Teturam - instructions for use, dose, side effects, contraindications

Auxiliary substances: potato starch, colloidal silicon dioxide (aerosil), povidone (polyvinylpyrrolidone low molecular weight medical), stearic acid, croscarmellose sodium (impellosis).

Description:Tablets are white or white with a slightly yellowish-greenish tint of color, flat-cylindrical with a bevel.

Pharmacotherapeutic group:An agent for the treatment of alcoholism

ATX: & nbsp

N.07.B.01.01 Disulfiram

Pharmacodynamics:

Inhibits acetaldehydecehydrogenase involved in the metabolism of ethanol; increases the concentration of acetaldehyde, which is a metabolite of ethanol and causes a number of unpleasant sensations after its use ("flushing" of blood to the skin of the face, nausea, vomiting, a feeling of malaise, tachycardia, lowering blood pressure). As a result, a conditioned reflex reaction of aversion to taste and the smell of ethanol occurs.

The maximum therapeutic effect is achieved 12 hours after oral administration and can last for 10-14 days after discontinuation of treatment.

Pharmacokinetics:After oral administration, absorption of disulfiram from the gastrointestinal tract is from 70 to 90%. It is rapidly metabolized, recovering to dithiocarbamate, which itself is excreted as a glucuronconjugate or converted to diethylamine and carbon sulphide, some of which (4-53%) is excreted through the lungs.

Indications:

Treatment and prevention of recurrences of chronic alcoholism.

In addition, the drug is used as a detoxification agent for chronic nickel poisoning.

Contraindications:Absolute: Hypersensitivity, thyrotoxicosis, diseases of the cardiovascular system in the stage of decompensation (including pronounced cardiosclerosis, atherosclerosis of cerebral vessels, pre-and postinfarction states, aortic aneurysm, coronary insufficiency, arterial hypertension II-III, chronic heart failure) , pulmonary tuberculosis with hemoptysis, bronchial asthma, chronic obstructive pulmonary disease, severe emphysema,erosive lesions of the mucous membrane of the gastrointestinal tract, gastric ulcer and duodenal ulcer (at the stage of exacerbation), bleeding from the gastrointestinal tract, kidney disease, liver failure, diabetes mellitus, epilepsy, neuropsychiatric diseases, infectious diseases of the central nervous system, poly neuropathy, neuritis of the auditory and optic nerves, glaucoma, malignant tumors, pregnancy, lactation.

Relative: cardiovascular diseases in the compensation stage, elderly age (over 60 years), gastric and duodenal ulcer in remission, residual effects after cerebral circulation, endarteritis, previously transferred teturam (antabuse) psychoses.

Dosing and Administration:Treatment is appointed after careful examination of the patient and warning of the consequences and complications. The drug is taken orally 150-500 mg 2 times a day, according to an individual scheme. After 7-10 days, a teturamalk alcohol test is performed (20-30 ml of 40% ethanol (vodka) after taking 500 mg of the drug), with a weak reaction, the dose of alcohol is increased by 10-20 ml (the maximum dose of vodka is 100-120 ml).The sample is repeated after 1-2 days in the hospital and 3-5 days later in an outpatient setting, with the correction of the doses of alcohol and / or the drug as needed. In the future, you can use a maintenance dose of 150-200 mg per day for 1-3 years.

Side effects:

Conditioned by the properties of disulfiram:

- Metallic taste in mouth

- Unpleasant odor in patients with colostomy (associated with carbon sulphide).

- Rare cases of hepatitis, sometimes found in patients with nickel eczema, not suffering from alcoholism.

- Polyneuritis of the lower extremities, optic neuritis,

- Decreased memory, confusion, asthenia.

- Headache.

- Skin allergic manifestations.

Coupled with the combination of disulfiram-ethyl alcohol:

Cases of respiratory failure, collapse, cardiac rhythm disturbances or acute angina, sometimes myocardial infarction, hemorrhagic stroke, as well as neurologic disorders, cerebral edema are described.

Complications with long-term use: psychoses, reminiscent of alcohol, hepatitis, gastritis; in people suffering from cardiovascular diseases, there is a possible thrombosis of the brain vessels, so when complaints about paresthesia in the limbs and face should immediately cancel the drug; aggravation of polyneuritis.

At reception of doses of alcohol over 50-80 ml (in recalculation on 40% ethanol) on the background of taking Teturam severe disorders of the cardiovascular and respiratory systems, swelling, convulsions develop. In this case, urgently carry out detoxification therapy, inject analeptics, perform symptomatic treatment.

Overdose:Oppression of consciousness up to coma, cardiovascular collapse, neurological, complications. Treatment is symptomatic.

Interaction:

Contraindicated combinations:

-Alcohol. The reaction of intolerance ("hot flashes" of blood, erythema, vomiting, tachycardia). Avoid taking alcoholic beverages and medicines containing alcohol.

Unwanted combinations:

- Isoniazid: impaired behavior and coordination.

The derivatives of 5-nitroimidazole (metronidazole, ornidazole, secnidazole, tinidazole): delirious disorders, confusion.

- Phenytoin: a significant and rapid rise in the concentration of phenytoin in the blood plasma with toxic symptoms (suppression of its metabolism).

If the combination can not be avoided, clinical monitoring and control of plasma concentrations in the plasma should be performed during and after disulfiram treatment.

Combinations requiring caution:

- Warfarin (and other oral anticoagulants): increased effect of oral anticoagulants and the risk of bleeding (reduced metabolism of warfarin in the liver). It is recommended more frequent monitoring of the concentration of warfarin and correction of the dose of anticoagulants within 8 days after the disulfiram cancellation.

- Theophylline: disulfiram inhibits theophylline metabolism. As a result, the dose of theophylline should be adjusted (reduced dosage), depending on the clinical symptoms and the concentration of the drug in the plasma.

- Benzodiazepines: disulfiram can enhance the sedative effect of benzodiazepines by inhibiting their oxidative metabolism (especially chlordiazepoxide and diazepam). The dosage of benzodiazepine should be adjusted in accordance with clinical manifestations.

Tricyclic antidepressants: an increase in the reaction of alcohol intolerance.

Form release / dosage:

Tablets 150 mg.

Packaging:

10 or 15 tablets in a planar cell package.

3 or 5 contour packs of 10 tablets or 2 contour packs of 15 tablets together with instructions for use in a pack of cardboard.

Storage conditions:

Store at a temperature not exceeding 25 ° C.Keep out of the reach of children.

Shelf life:4 years. Do not use after the expiry date printed on the package.

Terms of leave from pharmacies:On prescription

Registration number:P N002629 / 01

Date of registration:26.05.2009

The owner of the registration certificate:PHARMSTANDART-FORESTRY, OJSC PHARMSTANDART-FORESTRY, OJSC Russia

Manufacturer: & nbsp

PHARMSTANDART-FORESTRY, OJSC Russia

Information update date: & nbsp24.04.2016

Illustrated instructions

Instructions

Teturam (Teturam)