L-VIAVA

 

TRADE NAME

L-Viava

 

INTERNATIONAL NONPROPRIETARY NAME

Levocarnitine

 

PHARMACEUTICAL FORM  

Oral solution.

Description: clear colourless or light yellow solution.

 

COMPOSITION

Vial of drug contains

Active substance: levocarnitine 1.0 g or 2.0 g.

Excipients: malic acid, sodium benzoate, saccharin sodium, orange flavor, purified water.

 

АТС CODE     А16АА01

 

PHARMACOTHERAPEUTIC GROUP

Amino acids and their derivatives.

 

PHARMACOLOGIC PROPERTIES

PHARMACODYNAMICS

L-Viava - 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

Bioavailability of the oral levocarnitine is 15.9%. It penetrates in all the tissues, the highest concentrations are in liver, skeletal muscles and myocardium. Maximum concentration is reached in 3.3 hours after administration, therapeutic concentration is maintained for 9 hours.          

It is excreted by the kidneys, especially acyl ethers.

 

THERAPEUTIC INDICATIONS

- primary and secondary carnitine deficiency;

- carnitine deficiency in patients with terminal stage of renal failure, and on hemodialysis;

- metabolic disorders in the myocardium against CHD (acute myocardial infarction, postinfarction state, cardiogenic shock hypoperfusion);

- cardiotoxicity prophylaxis at cytostatic administration;

- disease and conditions, accompanied by loss of appetite and food reflexes, decrease of body weight, attenuation in children and adults (neurogenic anorexia, mental disorders, dyscirculatory and traumatic encephalopathy; chronic subacid gastritis, chronic pancreatitis with exocrine insufficiency; decubation after severe diseases and surgical interventions; prematurity, birth trauma, respiratory distress syndrome of the newborn; syndrome complex, similar to the Reye's syndrome (hypoglycemia, hyperketonaemia, coma), developed in children against valporic acid administration; growth delay and decreased body mass index in children and adolescents under 16 years);

- mild form of thyrotoxicosis in children and adolescents under 16 years;

- in complex therapy of skin diseases (psoriasis, seborrheic eczema, circumscribed scleroderma and  discoid lupus erythematosus);

- long-term intensive training or other high training loads (as anabolic and adaptogene).

 

POSOLOGY AND METHOD OF ADMINISTRATION

Only for oral administration.

L-Viava could be administered directly or dissolved in water or fruit juice. The drug should be administered          at regular intervals 2-4 times a day, without regard to timing of food ingestion.

To adults and children over 12 years it is prescribed in the doses of 2-6 g a day.

The recommended dose of L-Viava for 50 kg of body weight is 1 g 2-3 times a day. The initial dose of L-Viava is 50 mg/kg a day, which is divided in 2-3 parts. Later the dose could be increased on the base of the therapeutic response and tolerability of the drug, including a physical activity during the therapy.

To children under 12 years and neonates: 50-100 mg/kg a day, but not more than 3 g a day.

In primary and secondary carnitine deficiency the dose depends on an inborn error of metabolism and a degree of manifestations in the period of the therapy. In the majority of cases the recommended oral dose is 100-200 mg/kg a day divided in 2-4 parts. If clinical and biochemical values do not improve, the dose could be increased for a short time.  

In acute metabolic decompensation the drug is prescribed in high doses - 400 mg/kg a day.

In carnitine deficiency in hemodialysis patients, the drug is prescribed for oral administration in the dose of 1 g a day. In the day of hemodialysis the drug is administered after hemodialysis session.

It is prescribed to adults with a syndrome of anorexia nervosa, as well as in the period of recovery after past disease and surgical interventions in the dose of 2 g 2 times a day. Duration of use: 1-2 months.

In long-term physical activity - 1-2 g 2-3 times a day.

For appetite stimulation and increasing of body weight patients with chronic subacid gastritis and chronic pancreatitis with exocrine insufficiency the drug is prescribed as a single dose - 500 mg 2 times a day. Duration of use: 1-1.5 months.

In the therapy of skin diseases a single dose of the drug is 1 g 2 times a day. Duration of use: 2-4 weeks.

In growth delay and hyperthyroidism – the single dose of the drug is 250 mg 2-3 times a day for 20 days. The course of treatment should be repeated after the 1-2 months break or it should be used for 3 months without a break.

In cerebral affections of vascular, toxic and traumatic genesis – 0.5-1 g a day for 3-5 days. If necessary the course of treatment is repeated after 12-14 days.

The treatment duration is 1 - 12 months. If necessary the life-long therapy is carried out. The monitoring should include periodic carrying out of biochemical blood assay, evaluation of vital signs, establishing of carnitine concentration in plasma and evaluation of general clinical state. It is recommended to control the therapy, measuring the concentrations of free and acyl levocarnitine in plasma and in urine for appropriate dose determination. The carnitine plasma concentration is 35-60 μmol/l. The free and acyl levocarnitine correlation in plasma normally is 0.35.

 

CONTRAINDICATIONS

- hypersensitivity to the drug components.

 

ADVERSE REACTIONS

Digestive system: pain in the upper abdomen, dyspepsia.

Other: a specific body odor, seizures and increase of their frequency in patients with a history of convulsive disorder.

 

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 MECHANISMS

Drug doesn’t influence on the ability to drive or operate with 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

Drug interactions with the drug L-Viava are not described.

 

OVERDOSAGE

There have been no reports of toxicity from levocarnitine overdosage.

 

PACKAGE

L-Viava 1 g/10 ml or 2 g/10 ml oral solution

Oral solution in amber glass vial of 10 ml closed with white plastic cap.

10 vials together with a leaflet in a carton box.

 

STORAGE CONDITIONS

Store at temperature not exceeding 25°C.

Keep out of reach of children!

 

SHELF-LIFE

4 years from the date of manufacture.

Do not apply after the shelf-life expiration.

 

SALES TERMS

Sold without prescription.

 

MANUFACTURER

The holder of trade mark and Marketing Authorization is

“DR SERTUS İLAÇ SANAYİ VE TİCARET LİMİTED ŞİRKETİ”, TURKEY.

Manufactured by

“Abdi İbrahim İlaç San. ve Tic. A.Ş.”, Turkey

(Sanayi Mahallesi, Tunç Caddesi No: 3 Esenyurt 34555 / İstanbul).