DISULFIRAM tablet

দেশ: মার্কিন যুক্তরাষ্ট্র

ভাষা: ইংরেজি

সূত্র: NLM (National Library of Medicine)

সক্রিয় উপাদান:

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

থেকে পাওয়া:

Teva Pharmaceuticals USA, Inc.

INN (আন্তর্জাতিক নাম):

DISULFIRAM

রচনা:

DISULFIRAM 250 mg

প্রশাসন রুট:

ORAL

প্রেসক্রিপশন টাইপ:

PRESCRIPTION DRUG

থেরাপিউটিক ইঙ্গিত:

Disulfiram Tablets USP are 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 Tablets USP are 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.

পণ্য সারাংশ:

Disulfiram Tablets USP are available as follows: 250 mg - white, round, unscored, biconvex tablets, debossed with OP over 706 on one side and plain on the other side, in bottles of 100 tablets (NDC 0093-5035-01). 500 mg - white, round, scored tablets, debossed with OP over 707 on one side and scored on the other side, in bottles of 100 tablets (NDC 0093-5036-01). Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. Manufactured In Croatia By: PLIVA HRVATSKA d.o.o. Zagreb, Croatia Manufactured For: TEVA PHARMACEUTICALS USA, INC. North Wales, PA 19454 Rev. B 9/2015

অনুমোদন অবস্থা:

Abbreviated New Drug Application

পণ্য বৈশিষ্ট্য

DISULFIRAM- DISULFIRAM TABLET
TEVA PHARMACEUTICALS USA, INC.
----------
DISULFIRAM TABLETS USP
IN ALCOHOLISM
5035
5036
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, USP 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, 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, lactose anhydrous, 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.
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