Risperidone Dosage

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Usual Adult Dose for:

Usual Geriatric Dose for:

Usual Pediatric Dose for:

Additional dosage information:

Usual Adult Dose for Schizophrenia

Oral Formulations:
Initial dose: 2 mg orally per day
Titration dose: May increase in increments of 1 to 2 mg per day at interval of 24 hours or more, as tolerated.
Target dose: 4 to 8 mg orally per day
Maximum dose: 16 mg orally per day

Comments:
-May be administered orally once a day or in divided doses twice a day.
-Doses above 12 mg per day were not demonstrated to be more efficacious and were associated with more extrapyramidal symptoms and other adverse effects.

Long-acting IM Injection:

For patients who have never taken oral risperidone, it is recommended to establish tolerability with the oral formulation prior to initiating treatment with long acting injection.

Initial dose: 25 mg IM every 2 weeks
Titration dose: May increase to 37.5 mg or 50 mg if needed; dose titration should occur no more frequently than every 4 weeks as expected drug release starts 3 weeks after injection.
Maximum dose: 50 mg IM every 2 weeks

Comments:
-Should be administered by a health care professional as deep IM deltoid or gluteal injection; do not administer IV.
-To ensure adequate therapeutic plasma concentrations are maintained prior to the main release phase of drug from the injection, oral risperidone (or another antipsychotic drug) should be given for 3 weeks following the first injection.
-Some patients not responding to the 25 mg dose may benefit from a 37.5 mg or 50 mg dose, and some patients who have a history of poor tolerability to psychotropic medications may benefit from a lower initial dose of 12.5 mg, however, the efficacy of the 12.5 mg dose has not been studied in clinical trials.

Use: Treatment of schizophrenia

Usual Adult Dose for Bipolar Disorder

Oral formulations:
Initial dose: 2 to 3 mg orally per day
Titration dose: May increase in increments of 1 mg per day at interval of 24 hours or more, as tolerated.
Effective dose range: 1 to 6 mg orally per day
Maximum dose: 6 mg orally per day

Comments: May be administered orally once a day or in divided doses twice a day; patients experiencing somnolence may benefit from twice a day dosing.

Long-acting IM Injection:

For patients who have never taken oral risperidone, it is recommended to establish tolerability with oral formulation prior to initiating treatment with long acting injection.

Initial dose: 25 mg IM every 2 weeks
Titration dose: May increase to 37.5 mg or 50 mg if needed; dose titration should occur no more frequently than every 4 weeks as expected drug release starts 3 weeks after injection.
Maximum dose: 50 mg IM every 2 weeks


Comments:
-Should be administered by a health care professional as deep IM deltoid or gluteal injection; do not administer IV.
-To ensure adequate therapeutic plasma concentrations are maintained prior to the main release phase of drug from the injection, oral risperidone (or another antipsychotic drug) should be given for 3 weeks following the first injection.
-Some patients not responding to the 25 mg dose may benefit from a 37.5 mg or 50 mg dose, and some patients who have a history of poor tolerability to psychotropic medications may benefit from a lower initial dose of 12.5 mg, however, the efficacy of the 12.5 mg dose has not been studied in clinical trials.

Uses: As monotherapy or as adjunctive therapy with lithium or valproate for the treatment of acute manic or mixed episodes associated with Bipolar I Disorder.

Usual Geriatric Dose for Schizophrenia

Oral formulations:
Initial dose: 0.5 mg orally twice a day
Titration dose: May increase in increments of 1 to 2 mg per day at interval of 24 hours or more, as tolerated.
Target dose: 4 to 8 mg orally per day
Maximum dose: 16 mg orally per day

Comments:
-May be administered orally once a day or in divided doses twice a day.
-Elderly patients exhibit a greater tendency to orthostatic hypotension, careful titration with monitoring of orthostatic vital signs should be considered.
-Doses above 12 mg per day were not demonstrated to be more efficacious and were associated with more extrapyramidal symptoms and other adverse effects.

Long-acting IM Injection:

For patients who have never taken oral risperidone, it is recommended to establish tolerability with oral formulation prior to initiating treatment with long acting injection.

Initial dose: 25 mg IM every 2 weeks
Titration dose: May increase to 37.5 mg or 50 mg if needed; dose titration should occur no more frequently than every 4 weeks as expected drug release starts 3 weeks after injection.
Maximum dose: 50 mg IM every 2 weeks

Comments:
-Should be administered by a health care professional as deep IM deltoid or gluteal injection; do not administer IV.
-Elderly patients exhibit a greater tendency to orthostatic hypotension, careful titration with monitoring of orthostatic vital signs should be considered.
-To ensure adequate therapeutic plasma concentrations are maintained prior to the main release phase of drug from the injection, oral risperidone (or another antipsychotic drug) should be given for 3 weeks following the first injection.
-Some patients not responding to the 25 mg dose may benefit from a 37.5 mg or 50 mg dose, and some patients who have a history of poor tolerability to psychotropic medications may benefit from a lower initial dose of 12.5 mg, however, the efficacy of the 12.5 mg dose has not been studied in clinical trials.

Use: Treatment of schizophrenia

Usual Geriatric Dose for Bipolar Disorder

Oral formulations:
Initial dose: 0.5 mg orally twice a day
Titration dose: May increase in increments of 1 mg per day at interval of 24 hours or more, as tolerated.
Effective dose range: 1 to 6 mg orally per day
Maximum dose: 6 mg orally per day

Comments:
-May be administered orally once a day or in divided doses twice a day; patients experiencing somnolence may benefit from twice a day dosing.
-Elderly patients exhibit a greater tendency to orthostatic hypotension, careful titration with monitoring of orthostatic vital signs should be considered.

Long-acting IM Injection:

For patients who have never taken oral risperidone, it is recommended to establish tolerability with oral formulation prior to initiating treatment with long acting injection.

Initial dose: 25 mg IM every 2 weeks
Titration dose: May increase to 37.5 mg or 50 mg if needed; dose titration should occur no more frequently than every 4 weeks as expected drug release starts 3 weeks after injection.
Maximum dose: 50 mg IM every 2 weeks

Comments:
-Should be administered by a health care professional as deep IM deltoid or gluteal injection; do not administer IV.
-Elderly patients exhibit a greater tendency to orthostatic hypotension, careful titration with monitoring of orthostatic vital signs should be considered.
-To ensure adequate therapeutic plasma concentrations are maintained prior to the main release phase of drug from the injection, oral risperidone (or another antipsychotic drug) should be given for 3 weeks following the first injection.
-Some patients not responding to the 25 mg dose may benefit from a 37.5 mg or 50 mg dose, and some patients who have a history of poor tolerability to psychotropic medications may benefit from a lower initial dose of 12.5 mg, however, the efficacy of the 12.5 mg dose has not been studied in clinical trials.

Uses: As monotherapy or as adjunctive therapy with lithium or valproate for the treatment of acute manic or mixed episodes associated with Bipolar I Disorder.

Usual Pediatric Dose for Schizophrenia

13 years or older:
Initial dose: 0.5 mg orally once a day
Titration dose: May increase in increments of 0.5 mg to 1 mg per day at interval of 24 hours or more, as tolerated.
Target dose: 3 mg orally per day
Maximum dose: 6 mg orally per day

Comments:
-May be administered orally once a day or in divided doses twice a day; patients experiencing somnolence may benefit from twice a day dosing.
-Doses greater than 6 mg per day have not been studied

Use: Treatment of schizophrenia

Usual Pediatric Dose for Bipolar Disorder

10 years or older:
Initial dose: 0.5 mg orally once a day
Titration dose: May increase in increments of 0.5 mg to 1 mg per day at interval of 24 hours or more, as tolerated.
Target dose: 1 to 2.5 mg orally per day
Maximum dose: 6 mg orally per day

Comments: May be administered orally once a day or in divided doses twice a day; patients experiencing somnolence may benefit from twice a day dosing.

Use: As monotherapy or as adjunctive therapy with lithium or valproate for the treatment of acute manic or mixed episodes associated with Bipolar I Disorder.

Usual Pediatric Dose for Autism

Ages 5 to 17 years:
-Weight greater than 15 kg and less than 20 kg:
Initial dose: 0.25 mg orally once a day
Titration: after a minimum of 4 days, may increase to 0.5 mg per day; maintain this dose for a minimum of 14 days; subsequent dose increases may be made in increments of 0.25 mg at intervals of 2 weeks or more, as tolerated
Recommended dose: 0.5 mg orally per day
-Weight 20 kg or greater:
Initial dose: 0.5 mg orally once a day
Titration: After a minimum of 4 days, may increase to 1 mg per day; maintain this dose for a minimum of 14 days; subsequent dose increases in increments of 0.5 mg at intervals of 2 weeks or more, as tolerated.
Recommended dose: 1 mg orally per day

Effective dose range: 0.5 mg to 3 mg orally per day; individualize dose according to response and tolerability.
Maximum dose: 3 mg orally per day
Maintenance dose: Once sufficient clinical response has been achieved and maintained, consider gradually reducing the dose to achieve the optimal balance of safety and efficacy.

Comments:
-Dosing data is not available for children weighing less than 15 kg.
-May be administered orally once a day or in divided doses twice a day; patients experiencing somnolence may benefit from twice a day dosing.

Use: For the treatment of irritability associated with autistic disorder, including symptoms of aggression towards others, deliberate self-injuriousness, temper tantrums, and quickly changing moods.

Renal Dose Adjustments

Oral formulations:
Severe renal impairment (CrCl less than 30 mL/min): Initial starting dose: 0.5 mg orally twice a day; increase in increments of 0.5 mg or less, administered twice a day. For doses above 1.5 mg twice a day, increase in intervals of 1 week or greater.

Long-acting IM Injection:
If a total daily oral dose of at least 2 mg once daily is well tolerated, the long acting intramuscular formulation may be used.

Initial dose: 25 mg every 2 weeks by deep IM deltoid or gluteal injection.

Comments:
-A starting dose of 12.5 mg IM may be considered when clinical factors warrant a dose adjustment; however, the efficacy of the 12.5 mg dose has not been studied in clinical trials.

Liver Dose Adjustments

Oral formulations:
Severe hepatic impairment (Child-Pugh 10 to 15): Initial starting dose: 0.5 mg orally twice a day; increase in increments of 0.5 mg or less, administered twice a day. For doses above 1.5 mg twice a day, increase in intervals of 1 week or greater.

Long-acting IM Injection:
If a total daily oral dose of at least 2 mg once daily is well tolerated, the long acting intramuscular formulation may be used.

Initial dose: 25 mg every 2 weeks by deep IM deltoid or gluteal injection.

Comments:
-A starting dose of 12.5 mg IM may be considered when clinical factors warrant a dose adjustment; however, the efficacy of the 12.5 mg dose has not been studied in clinical trials.

Dose Adjustments

Concomitant Administration with Enzyme Inducers (e.g., carbamazepine, phenytoin, rifampin, and phenobarbital)
Oral:
-When initiating an enzyme inducer while receiving risperidone, the risperidone dose may need to be increased up to double.
-When the enzyme inducer is stopped, may need to decrease the oral risperidone dose.
Injection:
-When initiating an enzyme inducer while receiving injectable risperidone, monitor patients closely for the first 4 to 8 weeks for possible dose adjustment (increased injection dose or supplementation with oral risperidone).
-When the enzyme inducer is stopped, the dose of the long-acting injection should be reduced 2 to 4 weeks before the enzyme inducer is stopped due to the delayed release of the drug; if the patient is already receiving the 25 mg dose, may continue with this dose unless clinical judgment necessitates lowering the dose to 12.5 mg; the efficacy of the 12.5 mg has not been investigated.

Concomitant Administration with Fluoxetine or Paroxetine:
Oral:
-When initiating fluoxetine or paroxetine, may need to reduce the oral risperidone dose; maximum dose should not exceed 8 mg/day.
-If initiating risperidone in a patient receiving fluoxetine or paroxetine, titrate risperidone dose slowly.
-When stopping fluoxetine or paroxetine, may need to increase oral risperidone dose.
Injection:
-When initiating fluoxetine or paroxetine, the dose of the long-acting injection should be reduced 2 to 4 weeks before the planned start of fluoxetine or paroxetine due to the delayed risperidone release from the microspheres; if already receiving the 25 mg dose, may continue with 25 mg dose unless clinical judgment necessitates lowering the dose to 12.5 mg or interrupting treatment; the efficacy of the 12.5 mg dose has not been investigated.
-The effects of stopping fluoxetine or paroxetine on the pharmacokinetics of the long-acting injection have not been studied.

Precautions

US BOXED WARNING:
Increased Mortality in Elderly Patients with Dementia-Related Psychosis
-Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death.
-Risperidone is not approved for the treatment of patients with dementia-related psychosis.

Safety and efficacy of the long-acting injection in patients younger than 18 years have not been established.

Safety and efficacy of risperidone in patients younger than 13 years in the treatment of schizophrenia have not been established.

Safety and efficacy of risperidone in patients younger than 10 years in the treatment of bipolar disorder have not been established

Safety and efficacy of risperidone in patients younger than 5 years in the treatment of autistic disorder have not been established.

Consult WARNINGS section for additional precautions.

Dialysis

Hemodialysis: Data not available
Peritoneal dialysis: Data not available

Other Comments

Administration Advice:
-Oral: May take with or without food
-Oral solution: May administer directly from calibrated pipette, or mix with noncarbonated water, coffee, orange juice, or low-fat milk; do not mix with cola or tea
-Oral disintegrating tablets: With dry hands, place the disintegrating tablet on tongue and allow to disintegrate for a few seconds, then swallow with or without water; do not split or chew the tablet
-Injection: Should be administered by a health care professional by deep IM deltoid or gluteal injection using the appropriate enclosed safety needle; do not combine 2 different dose strengths in a single administration; do not administer IV.

Storage requirements:
-Oral tablets: Protect from light
-Oral solution: Protect from light and freezing
-Oral disintegrating tablets: Do not open blister package until ready to administer; child resistant pouch should be torn at notch to access the blister; remove tablets from blister by tearing apart at the perforations and peeling back the foil to expose the tablet; do not push tablet through foil as it may damage the tablet.
-Injection: Store in refrigerator and protect from light; may be unrefrigerated at temperatures not exceeding 25C for no more than 7 days.
-Once reconstituted, use immediately; chemical and physical stability has been demonstrated for 24 hours at 25C, must re-suspend prior to injection.

Reconstitution/preparation techniques - Long-Acting Injection:
-Close attention to step-by-step Instructions for Use is needed to ensure successful administration; the manufacturer product information should be consulted.

General:
-For patients reinitiating treatment, follow the initial titration schedule.
-Controlled clinical trials assessing long-term use are not available; the physician who prescribes risperidone for extended periods should periodically re-evaluate the long-term risks and benefits of the drug for the individual patient.
-No specific recommendations are available regarding switching from other antipsychotics or for the use of concomitant antipsychotics.

Monitoring:
-Cardiovascular: Orthostatic vital signs in at-risk patients
-Hematologic: CBC frequently during the first few months in patients with preexisting low WBC and/or a prior history of drug-induced leukopenia or neutropenia
-Metabolic: Increases in blood sugar, weight, and lipids

Patient Advice:
-Inform patient that this drug may cause dizziness upon arising; it is best to get up slowly form a seated or lying position.
-This drug may impair judgment, thinking, or motor skills; have patient avoid driving or operating machinery until adverse effects are determined.
-Advise patient to speak to physician or health care professional if pregnant, intend to become pregnant, or are breastfeeding.
-Advise patient that this drug may cause metabolic changes such as increases in blood sugar, body weight and lipids.

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