ELARI [Levocarnitine] 200 mg/1 ml Solution for IV injection
instructions for the medical use of a medicinal product
ELARI
Tradename
Elari,
Элари
International non-proprietary name or generic name
Levocarnitine,
Левокарнитин
Dosage form
Solution
for intravenous injection.
Composition
Each
ml contains:
active
substance: levocarnitine
USP 200 mg;
excipients: sodium
hydroxide, water for injection.
Pharmacotherapeutic group
Metabolic
agent.
Code АТХ: А16AА01
Pharmacodynamics
Levocarnitine is a natural substance related to B vitamins.
It participates in metabolic processes as a carrier of fatty acids through cell
membranes from the cytoplasm to the mitochondria, where these acids undergo
beta-oxidation with the formation of a large amount of metabolic energy (in the
form of ATP).
Normalizes protein and fat metabolism, restores the
alkaline reserve of the blood, inhibits the formation of keto acids and
anaerobic glycolysis, reduces the degree of lactic acidosis, and also increases
motor activity and increases tolerance to physical activity, while promoting
the economical use of glycogen and an increase in its reserves in the liver. It
has an anabolic effect, normalizes increased basal metabolism in
hyperthyroidism, being a partial antagonist of thyroxine, stimulates the
secretion of gastric juice, slows the breakdown of protein and carbohydrate
molecules. Reduces excess body weight and reduces the fat content in muscles.
It has a neurotrophic effect, inhibits the development of apoptosis, limits the
area of damage and restores the structure of nervous tissue.
After
intravenous administration, it is almost completely eliminated from the blood
within 3 hours. It easily penetrates the liver and myocardium, and more slowly
– into the muscles. It is excreted by the kidneys mainly in the form of acyl
esters (more than 80% in 24 hours).
Indications for use
It is used as part of complex therapy for acute
hypoxic conditions (acute cerebral hypoxia, ischemic stroke, transient ischemic
attack); in the acute, subacute and recovery periods of cerebral circulatory
disorders; in cerebrovascular insufficiency and various traumatic and toxic
brain lesions, in the recovery period after surgery; in primary and secondary
carnitine deficiency, including in patients with chronic renal failure
undergoing hemodialysis; in cardiomyopathy, coronary heart disease (angina
pectoris, acute myocardial infarction, post-infarction conditions),
hypoperfusion due to cardiogenic shock and other myocardial metabolic
disorders.
Contraindications
Hypersensitivity
to the components of the drug.
Method of administration and dosage
Administer
intravenously by drip slowly or jet (2-3 min). Before intravenous
administration, the contents of the ampoule are dissolved in 100-200 ml of
solvent (0.9% sodium chloride solution or 5% dextrose (glucose) solution).
In acute
cerebrovascular accidents, prescribe 1 g / day (2 ampoules) for 3 days, and
then 0.5 g / day (1 ampoule) for 7 days. After 10-12 days, repeated courses are
possible for 3-5 days.
When prescribing
the drug in the subacute and recovery period, with discirculatory
encephalopathy and various brain lesions, carnitine deficiency, patients are
administered a solution of levocarnitine at the rate of 0.5-1 g / day (1-2
ampoules) intravenously (drip, jet) for 3-7 days. If necessary, a repeat course
is prescribed after 12-14 days. Intravenous administration, slowly (2-3 min) is
prescribed for secondary carnitine deficiency during hemodialysis - 2 g (4
ampoules) once (after the procedure); for acute myocardial infarction, acute
heart failure - 3-5 g / day (6-10 ampoules), divided into 2-3 doses during the
first 2-3 days with a subsequent reduction in dose by 2 times; for cardiogenic
shock - 3-5 g / day (6-10 ampoules), divided into 2-3 doses until the patient
recovers from shock. Then switch to oral administration of the drug.
Special instructions and precautions
Consult your doctor before using the drug.
In
children and adolescents under 18 years of age, the drug is used in appropriate
dosage forms.
Serious
hypersensitivity reactions, including anaphylaxis, laryngeal edema, and
bronchospasm, have been reported following administration of the drug,
primarily in patients with end-stage renal disease undergoing dialysis. Some
reactions occurred within minutes of intravenous administration. If a severe
hypersensitivity reaction occurs, discontinue treatment and initiate
appropriate treatment. If a decision is made to re-administer the drug, monitor
patients for recurrence of signs and symptoms of a severe hypersensitivity
reaction.
Increased glucose
uptake with levocarnitine in patients with diabetes mellitus receiving insulin
or oral hypoglycemic agents may cause hypoglycemia. For this reason, blood
glucose levels should be monitored frequently in these patients during
treatment with Elari to promptly adjust the dosing regimen of hypoglycemic
agents. Long-term use of levocarnitine in high doses in patients with severe
renal impairment may cause increased concentrations of potentially toxic
metabolites, trimethylamine and trimethylamine-N-oxide, since these metabolites
are usually excreted in the urine. In this case, urine, breath and sweat have
an unpleasant odor.
Application during pregnancy and during breastfeeding
During pregnancy and breastfeeding, the use of the
drug is possible only if the expected positive effect for the mother outweighs
the potential risk to the fetus and child.
Side effect
Transient nausea
and vomiting, allergic reactions, muscle weakness (in patients with uremia) are
possible.
With rapid
administration (80 drops/min or more), pain along the vein may occur, which
passes when the administration rate is reduced.
If any of the side effects listed in the instructions
worsen, or you notice any other side effects not listed in the instructions,
tell your doctor.
Interaction with other medicinal products
There is evidence that concomitant administration of
anticoagulants such as acenocoumarol or warfarin with levocarnitine may result
in an increase in INR. INR or other relevant coagulation parameters should be
monitored weekly until values are stable, and then monthly. Concomitant use of
levocarnitine with drugs that induce hypocarnitinemia due to increased renal
excretion of carnitine (valproic acid, prodrugs containing pivalic acid,
cephalosporins, cisplatin, carboplatin and ifosfamide) may reduce the
availability of levocarnitine.
Overdose
There are no data on toxicity in case of overdose of levocarnitine.
Levocarnitine is easily removed from the blood by dialysis. In case of
overdose, treatment is prescribed to maintain vital functions, symptomatic
treatment.
Store in a dark place at a
temperature not exceeding 25 °C.
Keep out of reach of
children.
Shelf
life
2 years. Do not use after the expiration date stated
on the package.
Vacation
conditions
Dispensed by prescription.
Release
form
5 ampoules of 5 ml in a plastic tray. 1 tray together with instructions for medical use in a cardboard box.