Oral
Schizophrenia
Adult: Initially, 2 mg daily, may be increased to 4 mg on the 2nd day. Subsequent dosage may be maintained or adjusted further if needed in increments of 1-2 mg, as tolerated, at intervals of at least 24 hours. Usual dose range: 4-6 mg daily. Doses may be given once or twice daily. Max: 16 mg daily.
Child: 13-17 years Initially, 0.5 mg once daily, may be increased in increments of 0.5-1 mg daily at intervals of at least 24 hours, as tolerated, to a target dose of 3 mg daily. Dose range: 1-6 mg daily.
Elderly: Initially, 0.5 mg bid, gradually increased in 0.5 mg bid increments to 1-2 mg bid.
Renal impairment: Initial and subsequent doses must be halved. Dose titration must be slower. Dosing recommendation may vary among countries and individual products, refer to local treatment or specific product guidelines.
CrCl (ml/min) | Dosage Recommendation |
<30 | Initially, 0.5 mg bid, may be increased gradually in increments of 0.5 mg (or less) bid, if necessary; for doses >1.5 mg bid, dose increase must be done at intervals of at least 1 week. |
Oral
Acute manic episodes of bipolar disorder
Adult: As monotherapy or adjunctive therapy with lithium or valproate: Initially, 2-3 mg once daily. Dosage may be increased in increments of 1 mg daily at intervals of at least 24 hours. Max: 6 mg daily.
Child: 10-17 years As monotherapy: Initially, 0.5 mg once daily, may be increased in increments of 0.5-1 mg daily at intervals of at least 24 hours, as tolerated, to a target dose of 1-2.5 mg daily. Max: 6 mg daily.
Elderly: Initially, 0.5 mg bid, gradually increased in 0.5 mg bid increments to 1-2 mg bid.
Renal impairment: Initial and subsequent doses must be halved. Dose titration must be slower. Dosing recommendation may vary among countries and individual products, refer to local treatment or specific product guidelines.
CrCl (ml/min) | Dosage Recommendation |
<30 | Initially, 0.5 mg bid, may be increased gradually in increments of 0.5 mg (or less) bid, if necessary; for doses >1.5 mg bid, dose increase must be done at intervals of at least 1 week. |
Oral
Acute mixed episodes of bipolar disorder
Adult: As monotherapy or adjunctive therapy with lithium or valproate: Initially, 2-3 mg once daily. Dosage may be increased in increments of 1 mg daily at intervals of at least 24 hours. Max: 6 mg daily.
Child: 10-17 years As monotherapy: Initially, 0.5 mg once daily, may be increased in increments of 0.5-1 mg daily at intervals of at least 24 hours, as tolerated, to a target dose of 1-2.5 mg daily. Max: 6 mg daily.
Elderly: Initially, 0.5 mg bid, gradually increased in 0.5 mg bid increments to 1-2 mg bid.
Renal impairment: Initial and subsequent doses must be halved. Dose titration must be slower. Dosing recommendation may vary among countries and individual products, refer to local treatment or specific product guidelines.
CrCl (ml/min) | Dosage Recommendation |
<30 | Initially, 0.5 mg bid, may be increased gradually in increments of 0.5 mg (or less) bid, if necessary; for doses >1.5 mg bid, dose increase must be done at intervals of at least 1 week. |
Oral
Conduct disorder
Child: Short-term symptomatic treatment (up to 6 weeks) of persistent aggression in patients with subaverage intellectual functioning or mental retardation, in whom the severity of condition requires pharmacologic treatment: 5-18 years <50 kg: Initially, 0.25 mg once daily. Adjusted individually in increments of 0.25 mg once daily on alternate days, if required. Usual dose: 0.5 mg once daily; some may require up to 0.75 mg once daily. ≥50 kg: Initially, 0.5 mg once daily. Adjusted individually in increments of 0.5 mg once daily on alternate days, if required. Usual dose: 1 mg once daily; some may require up to 1.5 mg once daily.
Renal impairment: Dosing adjustment may be required.
Hepatic impairment: Dosing adjustment may be required.
Oral
Persistent aggression associated with dementia in Alzheimer's disease
Adult: Short-term treatment in patients with moderate to severe dementia who are unresponsive to non-pharmacological intervention, and when there is a risk of harm to self or others: Initially, 0.25 mg bid. Adjusted individually in increments of 0.25 mg bid on alternate days, if required. Usual dose: 0.5 mg bid (up to 1 mg bid, if needed). Max treatment duration: 6 weeks.
Renal impairment: Initial and subsequent doses must be halved. Dose titration must be slower.
Hepatic impairment: Initial and subsequent doses must be halved. Dose titration must be slower.
Oral
Irritability associated with autistic disorder
Child: 5-17 years Dosage is individualised according to patient response and tolerability. 15-<20 kg: Initially, 0.25 mg daily, may be increased to 0.5 mg daily after at least 4 days; maintain dose for at least 14 days. If response is insufficient, dose may be increased in increments of 0.25 mg daily at intervals of ≥2 weeks. ≥20 kg: Initially, 0.5 mg daily, may be increased to 1 mg daily after at least 4 days; maintain dose for at least 14 days. If response is insufficient, dose may be increased in increments of 0.5 mg daily at intervals of ≥2 weeks. All doses may be given as single or in 2 divided doses. Max: 3 mg daily. Consider gradually reducing the dose to lowest effective dose once sufficient response has been achieved.
Renal impairment: Dosing adjustment may be required.
Hepatic impairment: Dosing adjustment may be required.
Intramuscular
Schizophrenia
Adult: Patient naive to risperidone use must receive oral risperidone 1st to establish tolerability before initiation of inj. Initially, 25 mg every 2 weeks. For patients on fixed dose of oral risperidone treated with >4 mg daily for ≥2 weeks: Initially, 37.5 mg every 2 weeks. Doses may be increased in increments of 12.5 mg at intervals of at least 4 weeks. Max: 50 mg every 2 weeks. Continue oral supplementation for 3 weeks after the 1st inj.
Renal impairment: Initiate 1st with oral risperidone (0.5 mg bid for the 1st week followed by 1 mg bid or 2 mg once daily for the 2nd week). If total daily dose of at least 2 mg oral risperidone is well tolerated, dose of 25 mg inj every 2 weeks may be given. Continue oral supplementation for 3 weeks after the 1st inj until the main release from the inj site has begun.
Hepatic impairment: Initiate 1st with oral risperidone (0.5 mg bid for the 1st week followed by 1 mg bid or 2 mg once daily for the 2nd week). If total daily dose of at least 2 mg oral risperidone is well tolerated, dose of 25 mg inj every 2 weeks may be given. Continue oral supplementation for 3 weeks after the 1st inj until the main release from the inj site has begun.
Intramuscular
Bipolar disorder
Adult: Patient naive to risperidone use must receive oral risperidone 1st to establish tolerability before initiation of inj. As monotherapy or adjunctive therapy to lithium or valproate for maintenance treatment: Initially, 25 mg every 2 weeks. Dose may be increased, if necessary, in increments of 12.5 mg at intervals of at least 4 weeks. Max: 50 mg every 2 weeks. Continue oral supplementation for 3 weeks after the 1st inj.
Renal impairment: Initiate 1st with oral risperidone (0.5 mg bid for the 1st week followed by 1 mg bid or 2 mg once daily for the 2nd week). If total daily dose of at least 2 mg oral risperidone is well tolerated, dose of 25 mg inj every 2 weeks may be given. Continue oral supplementation for 3 weeks after the 1st inj until the main release from the inj site has begun.
Hepatic impairment: Initiate 1st with oral risperidone (0.5 mg bid for the 1st week followed by 1 mg bid or 2 mg once daily for the 2nd week). If total daily dose of at least 2 mg oral risperidone is well tolerated, dose of 25 mg inj every 2 weeks may be given. Continue oral supplementation for 3 weeks after the 1st inj until the main release from the inj site has begun.
Subcutaneous
Schizophrenia
Adult: Patient naive to risperidone use must receive oral risperidone 1st to establish tolerability before initiation of inj. Usual dose: 90 mg or 120 mg once monthly. Patients on stable oral risperidone doses of <3 mg daily or >4 mg daily may not be eligible for this route.
Renal impairment: Initiate 1st with oral risperidone and carefully titrate up to at least 3 mg daily. If tolerated and patient is psychiatrically stable, dose of 90 mg inj once monthly may be considered.
Hepatic impairment: Initiate 1st with oral risperidone and carefully titrate up to at least 3 mg daily. If tolerated and patient is psychiatrically stable, dose of 90 mg inj once monthly may be considered.
Special Populations: Oral: Patients receiving enzyme inducers (e.g. carbamazepine): Increase up to double of the usual dose. Patients receiving CYP2D6 inhibitors (fluoxetine or paroxetine): Dose reduction may be required. Titrate risperidone dose slowly during initial therapy. Max: 8 mg daily. IM: Patients receiving enzyme inducers (e.g. carbamazepine): Dose increase or additional oral risperidone may be required (refer to specific product guideline). Patients receiving CYP2D6 inhibitors (fluoxetine or paroxetine): Dose reduction may be required (refer to specific product guideline). SC: Patients receiving enzyme inducers (e.g. carbamazepine): Dose increase or additional oral risperidone may be required (refer to specific product guideline). Patients receiving strong CYP2D6 inhibitors (fluoxetine or paroxetine): May give the lowest dose of 90 mg once monthly (refer to specific product guideline). Pharmacogenomics: Risperidone is well absorbed and is extensively metabolised via hydroxylation by CYP2D6 isoenzyme into the primary active metabolite 9-hydroxyrisperidone. The combination of the concentrations of these two entities comprises the total active moiety. CYP2D6 is subject to genetic polymorphism and to inhibition by a variety of substrates and some non-substrates. CYP2D6 poor metabolisers convert risperidone more slowly into its active metabolite. The prevalence of poor metabolisers is approx 6-8% of Caucasians and a very low percentage of Asians. CYP2D6 ultrarapid metabolisers and poor metabolisers had a higher rate of treatment failure (37% and 26%, respectively), defined as switching to an alternative agent within 1 year as compared to extensive metabolisers. Several published studies have various data on the significance of CYP2D6 phenotype in response to risperidone. Currently, there are insufficient evidences to recommend genetic testing prior to initial treatment. Local treatment guidelines or protocols must be considered. Royal Dutch Pharmacists Association - Pharmacogenetics Working Group (DPWG) Guideline as of May 2020: CYP2D6 ultrarapid metabolisers Individuals have high ratio of 9-hydroxyrisperidone as compared to risperidone. Recommendations: Choose an alternative agent or titrate dose according to Max dose of the active metabolite (Oral: Adults and children ≥15 years ≥51 kg: 12 mg daily; children ≥15 years <51 kg: 6 mg daily. IM: 75 mg per 2 weeks). CYP2D6 poor metabolisers Individuals have increased plasma concentration of active moiety (risperidone plus 9-hydroxyrisperidone) and increases the proportion of risperidone in this ratio. Recommendation: Use 67% of standard dose; if problematic CNS adverse effects occur, reduce dose further to 50% of standard dose. In contrast, the FDA drug label annotation for risperidone states that although extensive metabolisers have lower risperidone and higher 9-hydroxyrisperidone concentrations than poor metabolisers, the concentration of the active moiety does not substantially differ by CYP2D6 status therefore no dosing adjustment is needed.