name: Elcar®. 

International non-patented name (INN):  levocarnitine. 

Drug form: oral solution.

Description: a clear or slightly rigmented liquid. A specific smell is allowed.

Composition:drug substance: levocarnitine (carniphyte) 300 mg; excipients: cithic acid monohydrate 1,2 mg, methyl parahydroxybenzoate 0,5 mg, propyl parahydroxybenzoate  0,2 mg, water purified up to 1 ml.

Pharmacotherapeutic group: metabolic drug. .

АТХ Code: А16АА01.

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Pharmacological properties

Pharmacodynamics. L-carnitine is a natural compound, similar to a group B vitamins. It takes a part in metabolism processes as a transport form of long chain fatty acids (palmitic acid and other) from the cytoplasm to mytochondrions, where these acids are beta-oxidated with ay adenosin triphosphate acid and acetyl-CoA formation. It improves a protein and lipid metabolism, increases a secretion and enzymatic activity of gastric and intestinal secrets, imropes a food digestion, decreases an excess of a body weight and decreases a fat content in muscles. It increases a tolerability to physical loads, suppresses a cetoadids formation and an anaerobic glycolysis, decreases a lactic acid acidosis degree, promotes a more effective glycogen use and increases its content in liver and muscles.

L-carnitine has an anabolic and lypolytic action; normalizes an increased basic metabolism (in a case of the hyperthyreosis), is a peripheral (non-direct) antagonist of thyroid hormones, but not a direct inhibitor of a thyroid gland function. It improves a metabolism and energy supply in tissues.

Pharmacokinetics. The drug is absorbed well in intestines; a peak plasma concentration is reached after 3 hours and it stays in the therapeutic interval during 9 hours. The drug easily goes into liver and myocardium, more slowly – into muscles. Is excreted by kidneys, mostly as acyl esthers.

Indications

The drug is used as a part of complex therapy:

• intensive physical loads and psycho-emotional loads: for a workability and tolerability increase, decrease a fatigue, including elderly patients;

• during the rehabilitation period after diseases and surgical invasions, traumas (including the tissues regeneration acceleration);

• a complex treatment of chronic gastritis and chronic pancreatitis with a decreased secretory function;

• a complex treatment of skin diseases (psoriasis, seborrheic eczema, focal sclerodermia and a discoid form of a systemic lupus erythematosus);

• mild hyperthyreosis;

• neurological manifestations of vasculary, traumatic and toxic affection of a brain;

• a nervous anorexia syndrome;

• diseases are accompanied with carnitine deficiency or its increased loss (myopathys, cardiomyopathys, mytochondrial diseases, hereditary diseases with an accompanying mytochondrial insufficiency) – for a replacement a deficiency as a part of a complex therapy;

• in pediatrics (the treatment of children under 3 years is performed under the doctor's observation): treatment of premature infants, infants with a delivery trauma of asphyxia; treatment of children with a weak suction reflex and a small weight gain; treatment of children with a decreased muscular tone, insufficient development of motoric and psychic functions; also for a prevention of these states in children of the “group of the risk”; treatment of children and adolescents under 16 years in cases of a growth delay and a body mass deficiency.

• for adults in a sports medicine and during the intensive training (development of an aerobic performance): for a velocity and power parameters and movements coordination improvement, for a muscles mass gain and a reduction of a fat mass; for a prevention a post-trainig syndrome (acceleration of restorative processes after physical loads), after injuries for muscles regeneration acceleration.

Contraindications

Individual intolerability.

Method of use and dosages

The drug is used as a part of a complex therapy, orally, at 30 minutes before meals, diluted by liquid.

Long-lasting physical and psycho-emotional loads: from 0,75 g (1/2 of measurement spoon, or 2,5 ml) 3 times a day to 2,25 g (1,5 of measurement spoon or 7,5 ml) 2-3 times a day.

Nervous anorexia or rehabilitation after diseases, surgical invasions or traumas:  1,5 g (1 measurement spoon or 5 ml) 2 times a day. The treatment duration 1-2 months.

As a part of the complex therapy of chronic gastritis and chronic pancreatitis with a decreased secretory function: 0,375 g (1/4 of measurement spoon or 1,25 ml) 2 times a day. The treatment duration 1-1,5 months.

Skin diseases: 0,75 g (1/2 of measurement spoon or 2,5 мл). The treatment duration 2-4 weeks.

A mild hyperthyreosis: 0,25 g (13 drops) 2-3 times a day. The treatment duration - 20 days. The treatment can be repeated after a interrupt (1-2 months) or the treatment can be performed during 3 months without an interrupt.

Vasculary, toxic or traumatic affections of brain: 0,75 g (1/2 of measurement spoon or 2,5 ml) per day. The treatment duration 3-5 days. The treatment can be repeated after 12-14 days breakout, if necessary.

Diseases, accompanied by a carnitine deficiency (primary and secondary carnitine deficiency): up to 50-100 mg/kg (2-5 drops/kg) of body mass, 2-3 times a day. The treatment duration – 3-4 months.

For children the drug has to be given as ab additive to sweet foods (kissel, compote, juices). Dose for children under 3 years is determined by a doctor. For children from 3 to 6 years -  0,1 g (5 drops) 2-3 times a day, daily dose 0,2-0,3 g (11-16 drops). The treatment duration - 1 month. For children from 6 to 12 years - 0,2-0,3 g (11-16 drops) 2-3 times a day, daily dose 0,4-0,9 g (22-48 drops). The treatment duration – not less that 1 month.

Growth delay: 0,25 g (13 drops) 2-3 times a day. The treatment duration - 20 days. he treatment can be repeated after 1-2 months breakout, or during 3 months continuously.

In the sports medicine or intensive training: 2,5 g 1-3 times a day (daily dose is 2,5 -7,5 g); if the drug is used for a treatment -70-100 mg/kg/day (5-7,5 g/day). Courses of the treatment: before competitions – 3-4 weeks; during trainings – up to 6-8 weeks.

Side effects

Allergic reactions are possible, gastralgia, dyspepsy, miasthenia (in patients with an uremia).

Over-dosage

Symptoms: dyspepsy, miasthenic disorders (in patients with an uremia).

Treatment: gastric lavage, use of an activated charcoal.

Use during pregnancy and lactation

There are no data about the drug use in pregnant or lactating women, so it is not recommended to use a drug under these conditions.

Interaction with other medicines

Glucocorticoids promote an accumulation of the drug in tissues (except the liver), other anabolic medicines potentate its effect.

Precautions

The treatment of children under 3 years has to be performed under the doctor's observation. The drug has no effect on performing potentially dangerous activities that are require an additive attention or quick reactions (vehicles driving, work with moving mechanisms, work as dispatcher or operator, etc.).

Drug form:

Oral solution 300 mg/ml.

100 ml glass bottle. 100 ml dark glass bottles, sealed by caps with control rings of the first opening. There is a measurement 20 ml cup on a bottle.

Each bottle is packed into a carton box with an instruction.

50 ml glass bottle. 50 ml dark glass bottles, sealed by caps with droppers and control rings of the first opening. Each bottle with a measurement spoon (nominal volume 5 ml, with lines and marks “1/4” and “1/2”, accordant to 1,25 ml and 2,5 ml) and an instruction is packed into a carton box.

25 ml glass bottle. 25 ml dark glass bottles, sealed by caps with droppers and control rings of the first opening. Each bottle and an instruction is packed into a carton box.

25 ml plastic bottle. 25 ml plastic bottles, sealed by caps with droppers and control rings of the first opening. 10 or 20 plastic bottles and an instruction are packed into a carton box.

Keeping conditions

Keep in protected from direct light place at temperature not higher than 25 °С. Keep out of the reach of children. After the bottle opening keep it in refrigerator not longer than 2 months.

Shelf life

3 years. Do not use after the expiry date.

Selling conditions

Without a prescription

 Manufacturer

PIQ-PHARMA, LLC, 125047 Moscow, Oruzheiny st., 25/1

Manufactured by:

 PIQ-PHARMA PRO, LLC, 188663 Leningradskaya region, Vsevolozhsky district, Kuzmolovsky, Workshop # 92.

or

 Vips-Med” Ltd., 141190, Moscovskaya region, Fryazion, Zavodskoy way, 3А.

 Claims have to be sent to

PIQ-PHARMA, LLC,  Phone/fax: +7 495 925 57 00.

www.elkar.ru