Elcar® solution for intravenous and intramuscular injection

Registration number: .ЛСР-002224/08

Trade name: Elcar®. 

International non-patented name (INN):  levocarnitine. 

Drug form: solution for injections

Composition: levocarnitine (carniphyte) 0,1g; water for injections up to 1 ml. 

Description: clear colorless liquid

Pharmacotherapeutic group: metabolic drug. .

АТХ Code: А16АА01.

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Pharmacological properties

Elcar is a drug for a metabolic processes correction.

L-carnitine is a natural compound, similar to a group B vitamins takes a part in metabolic processes as a fatty acids transmitter through cell membranes, where these acids are oxidized (beta-oxidation process) with a production of a big quantity of energy (in the ATP form). L-carnitine increases a resistance of nervous tissue to injuries (hypoxia, trauma, toxins, etc.), suppresses a cetoacids formation and anaerobic glycolysis, decreases a lactate acidosis degree. The drug refills a base reserve of blood, promotes a restoration of a cerebral hemodynamics auto-regulation and increase a blood supply of the affected area, accelerates reparation processes in the affected area, has an anabolic effect.

Pharmacokinetics.

After the i/v injection the drug is almost totally removed from blood after 3 hours.  The drug easily goes into liver and myocardium, more slowly – into muscles. Is excreted by kidneys, mostly as acyl ethers. (more than  80 % per 24 ч ).

Indications

Elcar is used as a component of the complex therapy of acute hypoxia states (acute brain hypoxia, ischemic cerebral attack, transitory ischemic attack). The drug is used in acute, subacute and rehabilitation periods of brain circulation disturbances. It is also used for the treatment of a dyscirculatory encephalopathy and different traumatic and toxic injuries of brain, in a rehabilitation period after surgical invasions. Elcar is indicated for the treatment of a primary and secondary carnitine deficiency, including patients with a chronic renal insufficiency, treated with a hemodialysis; for treatment a cardiomyopathy, ischemic heart disease (angina pectoris, acute myocardial infarction, post-infarction states), hypo-perfusion due to a cardiogenic shock and other metabolism disturbances in myocardium.

Contraindications

Individual intolerability, pregnancy, lactation (there are no data about possibility and safety of the drug use in these states).

Method of use and dosages

1 ampule contains 0,5 g of drug substance.

Elcar® is injected intravenously slowly by drops or by stream (2-3 minutes) or intramuscularly. Before the i/v injection an ampule contents is dissolved in 100-200 ml of a solvent (0,9 % solution of sodium chloride or 5 % solution of dextrose (glucose)).

For the treatment of acute cerebral circulation affections 1 g per day (2 ampules) is used during 3 days, than 0,5 g/day (1 ampule) during 7 days. After 10-12 days repeated courses are possible (repeated course duration 3-5 days).

For treatment in sub-acute and rehabilitation periods, dyscirculatory encephalopathy and different diseases of brain, carnitine deficiency an Elcar® solution is injected 0,5-1 g/day (1-2 ampules) intravenously (by drops or by stream) or i/m (2-3 times a day) without a dissolving during 3-7 days. If it is necessary, a repeated treatment is used after 12-14 days.

An intravenous slow injection (2-3 minutes) is used for the treatment of the secondary carnitine deficiency due to a hemodialysis - 2 g (4 ampules) fo 1 time (after the procedure); for treatment of an acute myocardial infarction, acute cardiac insufficiency - 3-5 g/day (6-10 ampules), divided into 2-3 steps during first 2-3 days, than dose is decreased by half; for the treatment a cardiogenic shock - 3-5 g/day (6-10 ampules), divided into 2-3 steps until a patient's exit from the shock state. After it an oral administration of Elcar® is used.

Side effects

Allergic reactions are possible, miasthenia (in patients with an uremia). If the druf is injected too quickly (80 drops per minute and more) a pain along a vein is possible; pain disappears after the decrease of the injection rate.

Interaction with other medicines

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

Drug form:

Solution for injections 100 mg/ml. 5 ml clear glass ampules with a point or a ring of breaking. 10 ampules are packed into a carton box with septa, or 5 ampules are packed into a PVC blister. Two blisters are packed into a carton box. An instruction is present in an each box.

Pack for use for inpatients. 10 or 20 blisters packed into carton or goffered carton boxes. The number of instructions in the each box is equal to number of blisters.

Keeping conditions

Keep in protected from direct light place at temperature 15-25 °С. Keep out of the reach of children.

Shelf life

3 years. Do not use after the expiry date.

Selling conditions

By  prescription

 Manufacturer

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

Manufactured by:

Ellara LLC, 601122, Vladimirskaya region, Petushinsky district, Pokrov, Franze Shtolwerk st., 20/2

 Claims have to be sent to

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

www.elkar.ru