Universal reference book for medicines
Product name: VITAXON (VITAXON)

Active substance: comb.
drug
Type: Complex of B vitamins

Manufacturer: ФАРМАК (Украина)
Composition, form of production and packaging
The solution for the / m administration is
transparent, red, with a specific odor.

1 amp.

thiamine hydrochloride in terms of 100% anhydrous substance 100 mg

pyridoxine hydrochloride in terms of 100% dry matter 100 mg

cyanocobalamin in terms of 100% dry matter 1 mg

lidocaine hydrochloride in terms of 100% dry matter 20 mg

Excipients: benzyl alcohol - 40 mg, sodium polyphosphate - 20 mg, potassium hexacyanoferrate III - 0.2 mg, sodium hydroxide solution 0.1 M - up to pH 4.4-4.8, water d / u - up to 2 ml.

2 ml - ampoules glass (5) - blisters (1) from a polymer film - packs cardboard.

2 ml - ampoules glass (5) - blisters (2) from polymer film - packs cardboard.

INSTRUCTION FOR THE SPECIALIST.

Description of the drug approved by the manufacturer for the printed edition of 2014.

PHARMACHOLOGIC EFFECT

The drug contains vitamins B 1 (thiamine), B 6 (pyridoxine) and B 12 (cyanocobalamin), the deficiency of which can lead to neurological disorders, the main reverse, from the peripheral nervous system.
The drug quickly replenishes the deficiency of these vitamins.
Thiamine is a cofactor of enzymes that carry two-carbon groups in decarboxylation reactions.

Pyridoxine is a cofactor of transaminases, as well as a cofactor in several other amino acid metabolism reactions.

Cyanocobalamin is a cofactor in the transport reactions of single-carbon groups.

Lidocaine is a local anesthetic that causes all kinds of local anesthesia: terminal, infiltration, and conductive.

PHARMACOKINETICS

After intramuscular administration, thiamin is rapidly absorbed from the injection site and enters the blood (484 ng / ml after 15 minutes on the first day of dosing at 50 mg) and is distributed unevenly in the body, with its content in leukocytes 15%, erythrocytes 75% and in plasma 10 %.
Thiamine penetrates through the blood-brain and placental barriers and is found in breast milk. Thiamine is excreted in the urine in the? -phase after 0.15 h, in the? -phase - after 1 h and in the terminal phase - for 2 days. The main metabolites are: thiaminic acid, pyramine and some unknown metabolites. Of all the vitamins, thiamine is stored in the body in the smallest amounts. The adult body contains about 30 mg of thiamine in the form of 80% thiamine pyrophosphate, 10% thiamine triphosphate, and the rest in the form of thiamine monophosphate.
In the intramuscular position, pyridoxine is rapidly absorbed into the bloodstream and distributed in the body, after phosphorylation of the CH 2 OH group in the 5-position, forms a metabolically active pyridoxal phosphate.
About 80% of the vitamin binds to plasma proteins. Pyridoxine is distributed throughout the body and penetrates the placenta and is found in breast milk, is deposited in the liver and oxidized to 4-pyridoxic acid, which is excreted in the urine, maximum 2-5 hours after absorption. In the human body contains 40-150 mg of vitamin B 6 and its daily elimination rate of about 1.7-3.6 mg at a replenishment rate of 2.2-2.4%.
After parenteral administration, cyanocobalamin forms complexes with the transport protein transcobalamin, which are rapidly absorbed by the liver, bone marrow and other organs.
Cyanocobalamin is excreted into the bile and takes part in the intestinal-hepatic circulation. Penetrates through the placenta.
INDICATIONS

In the complex therapy of the following diseases:

- Neuropathic pain caused by polyneuropathy (including diabetic and alcoholic);

Neuritis and neuralgia: trigeminal neuralgia, facial nerve neuritis, intercostal neuralgia, pain syndrome caused by diseases of the spine (dorsalgia, lumboschialgia, plexopathy, radicular syndrome caused by degenerative changes of the spine).

DOSING MODE

Dosing regimen

In order to quickly achieve high plasma concentrations in severe and acute pain during the first days of 2 ml / day.
As the state subsides and in more mild cases, 2.0 ml 2-3 times a week is administered.
It is recommended to carry out weekly medical supervision.

It is recommended to go to the reception as soon as possible.

The route of administration

The drug is injected deep into the muscle.

Unintentional intravenous administration

The drug should be administered exclusively intramuscularly, not allowing it to enter the vascular bed.
In case of unintentional intravenous administration, medical supervision should be performed (for example, in a hospital setting), depending on the severity of the symptoms.
In the intervals between the injections the drug is taken orally.

SIDE EFFECT

The following concepts and frequencies are used: very often (? 1/10), often (? 1/100 to <1/10), infrequently (? 1/1000 to <1/100), rarely (? 1/10 000 to < 1/1000), very rarely (up to <1/10 000) and the frequency is unknown (it is impossible to estimate based on available data).

Individual cases of increased sweating, tachycardia, acne, skin reactions, including pruritus and urticaria, have been reported.

In some cases, hypersensitivity reactions (such as rash, dyspnea, anaphylactic shock, angioedema) may develop.

With rapid administration (for example, due to unintentional intravascular injection or introduction into tissues with rich blood supply) or when the dose is exceeded, systemic reactions can occur including confusion, vomiting, bradycardia, arrhythmia, dizziness and convulsions.

In rare cases, due to the presence of benzyl alcohol, hypersensitivity reactions may develop.

Frequency unknown: burning at the injection site.

CONTRAINDICATIONS

- hypersensitivity to active or auxiliary substances of the drug;

- severe conduction disorders in the conduction system of the heart, acute decompensated heart failure;

- pregnancy and the period of breastfeeding (in a daily dose of up to 25 mg vitamin B 6 does not pose a threat to safety during pregnancy and during breastfeeding: the drug contains 100 mg of vitamin B 6 , so it should not be used during these periods);

- childhood.

PREGNANCY AND LACTATION

Pregnancy

The recommended daily intake of vitamin B 1 during pregnancy and during breastfeeding is 1.4-1.6 mg, vitamin B 6 - 2.4-2.6 mg.
Excess of these doses during pregnancy is allowed only with the confirmed deficiency of vitamins B 1 and B 6 , since the safety of the use of doses exceeding the recommended daily requirement is not confirmed.
Application during pregnancy is contraindicated.

Breast-feeding

Vitamins B 1 and B 6 penetrate into breast milk.

High doses of vitamin B 6 inhibit the formation of milk.

Application in the period of breastfeeding is contraindicated.

APPLICATION FOR CHILDREN

Contraindicated in children


SPECIAL INSTRUCTIONS

The drug should be administered exclusively intramuscularly and not to enter the vascular bed.
In case of unintentional intravenous administration, medical supervision should be performed (for example, in a hospital setting), depending on the severity of the symptoms.
When using the drug for more than 6 months, the development of neuropathy is possible.

In one ampoule (2 ml) the preparation contains less than 1 mmol (23 mg) of sodium.

Influence on ability to drive vehicles and work with mechanisms

Special precautions are not required.

OVERDOSE

In case of an overdose, seek medical attention.
Treatment is symptomatic.
DRUG INTERACTION

In the presence of sulfite-containing solutions, thiamine is completely degraded.
In the presence of products, degradation of vitamin B 1, other vitamins may be inactivated.
Therapeutic doses of vitamin B 6 can reduce the action of levodopa.

Possible interaction with isoniazid, penicillamine and cyclosporine.

If epinephrine or norepinephrine is used concomitantly with parenteral administration of lidocaine, there may be an increase in undesirable reactions from the heart.Possible interaction with sulfonamides.

In case of an overdose with local anesthetics, the use of epinephrine or norepinephrine is not allowed.

TERMS OF RELEASE FROM PHARMACY

On prescription.

TERMS AND CONDITIONS OF STORAGE

Store in a dark place at a temperature of no higher than 15 В° C.
Keep out of the reach of children. Shelf life - 2 years.
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