ANTABUSE disulfiram 200mg tablet bottle

Страна: Австралия

Език: английски

Източник: Department of Health (Therapeutic Goods Administration)

Активна съставка:

disulfiram, Quantity: 200 mg

Предлага се от:

Arrotex Pharmaceuticals Pty Ltd

Лекарствена форма:

Tablet, effervescent

Композиция:

Excipient Ingredients: tartaric acid; magnesium stearate; povidone; maize starch; microcrystalline cellulose; sodium bicarbonate; colloidal anhydrous silica; purified talc; polysorbate 20

Начин на приложение:

Oral

Броя в опаковка:

30 tablets

Вид предписание :

(S4) Prescription Only Medicine

Терапевтични показания:

Antabuse tablets are indicated as a deterrent to alcohol comsumption and as 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.

Каталог на резюме:

Visual Identification: White flat tablet with breakline, 11mm in diameter and engraved "CDC".; Container Type: Bottle; Container Life Time: 5 Years; Container Temperature: Store below 25 degrees Celsius

Статус Оторизация:

Licence status A

Дата Оторизация:

1999-08-19

Листовка

_ANTABUSE_
_®_
_ _
_Consumer Medicine Information _
1
AN
T
ABUS
E
®
Disulfiram Effervescent Tablets
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common questions about
Antabuse. It does not contain all of the available
information. It does not take the place of talking to your
doctor or pharmacist.
IF YOU HAVE ANY CONCERNS ABOUT TAKING ANTABUSE, ASK
YOUR DOCTOR OR PHARMACIST.
Your doctor and pharmacist
have more information.
KEEP THIS LEAFLET WITH THE MEDICINE
. You may need to read
it again.
WHAT ANTABUSE IS USED FOR
Antabuse is designed to act as a deterrent to alcohol
consumption.
Antabuse inhibits an enzyme, which assists in the breakdown
of alcohol in the body. A build-up of a substance called
acetaldehyde results. If alcohol is consumed when a patient
has received Antabuse the so called "aldehyde reaction" may
occur.
Antabuse tablets have been approved for the uses listed
above. However, your doctor may prescribe this medicine
for another use. If you want more information, ask your
doctor.
Antabuse tablets are not addictive.
_What will happen if you take alcohol and _
_Antabuse _
THE "ALDEHYDE REACTION", WHICH MAY OCCUR IF YOU TAKE
ANTABUSE AND ALCOHOL TOGETHER, STARTS WITH A FLUSHING
FROM THE HEAD DOWNWARDS INVOLVING THE FACE, ARMS AND
CHEST. THIS IS ACCOMPANIED BY A FEELING OF HEAT, SWEATING,
PALPITATIONS, FAST HEART BEAT, SHORTNESS OF BREATH,
HYPERVENTILATION AND HEADACHE. THERE IS A FEELING OF
CONSTRICTION AND IRRITATION IN THE THROAT RESULTING IN
SPASMS AND COUGHING. CHEST PAINS MAY OCCUR.
RESTLESSNESS OR A SENSE OF UNEASINESS AND FEAR OF DYING
MAY DEVELOP. THESE SYMPTOMS ARE ACCOMPANIED BY A
STEEP RISE IN BLOOD PRESSURE, WHICH MAY BE FOLLOWED BY A
DROP IN BLOOD PRESSURE.
FLUSHING IS THEN REPLACED BY THE PATIENT BECOMING PALE,
WEAK, FEELING DIZZY AND SICK, WHICH TURNS INTO VIOLENT
VOMITING AND STOMACH CRAMPS. OTHER SYMPTOMS MAY
INCLUDE THIRST, DIZZINESS, BLURRED VISION, NUMBNESS OF THE
HANDS AND FEET AND THE INABILITY TO SLEEP. SEVERE REACTIONS
MAY AFFECT THE HEART,

Данни за продукта

1
AUSTRALIAN PRODUCT INFORMATION –
ANTABUSE
 (DISULFIRAM) 200 MG EFFERVESCENT TABLET
1
NAME OF THE MEDICINE
Disulfiram.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Antabuse:
disulfiram 200 mg effervescent tablets
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Antabuse 200 mg effervescent tablets are white, flat tablets, scored
and engraved CDC.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
ANTABUSE tablets are indicated to act as a deterrent to alcohol
consumption and an aid in the
overall management of selected chronic alcoholic patients involved in
an integrated programme 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 programme of
rehabilitation, should be selected for ANTABUSE administration.
4.2
D
OSE AND METHOD OF ADMINISTRATION
ANTABUSE tablets are administered as a single daily dose. They should
be taken preferably on
waking, although in patients who experience a sedative effect,
ANTABUSE tablets may be taken on
retiring. Alternatively, to minimise the sedative effect, the initial
dosage may be reduced.
INITIAL DOSAGE - One half of a tablet (100 mg) is given daily for 7-14
days, escalating the dosage after
that if required, to a maximum of one and one-half tablets (300 mg).
MAINTENANCE DOSAGE - The recommended maintenance dosage is one tablet
daily, taken for 6 weeks
to 6 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.
4.3
C
ONTRAINDICATIONS
ANTABUSE tablets are contraindicated in individuals who are
hypersensitive to this drug or to other
thiuram derivatives used in pesticides and rubber vulcanization.
ANTABUSE tablets are contraindicated in patients with severe
myocardial disease, or
ischaemic heart disease, uncompensated cardiac