DISULFIRAM tablet

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv bestanddel:

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

Tilgængelig fra:

Hikma Pharmaceuticals USA Inc.

INN (International Name):

DISULFIRAM

Sammensætning:

DISULFIRAM 250 mg

Indgivelsesvej:

ORAL

Recept type:

PRESCRIPTION DRUG

Terapeutiske indikationer:

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.

Produkt oversigt:

Disulfiram Tablets, USP 250 mg tablets are supplied as a white to off-white, round, biconvex tablet; debossed with product identification “54“ over “734” on one side and plain on the other side. NDC 0054-0356-25: Bottle of 100 Tablets NDC 0054-0356-13: Bottle of 30 Tablets 500 mg tablets are supplied as a white to off-white, oval, biconvex tablet; debossed with product identification “54 544” on one side and scored on the other side. NDC 0054-0357-25: Bottle of 100 Tablets NDC 0054-0357-13: Bottle of 30 Tablets Dispense in a tight, light-resistant container as defined in the USP/NF. Storage Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Distributed by: Hikma Pharmaceuticals USA Inc. Berkeley Heights, NJ 07922 C50000491/02 Revised August 2023

Autorisation status:

Abbreviated New Drug Application

Produktets egenskaber

DISULFIRAM- DISULFIRAM TABLET
HIKMA PHARMACEUTICALS USA INC.
----------
DISULFIRAM TABLETS, USP
RX ONLY
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, USP occurs as a white to off-white, odorless 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 and the
following inactive ingredients: colloidal silicon dioxide, magnesium
stearate, silicified
microcrystalline cellulose and sodium starch glycolate.
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.
10 20 2 4
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 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
longer a patient
remains on therapy, th