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Disulfiram
Overview
What is Disulfiram?
Disulfiram is an alcohol antagonist drug.
CHEMICAL NAME:
bis(diethylthiocarbamoyl) disulfide.
STRUCTURAL FORMULA:
Disulfiram occurs as a white to off-white, odorless, and almost tasteless powder, soluble in water to the extent of about 20 mg in 100 mL, and in alcohol to the extent of about 3.8 g in 100 mL.
Each tablet for oral administration contains 250 mg disulfiram, USP. Tablets also contain colloidal silicon dioxide, anhydrous lactose, magnesium stearate, microcrystalline cellulose, sodium starch glycolate, and stearic acid.
What does Disulfiram look like?
What are the available doses of Disulfiram?
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What should I talk to my health care provider before I take Disulfiram?
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How should I use Disulfiram?
Disulfiram is an aid in the management of selected chronic alcohol patients who 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.
Disulfiram should never be administered until the patient has abstained from alcohol for at least 12 hours.
Initial Dosage Schedule:
maximum
Maintenance Regimen:
Note:
Duration of Therapy:
Trial with Alcohol:
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.
Management of Disulfiram-Alcohol Reaction:
What interacts with Disulfiram?
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What are the warnings of Disulfiram?
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What are the precautions of Disulfiram?
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What are the side effects of Disulfiram?
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What should I look out for while using Disulfiram?
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 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.
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:
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:
What might happen if I take too much Disulfiram?
No specific information is available on the treatment of overdosage with disulfiram. It is recommended that the physician contact the local Poison Control Center.
How should I store and handle Disulfiram?
Care should be exercised in the handling of REVLIMID. REVLIMID capsules should not be opened or broken. If powder from REVLIMID contacts the skin, wash the skin immediately and thoroughly with soap and water. If REVLIMID contacts the mucous membranes, flush thoroughly with water.Procedures for the proper handling and disposal of anticancer drugs should be considered. Several guidelines on the subject have been published. Dispense no more than a 28-day supply.Care should be exercised in the handling of REVLIMID. REVLIMID capsules should not be opened or broken. If powder from REVLIMID contacts the skin, wash the skin immediately and thoroughly with soap and water. If REVLIMID contacts the mucous membranes, flush thoroughly with water.Procedures for the proper handling and disposal of anticancer drugs should be considered. Several guidelines on the subject have been published. Dispense no more than a 28-day supply.Care should be exercised in the handling of REVLIMID. REVLIMID capsules should not be opened or broken. If powder from REVLIMID contacts the skin, wash the skin immediately and thoroughly with soap and water. If REVLIMID contacts the mucous membranes, flush thoroughly with water.Procedures for the proper handling and disposal of anticancer drugs should be considered. Several guidelines on the subject have been published. Dispense no more than a 28-day supply.Disulfiram Tablets, USP are white, round, unscored tablets debossed 607.Bottle of 100 NDC 47781-607-01Bottle of 30 NDC 47781-607-30Dispense in a tight, light-resistant container as defined in the USP.Store at 20°-25°C (68°-77°F). [See USP Controlled Room Temperature].Manufactured by: Norwich, NY 13815 USADistributed by: Pine Brook, NJ 07058 USAPI607-01-01Rev. 04/2013PKG01653Disulfiram Tablets, USP are white, round, unscored tablets debossed 607.Bottle of 100 NDC 47781-607-01Bottle of 30 NDC 47781-607-30Dispense in a tight, light-resistant container as defined in the USP.Store at 20°-25°C (68°-77°F). [See USP Controlled Room Temperature].Manufactured by: Norwich, NY 13815 USADistributed by: Pine Brook, NJ 07058 USAPI607-01-01Rev. 04/2013PKG01653Disulfiram Tablets, USP are white, round, unscored tablets debossed 607.Bottle of 100 NDC 47781-607-01Bottle of 30 NDC 47781-607-30Dispense in a tight, light-resistant container as defined in the USP.Store at 20°-25°C (68°-77°F). [See USP Controlled Room Temperature].Manufactured by: Norwich, NY 13815 USADistributed by: Pine Brook, NJ 07058 USAPI607-01-01Rev. 04/2013PKG01653Disulfiram Tablets, USP are white, round, unscored tablets debossed 607.Bottle of 100 NDC 47781-607-01Bottle of 30 NDC 47781-607-30Dispense in a tight, light-resistant container as defined in the USP.Store at 20°-25°C (68°-77°F). [See USP Controlled Room Temperature].Manufactured by: Norwich, NY 13815 USADistributed by: Pine Brook, NJ 07058 USAPI607-01-01Rev. 04/2013PKG01653Disulfiram Tablets, USP are white, round, unscored tablets debossed 607.Bottle of 100 NDC 47781-607-01Bottle of 30 NDC 47781-607-30Dispense in a tight, light-resistant container as defined in the USP.Store at 20°-25°C (68°-77°F). [See USP Controlled Room Temperature].Manufactured by: Norwich, NY 13815 USADistributed by: Pine Brook, NJ 07058 USAPI607-01-01Rev. 04/2013PKG01653Disulfiram Tablets, USP are white, round, unscored tablets debossed 607.Bottle of 100 NDC 47781-607-01Bottle of 30 NDC 47781-607-30Dispense in a tight, light-resistant container as defined in the USP.Store at 20°-25°C (68°-77°F). [See USP Controlled Room Temperature].Manufactured by: Norwich, NY 13815 USADistributed by: Pine Brook, NJ 07058 USAPI607-01-01Rev. 04/2013PKG01653Disulfiram Tablets, USP are white, round, unscored tablets debossed 607.Bottle of 100 NDC 47781-607-01Bottle of 30 NDC 47781-607-30Dispense in a tight, light-resistant container as defined in the USP.Store at 20°-25°C (68°-77°F). [See USP Controlled Room Temperature].Manufactured by: Norwich, NY 13815 USADistributed by: Pine Brook, NJ 07058 USAPI607-01-01Rev. 04/2013PKG01653Disulfiram Tablets, USP are white, round, unscored tablets debossed 607.Bottle of 100 NDC 47781-607-01Bottle of 30 NDC 47781-607-30Dispense in a tight, light-resistant container as defined in the USP.Store at 20°-25°C (68°-77°F). [See USP Controlled Room Temperature].Manufactured by: Norwich, NY 13815 USADistributed by: Pine Brook, NJ 07058 USAPI607-01-01Rev. 04/2013PKG01653Disulfiram Tablets, USP are white, round, unscored tablets debossed 607.Bottle of 100 NDC 47781-607-01Bottle of 30 NDC 47781-607-30Dispense in a tight, light-resistant container as defined in the USP.Store at 20°-25°C (68°-77°F). [See USP Controlled Room Temperature].Manufactured by: Norwich, NY 13815 USADistributed by: Pine Brook, NJ 07058 USAPI607-01-01Rev. 04/2013PKG01653Disulfiram Tablets, USP are white, round, unscored tablets debossed 607.Bottle of 100 NDC 47781-607-01Bottle of 30 NDC 47781-607-30Dispense in a tight, light-resistant container as defined in the USP.Store at 20°-25°C (68°-77°F). [See USP Controlled Room Temperature].Manufactured by: Norwich, NY 13815 USADistributed by: Pine Brook, NJ 07058 USAPI607-01-01Rev. 04/2013PKG01653
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Disulfiram produces a sensitivity to alcohol which results in a highly unpleasant reaction when the patient under treatment ingests even small amounts of alcohol.
Disulfiram blocks the oxidation of alcohol at the acetaldehyde stage. During alcohol metabolism following disulfiram 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.
Accumulation of acetaldehyde in the blood produces a complex of highly unpleasant symptoms referred to hereinafter as the disulfiram-alcohol reaction. This reaction, which is proportional to the dosage of both disulfiram and alcohol, will persist as long as alcohol is being metabolized. Disulfiram does not appear to influence the rate of alcohol elimination from the body.
Disulfiram is absorbed slowly from the gastrointestinal tract and is eliminated slowly from the body. One (or even two) weeks after a patient has taken his last dose of disulfiram, ingestion of alcohol may produce unpleasant symptoms.
Prolonged administration of disulfiram does not produce tolerance; the longer a patient remains on therapy, the more exquisitely sensitive he becomes to alcohol.
Non-Clinical Toxicology
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 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.
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:
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:
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.
Patients with a history of rubber contact dermatitis should be evaluated for hypersensitivity to thiuram derivatives before receiving disulfiram (see ).
It is suggested that every patient under treatment carry an stating that he is receiving disulfiram and describing the symptoms most likely to occur as a result of the disulfiram-alcohol reaction. In addition, this card should indicate the physician or institution to be contacted in an emergency. (Cards may be obtained from Alvogen, Inc. upon request.)
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.
(See , , and .)
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.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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