A1,
A2,
B,
C1,
C2,
D,
E,
F,
G-H,
I-K,
L,
M,
N,
O,
P1,
P2,
Q-R,
S,
T,
U-V,
W-Z
Antabuse Indications, Dosage, Storage, Stability - Disulfiram
Antabuse Indications, Dosage, Storage, Stability - Disulfiram
INDICATIONS
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.
DOSAGE AND ADMINISTRATION
Disulfiram should never be administered until the patient
has abstained from alcohol
for at least 12 hours.
Initial Dosage Schedule: In
the first phase of treatment.
a maximum of 500 mg daily
is given in a single dose
for one to two weeks. Although usually taken in the morning, Disulfiram
may be taken on retiring by patients who experience
a sedative effect.
Alternatively, to minimize, or eliminate, the sedative
effect, dosage may be
adjusted downward.
Maintenance Regimen: The average
maintenance dose is 250
mg daily (range, 125 to 500
mg). it should not exceed 500 mg
daily.
Note: Occasionally patients. while seemingly on adequate
maintenance doses of disutfiram, report
that they are able to drink alcoholic
beverages with impunity and without any symptomatology. All appearances
to the contrary. such patients must be presumed to be disposing
of their tablets in some manner without actually taking them. Until
such patients have been
observed reliably taking their daily disutfiram tablets (preferably
crushed and well mixed
with liquid), it cannot be concluded thal disulfiram
is ineffective.
Duration of Therapy
The daily, uninterrupted administration
of disulfiram must
be continued until the patient
is fully recovered socially and a basis
for permanent self-control is established. Depending on the individual
patient, maintenance
therapy may be required for months or even years trial with Alcohol:
During early experience
with disulfiram, it was thought advisable for each patient to have
at least one supervised alcohol-drug reaction. More recently, the
test reaction
has been largely abandoned. Furthermore, such
a test reaction should never be administered to a patient
over 50 years of age. A clear, detailed and convincing description
of the reaction is
felt to be sufficient in most cases.
However, where a test
reaction is deemed
necessary, the suggested procedure is as follows:
After the first one to two weeks’ therapy
with 500 mg daily, a drink
of 15 mL (1/2 oz) of 100 proof whiskey, or equivalent, is taken
slowly. This test dose
of alcoholic beverage
may be repeated once only, so that the total dose
does not exceed 30 ml (1
oz) of whiskey. Once a reaction develops, no
more alcohol should
be consumed. Such tests should be carried out only when the patient
is hospitalized, or comparable supervision and facilities, including
oxygen, are available. Management o f Disulfiram-Alcohol Reaction
In severe reactions, whether
caused by an excessive test
dose or by the patient’s unsupervised ingestion
of alcohol, supportive
measures to restore blood
pressure and treat
shock should be instituted.
other recommendations include: oxygen, carbogen (95% oxygen
and 5% carbon dioxide),
vitamin C intravenously
in massive doses (1
g) and ephedrine sulfate.
Antihistamines have also been used intravenously. Potassium levels
should be monitored, particularly in patients on digitalis, since
hypokatemia has been reported.
HOW SUPPLIED
Disulfiram Tablets, USP:
- 250 mg -White, round,
unscored tablets in bottles of 100 and 1000, Debossed: SL 331
- 500 mg -White, round,
scored tablets in bottles of 50, 100 and 500, Debossed: SL 332
Dispense in a tight, light-resistant container
as defined in the USP
CAUTION: Federal law
prohibits dispensing without prescription.
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