AdultPediatricGeriatricDosage Forms & Strengths tablet (Risperdal) 0.25mg 0.5mg 1mg 2mg 3mg 4mg oral solution (Risperidal) 1mg/mL kit, long-acting injectable IM suspension (Risperdal Consta) Kit contains prefilled 2-mL diluent syringe, vial containing risperidone microspheres, vial adapter, and needles for deltoid or gluteal IM administration 12.5mg 25mg 37.5mg 50mg kit, extended-release IM injectable suspension (Rykindo) Kit includes a vial containing risperidone powder, a prefilled syringe containing diluent, vial adapter, and needle for IM administration 12.5mg 25mg 37.5mg 50mg kit, extended-release SC injectable suspension (Perseris) Kit includes a prefilled syringe containing risperidone powder, a syringe prefilled with the delivery system and desiccant, and needle for SC administration into the abdomen 90mg 120mg kit, extended-release SC injectable suspension (Uzedy) Kit includes a prefilled, single-dose syringe containing risperidone suspension and a 21-ga, 5/8-in needle for SC administration 50mg/0.14mL 75mg/0.21mL 100mg/0.28mL 125mg/0.35mL 150mg/0.42mL 200mg/0.56mL 250mg/0.7mL Schizophrenia PO (Risperdal or Risperdal M-Tabs) 2 mg/day initially; may increase in increments of 1-2 mg/day at intervals ≥24 hr Recommended target dosage: 2-8 mg/day once daily or divided q12hr (efficacy follows bell-shaped curve; 4-8 mg/day more effective than 12-16 mg/day) IM (Risperdal Consta) 25 mg IM q2Weeks initially If unresponsive, may benefit from a higher dose of 37.5 or 50 mg Not to exceed 50 mg every 2 weeks Oral risperidone or another antipsychotic medication should be given with first injection of Risperdal Consta; may continue for 3 weeks (and then discontinued) to ensure adequate therapeutic plasma concentrations from Risperdal Consta Upward dose titration should not be made more frequently than q4Weeks Clinical effects of each upward dose adjustment should not be anticipated earlier than 3 weeks after injection IM (Rykindo) Patients who are risperidone naïve: Establish tolerability with oral risperidone before initiating Rykindo 25 mg IM q2Weeks Do not combine 2 different dose strengths of Rykindo in a single administration Administer first dose along with 7 days of oral risperidone If unresponsive, may benefit from a higher dose of 37.5 or 50 mg Not to exceed 50 mg q2Weeks No additional benefit was observed with dosages >50 mg of risperidone long-acting injection (IM); a higher incidence of adverse reactions was observed Do not titrate dose more frequently than q4Weeks SC (Perseris) Establish tolerability with oral risperidone before initiating SC 90 mg or 120 mg SC once monthly initially Supplementation with oral risperidone is not recommended Patients who are on stable oral risperidone doses <3 mg/day or >4 mg/day may not be candidates for Perseris Switching from PO risperidone 3 mg/day PO: Initiate 90 mg SC 1 day after last oral dose 4 mg/day PO: Initiate 120 mg SC 1 day after last oral dose SC (Uzedy) Establish tolerability with oral risperidone before initiating SC Initiate SC as either a once monthly injection or once every 2 month injection Supplementation with oral risperidone is not recommended Switching from PO to once monthly risperidone SC Initiate SC the day after last PO dose 2 mg/day PO: 50 mg SC 3mg/day PO: 75 mg SC 4mg/day PO: 100 mg SC 5 mg/day PO: 125 mg SC Switching from PO to every 2 month risperidone SC Initiate SC the day after last PO dose 2 mg/day PO: 100 mg SC 3mg/day PO: 150 mg SC 4mg/day PO: 200 mg SC 5 mg/day PO: 250 mg SC Switching between once monthly and every 2 month SC dosing Can switch between once monthly and once every 2 months by administering the first dose of the new dosing regimen on next scheduled date of administration in original dosing regimen Revise dose administration schedule to reflect change Bipolar Mania PO (Risperdal or Risperidal M-Tabs) 2-3 mg/day initially; may be increased if necessary in increments of 1 mg/day at intervals of 24 hours to 6 mg/day; dosage recommendations not available for treatment duration >3 weeks Bipolar Disorder IM (Risperdal Consta) Monotherapy or in combination with lithium or valproate: 25 mg IM q2Weeks; some patients may benefit from a higher dose of 37.5 mg or 50 mg May continue for 3 weeks (and then discontinued) to ensure adequate therapeutic plasma concentrations from Risperdal Consta Upward dose titration should not be made more frequently than q4Weeks Clinical effects of each upward dose adjustment should not be anticipated earlier than 3 weeks after injection Dosages above 50 mg not studied in this population Periodically re-evaluate the long-term risks and benefits of the drug for the individual patient IM (Rykindo) Monotherapy or in combination with lithium or valproate 25 mg IM q2Weeks Administer the first Rykindo dose along with 7 days of oral risperidone If unresponsive, may benefit from a higher dose of 37.5 or 50 mg Dosages >50 mg have not studied in this population Do not titrate dose more frequently than q4Weeks Tourette Syndrome (Off-label) 0.5-1 mg/day PO; may be increased or decreased in increments of 0.5 mg q12hr at intervals >3 days; not to exceed 6 mg/day Posttraumatic Stress Disorder (Off-label) 0.5-8 mg/day PO Dosing Modifications Renal impairment SC Perseris: Not to exceed 90 mg once monthly Uzedy: Not to exceed 50 mg once monthly PO CrCl <30 mL/min: 0.5 mg q12hr initially; consider longer titration intervals; may be increased by up to 0.5 mg/day PO divided q12hr; dosage increase >1.5 mg q12hr should occur no more frequently than once weekly Long-acting IM injection (Risperdal Consta, Rykindo) Titrate with oral risperidone (up to at least 2 mg) before initiating long-acting IM injection Start with oral risperidone 0.5 mg PO BID during first week, which can be increased to 1 mg BID or 2 mg qDay during second week; some patients may require slower titration If a total daily dose of at least 2 mg oral risperidone is well tolerated, administer 25 mg q2Weeks with oral supplementation for 7 days following first injection Alternatively, initiating at a 12.5-mg dose may be appropriate Although not studied in patients with renal impairment, these patients may have reduced risperidone elimination compared to patients with normal renal function Hepatic impairment SC Perseris: Not to exceed 90 mg once monthly Uzedy: Not to exceed 50 mg once monthly Child-Pugh 10-15 points (PO) 0.5 mg q12hr initially; consider longer titration intervals; may be increased by up to 0.5 mg/day PO divided q12hr; dosage increase >1.5 mg q12hr should occur no more frequently than once weekly Long-acting IM injection (Risperdal Consta, Rykindo) Titrate with oral risperidone (up to at least 2 mg) before initiating long-acting IM injection Start with oral risperidone 0.5 mg PO BID during first week, which can be increased to 1 mg BID or 2 mg qDay during second week; some patients may require slower titration If a total daily dose of at least 2 mg oral risperidone is well tolerated, administer 25 mg q2Weeks with oral supplementation for 7 days following first injection Alternatively, initiating at a 12.5-mg dose may be appropriate Although not studied in patients with hepatic impairment, these patients may have clinically significant increase in the free fraction of risperidone, possibly resulting in an enhanced effect Patients with Parkinson disease or dementia with Lewy bodies Patients with Parkinson disease or dementia with Lewy bodies can experience increased sensitivity to long-acting IM injection Manifestations can include confusion, obtundation, postural instability with frequent falls, extrapyramidal symptoms, and clinical features consistent with neuroleptic malignant syndrome Coadministration with strong CYP2D6 inhibitors SC, ER suspension Consider reducing to lowest risperidone SC dose 2-4 weeks before planned start of strong CYP2D6 inhibitors (eg, fluoxetine, paroxetine) to adjust for expected increase in plasma concentrations of risperidone Perseris: 90 mg once monthly Uzedy: 50 mg once monthly or 100 mg once every 2 months Continue treatment with these doses unless clinical judgment necessitates interruption IM, long-acting injectable suspension When initiating or discontinuing a strong CYP2D6 inhibitor (eg, fluoxetine, paroxetine), reduce IM risperidone dose between 2-4 weeks before planned initiation or discontinuation of CYP2D6 inhibitor to adjust for the expected increase in plasma risperidone concentrations When a CYP2D6 inhibitor initiated in patients receiving 25 mg IM of long-acting risperidone suspension, continue with 25 mg unless clinical judgment requires lowering to 12.5 mg IM or interrupting treatment If long-acting IM risperidone suspension is initiated in patients already receiving a strong CYP2D6 inhibitor, consider initiating at 12.5 mg IM; efficacy of the 12.5 mg dose has not been investigated in clinical trials PO When a strong CYP2D6 inhibitor (eg, fluoxetine, or paroxetine) is coadministered with oral risperidone, reduce oral risperidone dose; dose should not exceed 8 mg/day in adults when coadministered with these drugs When initiating therapy, titrate oral risperidone slowly If enzyme inhibitor is discontinued, assess risperidone dose and increase if necessary Coadministration with strong CYP3A4 inducers SC, ER injectable suspension At initiation of therapy with CYP3A4 inducers (eg, carbamazepine, phenytoin, rifampin, phenobarbital), closely monitor during the first 4-8 weeks In patients receiving risperidone ER suspension 90 mg, consider increasing the dose to 120 mg Perseris 90 mg/month: Consider increasing to 120 mg/month Perseris 120 mg/month: Consider additional oral risperidone therapy Uzedy: A dose increase or additional oral risperidone, may be considered On discontinuation of strong CYP3A4 inducers, re-evaluated risperidone dose and if necessary, decrease to adjust for expected increase in plasma concentration IM, long-acting injectable suspension Coadministration with strong CYP3A4 inducers (eg, carbamazepine, phenytoin, rifampin, phenobarbital) with risperidone would be expected to cause decreases in the plasma concentrations of the sum of risperidone and 9-hydroxyrisperidone combined, which could lead to decreased efficacy of IM risperidone; titrate accordingly for patients receiving these enzyme inducers, especially during initiation or discontinuation of therapy with these inducers At the initiation of therapy with CYP3A4 inducers, patients should be closely monitored during the first 4-8 weeks, since the dose of IM risperidone may need to be adjusted; a dose increase, or additional oral risperidone, may need to be considered If enzyme inducer is discontinued, re-evaluate risperidone dose and decrease if necessary May lower dose of IM risperidone between 2-4 weeks before planned discontinuation CYP3A4 inducers to adjust for expected increase in plasma concentrations of risperidone plus 9-hydroxyrisperidone For patients treated with 25 mg and discontinuing from CYP3A4 inducers, continue treatment with the 25-mg dose unless clinical judgment necessitates lowering dose to 12.5 mg or necessitates interruption of IM risperidone treatment Efficacy of the 12.5 mg dose has not been investigated in clinical trials PO Coadministered with enzyme inducers (eg, carbamazepine), the risperidone dose should be increased up to double the patient’s usual dose If enzyme inducer is discontinued, assess risperidone dose and decrease if necessary Dosing Considerations For patient who have never taken risperidone, establish tolerability with PO risperidone before initiating the IM or SC dosage forms Switching from other antipsychotics to IM risperidone (Risperdal Consta only) No collected data specifically addresses switching patients from other antipsychotics to IM risperidone or concerning concomitant administration with other antipsychotics Continue previous antipsychotics for 3 weeks after the first injection of IM risperidone to maintain therapeutic concentrations until main release phase of risperidone from the injection site has begun As recommended with other antipsychotic medications, periodically re-evaluate the need for continuing existing EPS medication Switching from long-acting IM injection (eg, Risperdal Consta) to another long-acting IM injection (eg, Rykindo) Current long-acting IM injection (eg, Rykindo) dose for patients receiving another long-acting IM injection (eg, Risperdal Consta) should be the same as that of the previous Risperdal Consta dose Give first injection of Rykindo 4 weeks (no later than 5 weeks) after last Risperdal Consta was administered Supplementing with oral risperidone is not recommended Do not titrate more frequently than q4Weeks Reinitiating treatment in patients previously discontinued (Risperdal Consta, Rykindo) No data are available When restarting after a period off treatment, reinitiate previously established dosage if patient’s general medical condition has not change Supplementation with oral risperidone is required Dosage Forms & Strengths tablet 0.25mg 0.5mg 1mg 2mg 3mg 4mg oral solution 1mg/mL Schizophrenia <13 years: Safety and efficacy not established >13 years: 0.5 mg/day PO in morning or evening initially; may be increased in increments of 0.5-1 mg/day at intervals ≥24 hr to recommended dosage of 3 mg/day; dosage range: 1-6 mg/day (dosages >3 mg/day have not been proved more effective and are associated with increased incidence of adverse effects) If persistent somnolence occurs, daily dose may be divided q12hr Bipolar Mania <10 years: Safety and efficacy not established >10 years: 0.5 mg/day PO in morning or evening initially; may be increased in increments of