Complications B - instructions for use, doses, side effects, contraindications

1 ampoule (2 ml) contains as active substance: Thiamine hydrochloride - 100 mg, pyridoxine hydrochloride - 100 mg, cyanocobalamin - 1 mg, lidocaine hydrochloride - 20 mg.

Excipients: gasoline alcohol, sodium polyphosphate, sodium tripolyphosphate, potassium hexacyanoferrate, sodium hydroxide solution 1 M, water for injection.

Description:

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

Pharmacotherapeutic group:Multivitamin + other preparations

ATX: & nbsp

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

Pharmacodynamics:

Neurotropic B vitamins have a beneficial effect on inflammatory and degenerative diseases of the nerves and motor apparatus. They are not used to eliminate scarce conditions,and in high doses have analgesic properties, promote blood flow, normalize the work of the nervous system and the process of hematopoiesis (vitamin B₁₂).

Thiamine (B₁) 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 TPPthiamine pyrophosphate) and ATP (adenosine triphosphate). Pyridoxine (AT₆) is involved in the metabolism of proteins, and in part, in the metabolism of carbohydrates and fats. The physiological function of both vitamins (B₁, AT₆) is the potentiation of each other's actions, manifested in a positive effect on the nervous, neuromuscular and cardiovascular systems.

Cyanocobalamin (B₁₂) is involved in the synthesis of the myelin sheath, stimulates hemopoiesis, reduces pain associated with damage to the peripheral nervous system, stimulates nucleic acid metabolism through the activation of folic acid.

Lidocaine is a local anesthetic that causes all kinds of local anesthesia.

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 administration of the 50 mg dose) and is distributed unevenly in the body with a content of 15% in the leukocytes,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 in the urine in the alpha phase after 0.15 hours, in the beta phase after 1 hour and in the 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 in the form: 80% in the form of 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, performing the role of coenzyme after phosphorylation of the CH group₂OH in the 5th position. About 80% of the vitamin binds to blood plasma proteins. Pyridoxine distributed throughout the body, penetrates the placenta, found in breast milk. Deposited in the liver and oxidized to 4-pyridoxic acid, which is excreted in the urine, a maximum of 2-5 hours after absorption. The human body contains 40-150 mg of vitamin B₆, its daily elimination rate is about 1.7 - 3.6 mg with a replacement rate of 2.2 - 2.4%.

Indications:

As a pathogenetic and symptomatic agent in the treatment of diseases and syndromes of the nervous system of various origins:

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);
nocturnal muscle cramps, especially in older age groups;
plexopathy, ganglionitis (including herpes zoster);
neurological manifestations of osteochondrosis of the spine (radiculopathy, lumboeishalgia, muscular-tonic syndromes).

Contraindications:

Hypersensitivity to any of the components of the drug;
severe and acute forms of decompensated chronic heart failure;
children's age (due to lack of research).

Pregnancy and lactation:

Not recommended.

Dosing and Administration:

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

Side effects:

Allergic reactions. In some cases, there may be increased sweating, tachycardia, an acne appears. Described skin reactions in the form of itching, urticaria.

In rare cases, there may be phenomena of hypersensitivity to the drug, for example, rash, shortness of breath, angioedema, anaphylactic shock.

Overdose:

Symptoms: in cases of very rapid administration of the drug there may be systemic reactions (dizziness, arrhythmia, convulsions), they can also be the result of an overdose.

Treatment: symptomatic therapy.

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.

Pyridoxine is not prescribed concomitantly 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, it is possible to increase the side effect on the heart.In case of an overdose of local anesthetics, adrenaline and norepinephrine can not be used additionally.

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

Form release / dosage:Solution for intramuscular injection.

Packaging:

2 ml into the ampoules of the light-protective glass. 5 ampoules are placed in a contour mesh package made of a polyvinylchloride film and aluminum foil or without foil. 1 or 2 contour squares, together with instructions for use, are placed in a pack of cardboard.

Storage conditions:

In the dark place at a temperature of 2 to 8 ° C.

Do not store or transport at temperatures below 2 ° C.

Keep out of the reach of children.

Shelf life:

3 years. Do not use after expiry date.

Terms of leave from pharmacies:On prescription

Registration number:LSR-001758/09

Date of registration:10.03.2009 / 31.08.2010

Expiration Date:Unlimited

The owner of the registration certificate:FarmSirma Soteks, ZAO FarmSirma Soteks, ZAO Russia

Manufacturer: & nbsp

SOTEKS, ZAO Russia

Information update date: & nbsp02.02.2018

Illustrated instructions

Instructions

Complym B® (Compligam B®)