BOXED WARNING Increased mortality in elderly patients with dementia-related psychosis; suicidal thoughts and behaviors in pediatric/young adults. Not approved for dementia-related psychosis.
FDA dosing
Population
Start
Target
Max
Schizophrenia
Adults
40 mg QD
40–160 mg/day
160 mg/day
Schizophrenia
Adolescents 13–17 yr
40 mg QD
40–80 mg/day
80 mg/day
Bipolar I depression (monotherapy or adjunct to lithium/valproate)
Adults
20 mg QD
20–120 mg/day
120 mg/day
Bipolar I depression (monotherapy)
Pediatric 10–17 yr
20 mg QD
20–80 mg/day
80 mg/day
Titration Initial titration not required; pediatric bipolar dose may be increased after 1 week per clinical response.
Renal Moderate or severe (CrCl <50 mL/min): start 20 mg/day, max 80 mg/day.
Hepatic Moderate (Child-Pugh 7–9): start 20 mg/day, max 80 mg/day. Severe (10–15): start 20 mg/day, max 40 mg/day.