DISULFIRAM tablet

Pays: États-Unis

Langue: anglais

Source: NLM (National Library of Medicine)

Ingrédients actifs:

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

Disponible depuis:

Rising Pharmaceuticals, 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: 250 mg - White, capsule shaped tablets debossed “Σ 28” on one side and plain on the other side. They are available in bottles of 30’s (NDC 64980-171-03). 500 mg - White, capsule shaped bisected tablets debossed with “Σ” and “29” on either side of the bisection and plain on the other side. They are available in bottles of 30’s (NDC 64980-172-03). Dispense in original container. Do not remove desiccant and adsorbent canisters from the bottle. Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature]. Manufactured for: Rising Pharmaceuticals, Inc. Allendale, NJ 07401 Manufactured by: Sigmapharm Laboratories, LLC Bensalem, PA 19020 OS029-04 REV.0516

Statut de autorisation:

Abbreviated New Drug Application

Résumé des caractéristiques du produit

DISULFIRAM- DISULFIRAM TABLET
RISING PHARMACEUTICALS, INC.
----------
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:
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
crospovidone, lactose monohydrate, magnesium stearate,
microcrystalline cellulose, povidone and
silicon dioxide.
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 more exquisitely sensi