pharmacopeia

Mechanism of action

Sourced from openFDA

Mechanism-of-action class: Acetyl Aldehyde Dehydrogenase Inhibitors.

Acetyl Aldehyde Dehydrogenase

Indications

Sourced from openFDA
  • 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.

Contraindications

Sourced from openFDA
  • 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.contraindicated

Dosage & administration

Sourced from openFDA

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.

Warnings & precautions

Sourced from openFDA

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.

Adverse reactions

Sourced from openFDA

(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.

Overdosage

Sourced from openFDA

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

Approval history

Sourced from openFDA
  • Mar 28, 2011ANDAANDA091619Sigmapharm Labs Llc
  • Dec 31, 2012ANDAANDA091563Chartwell Molecules
  • Aug 8, 2013ANDAANDA091681Alvogen

FAERS reports

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Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
1,104 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Off Label Use12411%
  2. 2Drug Interaction12111%
  3. 3Fatigue837.5%
  4. 4Drug Ineffective655.9%
  5. 5Toxicity To Various Agents645.8%
  6. 6Nausea504.5%
  7. 7Confusional State474.3%
  8. 8Psychiatric Symptom444.0%
  9. 9Drug Abuse433.9%
  10. 10Overdose433.9%
  11. 11Anxiety403.6%
  12. 12Drug-induced Liver Injury403.6%
  13. 13Condition Aggravated363.3%
  14. 14Somnolence363.3%
  15. 15Toxic Encephalopathy363.3%

Literature

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Recent PubMed references pinned to Disulfiram as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Clinical trials

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The 10 most recently updated of 64 ClinicalTrials.gov registrations naming Disulfiram as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Frequently asked questions

How does Disulfiram work?
Mechanism-of-action class: Acetyl Aldehyde Dehydrogenase Inhibitors.
What is Disulfiram used for?
According to FDA labeling, Disulfiram carries indications including: 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.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Disulfiram?
Disulfiram is classified as Drugs used in alcohol dependence, Sulfur containing products, Aldehyde Dehydrogenase Inhibitor, Acetyl Aldehyde Dehydrogenase Inhibitors, Emesis, Positive Chronotropy.
What are the brand names for Disulfiram?
Disulfiram is marketed under brand names including Antabuse.
What are the contraindications for Disulfiram?
Disulfiram labeling lists contraindications including: 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.. Always consult the full prescribing information and a clinician.
Note. Data for disulfiram is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

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