Unigamma - instructions for use, doses, side effects, contraindications

active active ingredients: benfotiamine 100 mg, pyridoxine hydrochloride in terms of pyridoxine (vitamin B₆) 100 mg, cyanocobalamin (atitamin B₁₂) 200 μg¹⁾;

Excipients: calcium hydrophosphate 80.80 mg, microcrystalline cellulose 16.00 mg, stearic acid 10.00 mg, croscarmellose sodium 6.00 mg, magnesium stearate 5.00 mg, silicon dioxide colloidal 3.00 mg;

sheath: Opadrai II white (hypromellose, titanium dioxide, polydextrose, talcum, maltodextrin, medium chain triglycerides) 20.00 mg.

¹⁾in connection with the features of the technological process is laid in the form of 1% of the mixture of cyanocobalamin in the microcrystalline cellulose in an amount of 24.0 mg.

Description:

Round, biconvex tablets, covered with a film coat from white to almost white.

Pharmacotherapeutic group:multivitamin

ATX: & nbsp

A.11.B.A Multivitamins

Pharmacodynamics:

Complex of vitamins of group B (B₁ AT₆, AT₁₂) has an effect on the state and function of the nervous tissue.

Benzothiamine - fat-soluble form of vitamin B₁ (thiamine). In the human body thiamine is converted to the active thiamine pyrophosphate and as a coenzyme is included in the pyruvate decarboxylase, alpha-ketoglutarate decarboxylase complexes that participate in the oxidative decarboxylation of pyruvic and alpha-ketoglutaric acids; transketolase - an 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 mellitus is the inhibition of the enzyme transketolase. Thiamine takes an active part in the synthesis of ATP (adenosine triphosphate), 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 It is necessary for the normal functioning of the central and peripheral nervous systems. 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 participates in a number of important biochemical reactions that ensure the vital activity of the organism (the synthesis of nucleic acids, protein, the exchange of amino acids, carbohydrates, lipids).In the body (mainly in the liver) is converted to methylcobalamin and 5-deoxyadenosylcobalamin. Methylcobalamin participates in the homocysteine conversion reaction in 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-deoxyadenosylcobalamin serves as a cofactor for isomerization L-methylmalonil-CoA in succinyl-CoA - an important reaction of the metabolism of carbohydrates and lipids. Vitamin B deficiency₁₂ leads to a violation of the proliferation of rapidly dividing cells of the hematopoietic tissue and epithelium, as well as to the violation of the formation of the myelin sheath of neurons.

Pharmacokinetics:After oral administration benfotiamine and pyridoxine 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 inside benfotiamine quickly absorbed from the gastrointestinal tract (GIT).Absorption of benfotiamine occurs 5 times faster than conventional thiamine. FROM_mOh is achieved 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 oxidized to 4-pyridoxic acid, which is excreted in the urine, a maximum of 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 of vitamin B₁₂is transported to 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:

It is used in the complex therapy of the following neurological diseases:

- polyneuropathy of various etiologies, including 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.

Contraindications:

Hypersensitivity to the components of the drug. Heart failure in the stage of decompensation. Children under 18 years.

Pregnancy and lactation:

Use during pregnancy and lactation (breastfeeding) is not recommended.

Dosing and Administration:

Dosing and Administration Inside, 1 tablet 1-3 times a day after meals, squeezed a sufficient amount of liquid. Duration of treatment and repeated courses - on the advice of a doctor. It is not recommended to treat high doses of the drug for more than 4 weeks.

Side effects:

Allergic reactions are possible: skin rash, hives, shortness of breath, Quincke's edema, anaphylactic shock.

In some cases - increased sweating, acne, tachycardia.

Overdose:

Symptoms of overdose: nausea, weakness, gastrointestinal disorders.

In case of an overdose, consult a doctor.

Treatment: Activated carbon inside, gastric lavage, symptomatic treatment.

Interaction:

Levodopa reduces the effect of therapeutic doses of pyridoxine.

When combined with cycloserine, penicillamine, epinephrine, norepinephrine, sulfonamides, the effectiveness of pyridoxine may be reduced.

Copper accelerates the destruction of benfotiamine; Besides, benfotiamine 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.

Special instructions:

Do not exceed the recommended dose.

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

No data.

Form release / dosage:

Film-coated tablets.

Packaging:

For 30 or 60 tablets coated with a film shell in a white bottle of high-density polyethylene with a screw cap made of the same material and a safety valve made of foil. A label is attached to the vial,the bottle is tightened with a polyethylene film and, together with the instruction for use, is placed in a cardboard box.

For 30 tablets coated with a film sheath in a blister of aluminum foil / PVC.

1 or 2 blisters together with instructions for use are placed in a cardboard box.

Storage conditions:

In a dry place, at a temperature of 10-30 ° C.

Keep out of the reach of children.

Shelf life:

3 years.

Do not use after the expiration date.

Terms of leave from pharmacies:On prescription

Registration number:LSR-006140/10

Date of registration:30.06.2010

The owner of the registration certificate:Unipharm, Inc.Unipharm, Inc. USA

Manufacturer: & nbsp

UNIPHARM ,, Inc. USA

Representation: & nbspUNIFARM, Inc. UNIFARM, Inc. USA

Information update date: & nbsp20.08.2015

Illustrated instructions

Instructions

Unigamma (Unigamma)