Medically reviewed by Drugs.com. Last updated on April 26, 2021.
Applies to the following strengths: 40 mg; 60 mg; 80 mg; 40 mg-80 mg
Usual Adult Dose for:
Additional dosage information:
Usual Adult Dose for Tardive Dyskinesia
-Initial Dose: 40 mg orally once a day
-Maintenance Dose: Increase to 80 mg orally once a day after one week at the initial dose; however, continuation of the initial dose may be considered for some patients.
Comments: Administer with or without food.
Use: Treatment of tardive dyskinesia.
Renal Dose Adjustments
-Mild to Moderate Renal Impairment (CrCl 30 to 90 mL/min): No adjustment recommended.
-Severe Renal Impairment (CrCl less than 30 mL/min): Not recommended.
Liver Dose Adjustments
-Moderate to Severe Hepatic Impairment (Child-Pugh score 7 to 15): 40 mg orally once a day.
CYP450 2D6 POOR METABOLIZERS: Consider reducing the dose based on tolerability.
CONCOMITANT USE WITH MONOAMINE OXIDASE INHIBITORS (MAOIs): Avoid concomitant use.
CONCOMITANT USE WITH STRONG CYP450 INDUCERS/INHIBITORS:
-CYP450 3A4 Inducers: Not recommended.
-CYP450 3A4 Inhibitors: 40 mg orally once a day.
-CYP450 2D6 Inhibitors: Consider reducing the dose based on tolerability.
Safety and efficacy have not been established in patients younger than 18 years.
Consult WARNINGS section for additional precautions.
Data not available.
-Store at 20 to 25 degrees Celsius (68 to 77 degrees Fahrenheit); excursions permitted to 15 to 30 degrees Celsius (59 to 86 degrees Fahrenheit).
-This drug and its active metabolite ([+]-alpha-HTBZ) have no appreciable binding affinity for dopaminergic, serotonergic, adrenergic, histaminergic, or muscarinic receptors.
-Overdosage: No specific antidotes are known, and there is no information regarding overdose symptoms from clinical trials. Provide supportive care and consider the possibility of multiple drug involvement in managing overdose.
Frequently asked questions
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