DISULFIRAM tablet

Pays: États-Unis

Langue: anglais

Source: NLM (National Library of Medicine)

Ingrédients actifs:

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

Disponible depuis:

Golden State Medical Supply, Inc.

DCI (Dénomination commune internationale):

DISULFIRAM

Composition:

DISULFIRAM 250 mg

Mode d'administration:

ORAL

Type d'ordonnance:

PRESCRIPTION DRUG

indications thérapeutiques:

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.

Descriptif du produit:

Disulfiram Tablets, USP are white, round, unscored tablets debossed 607. Bottle of 30 NDC 60429-196-30 Bottle of 100 NDC 60429-196-01 Dispense in a tight, light-resistant container as defined in the USP. Store at 20°C to 25°C (68°F to 77°F). [See USP Controlled Room Temperature]. Manufactured by: Norwich Pharmaceuticals, Inc. Norwich, NY 13815 USA Distributed by: Alvogen, Inc. Morristown, NJ 07960 USA PI607-03 Rev. 01/2020 PKG02698 Marketed by: GSMS, Inc. Camarillo, CA 93012 USA

Statut de autorisation:

Abbreviated New Drug Application

Résumé des caractéristiques du produit

DISULFIRAM- DISULFIRAM TABLET
GOLDEN STATE MEDICAL SUPPLY, INC.
----------
DISULFIRAM TABLETS, USP
IN ALCOHOLISM
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:
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 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 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, the