Clinical Information
Gen. Code and Des.
1192 disulfiram ORAL TABLET 250 MG
GCN and Des.
2881 disulfiram ORAL TABLET 250 MG
Strength
250MG
Dose Form
TABLET
Product Category
RX Pharmaceuticals
Fine Line Class
850085008510 All Rx Products
DEA Class
NC
OMP Family
AHFS Class
92040000 ALCOHOL DETERRENTS
Active Ingredients
752 disulfiram 97778
Inactive Ingredients
2432 lactose 64044515
ANTABUSE disulfiram tablet
Physicians Total Care, Inc.
WARNING:
Disulfiram should never be administered to patient when he is in state of alcohol intoxication, or without his full knowledge.
The physician should instruct relatives accordingly.
DESCRIPTION:
Disulfiram is an alcohol antagonist drug.
CHEMICAL NAME:
bis(diethylthiocarbamoyl) disulfide.
Disulfiram occurs as 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 in 100 mL.
Each tablet for oral administration contains 250 mg or 500 mg disulfiram, USP. Tablets also contain colloidal silicon dioxide, anhydrous lactose, magnesium stearate, microcrystalline cellulose, sodium starch glycolate, and stearic acid.
CLINICAL PHARMACOLOGY:
Disulfiram produces sensitivity to alcohol which results in highly unpleasant reaction when the patient under treatment ingests even small amounts of alcohol.
INDICATIONS AND USAGE:
Disulfiram is an aid in the management of selected chronic alcohol patients who want to remain in state of enforced sobriety so that supportive and psychotherapeutic treatment may be applied to best advantage.
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 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 vulcanizatio
Drug Interactions:
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 PATIENT ON PHENYTOIN THERAPY, 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 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.
ADVERSE REACTIONS:
OPTIC NEURITIS, PERIPHERAL NEURITIS, POLYNEURITIS, AND PERIPHERAL NEUROPATHY MAY OCCUR FOLLOWING ADMINISTRATION OF DISULFIRAM.
Initial Dosage Schedule:
In the first phase of treatment, maximum of 500 mg daily is given in single dose for one to two weeks. Although usually taken in the morning, disulfiram may be taken on retiring by patients who experience 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.
