Vitaxon - instructions for use, dose, side effects, contraindications

active substances: thiamine hydrochloride in terms of 100% anhydrous substance - 100.0 mg, pyridoxine hydrochloride in terms of 100% dry matter - 100.0 mg, cyanocobalamin in terms of 100% dry matter - 1.0 mg; lidocaine hydrochloride in terms of 100% dry matter - 20.0 mg.

Excipients: benzyl alcohol 40.0 mg, sodium polyphosphate 20.0 mg, potassium hexacyanoferrate III 0.2 mg, 0.1M sodium hydroxide solution up to pH 4.4-4.8, water for injection up to 2 ml .

Description:

Transparent liquid of red color with a specific smell.

Pharmacotherapeutic group:Vitamins of group B + others

ATX: & nbsp

A.11.E.X B group vitamins in combination with other drugs

Pharmacodynamics:

The drug contains vitamins B₁ (thiamine), AT₆ (pyridoxine) and B₁₂ (cyanocobalamin), the deficiency of which can lead to neurological disorders, mainly,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 injection thiamine is rapidly absorbed from the injection site and enters the blood (484 ng / ml after 15 minutes on the first day of dosing in 50 mg) and is distributed unevenly in the body with its content in leukocytes 15%, erythrocytes 75% and plasma 10%. Thiamine penetrates through blood-brain and placental barriers and is found in breast milk. Thiamine is excreted in the urine in the α-phase after 0.15 h, in the β-phase - after 1 h and in the terminal phase - within 2 days. The main metabolites are: thiaminic acid, pyramine and some unknown metabolites. Of all vitamins thiamine is stored in the body in the smallest amount. 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.

After intramuscular injection pyridoxine quickly absorbed into the bloodstream and distributed in the body, after phosphorylation of CH₂The OH group in the 5-th position forms a metabolically active pyridoxalphosphate. 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. The human body contains 40-150 mg of vitamin B₆ and its daily elimination rate is about 1.7-3.6 mg with a replenishment rate of 2.2-2.4%. After parenteral administration cyanocobalamin Forms complexes with transport protein transkobalaminom, which are quickly absorbed by the liver, bone marrow and other organs. Cyanocobalamin excreted in bile and takes part in 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: neuralgia of the trigeminal nerve, neuritis of the facial nerve, intercostal neuralgia, pain syndrome caused by diseases of the spine (dorsalgia, lumboschialgia, plexopathy, radicular syndrome caused by degenerative changes of the spine).

Contraindications:

Hypersensitivity to the active or auxiliary substances of the drug.
Severe disorders of conduction 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 of vitamin B₆ does not pose a safety hazard during pregnancy and during breastfeeding; the preparation contains 100 mg of vitamin B₆, so it should not be used during these periods).
Childhood.

Pregnancy and lactation:

Pregnancy

Recommended daily intake of vitamin B₁during pregnancy and during breastfeeding is 1.4-1.6 mg, vitamin B₆ - 2,4-2,6 mg.Excess of these doses during pregnancy is allowed only with a confirmed deficiency of vitamins B₁ and B₆, since the safety of the use of doses exceeding the recommended daily requirement is not confirmed.

Use during pregnancy is contraindicated.

Breast-feeding

Vitamins B₁ and B₆ penetrate into breast milk.

High doses of vitamin B₆inhibit the formation of milk.

Application in the period of breastfeeding is contraindicated.

Dosing and Administration:

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 the lighter cases, 2 ml 2-3 times a week are 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. When unintentional intravenous administration is necessary to carry out medical supervision (for example,in stationary conditions), depending on the severity of the symptoms.

In the intervals between the injections the drug is taken orally.

Side effects:

The following terms 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 the rapid introduction (e.g., due to inadvertent intravascular injection or injection into the tissue with a rich blood supply) or at excess dose may develop systemic reactions, including confusion, vomiting, bradycardia, arrhythmia, dizziness and cramps.

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

Frequency unknown: burning at the injection site.

Overdose:

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

Interaction:

In the presence of sulfite-containing solutions thiamine is completely degraded. In the presence of vitamin B degradation products₁andother vitamins may be inactivated.

Therapeutic doses of vitamin B₆can reduce the action of levodopa.

Possible interaction with isoniazid, penicillamine and cyclosporine.

If lidocaine is administered simultaneously with parenteral administration epinephrine or norepinephrine, it is possible to increase unwanted 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.

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.

Effect on the ability to drive transp. cf. and fur:

Special precautions are not required.

Form release / dosage:

Solution for intramuscular injection.

Packaging:

By 2 ml in ampoules glass brown with a break ring or break point. 5 ampoules per blister of polymer film.

For 1 or 2 blisters with ampoules, together with instructions for medical use, put in a pack of cardboard.

Storage conditions:

Store in a dark place at a temperature not exceeding 15 ° C.

Keep out of the reach of children.

Shelf life:

2 years.

Do not use after the expiry date printed on the package.

Terms of leave from pharmacies:On prescription

Registration number:LP-002545

Date of registration:25.07.2014

Expiration Date:25.07.2019

The owner of the registration certificate:FARMAK, PAO FARMAK, PAO Ukraine

Manufacturer: & nbsp

FARMAK, PAO Ukraine

Information update date: & nbsp21.02.2017

Illustrated instructions

Instructions

Vitaxon® (Vitaxon)