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Producer: CJSC Pharmfirma Soteks Russia
Code of automatic telephone exchange: A11EX
Release form: Liquid dosage forms. Solution for injections.
General characteristics. Structure:
Active agent: thiamin a hydrochloride – 100 mg, a pyridoxine a hydrochloride – 100 mg, cyanocobalamine – 1 mg, lidocaine a hydrochloride – 20 mg.
excipients: benzyl alcohol, sodium polyphosphate, sodium tripolyphosphate, potassium hexacyanoferrate, sodium hydroxide solution of 1 M, water for injections.
Description: transparent solution of pinkish-red color with a characteristic specific smell.
Pharmacological properties:
Pharmacodynamics. Neurotropic vitamins of group B have favorable effect on inflammatory and degenerative diseases of nerves and the motive device. They are applied not to elimination of scarce states, and in high doses have analgetic properties, promote strengthening of a blood-groove, normalize work of a nervous system and process of a hemopoiesis (B12 vitamin).
Thiamin (B1) plays a key role in the processes of carbohydrate metabolism having crucial importance in exchange processes of nervous tissue and also in a tricarbonic acid cycle with the subsequent participation in synthesis of TPF (thiamin a pyrophosphate) and ATP (adenosine triphosphate). The pyridoxine (B6) participates in metabolism of proteins, and partially, in metabolism of carbohydrates and fats. Physiological function of both vitamins (B1, B6) is the potentiation of action of each other which is shown in positive influence on nervous, neuromuscular and cardiovascular systems.
Cyanocobalamine (B12) participates in synthesis of a myelin cover, stimulates a hemogenesis, reduces the pain connected with defeat of a peripheral nervous system, stimulates nucleinic exchange through activation of folic acid.
Lidocaine - the mestnoanesteziruyushchy means causing all types of local anesthesia.
Pharmacokinetics. After intramuscular introduction thiamin is quickly absorbed from the place of an injection and comes to blood (484 ng/ml in 15 min. in the first day of introduction of a dose of 50 mg) and is distributed unevenly in an organism at contents it in leukocytes of 15%, erythrocytes of 75% and in a blood plasma of 10%. Due to the lack of considerable reserves of vitamin B an organism it has to come to an organism daily. Thiamin gets through hematoencephalic and placental barriers, it is found in maternal milk. Thiamin is removed with urine in an alpha phase in 0,15 hours, in a beta phase - in 1 hour and in a terminal phase - within 2 days. The main metabolites are: tiaminkarbonovy acid, pyramine and some unknown metabolites. From all vitamins thiamin remains in an organism in the smallest quantities. The organism of the adult contains about 30 mg of thiamin in a look: 80% in the form of thiamin of a pyrophosphate, 10% of thiamin of triphosphate and other quantity in the form of monophosphate thiamin. After an intramuscular injection the pyridoxine is quickly absorbed in a blood channel and distributed in an organism, carrying out a coenzyme role after phosphorylation of the CH2OH group in the 5th situation. About 80% of vitamin contact proteins of a blood plasma. The pyridoxine is distributed on all organism, gets through a placenta, it is found in maternal milk. It is deposited in a liver and is oxidized to 4-pyridoxynew acid which is excreted with urine, at most in 2-5 hours after absorption. The human body contains 40-150 mg of B6 vitamin, its daily speed of elimination makes about 1,7 - 3,6 mg at a speed of completion of 2,2 - 2,4%.
Indications to use:
As pathogenetic and symptomatic means at treatment of diseases and syndromes of a nervous system of various origin:
- neuropathy and polyneuropathy (diabetic, alcoholic and others);
- neuritis and polyneuritis, including retrobulbar neuritis;
- peripheral paresis, including facial nerve;
- neuralgia, including trifacial and intercostal nerves;
- pain syndrome (radicular, mialgiya);
- night muscular spasms, especially at persons of the senior age groups;
- plexopathies, ganglionites (including the surrounding herpes);
- neurologic displays of osteochondrosis of a backbone (radiculopathy, lyumboishalgiya, muscular and tonic syndromes).
Route of administration and doses:
At the expressed pain syndrome treatment is reasonable to begin with intramuscular introduction (deeply) 2 ml of drug daily within 5-10 days with transition further either on intake, or on more rare injections (2-3 times a week within 2-3 weeks).
Side effects:
Allergic reactions. In some cases the increased sweating, tachycardia can be noted, acne rash develops. Skin reactions in the form of an itch, a small tortoiseshell are described.
In rare instances the hypersensitivity phenomena to drug, for example, rash, the complicated breath, a Quincke's disease, an acute anaphylaxis can be observed.
Interaction with other medicines:
Thiamin completely breaks up in the solutions containing sulfites.
Thiamin is unstable in alkaline and neutral solutions; appointment with carbonates, citrates, barbiturates, drugs of copper is not recommended.
The pyridoxine is not appointed along with a levodopa as action of the last is weakened.
In view of existence in composition of drug of lidocaine, in case of additional use of adrenaline and noradrenaline, strengthening of side effect on heart is possible. In case of overdose of local anesthetics it is impossible to apply adrenaline and noradrenaline in addition.
B12 vitamin is incompatible with ascorbic acid, salts of heavy metals.
Contraindications:
Hypersensitivity to any of drug components;
severe and acute forms of dekompensirovanny chronic heart failure;
children's age (due to the lack of researches).
Use at pregnancy and in the period of a lactation. It is not recommended to apply.
Overdose:
Symptoms: in cases of very bystry administration of drug there can be system reactions (dizziness, arrhythmia, spasms), they can be also result of overdose.
Treatment: symptomatic therapy.
Storage conditions:
Period of validity - 2 years. Not to use after a period of validity. List B. In the place protected from light at a temperature from 2 to 8 °C. To store in the place, unavailable to children.
Issue conditions:
According to the recipe
Packaging:
Solution for intramuscular introduction.
On 2 ml in ampoules of light-protective glass. On 5 ampoules place in a blister strip packaging from a film of polyvinyl chloride and aluminum foil or without foil. 1 or 2 blister strip packagings together with the application instruction place in a pack from a cardboard.