Composition, form of production and packaging
Tablets covered with a film membrane from white to almost white, round, biconvex.
1 tab.
benfotiamine 100 mg
pyridoxine (in the form of hydrochloride) (Vit B 6 ) 100 mg
cyanocobalamin (Vit B 12 ) 200 Ојg *
Excipients: calcium hydrophosphate, microcrystalline cellulose, stearic acid, croscarmellose sodium, magnesium stearate, silicon dioxide colloid.
Sheath composition: opadrai II white (hypromellose, titanium dioxide, polydextrose, talcum, maltodextrin, medium chain triglycerides).
30 pcs. - blisters (1) - packs of cardboard.
30 pcs. - blisters (2) - packs of cardboard.
30 pcs. - bottles of high-density polyethylene (1) - packs of cardboard.
60 pcs. - bottles of high-density polyethylene (1) - packs of cardboard.
* Due to the peculiarities of the technological process, it is laid in the form of 1% of a mixture of cyanocobalamin in microcrystalline cellulose in an amount of 24 mg.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2011.
PHARMACHOLOGIC EFFECT
Complex of vitamins of group B (B 1 , B 6 , B 12 ), has an effect on the state and function of nervous tissue.
Benzothiamine is a fat-soluble form of vitamin B 1 (thiamine). In the human body, thiamine is converted to the active thiamine pyrophosphate and as a coenzyme is included in the pyruvate decarboxylase,?-Ketoglutarate decarboxylase complex, which participate in the oxidative decarboxylation of pyruvic and? -ketoglutaric acids: transketolase, the enzyme of the pentose phosphate shunt. An important result of the action of benfotiamine is a significant increase in the activity of transketolase: one of the major biochemical disorders in diabetes is the inhibition of the enzyme transketolase. Thiamine takes an active part in the synthesis of ATP, involved in the transfer of impulses in vegetative fibers and ganglia. Regulates the conduct of a nerve impulse, improving synoptic transmission. The effect of benfotiamine several times exceeds the action of thiamine, due to its high tropism to the phospholipids of the membranes of cells of the nervous tissue.
Pyridoxine (vitamin B 6 ) is necessary for the normal functioning of the central nervous system and the peripheral nervous system. Entering the body, it is phosphorylated, converted to pyridoxal-5-phosphate and is part of enzymes that carry out decarboxylation, transamination and racemization of amino acids, as well as enzymatic conversion of sulfur-containing and hydroxylated amino acids. Participates in the exchange of tryptophan (participation in the reaction of biosynthesis of serotonin). Accelerates regenerative processes in the nervous tissue.
Cyanocobalamin (vitamin B 12 ) participates in a number of important biochemical reactions that ensure the vital activity of the organism (synthesis of nucleic acids, protein, amino acid metabolism, carbohydrates, lipids). In the body (mainly in the liver) is converted to methylcobalamin and 5-deoxyadenosylcobalamin.Methylcobalamin participates in the reaction of homocysteine ​​to methionine and S-adenosylmethionine - the key reactions of the metabolism of pyrimidine and purine bases (and, consequently, DNA and RNA). If the vitamin is deficient in this reaction, it can be replaced by methyltetrahydrofolic acid, with folic acid reactions of metabolism being disturbed. 5-deoxyadenosyl cobalamin serves as a cofactor in the isomerization of L-methylmalonyl-CoA in succinyl-CoA, an important carbohydrate and lipid metabolism reaction. Deficiency of vitamin B 12 leads to a violation of the proliferation of rapidly dividing cells of the hematopoietic tissue into the epithelium, as well as to a violation of the formation of the myelin sheath of neurons.
PHARMACOKINETICS
After oral administration, benfotiamine and pyridoxine are absorbed in the proximal part of the intestine. The absorption of cyanocobalamin is largely determined by the presence of the "internal factor of the Castle" in the stomach and the proximal part of the intestine.
Benzothiamine
After taking the drug, benfotiamine is rapidly absorbed from the digestive tract. Absorption of benfotiamine occurs 5 times faster than conventional thiamine. Cmax isreached earlier than 1 hour. The bioavailability of benfotiamine is 4-5 times higher than that of thiamine, and according to some data it reaches 100%. At the cellular level, the effect of benfotiamine exceeds the action of the usual thiamine 5-25 times. Metabolised in the liver and excreted by the kidneys.
Pyridoxine
After absorption in the digestive tract, pyridoxine is distributed in the human body - the highest concentrations are found in the liver and myocardium, in which it is deposited. In the liver, pyridoxine is oxidized to 4-pyridoxic acid, which is excreted in the urine, maximum 2-5 hours after absorption.
Cyanocobalamin
Cyanocobalamin is absorbed in the small intestine after interaction in the stomach with the "internal factor of Kastla." After absorption, vitamin B 12 is transported to the tissues. Excess of vitamin accumulates in the liver. From the liver, it is excreted with bile into the intestine, where it is again absorbed. Through the kidneys, only a trace amount of this vitamin is excreted from the body.
INDICATIONS
As part of the complex therapy of the following neurological diseases:
- polyneuropathy of various etiology, incl. diabetic, alcoholic;
- intercostal neuralgia, lumboschialgia, radiculopathy, cervico-brachial syndrome, radicular syndrome caused by degenerative changes of the spine;
- neuritis of the facial nerve, neuralgia of the trigeminal nerve, retrobulbar neuritis.
DOSING MODE
Assign inside, 1 tab. 1-3 times / day after eating, squeezed with enough liquid. Duration of treatment and repeated courses - on the advice of a doctor. It is not recommended to use the drug in high doses for more than 4 weeks.
SIDE EFFECT
Allergic reactions: skin rash, hives, shortness of breath, Quincke's edema, anaphylactic shock.
Dermatological reactions: in some cases - increased sweating, acne.
Other: in some cases - tachycardia.
CONTRAINDICATIONS
- heart failure in the stage of decompensation;
- children's age till 18 years;
- Hypersensitivity to the components of the drug.
PREGNANCY AND LACTATION
It is not recommended to use Unigamma during pregnancy and lactation (breastfeeding).
APPLICATION FOR CHILDREN
Contraindicated: children under 18 years.
SPECIAL INSTRUCTIONS
Do not exceed the recommended dose of the drug.
OVERDOSE
Symptoms: nausea, weakness, gastrointestinal disorders.
Treatment: activated charcoal inside, gastric lavage, symptomatic therapy.
In case of an overdose, the patient should consult a doctor.
DRUG INTERACTION
Levodopa reduces the effectiveness of pyridoxine in therapeutic doses. When combined with cycloserine, penicillamine, epinephrine, norepinephrine, sulfonamides, the effectiveness of pyridoxine may be reduced.
Copper accelerates the destruction of benfotiamim; In addition, benfotiamin loses its effect with increasing pH (more than 3). With the combined use of benfotiamine with ethanol, the absorption of benfotiamine is sharply reduced.
Against the background of the combined use of cyanocobalamin with colchicine or biguanides, there is a decrease in the absorption of cyanocobalamin, which is part of the drug.
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, dry place at a temperature of 10 В° to 30 В° C. Shelf life - 3 years.
