Download L-VIAVA TRADE NAME L-VIAVA INTERNATIONAL

L-VIAVA
TRADE NAME
L-VIAVA
INTERNATIONAL NON-PROPRIETARY NAME
Levocarnitine
CHEMICAL NAME
(3R)-3-hydroxy-4-(trimethylammonio)butanoate
PHARMACEUTICAL FORM
Oral solution.
Description: a slightly coloured transparent solution.
COMPOSITION
Vial of the medicine contains
Active ingredient: levocarnitine 1.0 or 2.0 g.
Excipients: malic acid, sodium benzoate, saccharin sodium, orange flavor, water purified.
ATC CODE A16AA01
PHARMACOTHERAPEUTIC GROUP
Amino acids and their derivatives.
PHARMACOLOGICAL PROPERTIES
PHARMACODYNAMICS
A preparation for metabolic process correction.
Levocarnitine is a natural substance relative to B-group vitamins. Takes part in metabolic
process as a carrier of fatty acids through the cell memdrane from cytoplasm into
mitochondria where these acids are subjected to β-oxidation with the production of a large
amount of energy (as ATP). Releasing coenzyme A, levocarnitine intensifies the inflow of
metabolites in the Krebs cycle. By means of the same mechanism it stimulates the pyruvate
dehydrogenase activity within the skeletal muscles and branched-chain amino acids
oxidation. The preparation normalizes the protein and lipid metabolism, restores the blood
alkali reserve, suppresses keto acids formation and anaerobic glycolysis, decreases the
lactic acidosis degree, increases motion activity and effort tolerance as well as facilitates
economical glycogen consumption and increases its pool in liver.
PHARMACOKINETICS
Absorption and distribution
Following oral administration, bioavailability of levocarnitine is 15,9%. It penetrates into all
the body tissues; the highest concentrations are accumulated in liver, skeletal muscles and
myocardium. The maximum plasma concentration is achieved in 3.3 hours after
administration; the therapeutic concentration is retained for 9 hours.
Elimination
It is eliminated mainly by mechanism of renal excretion as acyl ethers.
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THERAPEUTIC INDICATIONS
Primary and secondary carnitine deficiency;
Carnitine deficiency in hemodialysis patients with end-stage renal disease;
Myocardial metabolic disturbance induced by ischemic heart disease (postinfarction
period).
DOSAGE AND ADMINISTRATION
For oral administration only.
L-VIAVA may be administered directly or diluted in water or fruit juice. The preparation
should be administered at regular dosing intervals independent from food consumption.
The initial dose of L-VIAVAe is 1 vial daily (1 or 2 g of levocarnitine); it may be increased
slowly while assessing tolerability and therapeutic response, considering also physical
activity during the treatment period. The recommended L-VIAVAe dose is 1-3 vials (2-6 g
of levocarnitine) daily divided into several administrations.
Monitoring should include periodic blood chemistry analysis, vital signs, plasma carnitine
concentration and overall clinical state assessment.
CONTRAINDICATIONS
Hypersensitivity to the components of the drug.
ADVERSE EFFECTS
From digestive system: pain in epigastrium, dyspeptic disorders.
Other: specific body odour may develop, the occurrence of convulsions and the increase of
their frequency in patients having
convulsive disorder in case history.
SPECIAL PRECAUTIONS
Prescribing L-VIAVA to patients with diabetes mellitus may lead to hypoglycaemia
development due to an improved glucose uptake. As a result, care should be taken to
monitor the glucose plasma level and, if necessary, to adjust the dose of hypoglycaemic
drugs and insulin.
THE INFLUENCE ON THE ABILITY FOR DRIVING VEHICLES AND OPERATING OF
MECHANISMS
The drug does not influence the ability for driving vehicles and operating mechanisms.
PEDIATRIC USE
L-VIAVA oral solution is not intended to be used in children aged under 12 years old.
ADMINISTRATION DURING PREGNANCY AND LACTATION
L-VIAVA administration during pregnancy is allowed only in cases, when the expected
benefit for the mother exceeds the potential risk for the fetus.
DRUG INTERACTION
Drug interactions have not been described.
OVERDOSE
Data on toxicity in case of levocarnitine overdose is not available.
PRESENTATION
Oral solution in amber glass vial of 10 ml sealed with an aluminium cap.
1 vial with the enclosed leaflet in a carton box.
STORAGE CONDITIONS
Store in a protected from light place at temperature not exceeding 25°C.
Keep out of reach of children!
SHELF LIFE
4 years from the date of manufacture.
Do not use after the expiry date.