Teturam (Teturam)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceDisulfiramDisulfiram
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    • Dosage form: & nbspPills.
    Composition:
    One tablet contains:

    Active substance: disulfiram - 150 mg.

    Auxiliary substances: potato starch - 2.70 mg, microcrystalline cellulose - 23.80 mg, silicon colloidal dioxide - 0.85 mg, croscarmellose sodium - 0.85 mg, stearic acid 0.36 mg, magnesium stearate - 1.44 mg.
    Description:Round, flat-cylindrical tablets white or white with a slightly yellowish-greenish hue, with a bevel.
    Pharmacotherapeutic group:An agent for the treatment of alcoholism
    ATX: & nbsp

    N.07.B.01.01   Disulfiram

    Pharmacodynamics:
    Disulfiram inhibits the enzyme acetaldehyde dehydrogenase involved in the metabolism of ethanol, which leads to an increase in the concentration of acetaldehyde, which is a metabolite of ethanol, 5-10 times. Acetaldehyde causes a number of unpleasant sensations: "tides" of blood to the skin of the face, nausea, vomiting, a feeling of malaise, tachycardia, lowering of blood pressure.As a result, a conditioned reflex reaction of aversion to taste and the smell of alcoholic beverages develops. The strength of the reactions caused by the drug is proportional to the dose taken.

    The maximum therapeutic effect is achieved 12 hours after oral administration and can last for 10-14 days after discontinuation of treatment. The longer the course of therapy, the more pronounced the effects of the drug.
    Pharmacokinetics:Absorption after oral administration is 70-90%. Rapidly metabolized in the liver by reduction to diethyl dithiocarbamate, released as glucuronide by the kidneys, or transformed into diethylamine and carbon disulfide, the proportion of which varies from 4 to 53%. The latter is secreted through the lungs. The minimum content of disulfiram in the blood is about 20 ng / ml.
    Indications:Disulfiram It is used as an auxiliary therapy of chronic alcoholism in patients undergoing treatment for alcohol dependence who intend to be in a state of abstinence from alcohol in order to achieve the best effect of supporting and psychotherapy. Disulfiram does not cure alcoholism.When used as monotherapy, without adequate motivation and maintenance treatment has no significant effect on the behavior of the alcoholic patients with chronic alcoholism.
    Contraindications:
    Hypersensitivity, thyrotoxicosis, cardio - vascular system (including pronounced kardiosklerosis, atherosclerosis of cerebral vessels, severe myocardial pre- and postinfarction state, aortic aneurysm, coronary vascular occlusion, arterial hypertension stage II-III and other diseases cardio - vascular system in the stage of decompensation), chronic obstructive pulmonary disease, pulmonary tuberculosis with hemoptysis, bronchial asthma, severe emphysema, erosive lesions of the gastrointestinal mucosa - ishechnogo tract, gastric ulcer and duodenal ulcers (acute phase), bleeding from the gastro - intestinal tract, kidney disease, liver failure, diabetes, epilepsy, infections of the central nervous system diseases, neuropathy, neuritis auditory and optic nerve, glaucoma, malignant tumors, pregnancy, lactation.In some cases, with prolonged admission of teturam, acute psychosis may occur, reminiscent of acute alcoholic paranoid, acute alcoholic hallucinosis or alcoholic delirium. The transition of the hallucinatory syndrome into a paranoid syndrome is possible, the paranoid syndrome is transformed into a schizophrenic syndrome, and so on.

    Simultaneous (or in the recent past) administration of metronidazole, paraldehyde, ethanol or ethanol-containing drugs and products. Children under 18 years.
    Carefully:Patients over the age of 60, peptic ulcer of the stomach and duodenum (in the remission phase), endarteritis, residual phenomena of cerebral circulation, psychoses on the background of taking disulfiram in the anamnesis.
    Pregnancy and lactation:It is contraindicated to use the drug during pregnancy and during lactation.
    Dosing and Administration:

    Before the start of treatment, the duration of abstinence from drinking should be at least 12 hours. Dosage regimen at the beginning of therapy During the first 2 to 2 weeks of treatment, a single dose of disulfiram should not exceed 500 mg / day. The drug is taken in the morning on an empty stomach, before breakfast. Usually disulfiram take in the morning, but in case of a sedative effect, the drug can be administered at night. To minimize or eliminate sedation, the dose can be adjusted downward.


    Supportive therapy The average maintenance dose is 250 mg / s (range from 125 to 500 mg), the maximum daily dose is 500 mg.


    Duration of therapy Daily regular disulfiram reception should continue until the patient is fully recovered, when he can exercise self-control over alcohol use. The drug should be taken until a stable remission is achieved.

    Side effects:"Metallic" taste in the mouth, unpleasant smell (due to carbon disulfide) in patients with colostomy, hepatitis, optic neuritis, peripheral neuritis, lower extremity polyneuropathy, neuropsychiatric disorders, memory loss, disorientation in time and space, asthenic syndrome, headache , skin allergic reactions. Side effects caused by the association disulfirametanol: collapse, arrhythmia, angina pectoris, myocardial infarction, cerebral edema, cerebral hemorrhage.
    Overdose:
    Symptoms: confusion, collapse, coma, neurological complications.

    Specific treatment for an overdose of disulfiram is not present. In severe disulfiram-alcohol reaction lasting 1.5 hours, oxygen inhalation, inhalation of carbogen (95% oxygen and 5% carbon dioxide), iv administration of high doses of ascorbic acid (up to 1 g), ephedrine sulfate and antihistamines. It is necessary to monitor the concentration of potassium in the blood serum, especially if the patient is taking digitalis preparations.
    Interaction:
    Disulfiram should be administered with caution to patients taking phenytoin and its derivatives, since the simultaneous administration of drugs can lead to intoxication with phenytoin. Before prescribing disulfiram, patients receiving phenytoin, it is necessary to determine the baseline level of phenytoin in the blood serum and subsequently monitor the content of phenytoin in the blood in order to correct the dose of the drug. Disulfiram enhances the effect of indirect anticoagulants and increases the risk of bleeding. In the case of simultaneous administration with oral anticoagulants, it is necessary to carry out more frequent monitoring of prothrombin content and correction of anticoagulant doses.It is also necessary to adjust the dose of disulfiram at the beginning and after the end of the course of therapy, since disulfiram may prolong prothrombin time. Effects of disulfiram, incl. neurotoxic, enhance tricyclic antidepressants (amitriptyline), metronidazole, isoniazid. Metronidazole increases the risk of developing mental disorders, the appearance of delusions.

    With concomitant administration with isoniazid, the risk of behavioral disorders and coordination of movements increases. If these signs are detected, disulfiram should be discontinued. Disulfiram increases the concentration in the plasma of drugs metabolized in the liver, due to the inhibition of microsomal liver enzymes. Increases the toxic effects of phenazone, chlordiazepoxide and diazepam by inhibiting their metabolism. Ascorbic acid reduces the response to ethanol.
    Special instructions:
    The drug should never be taken in a state of alcohol intoxication. It is unacceptable to prescribe the drug without informing the patient. Relatives of the patient should be instructed by the doctor about the features of the drug.

    Disulfiram with extreme caution should be used with the following concomitant diseases: diabetes mellitus, hypothyroidism, epilepsy, chronic and acute nephritis, as well as in patients over the age of 65 years. Data on the hepatotoxicity of the drug, including liver failure, requiring liver transplantation or fatal, have been reported. Severe and sometimes lethal hepatitis caused by disulfiram therapy may develop many months after the drug treatment is completed. The patient should be warned about the need to tell the doctor about all early symptoms of hepatitis, such as fatigue, weakness, malaise, decreased appetite, nausea, vomiting, jaundice, the appearance of dark urine. Every 10-14 days from the start of disulfiram therapy, a patient should conduct a follow-up study of liver function parameters, including general and biochemical blood tests.

    Patients receiving disulfiram should not be exposed to ethylene dibromide and its vapors. Results of studies in rats demonstrated,that inhalational administration of ethylene dibromide with disulfiram increases the development of tumors and mortality in rats. There are no analogous data on the effect of diethyl bromide vapors on patients. Reaction of alcohol and disulfiram interaction:

    The patient should be informed of all consequences of alcohol use during disulfiram treatment. The patient should be warned about the inadmissibility of secret consumption of alcohol, as well as alcohol in the composition of food products (sauces), medicines (spir-containing drugs), perfumes. Drinking alcohol simultaneously with disulfiram, even in small amounts, causes reddening of the face, pulsation in the head and neck region, throbbing headache, difficulty breathing, nausea, profuse vomiting, sweating, thirst, chest pain, increased heart rate, shortness of breath, weakness, confusion and loss of consciousness, severe anxiety, dizziness, blurred vision. In severe cases, respiratory depression, cardiovascular insufficiency, convulsions and death may develop.

    The intensity of the reaction is individual, but, as a rule, is proportional to the amount of alcohol and disulfiram taken inside. Initial manifestations of the reaction can be noted in persons with increased sensitivity with an increase in the concentration of alcohol to only 5-10 mg in 100 ml of blood. The full development of symptoms develops at an alcohol concentration of 50 mg per 100 ml. blood. At a level of alcohol in the blood from 125 mg to 150 mg per 100 ml, loss of consciousness is noted. The reaction time varies from 30 - 60 min to several hours; in more severe cases - as long as alcohol is detected in the blood.

    Effect on the ability to drive transp. cf. and fur:The drug affects the ability to drive vehicles or work with other mechanisms.
    Form release / dosage:
    Tablets of 150 mg.
    Packaging:
    For 10 tablets in a contour mesh box made of polyvinylchloride film and aluminum foil printed lacquered.

    For 3 or 5 contour squares, together with the instructions for use, are placed in a pack of cardboard.
    Storage conditions:
    Store in a place protected from moisture and light at a temperature of no higher than 25 ° C.

    Keep out of the reach of children.
    Shelf life:
    4 years.

    Do not use the product after the date shown on the package.
    Terms of leave from pharmacies:On prescription
    Registration number:LS-000545
    Date of registration:29.06.2010/26.07.2013
    The owner of the registration certificate:AVVA RUS, OJSC AVVA RUS, OJSC Russia
    Manufacturer: & nbsp
    Information update date: & nbsp23.04.2016
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