Consumer medicine information

Antabuse

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.

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, and there may be fits, loss of consciousness and death. The reaction usually lasts 2-4 hours and up to several hours in more severe cases.

Confusion, drowsiness and sleep usually follow. The intensity of the reaction varies with each individual, but generally depends on the amount of Antabuse and alcohol consumed.

If such a reaction is observed, the patient's doctor should be contacted. If the patient is not in hospital or a clinic, an ambulance should be called as the patient requires close monitoring.

BEFORE YOU TAKE ANTABUSE

When you must not take Antabuse

Do not use Antabuse:

  • if you know you are allergic to it or any of its ingredients, or certain other chemicals (thiuram derivatives) used in pesticides and rubber processing. (See the last section of this leaflet for a full list of ingredients). Signs of allergy include rash, itching, shortness of breath and/or swollen face;
  • if you have heart, liver or kidney disease; organic brain damage
  • if you are pregnant, or are planning to become pregnant;
  • if you have a mental illness with abnormal thoughts;
  • if you are taking paraldehyde or metronidazole;
  • if the packaging is torn or shows signs of being tampered with;
  • to treat any other complaints unless your doctor says it is safe to do so.
IMPORTANT NOTE
Under all circumstances when taking Antabuse you MUST NOT take alcohol or alcohol-containing preparations e.g. certain cough syrups, sauces, vinegar, tonics, food prepared with wine. You should even avoid the use of after-shave lotions and alcoholic back rubs.

Before you start to take it

You should not take Antabuse until you have not taken any alcohol for 24 hours. If you stop taking Antabuse, you should wait at least one week before consuming alcohol. Reactions may still occur for up to three weeks after taking Antabuse.

Your doctor may need to monitor closely if you suffer from certain conditions. Tell your doctor if you have any of the following:

  • diabetes;
  • epilepsy;
  • thyroid problems;
  • heart, kidney or liver disease;
  • an allergic skin reaction if you come into contact with certain irritants;
  • asthma;
  • mental illness with abnormal thoughts.

Tell your doctor or pharmacist if you are breastfeeding. They will advise you on whether you should take Antabuse.

Always tell your doctor if you are taking other medicines, including ones you buy from the pharmacy or supermarket.

Medicines which have interacted with Antabuse include:

  • phenytoin and isoniazid;
  • sleeping tablets such as Valium;
  • medicines which stop blood clotting (warfarin);
  • metronidazole and paraldehyde;
  • pain killers such as morphine, pethidine, amphetamines and barbiturates.

USING ANTABUSE

How to take it

The following are the usual doses, but your doctor may adjust them to suit your needs:

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. Your doctor will tell you the exact dosage. Then go back and see your doctor.

Maintenance dose: Take ONE tablet daily.
Take the tablets in the morning when you wake up. However if you find the tablets make you sleepy you can take them before bedtime. If you are taking Antabuse for a long time, then your doctor will need to do a regular check up. This may include a blood test.

If you forget to take it

  • If you forget to take Antabuse, do so as soon as you remember, and then go back to taking it as you would normally.
  • If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to. Do not take a double dose to make up for the one you missed.
  • If you have problems remembering when to take your medicine, ask your pharmacist for some hints.

Overdose

If you think you or anybody else has taken too much Antabuse, contact your doctor, pharmacist or the Poisons Information Centre in your state who will advise you what to do. (You can contact the Poisons Information Centre by dialling 1311 26 (Australia) and ask for your local Poisons Centre). If you have taken too much Antabuse you may get drowsy, experience some pain or numbness in the hands and feet which may get worse if not treated.

WHILE YOU ARE TAKING ANTABUSE

Things you must do

  • Always follow your doctor's instructions carefully, and seek your doctor's advice before changing or stopping treatment. Your doctor will be happy to discuss any concerns you may have with your treatment.
  • Always read labels of food and medicines bought to check they contain no alcohol.

Things you must not do

  • DO NOT, UNDER ANY CIRCUMSTANCES, TAKE ANY ALCOHOL OR ALCOHOL-CONTAINING PRODUCTS.
    You will suffer from the "aldehyde reaction" which needs immediate medical attention and, in some circumstances, may be fatal.
  • Do not take Antabuse if you have taken any alcohol in the last 24 hours. Also do not take any alcohol for at least a week after stopping Antabuse. You may still get a reaction for up to 3 weeks after stopping Antabuse.
  • Do not give this medicine to anybody else.

Things to be careful of

  • Ask your doctor before taking any other medicines. Antabuse can interact with other medicines. Especially check bought medicines from your chemist or supermarket to make sure they contain no alcohol.

SIDE EFFECTS

Tell your doctor as soon as possible if you do not feel well while you are taking Antabuse.

All medicines have side effects. Often they are not serious but sometimes they can be. You may need medical treatment if you get some of the side effects.

Tell your doctor immediately if you notice any of the following:

  • numbness, tingling, pain or weakness in hands or feet;
  • change in vision or eye tenderness or pain;
  • mood changes or abnormal thoughts;
  • fatigue;
  • malaise (generally feeling unwell);
  • loss of appetite;
  • nausea (feeling sick);
  • vomiting;
  • dark urine or yellowing of the skin or eyes (jaundice) or abdominal pain.

You may have some of the following effects for the first two weeks of treatment. If any of them worry you or continue please tell your doctor as soon as possible:

  • headache;
  • weakness;
  • acne or skin rash;
  • stomach upset;
  • impotence in men;
  • metallic or garlic-like after taste; bad breath (halitosis)

Do not hesitate to report any other side effects to your doctor or pharmacist.

AFTER USING ANTABUSE

Storage

  • Keep your Antabuse in a cool, dry place where the temperature stays below 25°C.
  • Do not store it or any medicines in the bathroom or near a sink. Heat and dampness can destroy some medicines.
  • Keep it where young children cannot reach it. A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.
  • Do not use Antabuse beyond the date (month and year) printed on the pack after the letters "EXP", even if it has been stored properly. Medicines cannot be stored indefinitely.

Disposal

Once you have finished using Antabuse, ask your pharmacist what to do with any that is left.

PRODUCT DESCRIPTION

What it looks like

Antabuse are white, flat tablets scored and marked with CDC. Antabuse comes in packs of 30 tablets.

Ingredients

Each tablet contains 200 milligrams of disulfiram as the active ingredient. They also contain maize starch, povidone, tartaric acid, sodium bicarbonate, microcrystalline cellulose, colloidal anhydrous silica, magnesium stearate, polysorbate 20 and purified talc.

Sponsor

Arrotex Pharmaceuticals Pty Ltd
15-17 Chapel St
Cremorne VIC 3121
Ph 1800 195 055

Australian Registration Number: AUST R 70468

This leaflet was updated in January 2023.

Published by MIMS February 2023

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

4.1 Therapeutic 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 Dose 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 to 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 Contraindications

Antabuse tablets are contraindicated in individuals who are hypersensitive to this drug or to other thiuram derivatives used in pesticides and rubber vulcanisation.
Antabuse tablets are contraindicated in patients with severe myocardial disease, or ischaemic heart disease, uncompensated cardiac failure, previous history of CVA, in pregnancy, advanced liver and renal disease, and in psychotic states, serious organic brain damage.
Under all circumstances, patients receiving Antabuse tablets must not take alcohol or alcohol containing preparations, e.g. certain cough syrups, sauces, vinegar, tonics, foods prepared with wine, and even should avoid the use of aftershave lotions and alcoholic back rubs.
Antabuse tablets should not be administered to patients receiving paraldehyde or metronidazole (see Section 4.5 Interactions with Other Medicines and Other Forms of Interactions).
Antabuse tablets should never be administered to a patient who is taking alcohol or is in a state of alcoholic intoxication.
Antabuse tablets should never be administered to patients without their consent and full explanation, and the physician should caution the relatives accordingly. The patient should be fully informed of the disulfiram-ethanol reaction and cautioned against the possible consequences of taking alcohol either surreptitiously or unwittingly.

4.4 Special Warnings and Precautions for Use

Do not administer Antabuse disulfiram tablets until the patient has abstained from alcohol for at least 24 hours.
Patients who stop taking Antabuse tablets should be advised to wait at least one week before taking alcohol and that reactions with alcohol may occur for up to three weeks after ingesting disulfiram.

The disulfiram-ethanol reaction.

Disulfiram irreversibly inhibits the enzyme system responsible for the conversion of acetaldehyde to acetate. The ingestion of ethanol subsequent to the administration of disulfiram results in raised blood acetaldehyde levels with accumulation in the tissues producing the so called 'aldehyde reaction'. Note that the aldehyde reaction can occur 10-14 days after discontinuation of disulfiram, and possibly up to three weeks after discontinuation.
A disulfiram-ethanol toxic reaction is heralded by an intense cutaneous flushing from the head downwards, involving the face, sclera, upper limbs and chest. The cutaneous flushing is caused by vasodilation and is accompanied by a sensation of heat and sweating, palpitations, with tachycardia, dyspnoea, hyperventilation and the patient develops a pounding headache. There is a feeling of constriction and irritation of the throat and trachea, resulting in spasms of coughing. Chest pains may occur simulating coronary spasm. Restlessness or a sense of uneasiness and fear of dying may develop. These symptoms are accompanied by a steep rise in blood pressure, followed by hypotension if vasodilation is significant. Flushing is then replaced by pallor, weakness, vertigo, and nausea develops that turns into violent vomiting with abdominal cramps. Other symptoms reported include thirst, dizziness, blurred vision, numbness of hands and feet, and insomnia. Severe reactions may affect the heart, and there may be convulsions, loss of consciousness, and death from cardiorespiratory failure.
The intensity of the reaction varies with each individual, but is generally proportional, albeit in a nonlinear fashion, to the amounts of disulfiram and ethanol ingested. Mild reactions may occur in the sensitive individual when the blood ethanol concentration is increased to as little as 5 to 10 mg per 100 mL. Symptoms are fully developed at 50 mg per 100 mL, and unconsciousness usually results when the blood ethanol level reaches 125 to 150 mg per 100 mL.
The duration of the reaction varies from 2-4 hours to several hours in the more severe cases, or as long as there is ethanol in the blood. Confusion, drowsiness and sleep usually follow. Frequently, there are transient ECG changes, such as flattening of T waves, depression of S-T segment, and Q-T prolongation in a pattern suggestive of right ventricular strain.

Management of disulfiram-ethanol reaction.

In the event of an aldehyde reaction as a consequence of a disulfiram treated patient receiving alcohol, supportive measures should be undertaken.
Generous amounts of ascorbic acid (1 g) should be administered intravenously.
It is possible that serotonin, histamine, and various catecholamines which are released play some part in the reaction, and the administration of intravenous or intramuscular antihistamines have been used in treatment. In uncomplicated reactions, chlorpromazine 5-100 mg intramuscularly has been found to be useful.
Maintenance care of a patient with an aldehyde reaction includes routine nursing care, intensive supportive therapy, and standard cardiorespiratory resuscitation measures, involving the treatment of hypotension, circulatory failure, correction of hypoxia, and fluid and electrolyte imbalance to restore haemodynamic equilibrium, all of which are determined by monitoring examinations. The foot of the bed should be elevated raising the patient's feet by about 20-25 cm. Other measures include an adequate patent airway, adequate ventilation with oxygen, if necessary, the correction of arterial pCO2 and pO2, pH, and the intravenous infusion of standard bicarbonate, if there is obvious acidaemia. An infusion of plasma to counteract shock and fluid therapy should be administered according to monitoring of central venous pressure.

Other precautions.

Strict caution is advised in patients with diabetes mellitus, hypothyroidism, epilepsy, renal function impairment, advanced liver disease, cardiovascular disorder, pregnancy, allergic eczematous contact dermatitis, asthma and psychosis. Although disulfiram may be taken without harm in these conditions, strict medical supervision is necessary.
In prolonged use, cautious monitoring of hepatic dysfunction as a result of disulfiram therapy should be carried out. It is also recommended that full blood counts and sequential multiple analysis (SMA-12) should be made regularly.
Hepatic toxicity including hepatic failure resulting in transplantation or death have been reported. Severe and sometimes fatal hepatitis associated with disulfiram therapy may develop even after many months of therapy. Hepatic toxicity has occurred in patients with or without prior history of abnormal liver function. Patients should be advised to immediately notify their physician of any early symptoms of hepatitis such as fatigue, weakness, malaise, anorexia, nausea, vomiting, jaundice or dark urine.
Careful clinical monitoring with discontinuation of disulfiram and laboratory (bilirubin and hepatic enzyme) determinations is recommended when hepatitis is suspected.

Use in the elderly.

No data available.

Paediatric use.

No data available.

Effects on laboratory tests.

No data available.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Concomitant ingestion of antacids containing divalent cations may reduce absorption. Large doses of ferrous salts similarly block absorption.
Disulfiram may retard the metabolism of certain drugs and thus prolong the duration of action or increase the possibility of clinical toxicity of drugs given concomitantly. The drugs include phenytoin and its congeners, and isoniazid.

Isoniazid.

The adverse reactions associated with concurrent use of isoniazid include ataxia and changes in mental state.

Phenytoin.

Concurrent use with phenytoin may increase serum levels of phenytoin and possibly lead to phenytoin intoxication. Phenytoin serum levels should be carried out and dosage adjustments of phenytoin may have to be made during concurrent therapy with Antabuse tablets. There is evidence that phenobarbitone is not affected by disulfiram.

Benzodiazepines.

The effects of chlordiazepoxide and diazepam, but not oxazepam, are increased and prolonged by the concurrent use of disulfiram.

Anticoagulants.

Since disulfiram may prolong prothrombin time, it may be necessary to adjust dosage of oral anticoagulants, e.g. warfarin, in patients receiving these drugs.

Metronidazole.

Acute psychotic reaction and confusion can result.

Paraldehyde.

Theoretically, concurrent use may cause a modified disulfiram-ethanol reaction, and is not recommended.
Potentiation of organic brain syndrome and choreoathetosis following pimozide have occurred rarely.
Disulfiram inhibits the oxidation and renal excretion of rifampicin.

Miscellaneous.

The toxicity of certain centrally acting drugs has been increased by disulfiram in rats. These drugs include morphine, pethidine, amphetamine and barbiturates.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

No data available.
(Category B2)
The safe use of this drug in pregnancy has not been established and Antabuse tablets should not be used. Therefore, the administration of Antabuse tablets in women of childbearing potential requires that the benefits of the drug be weighed against the possible hazards.
The safe use of this drug during lactation has not been established and use during lactation requires that benefits be weighed against possible hazards to the infant.

Breastfeeding.

No information is available on whether Disulfiram is excreted in breast milk. Its use during breast feeding is not advised especially where there is a possibility of interaction with medicines that the baby may be taking.

4.7 Effects on Ability to Drive and Use Machines

The effects of this medicine on a person's ability to drive and use machines were not assessed as part of its registration.

4.8 Adverse Effects (Undesirable Effects)

The principal toxic clinical effects to disulfiram administration alone are drowsiness, lassitude (psychotic reactions); depression, paranoia, schizophrenia, and sensorimotor peripheral neuropathy. Some of these reactions have been known to occur in dosages ranging from 200 mg to 400 mg daily and in associated combined toxicity, e.g. with metronidazole or isoniazid.
The following adverse reactions have been reported. Numbness, tingling, pain or weakness in hands or feet (peripheral neuritis, polyneuritis). Patients who are maintained on disulfiram 500 mg daily tend to develop peripheral neuropathy. This neuropathy improves when disulfiram is discontinued.
Eye pain or tenderness and changes in vision (optic neuritis), encephalopathy, mood and mental changes [psychotic reactions (including mania, depression, paranoia, schizophrenia, reduction in libido)], jaundice, hepatitis, hepatic necrosis, cirrhosis and altered liver function tests nausea, vomiting have been reported with the administration of Antabuse tablets, although rarely. Drug induced liver injury (fatal cases have been reported).
In addition, impotence, headache, fatigue, halitosis, acneiform eruption, allergic dermatitis, rashes, stomach upset, seizures, have been reported and a metallic or garlic-like aftertaste may be experienced during the first two weeks of therapy. These complaints disappear spontaneously or by reducing dosage.

Reporting suspected adverse effects.

Reporting suspected adverse reactions after registration of the medicinal product is important. It allows continued monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions at www.tga.gov.au/reporting-problems.

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

5.1 Pharmacodynamic Properties

Mechanism of action.

Antabuse tablets are designed to act as a deterrent to alcohol consumption in patients as an aid in the overall management of chronic alcoholism. Disulfiram is relatively pharmacologically inert when taken in small doses. Disulfiram produces irreversible inhibition of the enzyme responsible for oxidation of the ethanol metabolite acetaldehyde. The accumulation of acetaldehyde contributes to the reaction occurring after alcohol ingestion in disulfiram treated patients (see Section 4.3 Contraindications; Section 4.4 Special Warnings and Precautions for Use, The disulfiram-ethanol reaction). Blockage of the enzyme leads to accumulation of acetaldehyde, which is an important factor for the clinical disulfiram-alcohol reaction. Re-establishment of the enzymatic activity is dependent on new synthesis which occurs gradually during the course of 1 week or more. Disulfiram and its chief metabolite, diethyldithiocarbamate (DDC) also inhibit the enzyme, dopamine-beta-hydroxylase. This results in reduced synthesis of noradrenaline, which may contribute to the reaction.
The disulfiram-alcohol reaction provokes a number of unpleasant symptoms: intense flushing of the face, a feeling of difficulty in breathing, palpitations, a throbbing headache, nausea, and vomiting. Ingestion of large amounts of alcohol may cause the blood pressure to fall, with fainting and the risk of collapse. In patients receiving maintenance treatment with Antabuse, the ingestion of alcohol may bring about a typical reaction as quickly as within 5-10 minutes.
Disulfiram is a sulphydryl (-SH, thiol) group reagent and inhibits enzymes concerned with oxidation of active (-SH group) sites on enzyme protein molecules. The pharmacological action of disulfiram is based on its inhibition of enzymes involved in ethanol catabolism. Normally, ethanol is metabolised to carbon dioxide and water but, in the presence of disulfiram, the enzyme aldehyde dehydrogenase is inhibited and the metabolic chain of reactions stop after the production of acetaldehyde. Although it is accepted that acetaldehyde accumulation produces the disulfiram-ethanol reaction, it is also believed that the reaction may be caused by a toxic quaternary compound.
Disulfiram also diffuses readily into cells and raises intracellular -SH levels, and therefore can act on intracellular oxidation-reduction reactions. Notably, disulfiram has been shown to inhibit the enzymes xanthine oxidase and succinoxidase. Disulfiram has been shown to possess an antithyroid action attributable to the presence of the NCS grouping, common to many antithyroid compounds, presumably reacting with free iodine to form a stable complex substance.

Clinical trials.

No data available.

5.2 Pharmacokinetic Properties

Disulfiram is a prodrug.

Absorption.

Absorption of disulfiram from the gastrointestinal tract is rapid but incomplete and approximately 20% is excreted in the faeces.

Distribution.

Because of its high lipid solubility, disulfiram is widely distributed and accumulated in various fat depots.

Metabolism.

Disulfiram is rapidly metabolised to diethyldithiocarbamate (DDC), which is partly excreted as carbon disulphide in the expired air and is partly metabolised in the liver to Me-DDC. Me-DDC is metabolised further to the active metabolite Me-DTC (diethyldithiocarbamic acid methyl ester). The concentration of Me-DTC reaches its maximum after about 4 hours, but the maximum enzyme inhibiting effect (ALDH) is first reached after 3 daily doses. The plasma half-life for Me-DTC is about 10 hours, but the enzyme inhibiting effect of ALDH lasts considerably longer. The effect can thus persist for 7 to 14 days after discontinuation. In patients receiving disulfiram maintenance treatment, the ingestion of alcohol brings about a typical disulfiram-alcohol reaction within the course of 5-10 minutes. Metabolism is not appreciably affected by a mild to moderate decrease in liver function. Conversely, in the presence of liver cirrhosis an increased concentration of the metabolites is seen in the blood.

Excretion.

The metabolites are chiefly excreted with the urine. Part is recovered in the expired air as carbon disulphide.
Up to 20% of a dose may remain in the body for one week or longer.
It is possible that Antabuse tablets may be more bioavailable when given with food. It is also possible that Antabuse 200 mg effervescent tablets are more bioavailable than the previously marketed 250 mg Antabuse tablet.

5.3 Preclinical Safety Data

Genotoxicity.

No data available.

Carcinogenicity.

No data available.

6 Pharmaceutical Particulars

6.1 List of Excipients

The tablets also contain maize starch, povidone, tartaric acid, sodium bicarbonate (equivalent to 6.6 mg sodium per tablet), microcrystalline cellulose, silica colloidal anhydrous, magnesium stearate, polysorbate 20 and purified talc.

6.2 Incompatibilities

Incompatibilities were either not assessed or not identified as part of the registration of this medicine.

6.3 Shelf Life

In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG). The expiry date can be found on the packaging.

6.4 Special Precautions for Storage

Store below 25°C.

6.5 Nature and Contents of Container

Antabuse 200 mg Effervescent tablets in bottles (HDPE) of 30.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of by taking to your local pharmacy.

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.


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