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

Pyridoxine hydrochloride (in terms of 100% substance)	- 50 mg
Thiamine hydrochloride (in terms of 100% substance)	- 50 mg
Cyanocobalamin (in terms of 100% substance)	- 0.5 mg
Lidocaine hydrochloride (in terms of 100% of the substance)	- 10 mg

Excipients: benzyl alcohol - 20 mg, sodium polyphosphate - 10 mg, potassium hexacyanoferrate - 0.1 mg, sodium hydroxide - 6 mg, water for injections up to 1 ml.

Description:

A clear solution of red color, with a characteristic specific odor.

Pharmacotherapeutic group:Vitamins of group B + other preparations

ATX: & nbsp

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

Pharmacodynamics:

Combined multivitamin preparation. The effect of the drug is determined by the properties of the vitamins that make up its composition. Neurotropicvitamins of group B have a beneficial effect on inflammatory and degenerative diseases of the nervous system and motor apparatus.

Thiamine (vitamin B₁) - plays a key role in the processes of carbohydrate metabolism, which are crucial in the metabolic processes of the nervous tissue (participates in the nerve impulse), as well as in the Krebs cycle with subsequent participation in the synthesis of thiamine pyrophosphate (TPP) and adenosine triphosphate (ATP).

Pyridoxine (vitamin B₆) - has a vital effect on the exchange of proteins, carbohydrates and fats, is necessary for normal hematopoiesis, the functioning of the central and peripheral nervous system. It provides synaptic transmission, inhibition processes in the central nervous system (CNS), participates in the transport of sphingosine, which is part of the nerve shell, participates in the synthesis of catecholamines.

The physiological function of both vitamins (B₁ and B₆) is the potentiation of each other's actions, manifested in a positive effect on the nervous, neuromuscular and cardiovascular systems.

Cyanocobalamin (vitamin B₁₂) - involved in the synthesis of nucleotides, is an important factor in normal growth, hematopoiesis and the development of epithelial cells; is necessary for the metabolism of folic acid and myelin synthesis.

Lidocaine has an anesthetic effect at the injection site, dilates the blood vessels, contributing to the absorption of vitamins. The local anesthetic effect of lidocaine is due to the blockade of potential-dependent sodium channels, which prevents the generation of pulses in the endings of the sensory nerves and pain impulses along nerve fibers.

Pharmacokinetics:

Thiamine

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 administration of 50 mg dose) and is distributed unevenly in the body with its content in leukocytes 15%, erythrocytes 75% and in blood plasma 10%. In connection with the lack of significant vitamin stores in the body, it must enter the body daily. Thiamine penetrates through blood-brain and placental barriers, is found in breast milk. Thiamine is excreted by the kidneys in the alpha phase after 0.15 hours, in the beta phase - after 1 hour and in the terminal (terminal) phase - within 2 days. The main metabolites are: thiaminic acid, pyramine and some unknown metabolites. Of all vitamins thiamine remains in the body in the smallest amount.The adult body contains about 30 mg of thiamine: 80% in the form of thiamine pyrophosphate, 10% in the form of thiamine triphosphate and the rest in the form of thiamine monophosphate.

Pyridoxine

After intramuscular injection pyridoxine rapidly absorbed from the injection site and distributed in the body, acting as a coenzyme after phosphorylation of the CH group₂OH in the 5th position. About 80% Vitamin binds to blood plasma proteins. Pyridoxine distributed throughout the body, penetrates the placenta, found in breast milk. Accumulated in the liver and oxidized to 4-pyridoxic acid, which is excreted by the kidneys at most 2-5 hours after absorption.

In the human body contains 40-150 mg of vitamin AT₆ and its daily elimination rate is about 1.7-3.6 mg with a replenishment rate of 2.2-2.4%.

Cyanocobalamin

Cyanocobalamin after intramuscular administration binds to transcobalamins I and II, is transferred to various tissues of the body. The maximum concentration after intramuscular injection is achieved after 1 hour. Connection with blood plasma proteins - 90%. Penetrates through the placental barrier, is found in breast milk.Metabolized mainly in the liver with the formation of adenosylcobalamin, which is an active form of cyanocobalamin. Deposited in the liver, with bile enters the intestine and is again absorbed into the blood (the phenomenon of enterohepatic recirculation). The half-life period is long, excreted mostly by the kidneys (7-10%) and through the intestine (50%). With a decrease in kidney function is excreted by the kidneys - 0-7% and through the intestine - 70-100%.

Lidocaine

With intramuscular injection, the maximum plasma concentration of lidocaine is noted 5-15 minutes after the injection. Depending on the dose of the order of 60-80% lidocaine binds to plasma proteins. Rapidly distributed (within 6-9 minutes) in organs and tissues with good perfusion, incl. in the heart, lungs, liver, kidneys, then in muscle and adipose tissue. Penetrates through blood-brain and placental barriers, is found in breast milk (up to 40% of the concentration in the blood plasma of the mother). Metabolized in the liver with the participation of microsomal enzymes with the formation of active metabolites - monoethylglycinexylide and glycinexylide, having a half-life of 2 and 10 hours, respectively.The intensity of metabolism decreases with liver diseases. Excreted mainly in the form of metabolites by the kidneys and up to 10% in unchanged form.

Indications:

In complex therapy:

- mono- and polyneuropathies of various genesis;

- dorsalgia;

- Plexopathies;

- lumboschialgia;

- radicular syndrome caused by degenerative changes in the spine.

Contraindications:

- Hypersensitivity to the components of the drug;

- acute heart failure, chronic heart failure in the stage of decompensation;

- Children under 18 years of age (efficacy and safety of use not established);

- the period of pregnancy and breastfeeding.

Pregnancy and lactation:

The use of the drug is contraindicated during pregnancy and breastfeeding.

Dosing and Administration:

Injections are performed deeply intramuscularly (see section "Special instructions").

In cases of severe pain, it is advisable to start treatment with intramuscular injection (deep) 2 ml daily for 5-10 days with a transition in the future either for oral administration or for rarer injections (2-3 times a week for 2-3 weeks) with possible continuation of therapy with the oral dosage form.

Weekly monitoring of therapy by a physician is necessary.The duration of treatment is determined by the doctor individually, depending on the severity of the symptoms of the disease.

The transition to therapy with a dosage form for oral administration is recommended in the shortest possible time.

Side effects:

The frequency of unfavorable adverse reactions is given in accordance with the WHO classification: very often (≥1 / 10); often (≥1 / 100, <1/10); infrequently (≥1 / 1000, <1/100); rarely (≥1 / 10000, <1/1000); very rarely (<1/10000), including individual cases; frequency is unknown (can not be estimated from available data).

From the immune system:

rarely: allergic reactions (skin rash, shortness of breath, anaphylactic shock, Quincke's edema);

from the nervous system:

frequency is unknown: dizziness, confusion;

from the cardiovascular system:

rarely: tachycardia;

frequency is unknown: bradycardia, arrhythmia;

from the gastrointestinal tract:

frequency is unknown: vomiting;

from the skin and subcutaneous tissues:

rarely: increased sweating, acne, pruritus, urticaria;

from the osteomuscular and connective tissue:

frequency is unknown: convulsions;

General disorders and disorders at the site of administration:

frequency is unknown: irritation may occur at the injection site; Systemic reactions are possible with rapid administration or overdose.

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.

If any of the side effects listed in the manual are aggravated, or if you notice any other side effects not listed in the instructions, tell your doctor.

Overdose:

Symptoms: vomiting, bradycardia, arrhythmia, possible systemic reactions, including dizziness, confusion, convulsions.

Treatment: In case of symptoms of overdose, treatment with the drug should be canceled, if necessary, prescribe symptomatic therapy.

Interaction:

Vitamins of group B

Vitamin B₁ (thiamine) completely decomposes in solutions containing sulfites. And, as a consequence, the products of thiamine decomposition inactivate the action of other vitamins. Thiamine is incompatible with oxidizing and reducing compounds, including: mercuric chloride, iodide, carbonate, acetate, tannic acid, iron-ammonium citrate, as well as phenobarbital, riboflavin, benzylpenicillin, dextrose and metabisulphite. Copper accelerates the destruction of thiamine; Besides, thiamine Loses its effectiveness with increasing pH (more than 3).

Therapeutic doses of vitamin B₆ (pyridoxine) weaken the effect of levodopa (decreases the antiparkinsonian action of levodopa) with simultaneous application. There is also interaction with cycloserine, penicillamine, isoniazid.

Vitamin B₁₂ (cyanocobalamin) is incompatible with ascorbic acid, salts of heavy metals.

Lidocaine

When parenteral application of lidocaine, in case of additional use of norepinephrine and epinephrine, an increase in undesirable reactions to the heart is possible. Interactions with sulfonamides are also observed. In case of an overdose of local anesthetics, it is not possible to additionally apply epinephrine and norepinephrine.

Special instructions:

The drug should be administered only intramuscularly, not allowing it to enter the vascular bed.In case of accidental intravenous administration, the patient should be under the supervision of a doctor or hospitalized, depending on the severity of the symptoms.

The drug can cause neuropathy with a duration of application of more than 6 months.

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

Information on the effect of Binavit on the ability to drive a car and other vehicles, as well as on the performance of potentially hazardous activities requiring increased concentration of attention and speed of psychomotor reactions, is lacking. However, it is advisable to take care, given the possible development of unwanted reactions of the drug.

Form release / dosage:

Solution for intramuscular injection.

Packaging:

2 ml of the drug in ampoules of light-protective, neutral glass.

5 ampoules are placed in a contour plastic package (tray) made of a polyvinylchloride film or a polyethylene terephthalate film.

Five ampoules are placed in a contour mesh package made of a polyvinylchloride film, or a polyethylene terephthalate film, and aluminum foil printed lacquer or packing material.

1, 2, 4 contour plastic packages (pallets) or contoured cell packs with ampoules together with the instructions for use and the ampoule or ampoule ampoule with a knife are placed in a pack of cardboard.

5, 10, 20 ampoules, together with the instruction for use and the ampoule ampoule or ampoule ampoule with a knife, are placed in a pack with a separating insert made of cardboard.

If you use ampoules with a colored break point and a notch or a colored break ring, the ampoule knife or ampoule ampoule opener is not inserted.

Storage conditions:

In the dark place at a temperature of no higher than 15 ° C.

Keep out of the reach of children.

Shelf life:

2 years.

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

Terms of leave from pharmacies:On prescription

Registration number:LP-000604

Date of registration:21.09.2011 / 31.10.2016

Expiration Date:Unlimited

The owner of the registration certificate:BINERGIYA, CJSC BINERGIYA, CJSC Russia

Manufacturer: & nbsp

Armavir Biofactory, FKP

Information update date: & nbsp05.04.2017

Illustrated instructions

Instructions

Binawit (Binavit)