(and dosage form)
Each dispergette contains 400 mg disulfiram.
A.9 Medicines against alcoholism
ANTABUSE (disulfiram) interferes with the normal metabolic degradation of alcohol in the body, resulting in an increased concentration of acetaldehyde in the blood. When a patient undergoing treatment with ANTABUSE drinks alcohol, marked subjective and objective symptoms will be experienced within about 10 minutes. These symptoms are accompanied by pronounced discomfort and persist until the alcohol is eliminated. Reactions to alcohol may occur up to 14 days following withdrawal of disulfiram.
The marked unpleasantness of an ANTABUSE-alcohol reaction acts as a form of aversion treatment. Consequently, the regular administration of ANTABUSE permits the effective treatment of chronic alcoholics as outpatients.
As an adjunct in the treatment of chronic alcoholism.
ANTABUSE is contra-indicated in the presence of cardiovascular disease, cerebral damage, pregnancy, psychosis or severe personality disorders and drug addiction.
Disulfiram should not be administered until the patient has abstained from alcohol for at least 12 hours and the blood alcohol level is zero.
ANTABUSE is contra-indicated in patients known to be hypersensitive to disulfiram or to other thiuram compounds, such as those used in rubber compounds, pesticides or fungicides, isoniazid and metronidazole.
Phenothiazine antiemetics, i.e. chlorpromazine are contra-indicated in association with disulfiram-alcohol reaction.
ANTABUSE should not be given without the patient's knowledge unless the prescriber deems it fit. Patients should not use aftershave lotions, colognes or any other toilet preparations containing alcohol. Foods and medicines containing alcohol should also be avoided, e.g. cough syrups, fermented vinegar, sauces.
The liver function of patients with liver damage should also be closely monitored.
DOSAGE AND DIRECTIONS FOR USE:
ANTABUSE treatment should only be carried out under strict medical control.
½ - 1 dispergette daily or as directed by the physician. The dose can be given at longer intervals if desired, i.e. one ANTABUSE dispergette every two days instead of half dispergette daily. The whole or part dispergette should be dropped into a quarter glass of water or other liquid. It will effervesce at once and, after stirring for a few seconds, will form a palatable suspension. The suspension should be drunk before it has had time to settle. Alternatively, ANTABUSE dispergettes can be swallowed without chewing as normal tablets.
SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
ANTABUSE, taken by itself in small doses, is relatively non-toxic. Drowsiness and fatigue are common during initial treatment with disulfiram. In patients undergoing treatment for alcoholism, disulfiram may also give rise to a number of other side-effects, such as an unpleasant taste, gastrointestinal upsets, body odour, bad breath, headache, impotence, acetonaemia, restlessness, dizziness and occasional allergic dermatitis. Optic atrophy and peripheral neuropathies, psychotic reactions and hepatotoxicity (including hepatitis consistent with a hypersensitivity reaction) may occur. Isolated blood dyscrasias have been reported.
Concentrations of metals, particularly nickel, in the blood rise progressively during treatment with disulfiram. Since accumulation of metals in the brain is also promoted, the use of disulfiram should be avoided in those patients who are apt to encounter them in their environment.
Caution should be exercised in administering ANTABUSE to patients with impaired renal or hepatic function, respiratory disorders, hypothyroidism, or diabetes mellitus and in patients with a history of epilepsy or other seizure disorders.
No information is available on the relationship of age to the effects of disulfiram. Safety and efficacy in children have not been established. However, elderly patients are more likely to have age related renal function impairment. In addition, elderly patients with cardiac or cerebrovascular disease may not tolerate the disulfiram-alcohol reaction, as well as younger patients. See Contra-Indications.
Blood cell counts and blood chemistry profiles and liver function tests should be performed every 6 months during treatment.
Disulfiram may inhibit the metabolism of paraldehyde leading to an accumulation of acetaldehyde and these drugs should not be given concomitantly.
The use of alcohol or alcohol-containing products within 14 days of disulfiram therapy will result in a disulfiram-alcohol reaction.
Disulfiram inhibits hepatic enzymes and may interfere with the metabolism of other drugs taken at the same time e.g. mono amine oxidase inhibitors, barbiturates and alfentanil.
Disulfiram inhibits the metabolism and excretion of rifampicin and may similarly affect pethidine, morphine, amphetamines and other centrally active drugs mediated by noradrenaline or dopamine. There have been occasional reports of choreoathetosis in patients receiving disulfiram and pimozide.
Disulfiram enhances the effects of anticonvulsants. Hydantoin, especially phenytoin and coumarin or indandione anticoagulants and their dosage may need to be reduced.
Laboratory/physiological test values:
Serum cholesterol concentrations may be increased.
Vanillylmandelic acid (VMA) concentrations in urine may be decreased.
KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Treatment is symptomatic and supportive.
The syndrome of disulfiram intoxication in children, with sequelae of brain damage or death, is distinct from the disulfiram-alcohol interaction or acute disulfiram intoxication in adults. It is characterised by lethargy or somnolence, weakness, hypotonia and vomiting, begining approximately 12 hours after ingestion and progressing to stupor or coma. Dehydration, moderate tachycardia and marked tachypnea occur frequently, muscle tone is greatly decreased and deep-tendon reflexes may be weak or absent.
A severe reaction is likely to occur when an overdose of ANTABUSE and alcohol is taken. Psychotic reactions, such as depressive psychosis (with suicidal tendencies), paranoia, paranoid schizophrenia, mania and Korsakoff's psychosis have been reported as well as a few fatalities.
No specific treatment for severe ANTABUSE-alcohol reactions has yet been developed.
In severe disulfiram-alcohol reactions, supportive measures to restore blood pressure and treat shock should be instituted. Other recommendations include: administration of supplemental oxygen, monitoring of serum potassium levels; and monitoring of ECG tracings.
ANTABUSE dispergettes are white, round, flat tablets with a 15 mm diameter, scored on one side and marked "Dumex 150L". They are effervescent in water and form a palatable drink.
Amber glass bottles of 50 and amber HDPE bottles of 500 dispergettes.
Store below 25°C, in a well closed container and protect from light.
KEEP OUT OF REACH OF CHILDREN.
G 2932 (Act 101/1965)
NAME AND BUSINESS ADDRESS OF THE APPLICANT:
7 Fairclough Road
DATE OF APPLICATION OF THIS PACKAGE INSERT:
1 December 1974
Updated on this site: April 2005
Source: Hospital Pharmacy
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