Composition, form of production and packaging
The solution for the / m introduction is pinkish-red, transparent, with a characteristic specific smell.
1 ml of 1 amp.
thiamine hydrochloride (Vit B 1 ) 50 mg 100 mg
pyridoxine hydrochloride (Vit B 6 ) 50 mg 100 mg
cyanocobalamin (Vit B 12 ) 500 Ојg 1 mg
lidocaine hydrochloride 10 mg 20 mg
Excipients: benzyl alcohol - 40 mg, sodium polyphosphate or sodium tripolyphosphate - 20 mg, potassium hexacyanoferrate - 0.2 mg, sodium hydroxide solution 1M - up to pH 4.0-5.0, water d / u - up to 2 ml.
2 ml - dark glass ampoules (5) - packings of cellular contour (1) - packs of cardboard.
2 ml - ampoules of dark glass (5) - packings of cellular contour (2) - packs cardboard.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2015.
PHARMACHOLOGIC EFFECT
Combined drug containing B vitamins and lidocaine.
Neurotropic B vitamins have a beneficial effect on inflammatory and degenerative diseases of the peripheral nervous system and motor apparatus. In high doses have analgesic properties, promote blood flow, normalize the nervous system and the processes of hematopoiesis (vitamin B 12 ).
Thiamine (vitamin B 1 ) plays a key role in the processes of carbohydrate metabolism, which are crucial in the metabolic processes of the nervous tissue, as well as in the Krebs cycle with subsequent participation in the synthesis of thiamine pyrophosphate and ATP.
Pyridoxine (vitamin B 6 ) is involved in the metabolism of proteins, and in part, in the metabolism of carbohydrates and fats.
The physiological function of both vitamins (B 1 and B 6 ) is the potentiation of each other's action, manifested in a positive effect on the nervous, muscular and cardiovascular systems.
Cyanocobalamin (vitamin B 12 ) is involved in the synthesis of the myelin sheath, stimulates hemopoiesis, reduces pain associated with peripheral nervous system damage, stimulates nucleic acid metabolism through the activation of folic acid.
Lidocaine is a local anesthetic that causes all kinds of local anesthesia.
PHARMACOKINETICS
Suction and distribution
After an / m introduction, thiamin is rapidly absorbed from the injection site and enters the blood (484 ng / ml after 15 minutes on the first day of administration at a dose of 50 mg) and is distributed unevenly in the body (its content in leukocytes is 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.Tiamin penetrates through the BBB and the placental barrier, excreted in breast milk.
After intravenous injection, pyridoxine is quickly absorbed into the bloodstream and distributed in the body, acting as a coenzyme after phosphorylation of the CH2OH group in the 5-th position. About 80% of pyridoxine binds to blood plasma proteins. Pyridoxine is distributed throughout the body, penetrates through the placental barrier, excreted in breast milk.
Metabolism
The main metabolites are: thiaminic acid, pyramine and some unknown metabolites. Of all the vitamins, thiamine is retained in the body in the least amount. The adult body contains about 30 mg of thiamine in the form of thiamine pyrophosphate (80%), thiamine triphosphate (10%) and the rest in the form of thiamine monophosphate. Pyridoxine is deposited in the liver and oxidized to 4-pyridoxic acid.
Excretion
Thiamine is excreted in the urine in the alpha phase after 0.15 h, in the beta phase - after 1 h and in the terminal phase - for 2 days. 4-pyridoxic acid is excreted in the urine, a maximum of 2-5 hours after absorption. In the human body contains 40-150 mg of vitamin B 6 , its daily elimination rate is about 1.7-3.6 mg at a replenishment rate of 2.2-2.4%.
INDICATIONS
For pathogenetic and symptomatic therapy of diseases and syndromes from the nervous system of various origin:
- neuropathy and polyneuropathy (diabetic, alcoholic and others);
- neuritis and polyneuritis, incl. retrobulbar neuritis;
- peripheral paresis, incl. facial nerve;
- neuralgia, incl. trigeminal nerve and intercostal nerves;
- Pain syndrome (radicular, myalgia);
- Muscular nocturnal cramps, especially in people of older age groups;
- plexopathies, ganglionitis (including herpes zoster);
- neurological manifestations of osteochondrosis of the spine (radiculopathy, lumboeishalgia, muscular-tonic syndromes).
DOSING MODE
In severe pain syndrome, it is advisable to start treatment with a / m administration (deep) of 2 ml of the drug daily for 5-10 days with a transition in the future either for oral administration or for rarer injections 2-3 times a week during 2- 3 weeks.
SIDE EFFECT
Allergic reactions: skin reactions in the form of itching, hives; rarely - reactions of hypersensitivity to the drug, incl. rash, shortness of breath, angioedema, anaphylactic shock.
Other: in some cases - increased sweating, tachycardia, acne.
CONTRAINDICATIONS
- severe and acute forms of decompensated chronic heart failure;
- Children's age (due to lack of research);
- Hypersensitivity to the components of the drug.
PREGNANCY AND LACTATION
It is not recommended to use the drug during pregnancy and lactation (breastfeeding).
APPLICATION FOR CHILDREN
Contraindicated in childhood use (due to lack of research).
SPECIAL INSTRUCTIONS
In cases of very rapid administration of the drug, it is possible to develop systemic reactions (dizziness, arrhythmia, convulsions).
Impact on the ability to drive vehicles and manage mechanisms
Information about caution regarding the use of the drug by drivers of vehicles and persons working with potentially dangerous mechanisms is not available.
OVERDOSE
Symptoms: in cases of very rapid administration of the drug or overdose, it is possible to develop systemic reactions - dizziness, arrhythmia, convulsions.
Treatment: symptomatic therapy.
DRUG INTERACTION
Pyridoxine is not prescribed concurrently with levodopa, since the effect of the latter is weakened.
Taking into account the presence of lidocaine in the composition of the drug, in case of additional use of epinephrine and norepinephrine, there may be an increase in side effects on the heart. In case of an overdose of local anesthetics, epinephrine and norepinephrine should not be used additionally.
Pharmaceutical interaction
Thiamin completely dissolves in solutions containing sulfites.
Thiamine is unstable in alkaline and neutral solutions; the appointment with carbonates, citrates, barbiturates, copper preparations is not recommended.
Cyanocobalamin is incompatible with ascorbic acid, salts of heavy metals.
TERMS OF RELEASE FROM PHARMACY
The drug is released by prescription.
TERMS AND CONDITIONS OF STORAGE
The drug should be stored out of reach of children, protected from light at a temperature of 2 В° to 8 В° C. Storage and transport at temperatures below 2 В° C are not allowed. Shelf life - 2 years.
