DISULFIRAM tablet

Land: USA

Språk: engelska

Källa: NLM (National Library of Medicine)

Aktiva substanser:

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

Tillgänglig från:

Sigmapharm Laboratories, LLC

Administreringssätt:

ORAL

Receptbelagda typ:

PRESCRIPTION DRUG

Terapeutiska 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.

Produktsammanfattning:

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 42794-028-08). 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 42794-029-08). 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 by:  Sigmapharm Laboratories, LLC Bensalem, PA 19020 OS029A-01 REV.0321

Bemyndigande status:

Abbreviated New Drug Application

Produktens egenskaper

DISULFIRAM- DISULFIRAM TABLET
SIGMAPHARM LABORATORIES, LLC
----------
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