Consumer medicine information

Antabuse 200 mg Effervescent tablets

Disulfiram

BRAND INFORMATION

Brand name

Antabuse

Active ingredient

Disulfiram

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Antabuse 200 mg Effervescent tablets.

1. Why am I using Antabuse?


Antabuse contains the active ingredient disulfiram. Antabuse is used to act as a deterrent to alcohol consumption
For more information, see Section 1. Why am I using Antabuse? in the full CMI.

2. What should I know before I use Antabuse


Do not use if you have ever had an allergic reaction to disulfiram or any of the ingredients listed at the end of the CMI.
Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding.
For more information, see Section 2. What should I know before I use Antabuse? in the full CMI.

3. What if I am taking other medicines?


Some medicines may interfere with Antabuse and affect how it works.
A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

4. How do I use Antabuse


Starting dose: Take between half a tablet (100 mg) and one and a half tablets (300 mg) dissolved in water as a single dose daily for one to two weeks. One tablet daily is the usual maintenance dose.
Your doctor will tell you the exact dosage
More instructions can be found in Section 4. How do I use Antabuse? in the full CMI.

5. What should I know while using Antabuse

Things you should doRemind any doctor, dentist or pharmacist you visit that you are using Antabuse
Always follow your doctor's instructions carefully, and seek your doctor's advice before changing or stopping treatment
Things you should not doDo not take if you have consumed any alcohol in the last 24 hours.
DO NOT, UNDER ANY CIRCUMSTANCES, TAKE ANY ALCOHOL OR ALCOHOL-CONTAINING PRODUCTS
Driving or using machinesYou may feel drowsy or fatigue while taking Antabuse.
Drinking alcoholDo not take if you have consumed any alcohol in the last 24 hours.
DO NOT, UNDER ANY CIRCUMSTANCES, TAKE ANY ALCOHOL OR ALCOHOL-CONTAINING PRODUCTS
Looking after your medicineKeep your Antabuse in a cool, dry place where the temperature stays below 25°C

For more information, see Section 5. What should I know while using Antabuse? in the full CMI.

6. Are there any side effects?


In the first 2 weeks the following are common side effects, (headache, weakness, acne or skin rash, upset stomach, impotence in men and bad breath.
For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.

BRAND INFORMATION

Brand name

Antabuse

Active ingredient

Disulfiram

Schedule

S4

 

1 Name of 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

4.9 Overdose

High doses of disulfiram (up to 6 g daily) are relatively nontoxic in man. Disulfiram is toxic to animals only in large doses. The LD50 of a single dose administration in the dog is 3.5 g/kg and in the rat 8.6 g/kg. Death occurs by respiratory arrest, preceded by ascending paralysis, and pathological lesions are seen in the liver, spleen, kidney and CNS, with congestion in the adrenal gland and oedema in the heart muscle. Similar lesions have arisen in animals following chronic administration.
In overdosage situations the stomach should be emptied promptly by induced emesis or lavage. There is no specific therapy for acute overdosage with Antabuse tablets and general symptomatic and supportive measures should be instituted and maintained for as long as necessary (see Section 4.4 Special Warnings and Precautions for Use, The disulfiram-ethanol reaction).
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.3 Preclinical Safety Data

Genotoxicity. No data available.
Carcinogenicity. No data available.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Disulfiram is tetraethylthiuram disulphide, which occurs as a cream white, almost odourless, slightly bitter crystalline powder, practically insoluble in water (0.02 g/100 mL), soluble in ethanol and chloroform.
Chemical structure.
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSDISULF.gif Molecular formula: C10H20N2S4. Molecular weight: 296.5.
CAS number. 97-77-8.

7 Medicine Schedule (Poisons Standard)

Schedule 4 - Prescription only medicine.

Summary Table of Changes

https://stagingapi.mims.com/au/public/v2/images/fulltablegif/ANTABUST.gif