Medically reviewed by Drugs.com. Last updated on Feb 1, 2021.
Applies to the following strengths: 333 mg
Usual Adult Dose for:
Additional dosage information:
Usual Adult Dose for Alcohol Dependence
666 mg orally 3 times a day
-Doses should be taken with meals in patients who regularly eat 3 meals a day.
-Treatment should begin as soon as possible after the withdrawal period (when the patient achieves abstinence) and should be maintained if the patient relapses.
-This drug should be used as part of a comprehensive psychosocial treatment program.
-Lower doses may be effective in some patients.
Use: For the maintenance of abstinence from alcohol in patients with alcohol dependence who are abstinent at treatment initiation
Renal Dose Adjustments
Mild renal dysfunction (CrCl greater than 50 mL/min): Data not available
Moderate renal dysfunction (CrCl 30 to 50 mL/min):
-Initial dose: 333 mg orally 3 times a day
-Maintenance dose: 333 to 666 mg orally 3 times a day
Severe renal dysfunction (CrCl 30 mL/min and less): Contraindicated
Liver Dose Adjustments
Mild to moderate liver dysfunction (Child-Pugh Classes A and B): No adjustment recommended.
Severe liver dysfunction (Child-Pugh Class C): Data not available
-Hypersensitivity to the active component or any of the ingredients
-Severe renal dysfunction (CrCl less 30 mL/min or less)
Safety and efficacy have not been established in pediatric patients.
Consult WARNINGS section for additional precautions.
Data not available
-Tablets should be swallowed whole; crushing or chewing should be avoided.
-Doses should be administered with meals.
-Limitation of use: Treatment does not constitute treatment for the withdrawal period.
-Limitation of use: The efficacy in promoting abstinence from alcohol in patients with polysubstance abuse has not been adequately assessed.
-Limitation of use: Efficacy has not been demonstrated in promoting abstinence in patients who have not undergone detoxification and achieved abstinence prior to beginning treatment.
-Treatment does not prevent harmful effects of continuous alcohol abuse, and continued alcohol abuse negates therapeutic benefits of this drug.
-PSYCHIATRIC: Signs/symptoms of depression and suicidality
-Counsel patients regarding the signs and symptoms of depression and suicidality; instruct patients to contact their physician immediately if signs or symptoms occur.
-Advise patients to speak to their healthcare provider if they become pregnant, intend to become pregnant, or are breastfeeding.
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