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Antabuse (disulfiram)

BOXED WARNING

Do not administer to patients in a state of alcohol intoxication, or without his full knowledge. Instruct relatives accordingly.

THERAPEUTIC CLASS

Alcohol oxidation inhibitor

DEA CLASS

RX

INDICATIONS

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.

ADULT DOSAGE

Alcoholism

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

Abstain from alcohol for at least 12 hrs prior to therapy

Initial: 500mg/day as a single dose for 1-2 weeks
Maint: 250mg/day (range: 125-500mg) until patient is fully recovered socially and a basis for permanent self-control is established; maint therapy may be required for months or even yrs, depending on patient
Max: 500mg/day

DOSING CONSIDERATIONS

Elderly
Start at lower end of dosing range

ADMINISTRATION

Oral route

Although usually taken in am, may take qhs if a sedative effect is experienced. Alternatively, may adjust dose downward to minimize/eliminate sedative effect

Refer to PI for trial w/ alcohol and management of disulfiram-alcohol reaction

HOW SUPPLIED

Tab: 250mg, 500mg* *scored

CONTRAINDICATIONS

Severe myocardial disease or coronary occlusion, psychoses, hypersensitivity to thiuram derivatives used in pesticides and rubber vulcanization. Patients who are receiving or have recently received metronidazole, paraldehyde, alcohol, or alcohol-containing preparations (eg, cough syrups, tonics and the like).

WARNINGS/PRECAUTIONS

Not a cure for alcoholism; unlikely to have any substantive effect on the drinking pattern of the chronic alcoholics when used alone, without proper motivation and supportive therapy. Disulfiram plus alcohol may produce serious adverse reactions (eg, respiratory depression, cardiovascular collapse, arrhythmias, myocardial infarction, acute congestive heart failure, unconsciousness, convulsions, death); intensity of reaction varies with each individual but is generally proportional to amount of disulfiram and alcohol ingested. Caution with diabetes mellitus (DM), hypothyroidism, epilepsy, cerebral damage, chronic and acute nephritis, and hepatic cirrhosis or insufficiency. Evaluate for hypersensitivity to thiuram derivatives before receiving therapy in patients with history of rubber contact dermatitis. Hepatic toxicity including hepatic failure resulting in transplantation or death, reported. Severe and sometimes fatal hepatitis may develop even after many months of therapy. Perform baseline and follow-up LFTs (10-14 days) and monitor CBC and serum chemistries. Caution in elderly patients.

ADVERSE REACTIONS

Optic neuritis, peripheral neuritis, polyneuritis, peripheral neuropathy, hepatitis, drowsiness, fatigability, impotence, headache, acneiform eruptions, allergic dermatitis, metallic or garlic-like aftertaste.

DRUG INTERACTIONS

See Contraindications. Avoid ethylene dibromide and its vapors. May increase blood levels and the possibility of clinical toxicity of drugs given concomitantly. Caution with phenytoin and its congeners; may lead to phenytoin intoxication. May prolong PT; adjust dose of oral anticoagulants upon initiation or discontinuation of therapy. Observe for appearance of unsteady gait or marked changes in mental status with isoniazid; d/c disulfiram if such signs appear. Psychotic reactions reported due to combined toxicity with metronidazole or isoniazid.

PREGNANCY AND LACTATION

Safety not known in pregnancy, not for use in nursing.

MECHANISM OF ACTION

Alcohol oxidation inhibitor; blocks alcohol oxidation at the acetaldehyde stage.

PHARMACOKINETICS

Absorption: Slow.

ASSESSMENT

Assess for alcoholism, severe myocardial disease or coronary occlusion, psychoses, hypersensitivity to drug or other thiuram derivatives, DM, hypothyroidism, epilepsy, cerebral damage, chronic/acute nephritis, hepatic cirrhosis/insufficiency, history of rubber contact dermatitis, pregnancy/nursing status, and possible drug interactions. Assess if patient is in a state of alcohol intoxication. Obtain baseline LFTs.

MONITORING

Monitor for hepatotoxicity, disulfiram-alcohol reaction, and other adverse reactions. Monitor LFTs, CBC, and serum chemistries.

PATIENT COUNSELING

Inform patients of the disulfiram-alcohol reaction. Caution patients against drinking alcohol while on therapy. Advise to avoid alcohol in disguised forms (eg, sauces, vinegar, cough medicine, aftershave lotions, back rubs). Advise that disulfiram-alcohol reactions may occur up to 14 days after taking drug. Advise to notify their physician of any early symptoms of hepatitis, (eg, fatigue, weakness, malaise, anorexia, N/V, jaundice, or dark urine).

STORAGE

20-25°C (68-77°F).

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