Download L-VIAVA TRADE NAME L-VIAVA INTERNATIONAL

L-VIAVA
TRADE NAME
L-VIAVA
INTERNATIONAL NON-PATENTED NAME
Levocarnitine
PHARMACEUTICAL FORM
Solution for injections.
Description: clear colourless solution.
COMPOSITION
1 ampoule of solution contains:
Active substance: levocarnitine 1.0 g.
Excipients: hydrochloric acid, water for injection.
АТС CODE
А16AA01
PHARMACOTHERAPEUTIC GROUP
Other drugs that influence digestive system and metabolic processes.
Amino acids and their derivatives.
PHARMACOLOGIC PROPERTIES
PHARMACODYNAMICS
A drug for correction of metabolic processes.
Levocarnitine is a naturally occurring substance that is related to vitamin B complex. It is
involved in metabolic processes as a fatty acid carrier across cell membranes from
cytoplasm to mitochondria, where these acids undergo β-oxidation with the formation of a
great deal of energy
(in the form of ATP). By releasing coenzyme А, levocarnitine
intensifies metabolite entry into the Krebs cycle. It stimulates the activity of pyruvate
dehydrogenase in skeletal muscles and the oxidation of branched-chain amino acids by
the same mechanism. The drug improves protein and fat metabolism, restores the blood
alkaline reserve, inhibits ketoacid formation and anaerobic glycolysis, reduces the degree
of lactacidosis, as well as increases the motion activity and improves exercise tolerance,
herewith contributes to glycogen sparing and the increase in its stores in the liver.
PHARMACOKINETICS
Levocarnitine is not bound to plasma protein, penetrates into all body tissues. The highest
concentrations of levocarnitine are found in skeletal muscles and myocardium.
The elimination half-life is 17.4 hours.
The drug is excreted in the urine (76% within 24 hours).
THERAPEUTIC INDICATIONS
– primary and secondary carnitine deficiency;
− carnitine deficiency in end-stage renal disease patients undergoing hemodialysis;
− myocardial metabolic disturbance against CHD (acute myocardial infarction,
postinfarction period), cardiomyopathy;
− hypoperfusion state due to cardiogenic shock;
–acute and chronic disorders of cerebral circulation.
DOSAGE AND ADMINISTRATION
Solution for injections L-VIAVA administered intravenously and intramuscularly.
Primary carnitine deficiency: the daily dose depends on a concrete abnormal development,
and in case of acute decompensation it may amount up to 100 mg/kg a day given in four
or more injections. Standard daily dose is 50 mg/kg a day given in 3-4 injections.
Secondary carnitine deficiency: daily dose is 50 mg/kg as slow IV injections or infusions.
Carnitine deficiency in patients undergoing hemodialysis: initial dose is 10-20 mg/kg as slow
IV injection after dialysis session 3 times a week. The intravenous administration of LVIAVA should last for at least 3 months for restoration of carnitine stores in muscles. The
need for re-appointment is determined on the basis of control (at regular intervals), the
level of carnitine in plasma and patient monitoring.
Acute myocardial infarction: the daily dose is 100-200 mg/kg body weight in four slow IV
injections or continuous IV injection for the first 48 hours with the subsequent
intramuscular administration and 2-fold dose decrease till the end of the patient’s stay in
cardiovascular care unit.
At cardiogenic shock intravenous injection should be continued until the patient's
condition has stabilized.
Postinfarction period and cardiomiopathy: L-VIAVA administered at 0.5-1.0 g intravenously
or intramuscularly 1-2 times a day.
Acute disorders of cerebral circulation: 10-14 mg/kg body weight in the first 3 days by
intravenous or intramuscular injection; 7 mg/kg body weight in the subsequent days. Total
course of treatment is 7-10 days. If necessary, after 10-12 days carry out a second course
of 7 mg / kg intravenously or intramuscularly for 3-5 days.
Chronic disorders of cerebral circulation: 0.5-1.0 g of L-VIAVA administered intravenously
or intramuscular once daily for 3-5 days. If necessary, after 12-14 days a second course is
administered.
Before intravenous infusion, dissolve 0.5-1.0 g of preparation in 200-500 ml 0.9% sodium
chloride solution or lactated Ringer's solution.
Intravenous injection of the drug should be carried out slowly for 2-3 minutes.
CONTRAINDICATIONS
Hypersensitivity to any of the drug components.
SIDE EFFECTS
Transient nausea and vomiting have been observed. Less common side effects include
peculiar body odor and gastritis. Convulsions or increase in their frequency have been
reported to occur in patients with a history of convulsive disorders. In case of fast
intravenous injection (80 drops a minute or more) there may appear pain in veins that
subsides after decrease in rate of administration.
SPECIAL INDICATIONS
The administration of L-VIAVA in patients with diabetes mellitus may lead to the
development of hypoglycemia as a result of improvement in glucose uptake. Therefore,
blood glucose level should be regularly monitored and where it is necessary to carry out
the dosage adjustment of hypoglycemic drugs and insulin.
THE INFLUENCE ON THE ABILITY TO DRIVE AND TO OPERATE OTHER MECHANISMS
L-VIAVA doesn’t influence on the ability to drive or operate with complicated mechanisms.
APPLICATION DURING PREGNANCY AND LACTATION
L-VIAVA can be administered during pregnancy and lactation only if the expected benefit
to the mother is greater than any possible risk to the fetus or infant.
PEDIATRIC USE
The drug can be used in pediatric practice.
INTERACTION WITH OTHER DRUGS
The concurrent administration of glucocorticosteroids contributes to the accumulation of
levocarnitine in tissues (except for liver).
OVERDOSAGE
There have been no reports of toxicity from levocarnitine overdosage.
PACKAGING
Solution for injections in 5 ml amber glass ampoules.
5 ampoules in a contour tray.
1 contour tray together with a leaflet in a carton box.
STORAGE CONDITIONS
Store at temperature not exceeding 25°С.
Keep out of reach of children!
SHELF LIFE
3 years from the date of manufacture.
Do not apply after the shelf-life expiration.
SALES TERMS
Sold under prescription.