Teturamum

General characteristics. Structure:

Active ingredient: Disulfiramum; structure: 1 tablet contains Disulfiramum in terms of 100% dry matter – 150 mg; excipients: povidone, macrogoal 6000, lactoses monohydrate, sodium of a kroskarmeloz, magnesium stearate. Main physical and chemical properties: tablets of color, white or white with slightly yellowish-greenish shade, a round form, with a flat surface with slanted edges (facet) and risky.

Pharmacological properties:

Pharmacodynamics. Teturamum – specific means for treatment of an alcoholism. Action of Disulfiramum is caused by ability to break alcohol metabolism. In an organism Disulfiramum turns into N, N-diethyldithiocarbamic acid and other metabolites blocking ions of metals and sulphhydryl groups of the enzymes participating in alcohol neutralization. Ethanol in an organism is exposed to oxidizing transformations through a phase of acetic aldehyde and acetic acid. Blocking fermental biotransformation of alcohol alcohol dehydrogenase, Disulfiramum promotes accumulation of acetic aldehyde in blood after alcohol intake with development of characteristic toxic effects (nausea, vomiting, a dermahemia, feeling of heat of the person and an upper part of a trunk, a stethalgia, breath difficulty, noise in the head, a heart consciousness, dizziness, sensation of fear, a fever, a lowering of arterial pressure, etc.). Purpose of alcohol against the background of action of Disulfiramum allows to develop a resistant negative conditioned reflex on taste and a smell of alcohol and at prolonged treatment to reach partial or full intolerance of alcohol.

Pharmacokinetics. After intake quickly, but not completely (70–90%) it is absorbed in a digestive tract. Duration of action makes 48 hours. Disulfiramum is quickly metabolized by recovery in diethyldithiocarbamate which is emitted in the form of conjugates, or in diethyl amine and carbon sulfur (from 4 to 53%). Carbon sulfur is emitted through lungs.

Indications to use:

Alcoholism (prevention of a recurrence during treatment).

Route of administration and doses:

Teturamum is applied inside. Drug in doses of 150 - 450 mg a day is used 7 – 10 days. It is necessary to apply Teturamum in the morning, during a breakfast.
In 7 – 10 days from an initiation of treatment carry out the first Disulfiramum - alcoholic test: after administration of drug in the morning in a dose of 450 - 750 mg the patient drinks 20–30 ml of 40% of solution of alcohol or vodka, or other corresponding alcoholic drink.
Repeated tests carry out in the conditions of a hospital in 1 – 2 day, in out-patient conditions – in 3 – 5 days.
At weak reaction the alcohol dose when conducting the subsequent tests is raised on 10 – 20 ml. The maximum dose – 100 – 120 ml.

Features of use:

Before use of drug it is necessary to liquidate the abstinent phenomena completely.
For 1 – 3 day it is necessary to cancel completely reception of hypnagogues, tranquilizers,
antidepressants and neuroleptics.

Ability to influence speed of response at control of motor transport or other mechanisms.
Drug can influence ability to manage vehicles and work with other mechanisms.

Use during pregnancy or feeding by a breast.
During pregnancy and feeding by a breast use of drug is contraindicated.

Children.
Researches on use of drug in pediatric practice were not conducted.

Side effects:

Can be caused:
• directly and to be shown by Disulfiramum in the form of metal smack in a mouth, it is rare – hepatitis, psychological frustration, peripheral polyneurites, a memory impairment, a disorientation, an adynamy, a headache, skin and allergic reactions;
• and to be shown by Disulfiramum combination with alcohol in the form of a collapse, disturbances of a cordial rhythm, attacks of stenocardia, myocardial infarction, wet brain, a hemorrhagic stroke.

Interaction with other medicines:

Teturamum combinations are undesirable:
- with an isoniazid – are possible a behavior disorder and coordination;
- with nitroimidazoles (metronidazole, орнидазол, секнидазол, Tinidazolum) - acute delirium tremens, a condition of confusion of consciousness are possible;
- with Phenytoinum – perhaps essential and bystry increase in level of Phenytoinum in a blood plasma with toxic manifestations (owing to oppression of his metabolism).
The combinations demanding use with care: 
- with warfarin and other peroral anticoagulants the effect of peroral anticoagulants and danger of bleeding increases. It is necessary to control more often the level of a prothrombin and to adjust doses of anticoagulants in the course of treatment and within 8 days after cancellation of Disulfiramum;
- with theophylline – the dose of theophylline has to be lowered taking into account clinical symptoms and concentration of drug in a blood plasma (Disulfiramum changes theophylline metabolism);
- with benzodiazepines – Disulfiramum can exponentiate sedation of benzodiazepines by inhibition of their oxidizing metabolism (especially chlordiazepoxide and diazepam). The dosage of benzodiazepines has to be adjusted;
- with tricyclic antidepressants – strengthening of intolerance of alcohol is possible.

Contraindications:

Absolute contraindications: endocrine diseases (thyrotoxicosis, diabetes mellitus); the expressed cardiosclerosis; atherosclerosis of vessels of a brain; coronary heart disease; arterial hypertension of the II-III stage; serious illness of vessels; a pulmonary tuberculosis with a pneumorrhagia; recently arisen tubercular infiltrate; bronchial asthma; the expressed emphysema of lungs; the bleeding stomach ulcer; serious illness of a liver and kidneys; hemopoiesis disturbances; mental diseases; TsNS infections; epilepsy and epileptiform syndrome; polyneuritis; neuritis of acoustical and visual nerves; glaucoma; malignant tumors; pregnancy period; hypersensitivity to Disulfiramum.
Relative contraindications: the residual phenomena after organic lesion of a brain; the residual phenomena after infections of TsNS and a stroke; the age is more senior than 60 years; endarteritis; a round ulcer of a stomach and duodenum in an aggravation stage; earlier postponed disulfiramovy psychosis.

Overdose:

Symptoms: confusion of consciousness, collapse, coma, neurologic complications.
At heavy Disulfiramum - alcoholic reaction lasting 1,5 hours (the shown severe headache with feeling of a raspiraniye and pulsation, sharp difficulty of breath, a considerable lowering of arterial pressure, psychomotor excitement, spasms, confusion of consciousness) 15–20 ml of 1% of aqueous solution methylene blue, subcutaneously – Nikethamidum or camphor, intramusculary – Cytitonum or lobeline enter intravenously, carry out an oxygenotherapy.
At the expressed nausea and vomiting enter intravenously 10 ml of 10% of solution of Calcii chloridum or calcium of a gluconate, inside – the drugs containing belladonna extract subcutaneously enter Atropini sulfas.
At sharp oppression of cordial activity intravenously enter strophanthin, when developing spasms intramusculary enter 10 ml of 25% of solution of magnesium of sulfate, benzodiazepines, at psychomotor excitement – Chlorpromazinum.
The patient has to be in horizontal position.
The polyneuritis which arose at use of Disulfiramum passes at purpose of vitamins of group B.

Storage conditions:

To store in dry, protected from light and the place, unavailable to children, at a temperature not over 25 ºС.

Period of validity - 4 years.

Issue conditions:

According to the recipe

Packaging:

On 10 tablets in the blister, on 1 or 5 blisters in a pack. On 10 tablets in planimetric bezjyacheykovy packaging.