ANTABUSE- disulfiram tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

DISULFIRAM (UNII: TR3MLJ1UAI) (DISULFIRAM - UNII:TR3MLJ1UAI)

Available from:

Physicians Total Care, Inc.

INN (International Name):

DISULFIRAM

Composition:

DISULFIRAM 250 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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. 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. 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.

Product summary:

Disulfiram Tablets USP: 250 mg - White, round, unscored tablets, Debossed: OP 706 Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. Mfg. by PLIVA Krakow Pharmaceutical Company S.A. Krakow, Poland for Duramed Pharmaceuticals, Inc. Subsidiary of Barr Pharmaceuticals, L.L.C. Pomona, New York 10970 Iss. 2/2010 11001624 Relabeling and Repackaging by: Physicians Total Care, Inc. Tulsa, Oklahoma       74146

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ANTABUSE - DISULFIRAM TABLET
PHYSICIANS TOTAL CARE, INC.
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ANTABUSE®
(DISULFIRAM TABLETS USP)
IN ALCOHOLISM
WARNING:
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.
DESCRIPTION:
Disulfiram is an alcohol antagonist drug.
CHEMICAL NAME:
bis(diethylthiocarbamoyl) disulfide.
STRUCTURAL FORMULA:
C H N S M.W. 296.54
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 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 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
10
20
2
4
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
l