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Antabus

Antabus contains disulfiram, a medication classified as an antialcoholic agent and grouped among other nervous system drugs. It is registered in 14 countries, used as part of structured treatment programmes for alcohol dependence rather than as a standalone over-the-counter remedy. The brand has a long-established presence in European pharmacies and a smaller footprint in Latin America and parts of Eurasia.

Disulfiram-based therapy is prescribed in the context of managing alcohol use disorder, typically alongside counselling, psychosocial support, and medical follow-up. The structured indication block further down this page lists the registered uses for Antabus in each market where it is sold; the intent is to support a wider treatment plan agreed with a clinician, not to function as a self-administered intervention.

The 14 countries where Antabus is registered include Sweden, Spain, the Czech Republic, Chile, Russia, Iceland, and Turkey — a distribution skewed toward European markets with addiction-medicine traditions that have used disulfiram for decades, alongside several Latin American and Eurasian countries. Travellers and expatriates carrying an Antabus prescription from one of these markets may or may not find the same brand abroad: in some countries disulfiram is dispensed under a different commercial name, and in others it is not registered at all.

The active ingredient itself circulates internationally under various brand names, and a local pharmacist or addiction-medicine specialist is the right person to identify what is available in a given country. Because disulfiram-based treatment is closely tied to a broader clinical plan, any decision about starting, continuing, pausing, or switching this medication needs to be taken with a healthcare provider who knows the patient's full history.

Countries
Austria Chile Czech Republic Denmark Ecuador Iceland Netherlands Norway Russia Slovenia Spain Sweden Switzerland Turkey
Diseases
Alcoholism
Ingredients
Disulfiram
Drug Actions
Antialcoholic Other nervous system drugs

Drugs with the same active ingredients

Disulfix Antabuse Antietanol Sarcoton Disulfiram Chronol Ulfiram Esperal Lidevine Teturam Teturam tablets антабус дисульфирам лидевин сульфалонг тетурам тетурама таблетки эспераль Antalcol Tetradin

Overdose

No specific information is available on the treatment of overdosage with disulfiram. It is recommended that the physician contact the local Poison Control Center.

Contraindications

Patients who are receiving or have recently received metronidazole, paraldehyde, alcohol, or alcoholcontaining preparations, e.g., cough syrups, tonics and the like, should not be given disulfiram.

Disulfiram is contraindicated in the presence of severe myocardial disease or coronary occlusion, psychoses, and hypersensitivity to disulfiram or to other thiuram derivatives used in pesticides and rubber vulcanization.

Undesirable effects

(See CONTRAINDICATIONS, WARNINGS, and PRECAUTIONS.)

OPTIC NEURITIS, PERIPHERAL NEURITIS, POLYNEURITIS, AND PERIPHERAL NEUROPATHY MAY OCCUR FOLLOWING ADMINISTRATION OF DISULFIRAM.

Multiple cases of hepatitis, including both cholestatic and fulminant hepatitis, as well as hepatic failure resulting in transplantation or death, have been reported with administration of disulfiram.

Occasional skin eruptions are, as a rule, readily controlled by concomitant administration of an antihistaminic drug.

In a small number of patients, a transient mild drowsiness, fatigability, impotence, headache, acneform eruptions, allergic dermatitis, or a metallic or garlic-like aftertaste may be experienced during the first two weeks of therapy. These complaints usually disappear spontaneously with the continuation of therapy, or with reduced dosage.

Psychotic reactions have been noted, attributable in most cases to high dosage, combined toxicity (with metronidazole or isoniazid), or to the unmasking of underlying psychoses in patients stressed by the withdrawal of alcohol.

Therapeutic indications

Disulfiram is an aid in the management of selected chronic alcohol patients who want to remain in a state of enforced sobriety so that supportive and psychotherapeutic treatment may be applied to best advantage.

Disulfiram is not a cure for alcoholism. When used alone, without proper motivation and supportive therapy, it is unlikely that it will have any substantive effect on the drinking pattern of the chronic alcoholic.

Date of revision of the text

2012

Name of the medicinal product

Antabuse

Qualitative and quantitative composition

Disulfiram Tablets USP

250 mg - White, round, unscored tablets, Debossed: OP 706

Bottles of NDC 54868-10 5034-2
Bottles of 30 NDC 54868-5034-1
Bottles of 100 NDC 54868-5034-0

Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).

Store at 20° to 25°C (68° to 77°F).

KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

Mfg. by PLIVA Krakow Pharmaceutical Company S.A., Krakow, Poland for Duramed Pharmaceuticals, Inc., Subsidiary of Barr Pharmaceuticals, L.L.C., Pomona, New York 10970. Revised: 2012

Special warnings and precautions for use

WARNINGS

Disulfiram should never be administered to a patient when he is in a state of alcohol intoxication, or without his full knowledge.

The physician should instruct relatives accordingly.

The patient must be fully informed of the disulfiram-alcohol reaction. He must be strongly cautioned against surreptitious drinking while taking the drug, and he must be fully aware of the possible consequences. He should be warned to avoid alcohol in disguised forms, i.e., in sauces, vinegars, cough mixtures, and even in aftershave lotions and back rubs. He should also be warned that reactions may occur with alcohol up to 14 days after ingesting disulfiram.

The Disulfiram-Alcohol Reaction

Disulfiram plus alcohol, even small amounts, produce flushing, throbbing in head and neck, throbbing headache, respiratory difficulty, nausea, copious vomiting, sweating, thirst, chest pain, palpitation, dyspnea, hyperventilation, tachycardia, hypotension, syncope, marked uneasiness, weakness, vertigo, blurred vision, and confusion. In severe reactions there may be respiratory depression, cardiovascular collapse, arrhythmias, myocardial infarction, acute congestive heart failure, unconsciousness, convulsions, and death.

The intensity of the reaction varies with each individual, but is generally proportional to the amounts of disulfiram and alcohol ingested. Mild reactions may occur in the sensitive individual when the blood alcohol concentration is increased to as little as 5 to 10 mg per 100 mL. Symptoms are fully developed at 50 mg per 100 mL, and unconsciousness usually results when the blood alcohol level reaches 125 to 150 mg.

The duration of the reaction varies from 30 to 60 minutes, to several hours in the more severe cases, or as long as there is alcohol in the blood.

Concomitant Conditions

Because of the possibility of an accidental disulfiram-alcohol reaction, disulfiram should be used with extreme caution in patients with any of the following conditions: diabetes mellitus, hypothyroidism, epilepsy, cerebral damage, chronic and acute nephritis, hepatic cirrhosis or insufficiency.

PRECAUTIONS

Patients with a history of rubber contact dermatitis should be evaluated for hypersensitivity to thiuram derivatives before receiving disulfiram (see CONTRAINDICATIONS).

Alcoholism may accompany or be followed by dependence on narcotics or sedatives. Barbiturates and disulfiram have been administered concurrently without untoward effects; the possibility of initiating a new abuse should be considered.

Hepatic toxicity including hepatic failure resulting in transplantation or death have been reported. Severe and sometimes fatal hepatitis associated with disulfiram therapy may develop even after many months of therapy. Hepatic toxicity has occurred in patients with or without prior history of abnormal liver function. Patients should be advised to immediately notify their physician of any early symptoms of hepatitis, such as fatigue, weakness, malaise, anorexia, nausea, vomiting, jaundice, or dark urine.

Baseline and follow-up liver function tests (10-14 days) are suggested to detect any hepatic dysfunction that may result with disulfiram therapy. In addition, a complete blood count and serum chemistries, including liver function tests, should be monitored.

Patients taking disulfiram tablets should not be exposed to ethylene dibromide or its vapors. This precaution is based on preliminary results of animal research currently in progress that suggest a toxic interaction between inhaled ethylene dibromide and ingested disulfiram resulting in a higher incidence of tumors and mortality in rats. A correlation between this finding and humans, however, has not been demonstrated.

Usage In Pregnancy

The safe use of this drug in pregnancy has not been established. Therefore, disulfiram should be used during pregnancy only when, in the judgement of the physician, the probable benefits outweigh the possible risks.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

Nursing Mothers

It is not known whether this drug is excreted in human milk. Since many drugs are so excreted, disulfiram should not be given to nursing mothers.

Geriatric Use

A determination has not been made whether controlled clinical studies of disulfiram included sufficient numbers of subjects aged 65 and over to define a difference in response from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy.

Dosage (Posology) and method of administration

Disulfiram should never be administered until the patient has abstained from alcohol for at least 12 hours.

Initial Dosage Schedule

In the first phase of treatment, a maximum of 500 mg daily is given in a single dose for one to two weeks. Although usually taken in the morning, disulfiram may be taken on retiring by patients who experience a sedative effect. Alternatively, to minimize, or eliminate, the sedative effect, dosage may be adjusted downward.

Maintenance Regimen

The average maintenance dose is 250 mg daily (range, 125 to 500 mg), it should not exceed 500 mg daily.

Note: Occasionally patients, while seemingly on adequate maintenance doses of disulfiram, report that they are able to drink alcoholic beverages with impunity and without any symptomatology. All appearances to the contrary, such patients must be presumed to be disposing of their tablets in some manner without actually taking them. Until such patients have been observed reliably taking their daily disulfiram tablets (preferably crushed and well mixed with liquid), it cannot be concluded that disulfiram is ineffective.

Duration Of Therapy

The daily, uninterrupted administration of disulfiram must be continued until the patient is fully recovered socially and a basis for permanent self-control is established. Depending on the individual patient, maintenance therapy may be required for months or even years.

Trial With Alcohol

During early experience with disulfiram, it was thought advisable for each patient to have at least one supervised alcohol-drug reaction. More recently, the test reaction has been largely abandoned. Furthermore, such a test reaction should never be administered to a patient over 50 years of age. A clear, detailed and convincing description of the reaction is felt to be sufficient in most cases.

However, where a test reaction is deemed necessary, the suggested procedure is as follows:

After the first one to two weeks' therapy with 500 mg daily, a drink of 15 mL (½ oz) of 100 proof whiskey, or equivalent, is taken slowly. This test dose of alcoholic beverage may be repeated once only, so that the total dose does not exceed 30 mL (1 oz) of whiskey. Once a reaction develops, no more alcohol should be consumed. Such tests should be carried out only when the patient is hospitalized, or comparable supervision and facilities, including oxygen, are available.

Management Of Disulfiram-Alcohol Reaction

In severe reactions, whether caused by an excessive test dose or by the patient's unsupervised ingestion of alcohol, supportive measures to restore blood pressure and treat shock should be instituted. Other recommendations include: oxygen, carbogen (95% oxygen and 5% carbon dioxide), vitamin C intravenously in massive doses (1 g) and ephedrine sulfate. Antihistamines have also been used intravenously. Potassium levels should be monitored, particularly in patients on digitalis, since hypokalemia has been reported.

Interaction with other medicinal products and other forms of interaction

SIDE EFFECTS

(See CONTRAINDICATIONS, WARNINGS, and PRECAUTIONS.)

OPTIC NEURITIS, PERIPHERAL NEURITIS, POLYNEURITIS, AND PERIPHERAL NEUROPATHY MAY OCCUR FOLLOWING ADMINISTRATION OF DISULFIRAM.

Multiple cases of hepatitis, including both cholestatic and fulminant hepatitis, as well as hepatic failure resulting in transplantation or death, have been reported with administration of disulfiram.

Occasional skin eruptions are, as a rule, readily controlled by concomitant administration of an antihistaminic drug.

In a small number of patients, a transient mild drowsiness, fatigability, impotence, headache, acneform eruptions, allergic dermatitis, or a metallic or garlic-like aftertaste may be experienced during the first two weeks of therapy. These complaints usually disappear spontaneously with the continuation of therapy, or with reduced dosage.

Psychotic reactions have been noted, attributable in most cases to high dosage, combined toxicity (with metronidazole or isoniazid), or to the unmasking of underlying psychoses in patients stressed by the withdrawal of alcohol.

DRUG INTERACTIONS

Disulfiram appears to decrease the rate at which certain drugs are metabolized and therefore may increase the blood levels and the possibility of clinical toxicity of drugs given concomitantly.

DISULFIRAM SHOULD BE USED WITH CAUTION IN THOSE PATIENTS RECEIVING PHENYTOIN AND ITS CONGENERS, SINCE THE CONCOMITANT ADMINISTRATION OF THESE TWO DRUGS CAN LEAD TO PHENYTOIN INTOXICATION. PRIOR TO ADMINISTERING DISULFIRAM TO A PATIENT ON PHENYTOIN THERAPY, A BASELINE PHENYTOIN SERUM LEVEL SHOULD BE OBTAINED. SUBSEQUENT TO INITIATION OF DISULFIRAM THERAPY, SERUM LEVELS OF PHENYTOIN SHOULD BE DETERMINED ON DIFFERENT DAYS FOR EVIDENCE OF AN INCREASE OR FOR A CONTINUING RISE IN LEVELS. INCREASED PHENYTOIN LEVELS SHOULD BE TREATED WITH APPROPRIATE DOSAGE ADJUSTMENT.

It may be necessary to adjust the dosage of oral anticoagulants upon beginning or stopping disulfiram, since disulfiram may prolong prothrombin time.

Patients taking isoniazid when disulfiram is given should be observed for the appearance of unsteady gait or marked changes in mental status, the disulfiram should be discontinued if such signs appear.

In rats, simultaneous ingestion of disulfiram and nitrite in the diet for 78 weeks has been reported to cause tumors, and it has been suggested that disulfiram may react with nitrites in the rat stomach to form a nitrosamine, which is tumorigenic. Disulfiram alone in the rat's diet did not lead to such tumors. The relevance of this finding to humans is not known at this time.

Frequently asked questions

What conditions does Antabus treat?

Antabus is prescribed in the management of alcohol dependence, as part of a broader treatment programme that typically includes psychosocial support and medical follow-up. It is classified pharmacologically as an antialcoholic agent and falls within the wider category of medications acting on the nervous system. The structured indication block further down this page lists the registered uses recognised by national regulators in the markets where Antabus is sold.

Which active substance is in Antabus?

Antabus contains disulfiram, classified as an antialcoholic medication and grouped among other nervous system drugs. Disulfiram is the same molecule whether sold as Antabus or under other commercial names; internationally, the active ingredient circulates under several brand names depending on the country and the manufacturer holding marketing authorisation in that market.

In how many countries is Antabus available?

Antabus is registered in 14 countries, with a footprint that leans toward Europe but also reaches into Latin America and parts of Eurasia. Representative markets include Sweden, Spain, Chile, Russia, Iceland, the Netherlands, and Turkey. If your country is not on this list, a local pharmacist can usually confirm whether disulfiram is available under a different brand name or as a generic preparation locally.

Are there other medications with the same active ingredient as Antabus?

Disulfiram is sold under several brand names worldwide, and other medications used in the management of alcohol dependence exist within different pharmacological approaches, although they are not interchangeable without medical guidance. Treatment of alcohol dependence is highly individualised and depends on the patient's history and the broader care plan. To identify a local disulfiram-containing product, search the active ingredient on Pill2Trip or ask a pharmacist.

Should I consult a doctor before taking Antabus?

Yes. Antabus is a prescription medication, and disulfiram-based therapy is initiated and monitored within a structured treatment programme rather than started independently. Prescription requirements, available brand names, and the supporting clinical infrastructure vary considerably between countries, which matters for travellers and people relocating. Any decision to start, stop, switch, or substitute disulfiram should be made together with a healthcare provider familiar with the patient's history.

Antabus

Available in 14 countries