Activities may be mediated through a combination of dopamine and serotonin (5-HT2) antagonism; they are selective monoaminergic antagonists with a strong affinity for serotonin 5-HT2A and 5-HT2c receptors, and dopamine D1, D2, D3, and D4 receptors.

Dosing: Adult

Note: When reinitiating treatment after discontinuation, the initial titration schedule should be followed.

Bipolar mania: Oral: Recommended starting dose: 2-3 mg once daily; if needed, adjust dose by 1 mg/day in intervals ≥24 hours; dosing range: 1-6 mg/day.

Maintenance: No dosing recommendation available for treatment >3 weeks duration

Bipolar I maintenance: I.M. (Risperdal® Consta®): 25 mg every 2 weeks; if unresponsive, some may benefit from larger doses (37.5-50 mg); maximum dose: 50 mg every 2 weeks. Dosage adjustments should not be made more frequently than every 4 weeks. A lower initial dose of 12.5 mg may be appropriate in some patients (eg, demonstrated poor tolerability to other psychotropic medications).

Note: Oral risperidone (or other antipsychotic) should be administered with the initial injection of Risperdal® Consta® and continued for 3 weeks (then discontinued) to maintain adequate therapeutic plasma concentrations prior to main release phase of risperidone from injection site. When switching from depot administration to a short-acting formulation, administer short-acting agent in place of the next regularly-scheduled depot injection.

Schizophrenia:

Oral: Initial: 2 mg/day in 1-2 divided doses; may be increased by 1-2 mg/day at intervals ≥24 hours to a recommended dosage range of 4-8 mg/day; may be given as a single daily dose once maintenance dose is achieved; daily dosages >6 mg do not appear to confer any additional benefit, and the incidence of extrapyramidal symptoms is higher than with lower doses. Further dose adjustments should be made in increments/decrements of 1-2 mg/day on a weekly basis. Dose range studied in clinical trials: 4-16 mg/day. Maintenance: Recommended dosage range: 2-8 mg/day

I.M. (Risperdal® Consta®): Initial: 25 mg every 2 weeks; if unresponsive, some may benefit from larger doses (37.5-50 mg); maximum dose: 50 mg every 2 weeks. Dosage adjustments should not be made more frequently than every 4 weeks. A lower initial dose of 12.5 mg may be appropriate in some patients (eg, demonstrated poor tolerability to other psychotropic medications).

Note: Oral risperidone (or other antipsychotic) should be administered with the initial injection of Risperdal® Consta® and continued for 3 weeks (then discontinued) to maintain adequate therapeutic plasma concentrations prior to main release phase of risperidone from injection site. When switching from depot administration to a short-acting formulation, administer short-acting agent in place of the next regularly-scheduled depot injection.

Post-traumatic stress disorder (PTSD) (unlabeled use): Oral: 0.5-8 mg/day (Bandelow, 2008; Benedek, 2009)

Tourette's syndrome (unlabeled use): Oral: Initial: 0.25 mg once daily for 2 days, then 0.25 mg twice daily for 3 days, then 0.5 mg twice daily for 2 days; titrate slowly thereafter in increments/decrements ≤0.5 mg twice daily and at intervals ≥3 days; maximum dose: 6 mg/day (Dion, 2002)

Dosing: Pediatric

(For additional information see "Risperidone: Pediatric drug information" )

Note: When reinitiating treatment after discontinuation, the initial titration schedule should be followed.

Autism: Children ≥5 years and Adolescents: Oral:

<15 kg: Use with caution; specific dosing recommendations not available

<20 kg: Initial: 0.25 mg/day; may increase dose to 0.5 mg/day after ≥4 days, maintain dose for ≥14 days. In patients not achieving sufficient clinical response, may increase dose by 0.25 mg/day in ≥2-week intervals. Therapeutic effect reached plateau at 1 mg/day in clinical trials. Following clinical response, consider gradually lowering dose. May be administered once daily or in divided doses twice daily.

≥20 kg: Initial: 0.5 mg/day; may increase dose to 1 mg/day after ≥4 days, maintain dose for ≥14 days. In patients not achieving sufficient clinical response, may increase dose by 0.5 mg/day in ≥2-week intervals. Therapeutic effect reached plateau at 2.5 mg/day (3 mg/day in children >45 kg) in clinical trials. Following clinical response, consider gradually lowering dose. May be administered once daily or in divided doses twice daily.

Bipolar mania: Children and Adolescents 10-17 years: Oral: Initial: 0.5 mg once daily; dose may be adjusted in increments of 0.5-1 mg/day at intervals ≥24 hours to a dose of 2.5 mg/day. Doses ranging from 0.5-6 mg/day have been evaluated, however doses >2.5 mg/day do not confer additional benefit and are associated with increased adverse events.

Maintenance: No dosing recommendation available for treatment >3 weeks duration

Pervasive developmental disorder (unlabeled use): Children and Adolescents: Oral:

Initial: 0.25 mg twice daily; titrate up 0.25 mg/day every 5-7 days; optimal dose range: 0.75-1.5 mg/day (Fisman, 1996)

or

Initial: 0.5 mg at bedtime; titrate up 0.5 mg/day every 7 days in a morning and bedtime dosing regimen; dose range: 1-4 mg/day (McDougal, 1997)

Schizophrenia: Adolescents 13-17 years: Oral: Initial: 0.5 mg once daily; dose may be adjusted in increments of 0.5-1 mg/day at intervals ≥24 hours to a dose of 3 mg/day. Doses ranging from 1-6 mg/day have been evaluated, however, doses >3 mg/day do not confer additional benefit and are associated with increased adverse events.

Tourette's syndrome (unlabeled use): Adolescents: Oral: Refer to adult dosing.

Dosing: Geriatric

Oral: Initial: 0.5 mg twice daily; titration should progress slowly in increments of no more than 0.5 mg twice daily; increases to dosages >1.5 mg twice daily should occur at intervals of ≥1 week.

Note: Additional monitoring of renal function and orthostatic blood pressure may be warranted. If once-a-day dosing in the elderly or debilitated patient is considered, a twice daily regimen should be used to titrate to the target dose, and this dose should be maintained for 2-3 days prior to attempts to switch to a once-daily regimen.

Psychosis/agitation related to Alzheimer’s dementia (unlabeled use): Initial: 0.25-1 mg/day; if necessary, gradually increase as tolerated not to exceed 1.5-2 mg/day; doses >1 mg/day are associated with higher rates of extrapyramidal symptoms (Rabins, 2007)

I.M. (Risperdal® Consta®): 25 mg every 2 weeks; a lower initial dose of 12.5 mg may be appropriate in some patients.

Note: Oral risperidone (or other antipsychotic) should be administered with the initial injection of Risperdal® Consta® and continued for 3 weeks (then discontinued) to maintain adequate therapeutic plasma concentrations prior to main release phase of risperidone from injection site. When switching from depot administration to a short-acting formulation, administer short-acting agent in place of the next regularly-scheduled depot injection.

Dosing: Renal Impairment

Oral: Starting dose of 0.5 mg twice daily; titration should progress slowly in increments of no more than 0.5 mg twice daily; increases to dosages >1.5 mg twice daily should occur at intervals of ≥1 week. Clearance of the active moiety is decreased by 60% in patients with moderate-to-severe renal disease compared to healthy subjects.

I.M.: Initiate with oral dosing (0.5 mg twice daily for 1 week then 2 mg/day for 1 week); if tolerated, begin 25 mg I.M. every 2 weeks; continue oral dosing for 3 weeks after the first I.M. injection. An initial I.M. dose of 12.5 mg may also be considered.

Dosing: Hepatic Impairment

Oral: Starting dose of 0.5 mg twice daily; titration should progress slowly in increments of no more than 0.5 mg twice daily; increases to dosages >1.5 mg twice daily should occur at intervals of ≥1 week. The mean free fraction of risperidone in plasma was increased by 35% in patients with hepatic impairment compared to healthy subjects.

I.M.: Initiate with oral dosing (0.5 mg twice daily for 1 week then 2 mg/day for 1 week); if tolerated, begin 25 mg I.M. every 2 weeks; continue oral dosing for 3 weeks after the first I.M. injection. An initial I.M. dose of 12.5 mg may also be considered