Antabuse

Brand name:Antabuse
Generic name: disulfiram

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DESCRIPTION

Antabuse produces a sensitivity to alcohol which results in a highly unpleasant reaction when the patient under treatment ingests even small amounts of alcohol .

Antabuse blocks the oxidation of alcohol at the acetaldehyde stage . During alcohol metabolism following Antabuse intake, the concentration of acetaldehyde occurring in the blood may be 5- to 10-times higher than that found during metabolism of the same amount of alcohol alone.

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

Antabuse 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 .

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

Antabuse 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.

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

It is suggested that every patient under treatment carry an Identification Card , stating that he is receiving Antabuse and describing the symptoms most likely to occur as a result of the Antabuse- alcohol reaction . In addition, this card should indicate the physician or institution to be contacted in an emergency . (Cards may be obtained from Wyeth-Ayerst Laboratories upon request.)

Alcoholism may accompany or be followed by dependence on narcotics or sedatives. Barbiturates and Antabuse 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 .

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

Patients taking Antabuse 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.

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DOSAGE AND ADMINISTRATION
Antabuse 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, Antabuse 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 Antabuse, 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 Antabuse Tablets (preferably crushed and well mixed with liquid), it cannot be concluded that Antabuse is ineffective.

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Duration of Therapy
The daily, uninterrupted administration of Antabuse 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 Antabuse, 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 (1/2 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.

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Management Of Antabuse-Alcohol Reaction
In severe reactions, whether caused by an excessive test dose or by the patient ' 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.