Usual Adult Dose for Alcohol Dependence

• Initial dose: 500 mg orally once a day (this dose is generally continued for the first 1 to 2 weeks)
• Maintenance dose: 250 mg orally once a day (range: 125 mg to 500 mg once a day)

• Duration of therapy: Depending on the individual, therapy may last months or even years

• Although usually taken in the morning, this drug may be dosed in the evening by patients who experience a sedative effect. Also, the dosage may be adjusted downward.

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Data not available

Dose Adjustments

• Following the initial treatment period (6 weeks to 6 months), therapy should be reevaluated for efficacy prior to continuing with a more prolonged treatment.
• The initial dose may be decreased to minimize the sedative effect.

Precautions

US BOXED WARNING:

• This drug should never be administered to a patient when he is in a state of alcohol intoxication, or without his full knowledge.
• The physician should instruct relatives accordingly.

Dialysis

Data not available

Other Comments

Administration advice:

• Administration with food may increase the bioavailability of this drug.
• This drug should not be administered until the patient has abstained from alcohol for at least 24 hours.
• This drug is preferably administered in the morning; however, in patients who experience sedation, it may be given at bedtime.

• Therapy with this drug should only be considered as part of an integrated program including counseling and psychiatry.
• Patients who stop therapy should be advised to wait at least 1 week before taking alcohol and that reactions with alcohol may occur for up to 3 weeks after terminating therapy.
• Trial with Alcohol: During early experience with this drug, it was thought advisable for each patient to have at least 1 supervised alcohol-drug reaction. More recently, the test reaction has been largely abandoned. Such a test reaction should never be administered to a patient over 50 years of age. A clear, detailed and convincing description of the reaction is felt to be sufficient in most cases. However, where a test reaction is deemed necessary, the suggested procedure is outlined in the manufacturer product information.
• In severe reactions, whether caused by an excessive test dose or by the patient's unsupervised ingestion of alcohol, supportive measures to restore blood pressure and treat shock should be instituted. Other recommendations include: oxygen, carbogen (95% oxygen and 5% carbon dioxide), vitamin C IV in massive doses (1 g) and ephedrine sulfate. IV antihistamines have also been used. Potassium levels should be monitored, particularly in patients on digitalis, since hypokalemia has been reported.
• It is recommended that treatment should be initiated only in a hospital or specialized clinic and by physicians experienced in its use. The patient should have adequate social and family support to avoid ingestion of alcohol. Suitable patients should not have ingested alcohol for at least 24 hours and must be warned that a disulfiram-alcohol reaction is potentially dangerous.
• This drug should never be administered to a patient who is under the state of alcohol intoxication, or without the patient's full knowledge. Patients should be thoroughly educated, along with their relatives, about the reaction between this drug and alcohol.