Antabuse

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Disulfiram 200mg;  

Available from:

Teva Pharma (New Zealand) Limited

INN (International Name):

Disulfiram 200 mg (Hydrofile)

Dosage:

200 mg

Pharmaceutical form:

Effervescent tablet

Composition:

Active: Disulfiram 200mg   Excipient: Colloidal silicon dioxide Magnesium stearate Maize starch Microcrystalline cellulose Polysorbate 20 Povidone Purified talc Sodium bicarbonate Tartaric acid

Units in package:

Bottle, plastic, PET, 100 tablets

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Synthexim

Therapeutic indications:

deterrent to alcohol consumption and an aid in the overall management of selected chronic alcoholic patients involved in an integrated program of counselling and psychiatry. Only alcoholic patients who are motivated to abstain from drinking and who are undergoing supportive psychotherapeutic treatment ancillary to a total program of rehabilitation should be selected for Antabuse administration.

Product summary:

Package - Contents - Shelf Life: Bottle, plastic, PET - 100 tablets - 60 months from date of manufacture stored at or below 25°C

Authorization date:

1969-12-31

Patient Information leaflet

NEW ZEALAND CONSUMER MEDICINE INFORMATION
ANTABUSE
®
DISULFIRAM 200MG TABLETS
_(DIE-SUL-FEAR-AM) _
WHAT IS IN THIS LEAFLET?
This leaflet answers some common questions about Antabuse
®
.
It does not contain all the available information.
It does not take the place of talking to your doctor or pharmacist.
All medicines have risks and benefits. Your doctor has weighed the
risks of your taking
Antabuse
®
against the benefits they expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR
OR
PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT ANTABUSE
® IS USED FOR
ANTABUSE
® TABLETS
are used to treat people with drinking problems. When you drink
alcohol it is changed in the body into a chemical called acetaldehyde
(a-seat-al-de-hide).
Antabuse
®
prevents the chemical from being broken down, resulting in a high
level of
acetaldehyde in the body. This high level of acetaldehyde causes
unpleasant physical
reactions in the body. These unpleasant physical reactions should stop
you from drinking
further alcohol.
The physical reactions can be unpredictable and symptoms can vary from
person to
person. Your doctor will explain the type of symptoms you will
experience if you drink
alcohol while taking Antabuse
®
.
Your doctor may have prescribed Antabuse
®
for another reason. Ask your doctor or
pharmacist if you have any questions about why Antabuse
®
has been prescribed for you.
BEFORE YOU USE ANTABUSE
®
_WHEN YOU MUST NOT USE IT _
•
If you have consumed alcohol within the previous 24 hours. This
includes
alcohol-containing preparations such as food prepared with wine,
vinegar and
certain cough or cold medication.
•
If you have used any alcohol-containing remedies, tonics, toiletries,
perfumes or
sprays within the previous 24 hours.
•
If you are sensitive (allergic) to any of the ingredients listed at
the end of this
leaflet.
•
If you have severe heart disease or heart failure.
•
If you suffer severe mood or personality disorder.
•
I

Summary of Product characteristics

Version 1.1
1
NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
Antabuse
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each effervescent tablet contains 200 mg disulfiram (equivalent to
disulfiram hydrofile 201 mg).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Round white, effervescent flat tablet, 11 mm diameter, engraved CDC
with a breakline on one side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Deterrent to alcohol consumption and an aid in the overall management
of selected chronic alcoholic
patients involved in an integrated program of counselling and
psychiatry.
Only alcoholic patients who are motivated to abstain from drinking and
who are undergoing
supportive psychotherapeutic treatment ancillary to a total program of
rehabilitation should be
selected for Antabuse administration.
4.2
DOSE AND METHOD OF ADMINISTRATION
ADULTS
Dose
_Initial dosage: _
Four 200 mg tablets (800 mg) daily for 2 to 3 days.
_Maintenance dose: _
Reduce by 200 mg daily until a daily dose of 100 to 200 mg is
attained.
Antabuse should be taken for six weeks to six months as required. A
review of the effectiveness of
therapy should be undertaken before continuation on a longer term
basis. A few patients would
require higher doses of disulfiram and longer duration of treatment
under close supervision.
Method of administration
Add the prescribed dose to a quarter glass of water or fruit juice,
until completely dispersed and drink
immediately. Antabuse should be taken preferably on waking although in
patients who experience a
sedative effect, it may be taken on retiring. Alternatively, to
minimise the sedative effect the initial
dosage may be reduced.
PAEDIATRIC POPULATION
No data are available.
4.3
CONTRAINDICATIONS
Hypersensitivity
to
this
drug
or
to
other
thiuram
derivatives
used
in
pesticides
and
rubber
vulcanisation; severe myocardial disease, ischaemic heart disease or
uncompensated heart failure;
pregnancy; advanced hepatic and renal disease; suicidal risk or
psychosis; serious organic brain
damage.
Under a