Thiamin hlorid-Darnitsa (B1)

General characteristics. Structure:

Active ingredient: thiamine;

1 ml of solution contains thiamin of a hydrochloride 50 mg;

excipients: Unithiolum, water for injections.

Pharmacological properties:

Pharmacodynamics. Thiamin hlorid-Darnitsa – synthetic drug of B1 vitamin belongs to water-soluble vitamins. In a human body as a result of processes of phosphorylation turns into cocarboxylase, being a coenzyme of many fermental reactions. B1 vitamin plays an important role in a metabolism and neuroreflex regulation, exerts impact on carrying out nervous excitement in synapses, has ganglioblokiruyushchy and kurarepodobny effect. Drug can weaken kurarepodobny action of the depolarizing muscular relaxants.

Pharmacokinetics. Drug is well absorbed. Phosphorylation takes place in a liver. Collects in a liver, heart, a brain, kidneys, a spleen. About 8-10% – in not changed look are allocated with a liver and kidneys.

Pharmaceutical characteristics.

Main physical and chemical properties: transparent colourless or slightly yellowish liquid with a slight characteristic smell.

Incompatibility.

Thiamini chloridum should not be mixed in one syringe:

- with benzylpenicillin or streptomycin as it will lead to destruction of antibiotics;

-  with the niacin or solutions containing sulfites as it will lead to thiamin destruction;

-  with carbonates, citrates, barbiturates, with Cu2+, iodides, tannin acid as thiamin is unstable in alkaline and neutral solutions.

Indications to use:

Treatment hypo - and avitaminosis of B1, neuritis, polyneurites, radiculitis, neuralgia, flaccid paralyzes, encephalopathy, a neurasthenia, a peptic ulcer of a stomach and a duodenum, an atony of intestines, chronic damages of a liver, dystrophy of a myocardium, an endarteritis, a dermatosis of a neurogenic origin, a pyoderma, eczema, psoriasis.

Route of administration and doses:

Adult.

Drug is appointed intramusculary (deeply in a muscle) in a dose of 25-50 mg (0,5-1 ml) of 1 times a day, daily. Vvedeniya|vstup | begin with small doses – no more than 25 mg (0,5 ml of 5% of solution |) and to a tolko|lisha | under a condition хорошей|добрій | portability enter the highest doses – 50 mg (1 ml of 5% of solution) |запроваджують |. A course of treatment – 10-30 injections.

Vernike-Korsakov's encephalopathy: drug is appointed intramusculary (deeply in a muscle) in a dose of 50-100 mg (1-2 ml of 5% of solution) by 2 times a day before clinical improvement. It is necessary to consider probability of development of allergic reaction to administration of B1 vitamin.

To children 8 years are more senior.

Drug appoint in a dose 12,5 mg (0,25 ml of 5% of solution) of 1 times a day, daily. A course of treatment – 10-30 injections.

Features of use:

Use during pregnancy or feeding by a breast.

Use of drug during pregnancy or feeding by a breast after indications in the recommended doses is possible.

Children.

Usually apply 2,5% to children Thiamini chloridum solution. Introduction of 5% of solution to children in a vozdasta is allowed 8 years are more senior.

Before parenteral use of solution of Thiamini chloridum conducting skin test on individual sensitivity to drug is obligatory. After carrying out an injection control within 30 minutes because of possibility of heavy allergic reactions is necessary.

Anaphylactic reactions develop more often after intravenous administration in high doses.

It is desirable for injection of thiamin to do not earlier than in 12 hours after a pyridoxine injection.

At intramuscular introduction the drug should be administered deeply in a muscle, at intravenous – slowly.

Intramuscular and subcutaneous injections are painful because of a low rn of solution.

Daily need for B1 vitamin: for adult men – 1,2-2,1 mg, for elderly people – 1,2-1,4 mg, for women – 1,1-1,5 mg with addition of 0,4 mg of pregnant and 0,6 mg – to women during feeding by a breast, for children, depending on age, – 0,3-0,5 mg.

It is impossible to use drug as replacement of the balanced diet, only in a complex with a dietotherapy.

The injection form of drug needs to be applied at treatment of patients with disturbances of absorption in intestines or with a stomach resection, at impossibility of reception of thiamin in the tableted form (nausea, vomiting, to - and the postoperative period), and also at severe forms of a disease or in an initiation of treatment to more bystry achievement of therapeutic effect.

It is recommended to begin parenteral administration with small doses (no more than 0,5 ml adult), and only at good tolerance enter higher doses.

With care appoint at a hyperexcitability of a nervous system, hyperacid forms of a peptic ulcer of a duodenum.

At Vernike's encephalopathy before administration of glucose it is necessary to accept thiamin.

If the allergy to the B1 vitamin sick is found cancel rice, buckwheat, meat, bread (the grade baked of coarse flour).

At alcoholics strengthening of symptoms of side effect of drug is possible.
Thiamin can weaken action of the depolarizing muscle relaxants, adrenolytic and sympathomimetic means.

Drug (at acceptance of high doses) can distort results when determining theophylline in blood serum a spectrophotometric method and urobilinigen by means of Ehrlich's reagent.

Ability to influence speed of response at control of motor transport or work with other mechanisms.

During treatment it is necessary to be careful at control of vehicles and work with difficult mechanisms in connection with a possibility of development of side effects from a nervous system.

Side effects:

At use of drug the following side reactions are possible:

from cardiovascular system: tachycardia, heart consciousness, collapse;

from peripheral and central nervous system: headache, dizziness, concern, paresthesias;

from organs of sight: damage of an optic nerve;

from respiratory system: utrudnenny breath, asthma,

from a digestive tract: utrudnenny swallowing, nausea, intestinal hemorrhages;

from skin and hypodermic cellulose: hyperemia, itch;

from immune system: dermatitis, rashes, urticaria, a Quincke's edema, a bronkhospastichesky syndrome with spasms, an acute anaphylaxis;

from gepatobiliarny system: disturbance of activity of enzymes of a liver;

general disturbances: the increased sweating, a fever, a tremor, the general weakness, hypostases, fever;

reactions in the place of an injection: rashes, itch;

others: the sinaptoplegiya phenomenon – ability of thiamin to form complexes with different mediators can be followed by a lowering of arterial pressure, developing of cardiac arrhythmias, disturbance of reduction skeletal (including respiratory) muscles, oppression of the central nervous system; Thiamini chloridum promotes formation of resistance of staphylococcus to antibiotics.

Interaction with other medicines:

At combined use of drug with other medicines perhaps: with the depolarizing muscle relaxants (succinylcholine chloride), sincaline derivatives – weakening of their therapeutic action;

with thiosemicarbazone, 5-ftoruratsily – inhibition of activity of thiamin;

with the caffeine, drugs containing sulfur and estrogen – increase in need of an organism for thiamin;

with anticonvulsant drugs (phenobarbital, Phenytoinum, carbamazepine), digoxin, indometacin, antiacid drugs – development of deficit of thiamin;

with cyanocobalamine, a pyridoxine – difficulty of transformation of thiamin into fosforilirovanny biologically active form and strengthening of its allergenic action. Simultaneous parenteral administration of thiamin with a pyridoxine (B6 vitamin) or cyanocobalamine (B12 vitamin) is not recommended;

with ethanol – delay of speed of absorption of thiamin.

with adrenomimetika, sympathomimetics – weakening of their therapeutic action.

At intravenous administration along with the solutions containing sodium hydrosulphite as antioxidant or preservative, thiamin is unstable.

Thiamin is unstable in alkaline and neutral solutions, appointment with carbonates, citrates, barbiturates, with Cu2, iodide, iron-ammonium citrate, tannin acid it is not recommended.

Contraindications:

Hypersensitivity to drug components; allergic diseases; idiosyncrasy; the premenopausal and climacteric periods at women.

Overdose:

Symptoms: strengthening of symptoms of side effect of drug – hypercoagulation, disturbance of purine exchange is possible.

Treatment: drug withdrawal, symptomatic therapy.

Storage conditions:

Period of validity. 3 years. To store in the place, unavailable to children, in original packaging at a temperature not above 25 °C. Not to freeze.

Issue conditions:

According to the recipe

Packaging:

On 1 ml in an ampoule, on 10 ampoules in a box; on 5 ampoules in a blister strip packaging,    on the 2nd blister strip packagings in a pack; on 10 ampoules in a blister strip packaging, on 1 blister strip packaging in a pack.