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Uses

Alcohol Dependence

Management of alcohol dependence in selected, highly motivated patients; use in conjunction with supportive and psychotherapeutic treatment.

Not a cure for alcohol dependence; unlikely to have substantive effect when used without proper motivation and supportive therapy.

Dosage and Administration

General

• Initiate therapy in a hospital or physician’s office after a complete physical examination.
• Patient must be fully aware of therapy, thoroughly understand the disulfiram-alcohol reaction, and be supervised by regular office visits and psychotherapy.

Disulfiram-Alcohol Test Reaction

• Considered by most clinicians to be unnecessary and may be associated with increased drug toxicity.
• If deemed necessary, perform only under careful medical supervision (e.g., in a hospital) and with adequate facilities (including oxygen) available for treatment of a severe reaction. Do not perform test reaction in patients >50 years of age.
• After 1–2 weeks of disulfiram therapy, slowly administer 15 mL of 100-proof whiskey (or its equivalent) to the patient; dose of alcohol may be repeated once but should not exceed 30 mL of whiskey. Discontinue alcohol as soon as symptoms develop. (See Disulfiram-Alcohol Reaction under Cautions.)

Adherence to Therapy

• Assume patients on maintenance doses who report ability to drink alcoholic beverages without symptoms are disposing of disulfiram tablets without ingesting. Observe daily intake of tablets (preferably crushed and well mixed with liquid) before concluding disulfiram is ineffective.

Administration

Oral Administration

Administer orally once daily, usually in the morning. If sedation occurs, may administer at bedtime.

Do not administer until patient has abstained from alcohol for ≥12 hours. Never administer without the patient’s knowledge. (See Boxed Warning.)

If adherence is a problem, administer under close supervision, preferably as crushed tablets well mixed with liquid.

Reconstitution

Has been prepared and administered as an extemporaneous suspension of 1% disulfiram, ¼% methylcellulose, and 10% Tang^® in distilled water. (See Storage under Stability.)

Dosage

Adults

Alcohol Dependence

Oral

Initially, maximum 500 mg once daily for 1–2 weeks. May reduce dosage if sedation occurs.

Average maintenance dosage: 250 mg daily (range: 125–500 mg daily) until patient is fully recovered socially and a basis for permanent self-control is established. Treatment may be required for months or years.

Prescribing Limits

Adults

Alcohol Dependence

Oral

Maximum 500 mg daily.

Special Populations

Dosage in Hepatic Impairment

No specific dosage recommendations at this time. Use with extreme caution. (See Hepatic Effects and also Concomitant Diseases under Cautions.)

Dosage in Renal Impairment

No specific dosage recommendations at this time. Use with extreme caution in patients with acute or chronic nephritis. (See Concomitant Diseases under Cautions.)

Geriatric Patients

Select dosage with caution, usually starting at low end of dosing range, because of age-related decreases in hepatic, renal, and/or cardiac function and of concomitant disease and drug therapy.