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RisperiDONE

Pronunciation

Pronunciation

(ris PER i done)

Index Terms

  • Risperdal M-Tab

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Solution, Oral:

RisperDAL: 1 mg/mL (30 mL) [contains benzoic acid]

Generic: 1 mg/mL (30 mL)

Suspension Reconstituted, Intramuscular:

RisperDAL Consta: 12.5 mg (1 ea); 25 mg (1 ea); 37.5 mg (1 ea); 50 mg (1 ea)

Tablet, Oral:

RisperDAL: 0.25 mg, 0.5 mg, 1 mg

RisperDAL: 2 mg [contains fd&c yellow #6 aluminum lake]

RisperDAL: 3 mg [contains fd&c yellow #10 (quinoline yellow)]

RisperDAL: 4 mg [contains fd&c blue #2 aluminum lake, fd&c yellow #10 (quinoline yellow)]

Generic: 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, 4 mg

Tablet Dispersible, Oral:

RisperDAL M-TAB: 0.5 mg, 1 mg, 2 mg, 3 mg, 4 mg [contains aspartame, peppermint oil (mentha piperita oil)]

RisperiDONE M-TAB: 0.5 mg, 1 mg, 2 mg, 3 mg, 4 mg [contains aspartame]

Generic: 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, 4 mg

Brand Names: U.S.

  • RisperDAL
  • RisperDAL Consta
  • RisperDAL M-TAB
  • RisperiDONE M-TAB

Pharmacologic Category

  • Antimanic Agent
  • Second Generation (Atypical) Antipsychotic

Pharmacology

Risperidone is a benzisoxazole atypical antipsychotic with mixed serotonin-dopamine antagonist activity that binds to 5-HT2-receptors in the CNS and in the periphery with a very high affinity; binds to dopamine-D2 receptors with less affinity. The binding affinity to the dopamine-D2 receptor is 20 times lower than the 5-HT2 affinity. The addition of serotonin antagonism to dopamine antagonism (classic neuroleptic mechanism) is thought to improve negative symptoms of psychoses and reduce the incidence of extrapyramidal side effects. Alpha1, alpha2 adrenergic, and histaminergic receptors are also antagonized with high affinity. Risperidone has low to moderate affinity for 5-HT1C, 5-HT1D, and 5-HT1A receptors, weak affinity for D1 and no affinity for muscarinics or beta1 and beta2 receptors

Absorption

Oral: Rapid and well absorbed; food does not affect rate or extent

Injection: <1% absorbed initially; main release occurs at ~3 weeks and is maintained from 4 to 6 weeks

Distribution

Vd: 1 to 2 L/kg

Metabolism

Extensively hepatic via CYP2D6 to 9-hydroxyrisperidone (similar pharmacological activity as risperidone); N-dealkylation is a second minor pathway

Excretion

Urine (70%); feces (14%)

Time to Peak

Plasma: Oral: Risperidone: Within 1 hour; 9-hydroxyrisperidone: Extensive metabolizers: 3 hours; Poor metabolizers: 17 hours

Half-Life Elimination

Active moiety (risperidone and its active metabolite 9-hydroxyrisperidone)

Oral: 20 hours (mean)

Extensive metabolizers: Risperidone: 3 hours; 9-hydroxyrisperidone: 21 hours

Poor metabolizers: Risperidone: 20 hours; 9-hydroxyrisperidone: 30 hours

Injection: 3 to 6 days; related to microsphere erosion and subsequent absorption of risperidone

Protein Binding

Plasma: Risperidone 90%; 9-hydroxyrisperidone: 77%

Special Populations: Renal Function Impairment

Moderate to severe

Cl of parent drug and active metabolite decreased 60%. Dosage reduction recommended.

Special Populations: Hepatic Function Impairment

Mean free fraction of risperidone in plasma increased approximately 35%. Dosage reduction recommended.

Special Populations: Elderly

PO

Renal Cl of parent drug and active metabolite was decreased. Elimination half-life was prolonged. Modify dose accordingly.

IM

No dosing changes required.

Use: Labeled Indications

Oral: Treatment of schizophrenia; treatment of acute mania or mixed episodes associated with bipolar I disorder (as monotherapy in children or adults, or in combination with lithium or valproate in adults); treatment of irritability/aggression associated with autistic disorder

Canadian labeling: Additional use (not in US labeling): Short-term treatment of aggression or psychotic symptoms in patients with severe dementia of the Alzheimer type unresponsive to nonpharmacologic therapy and when there is risk of harm to self or others.

Injection: Treatment of schizophrenia; maintenance treatment of bipolar I disorder in adults as monotherapy or in combination with lithium or valproate

Use: Unlabeled

Treatment of Tourette's syndrome; psychosis/agitation related to Alzheimer’s dementia; post-traumatic stress disorder (PTSD)

Contraindications

Hypersensitivity to risperidone or any component of the formulation

Dosage

Note: When reinitiating treatment after discontinuation, the initial titration schedule should be followed. Use in patients <18 years of age is not recommended in the Canadian labeling.

Oral:

Children ≥5 years and Adolescents: Autism:

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

15 to <20 kg: Initial: 0.25 mg daily; may increase dose to 0.5 mg daily after ≥4 days, maintain dose for ≥14 days. In patients not achieving sufficient clinical response, may increase dose by 0.25 mg daily in ≥2-week intervals. Doses ranging from 0.5 to 3 mg daily have been evaluated; however, therapeutic effect reached plateau at 1 mg daily 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 daily; may increase dose to 1 mg daily after ≥4 days, maintain dose for ≥14 days. In patients not achieving sufficient clinical response, may increase dose by 0.5 mg daily in ≥2-week intervals. Doses ranging from 0.5 to 3 mg daily have been evaluated; however, therapeutic effect reached plateau at 2.5 mg daily (3 mg daily 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.

Children and Adolescents:

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

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

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

Tourette syndrome (off-label use): Oral: Initial: 0.125 to 0.5 mg once daily; increase gradually based on response and tolerability up to a usual dosage of 0.75 to 3.0 mg daily (AACAP [Murphy 2013]; Pringsheim 2012). Dosage adjustments in clinical trials were commonly in increments of <0.5 mg twice daily and at intervals ≥3 days; doses up to 4 mg daily in children and up to 6 mg daily in adolescents have been evaluated (Bruggeman 2001; Dion 2002; Ghanizadeh 2014; Gilbert 2004; Scahill 2003).

Adults: Note: Limiting initial dose to 2 mg daily (in 1 or 2 divided doses) may reduce the risk of orthostatic hypotension/syncope.

Schizophrenia:

Initial: 2 mg daily in 1 to 2 divided doses; may be increased by 1 to 2 mg daily at intervals ≥24 hours to a recommended dosage range of 4 to 8 mg daily; 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 to 2 mg daily on a weekly basis. Dose range studied in clinical trials: 4 to 16 mg daily.

Maintenance: Recommended dosage range: 2 to 8 mg daily

Bipolar mania:

Initial: 2 to 3 mg once daily; if needed, adjust dose by 1 mg daily in intervals ≥24 hours; dosing range: 1 to 6 mg daily

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

Major depressive disorder (adjunct to antidepressants; off-label use): Oral: Initial: 0.25 mg to 0.5 mg daily; slowly adjust dose based on response and tolerability up to 3 mg/day (Keitner 2009; Mahmoud 2007; Rapaport 2006; Reeves 2008). Average doses in clinical trials were 1.2 to 1.6 mg/day (Komossa 2010).

Post-traumatic stress disorder (PTSD) (off-label use): Oral: Initial: 0.5 to 1 mg at bedtime or 0.5 mg twice daily; may adjust dose based on response and tolerability to a maximum of 8 mg daily; total daily dose may be given in 2 or 3 divided doses. Average dose in clinical trials: 1.25 to 3.75 mg daily (Bandelow 2008; Bartzokis 2005; Hamner 2003; Padala 2006; Reich 2004; Rothbaum 2008).

Tourette syndrome (off-label use): Oral: Initial: 0.25 mg once daily; increase gradually based on response and tolerability up to a usual dosage of 0.25 to 6 mg daily (Pringsheim 2012; Roessner 2011). Dosage adjustments in clinical trials were commonly in increments of <0.5 mg twice daily and at intervals ≥3 days (Bruggeman 2001; Dion 2002; Scahill 2003).

Elderly: Note: Limiting initial dose to 1 mg daily (in 2 divided doses) may reduce the risk of orthostatic hypotension/syncope. Additional monitoring of renal function and orthostatic blood pressure may be warranted. If once-daily 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 to 3 days prior to attempts to switch to a once-daily regimen.

US labeling: 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.

Canadian labeling: Schizophrenia: Initial: 0.25 mg twice daily; titrate slowly to a maximum dose of 3 mg daily.

Psychosis/agitation related to Alzheimer disease and other dementias (labeled indication in Canada; off-label use in US):

Canadian labeling: Severe Alzheimer dementia (short-term management): Initial: 0.25 mg twice daily; titrate in increments of 0.25 mg every 2 to 4 days as needed. Most patients respond optimally to 0.5 mg twice daily; maximum dose: 2 mg daily in 2 divided doses. Consider periodic dosage adjustments to reduce or discontinue therapy as clinically indicated.

Alternative recommendations: Initial: 0.25 to 1 mg once daily; if necessary, gradually increase based on response and tolerability not to exceed 2 mg once daily. Doses >1 mg daily are associated with higher rates of extrapyramidal symptoms. Consider periodic dosage adjustments to reduce or discontinue therapy as clinically indicated (APA [Rabins] 2007; Brodaty 2003; De Deyn 1999; Katz 1999; Scheider 2006; Sultzer 2008).

IM: 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.

Adults: Schizophrenia, bipolar I maintenance (Risperdal Consta): Initial: 25 mg every 2 weeks; if unresponsive, some may benefit from larger doses (37.5 to 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).

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

Dosage adjustment in renal impairment: Adults: Note: Limiting initial dose to 1 mg daily (in 2 divided doses) may reduce the risk of orthostatic hypotension/syncope.

Oral:

US labeling:

Mild or moderate impairment (CrCl ≥30 mL/minute): There are no dosage adjustments provided in the manufacturer’s labeling. However, clearance may be decreased and doses should be reduced in patients with renal disease.

Severe impairment (CrCl <30 mL/minute): Initial: 0.5 mg twice daily; titrate 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 (CrCl <60 mL/minute) compared to healthy subjects.

Canadian labeling: Mild to severe impairment: Initial: 0.5 mg twice daily; titrate 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. Slower titrations may be appropriate in some patients.

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

Dosage adjustment in hepatic impairment: Adults: Note: Limiting initial dose to 1 mg daily (in 2 divided doses) may reduce the risk of orthostatic hypotension/syncope.

Oral:

US labeling:

Mild or moderate impairment (Child-Pugh class A or B): There are no dosage adjustments provided in the manufacturer’s labeling. However, based on pharmacokinetics, doses should be reduced in patients with liver disease.

Severe impairment (Child-Pugh class C): Initial: 0.5 mg twice daily; titrate 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.

Canadian labeling: Schizophrenia and related psychotic disorders: Mild to severe impairment (Child–Pugh Class A, B, or C): Initial: 0.25 mg to 0.5 mg twice daily; titrate slowly in increments of 0.5 mg twice daily up to maximum dose of 1 mg to 2 mg twice daily. Increases to dosages >1.5 mg twice daily should occur at intervals of ≥1 week.

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

Reconstitution

Hazardous agent; use appropriate precautions for handling and disposal (NIOSH 2014 [group 2]).

Risperdal Consta: Do not substitute any components of the dose pack. Bring to room temperature for ≥ 30 minutes prior to reconstitution (do not warm any other way). Reconstitute with provided diluent only. Refer to the manufacturer’s labeling for device assembly and reconstitution instructions. Do not store suspension after reconstitution; administer immediately after reconstitution.

Administration

Oral: May be administered without regard to meals.

Oral solution can be administered directly from the provided pipette or may be mixed with water, coffee, orange juice, or low-fat milk, but is not compatible with cola or tea.

In children or adolescents experiencing somnolence, half the daily dose may be administered twice daily or the once-daily dose may be administered at bedtime.

Risperdal M-Tab should not be removed from blister pack until administered. Do not push tablet through foil (tablet may become damaged); peel back foil to expose tablet. Using dry hands, place immediately on tongue. Tablet will dissolve within seconds, and may be swallowed with or without liquid. Do not split or chew.

IM: Shake syringe vigorously just before injection. Administer IM into either the deltoid muscle or the upper outer quadrant of the gluteal area. Not for intravenous use; administer only IM; avoid inadvertent injection into vasculature. Injection should alternate between the two arms or buttocks. Do not combine two different dosage strengths into one single administration. Do not substitute any components of the dose-pack; administer with needle provided (1-inch needle for deltoid administration or 2-inch needle for gluteal administration).

Hazardous agent; use appropriate precautions for handling and disposal (NIOSH 2014 [group 2]).

Dietary Considerations

May be taken without regard to meals. Some products may contain phenylalanine.

Storage

Injection: Risperdal Consta: Store at 2°C to 8°C (36°F to 46°F) and protect from light. May be stored at 25°C (77°F) for up to 7 days prior to administration; do not expose unrefrigerated product to temperatures above 77°F (25°C). Following reconstitution, administer immediately (do not store for future use).

Oral solution, tablet: Store at 15°C to 25°C (59°F to 77°F). Protect from light and moisture. Keep orally-disintegrating tablets sealed in foil pouch until ready to use. Do not freeze solution.

Drug Interactions

Abiraterone Acetate: May increase the serum concentration of CYP2D6 Substrates. Management: Avoid concurrent use of abiraterone with CYP2D6 substrates that have a narrow therapeutic index whenever possible. When concurrent use is not avoidable, monitor patients closely for signs/symptoms of toxicity. Consider therapy modification

AbobotulinumtoxinA: Anticholinergic Agents may enhance the anticholinergic effect of AbobotulinumtoxinA. Monitor therapy

Acetylcholinesterase Inhibitors: May diminish the therapeutic effect of Anticholinergic Agents. Anticholinergic Agents may diminish the therapeutic effect of Acetylcholinesterase Inhibitors. Monitor therapy

Acetylcholinesterase Inhibitors (Central): May enhance the neurotoxic (central) effect of Antipsychotic Agents. Severe extrapyramidal symptoms have occurred in some patients. Monitor therapy

Aclidinium: May enhance the anticholinergic effect of Anticholinergic Agents. Avoid combination

Alcohol (Ethyl): CNS Depressants may enhance the CNS depressant effect of Alcohol (Ethyl). Monitor therapy

Amisulpride: Antipsychotic Agents may enhance the adverse/toxic effect of Amisulpride. Avoid combination

Amphetamines: Antipsychotic Agents may diminish the stimulatory effect of Amphetamines. Monitor therapy

Analgesics (Opioid): Anticholinergic Agents may enhance the adverse/toxic effect of Analgesics (Opioid). Specifically, the risk for constipation and urinary retention may be increased with this combination. Monitor therapy

Anticholinergic Agents: May enhance the adverse/toxic effect of other Anticholinergic Agents. Exceptions: Levocabastine (Nasal). Monitor therapy

Antidiabetic Agents: Hyperglycemia-Associated Agents may diminish the therapeutic effect of Antidiabetic Agents. Monitor therapy

Anti-Parkinson's Agents (Dopamine Agonist): Antipsychotic Agents (Second Generation [Atypical]) may diminish the therapeutic effect of Anti-Parkinson's Agents (Dopamine Agonist). Management: Consider using an alternative antipsychotic agent when possible in patients with Parkinson's disease. If an atypical antipsychotic is necessary, consider using clozapine or quetiapine, which may convey the lowest interaction risk. Consider therapy modification

ARIPiprazole: CYP2D6 Inhibitors (Weak) may increase the serum concentration of ARIPiprazole. Management: Monitor for increased aripiprazole pharmacologic effects. Aripiprazole dose adjustments may or may not be required based on concomitant therapy and/or indication. Consult full interaction monograph for specific recommendations. Monitor therapy

Azelastine (Nasal): CNS Depressants may enhance the CNS depressant effect of Azelastine (Nasal). Avoid combination

Blood Pressure Lowering Agents: May enhance the hypotensive effect of Antipsychotic Agents (Second Generation [Atypical]). Monitor therapy

Brimonidine (Topical): May enhance the CNS depressant effect of CNS Depressants. Monitor therapy

Buprenorphine: CNS Depressants may enhance the CNS depressant effect of Buprenorphine. Management: Consider reduced doses of other CNS depressants, and avoiding such drugs in patients at high risk of buprenorphine overuse/self-injection. Initiate buprenorphine patches (Butrans brand) at 5 mcg/hr in adults when used with other CNS depressants. Consider therapy modification

Cannabis: May enhance the CNS depressant effect of CNS Depressants. Monitor therapy

CarBAMazepine: May decrease the serum concentration of RisperiDONE. Management: Consider increasing the dose of risperidone (to no more than double the original dose) if carbamazepine is initiated/dose increased. Monitor for reduced therapeutic effects of risperidone. Consider therapy modification

Cimetropium: Anticholinergic Agents may enhance the anticholinergic effect of Cimetropium. Avoid combination

CNS Depressants: May enhance the adverse/toxic effect of other CNS Depressants. Exceptions: Levocabastine (Nasal). Monitor therapy

Cobicistat: May increase the serum concentration of CYP2D6 Substrates. Monitor therapy

CYP2D6 Inhibitors (Moderate): May decrease the metabolism of CYP2D6 Substrates. Monitor therapy

CYP2D6 Inhibitors (Strong): May decrease the metabolism of CYP2D6 Substrates. Consider therapy modification

Darunavir: May increase the serum concentration of CYP2D6 Substrates. Monitor therapy

Doxylamine: May enhance the CNS depressant effect of CNS Depressants. Management: The manufacturer of Diclegis (doxylamine/pyridoxine), intended for use in pregnancy, specifically states that use with other CNS depressants is not recommended. Monitor therapy

Dronabinol: May enhance the CNS depressant effect of CNS Depressants. Monitor therapy

Droperidol: May enhance the CNS depressant effect of CNS Depressants. Management: Consider dose reductions of droperidol or of other CNS agents (e.g., opioids, barbiturates) with concomitant use. Consider therapy modification

Eluxadoline: Anticholinergic Agents may enhance the constipating effect of Eluxadoline. Avoid combination

Gastrointestinal Agents (Prokinetic): Anticholinergic Agents may diminish the therapeutic effect of Gastrointestinal Agents (Prokinetic). Monitor therapy

Glucagon: Anticholinergic Agents may enhance the adverse/toxic effect of Glucagon. Specifically, the risk of gastrointestinal adverse effects may be increased. Avoid combination

Glycopyrrolate: Anticholinergic Agents may enhance the anticholinergic effect of Glycopyrrolate. Avoid combination

Glycopyrrolate (Oral Inhalation): Anticholinergic Agents may enhance the anticholinergic effect of Glycopyrrolate (Oral Inhalation). Avoid combination

Highest Risk QTc-Prolonging Agents: QTc-Prolonging Agents (Indeterminate Risk and Risk Modifying) may enhance the QTc-prolonging effect of Highest Risk QTc-Prolonging Agents. Management: Avoid such combinations when possible. Use should be accompanied by close monitoring for evidence of QT prolongation or other alterations of cardiac rhythm. Consider therapy modification

Hydrocodone: CNS Depressants may enhance the CNS depressant effect of Hydrocodone. Management: Consider starting with a 20% to 30% lower hydrocodone dose when using together with any other CNS depressant. Dose reductions in the other CNS depressant may also be warranted. Consider therapy modification

HydrOXYzine: May enhance the CNS depressant effect of CNS Depressants. Monitor therapy

Ipratropium (Oral Inhalation): May enhance the anticholinergic effect of Anticholinergic Agents. Avoid combination

Itopride: Anticholinergic Agents may diminish the therapeutic effect of Itopride. Monitor therapy

Kava Kava: May enhance the adverse/toxic effect of CNS Depressants. Monitor therapy

Levosulpiride: Anticholinergic Agents may diminish the therapeutic effect of Levosulpiride. Avoid combination

Lithium: May enhance the neurotoxic effect of Antipsychotic Agents. Lithium may decrease the serum concentration of Antipsychotic Agents. Specifically noted with chlorpromazine. Monitor therapy

Loop Diuretics: May enhance the adverse/toxic effect of RisperiDONE. Management: Consider alternative diuretic therapy (e.g., thiazides) to more potent diuretics (e.g., furosemide) in elderly patients receiving risperidone. Patients who require use of more potent diuretic therapy should be closely monitored and adequately hydrated. Consider therapy modification

Lumacaftor: May decrease the serum concentration of P-glycoprotein/ABCB1 Substrates. Lumacaftor may increase the serum concentration of P-glycoprotein/ABCB1 Substrates. Monitor therapy

Magnesium Sulfate: May enhance the CNS depressant effect of CNS Depressants. Monitor therapy

Mequitazine: Antipsychotic Agents may enhance the arrhythmogenic effect of Mequitazine. Management: Consider alternatives to one of these agents when possible. While this combination is not specifically contraindicated, mequitazine labeling describes this combination as discouraged. Consider therapy modification

Methotrimeprazine: CNS Depressants may enhance the CNS depressant effect of Methotrimeprazine. Methotrimeprazine may enhance the CNS depressant effect of CNS Depressants. Management: Reduce adult dose of CNS depressant agents by 50% with initiation of concomitant methotrimeprazine therapy. Further CNS depressant dosage adjustments should be initiated only after clinically effective methotrimeprazine dose is established. Consider therapy modification

Methylphenidate: Antipsychotic Agents may enhance the adverse/toxic effect of Methylphenidate. Methylphenidate may enhance the adverse/toxic effect of Antipsychotic Agents. Monitor therapy

Metoclopramide: May enhance the adverse/toxic effect of Antipsychotic Agents. Avoid combination

Metyrosine: CNS Depressants may enhance the sedative effect of Metyrosine. Monitor therapy

Metyrosine: May enhance the adverse/toxic effect of Antipsychotic Agents. Monitor therapy

Mianserin: May enhance the anticholinergic effect of Anticholinergic Agents. Monitor therapy

Mifepristone: May enhance the QTc-prolonging effect of QTc-Prolonging Agents (Indeterminate Risk and Risk Modifying). Management: Though the drugs listed here have uncertain QT-prolonging effects, they all have some possible association with QT prolongation and should generally be avoided when possible. Consider therapy modification

Minocycline: May enhance the CNS depressant effect of CNS Depressants. Monitor therapy

Mirabegron: Anticholinergic Agents may enhance the adverse/toxic effect of Mirabegron. Monitor therapy

Mirtazapine: CNS Depressants may enhance the CNS depressant effect of Mirtazapine. Monitor therapy

Moderate Risk QTc-Prolonging Agents: QTc-Prolonging Agents (Indeterminate Risk and Risk Modifying) may enhance the QTc-prolonging effect of Moderate Risk QTc-Prolonging Agents. Monitor therapy

Nabilone: May enhance the CNS depressant effect of CNS Depressants. Monitor therapy

OnabotulinumtoxinA: Anticholinergic Agents may enhance the anticholinergic effect of OnabotulinumtoxinA. Monitor therapy

Orphenadrine: CNS Depressants may enhance the CNS depressant effect of Orphenadrine. Avoid combination

Paliperidone: RisperiDONE may enhance the adverse/toxic effect of Paliperidone. Management: Additive paliperidone exposure is expected with this combination. Consider using an alternative combination when possible. Consider therapy modification

Panobinostat: May increase the serum concentration of CYP2D6 Substrates. Management: Avoid concurrent use of sensitive CYP2D6 substrates when possible, particularly those substrates with a narrow therapeutic index. Consider therapy modification

Paraldehyde: CNS Depressants may enhance the CNS depressant effect of Paraldehyde. Avoid combination

Peginterferon Alfa-2b: May decrease the serum concentration of CYP2D6 Substrates. Peginterferon Alfa-2b may increase the serum concentration of CYP2D6 Substrates. Monitor therapy

Perampanel: May enhance the CNS depressant effect of CNS Depressants. Management: Patients taking perampanel with any other drug that has CNS depressant activities should avoid complex and high-risk activities, particularly those such as driving that require alertness and coordination, until they have experience using the combination. Consider therapy modification

P-glycoprotein/ABCB1 Inducers: May decrease the serum concentration of P-glycoprotein/ABCB1 Substrates. P-glycoprotein inducers may also further limit the distribution of p-glycoprotein substrates to specific cells/tissues/organs where p-glycoprotein is present in large amounts (e.g., brain, T-lymphocytes, testes, etc.). Monitor therapy

P-glycoprotein/ABCB1 Inhibitors: May increase the serum concentration of P-glycoprotein/ABCB1 Substrates. P-glycoprotein inhibitors may also enhance the distribution of p-glycoprotein substrates to specific cells/tissues/organs where p-glycoprotein is present in large amounts (e.g., brain, T-lymphocytes, testes, etc.). Monitor therapy

Potassium Chloride: Anticholinergic Agents may enhance the ulcerogenic effect of Potassium Chloride. Management: Patients on drugs with substantial anticholinergic effects should avoid using any solid oral dosage form of potassium chloride. Avoid combination

Pramlintide: May enhance the anticholinergic effect of Anticholinergic Agents. These effects are specific to the GI tract. Consider therapy modification

Quinagolide: Antipsychotic Agents may diminish the therapeutic effect of Quinagolide. Monitor therapy

Ramosetron: Anticholinergic Agents may enhance the constipating effect of Ramosetron. Monitor therapy

Ranolazine: May increase the serum concentration of P-glycoprotein/ABCB1 Substrates. Monitor therapy

RimabotulinumtoxinB: Anticholinergic Agents may enhance the anticholinergic effect of RimabotulinumtoxinB. Monitor therapy

Rufinamide: May enhance the adverse/toxic effect of CNS Depressants. Specifically, sleepiness and dizziness may be enhanced. Monitor therapy

Secretin: Anticholinergic Agents may diminish the therapeutic effect of Secretin. Management: Avoid using drugs with substantial anticholinergic effects in patients receiving secretin whenever possible. If such agents must be used in combination, monitor closely for a diminished response to secretin. Consider therapy modification

Selective Serotonin Reuptake Inhibitors: May decrease the metabolism of RisperiDONE. Exceptions: FluvoxaMINE. Monitor therapy

Selective Serotonin Reuptake Inhibitors: CNS Depressants may enhance the adverse/toxic effect of Selective Serotonin Reuptake Inhibitors. Specifically, the risk of psychomotor impairment may be enhanced. Monitor therapy

Serotonin Modulators: May enhance the adverse/toxic effect of Antipsychotic Agents. Specifically, serotonin modulators may enhance dopamine blockade, possibly increasing the risk for neuroleptic malignant syndrome. Antipsychotic Agents may enhance the serotonergic effect of Serotonin Modulators. This could result in serotonin syndrome. Monitor therapy

Sodium Oxybate: May enhance the CNS depressant effect of CNS Depressants. Management: Consider alternatives to combined use. When combined use is needed, consider minimizing doses of one or more drugs. Use of sodium oxybate with alcohol or sedative hypnotics is contraindicated. Consider therapy modification

Sulpiride: Antipsychotic Agents may enhance the adverse/toxic effect of Sulpiride. Avoid combination

Suvorexant: CNS Depressants may enhance the CNS depressant effect of Suvorexant. Management: Dose reduction of suvorexant and/or any other CNS depressant may be necessary. Use of suvorexant with alcohol is not recommended, and the use of suvorexant with any other drug to treat insomnia is not recommended. Consider therapy modification

Tapentadol: May enhance the CNS depressant effect of CNS Depressants. Management: Start tapentadol at a dose of one-third to one-half of the normal dose if being initiated in a patient who is taking another drug with CNS depressant effects. Monitor closely for evidence of excessive CNS depression. Consider therapy modification

Tetrahydrocannabinol: May enhance the CNS depressant effect of CNS Depressants. Monitor therapy

Thalidomide: CNS Depressants may enhance the CNS depressant effect of Thalidomide. Avoid combination

Thiazide Diuretics: Anticholinergic Agents may increase the serum concentration of Thiazide Diuretics. Monitor therapy

Tiotropium: Anticholinergic Agents may enhance the anticholinergic effect of Tiotropium. Avoid combination

Topiramate: Anticholinergic Agents may enhance the adverse/toxic effect of Topiramate. Monitor therapy

Umeclidinium: May enhance the anticholinergic effect of Anticholinergic Agents. Avoid combination

Valproate Products: May enhance the adverse/toxic effect of RisperiDONE. Generalized edema has developed. Monitor therapy

Verapamil: May increase the serum concentration of RisperiDONE. Monitor therapy

Zolpidem: CNS Depressants may enhance the CNS depressant effect of Zolpidem. Management: Reduce the Intermezzo brand sublingual zolpidem adult dose to 1.75 mg for men who are also receiving other CNS depressants. No such dose change is recommended for women. Avoid use with other CNS depressants at bedtime; avoid use with alcohol. Consider therapy modification

Adverse Reactions

>10%:

Central nervous system: Sedation (children 12% to 63%; adults 5% to 11%), parkinsonian-like syndrome (children 6% to 62%; adults 8% to 25%), drowsiness (adults 5% to 41%; children 4% to 11%), insomnia (≤32%), fatigue (children 18% to 31%; adults 1% to 9%), headache (12% to 21%), anxiety (≤8% to 16%), dizziness (3% to 16%), drooling (children 12%; adults <4%), akathisia (5% to 11%)

Endocrine & metabolic: Weight gain (≥7% kg increase from baseline: children 8% to 33%; adults 4% to 21%)

Gastrointestinal: Increased appetite (children 4% to 44%; adults 4%), vomiting (children 10% to 20%; adults <4%), constipation (5% to 17%), abdominal pain (children 6% to 16%; adults <4%), nausea (5% to 16%)

Genitourinary: Urinary incontinence (children 16%; adults <4%)

Neuromuscular & skeletal: Tremor (adults ≤24%; children ≤11%)

Respiratory: Nasopharyngitis (children 19%; adults ≤4%), cough (children ≤17%; adults ≤4%), rhinorrhea (children 12%; adults <4%)

Miscellaneous: Fever (children 16%; adults 1% to 2%)

1% to 10%:

Cardiovascular: Bradycardia (<4%), bundle branch block (<4%), buttock pain (<4%), chest pain (<4%), ECG changes (<4%), facial edema (<4%), first degree atrioventricular block (<4%), hypotension (<4%), orthostatic hypotension (<4%), palpitations (<4%), paresthesia (<4%), prolonged Q-T interval on ECG (<4%), tachycardia (adults <4%; children <1%), hypertension (≤3%), peripheral edema (≤3%), syncope (1% to 2%)

Central nervous system: Dystonia (2% to 6%), abnormal gait (4%), pain (1% to 4%), decreased attention span (≤4%), agitation (<4%), ataxia (<4%), depression (<4%), disturbed sleep (<4%), falling (<4%), lethargy (<4%), malaise (<4%), nervousness (<4%), orthostatic dizziness (<4%), seizure (<4%), tardive dyskinesia (<4%), vertigo (<4%), hypoesthesia (≤2%)

Dermatologic: Skin rash (<4% to 8%), eczema (<4%), pruritus (<4%), skin sclerosis (<4%), xeroderma (≤3%), acne vulgaris (<1% to 2%)

Endocrine & metabolic: Increased thirst (children ≤7%; adults <1%), weight loss (≤4%), amenorrhea (4%), decreased libido (<4%), galactorrhea (<4%), gynecomastia (<4%), hyperglycemia (<4%), hyperprolactinemia (<4%), increased gamma-glutamyl transferase (<4%), oligomenorrhea (<4%)

Gastrointestinal: Xerostomia (≤7% to 10%), dyspepsia (3% to 10%), sialorrhea (1% to 10%), diarrhea (<4% to 8%), decreased appetite (≤6%), anorexia (<4%), gastritis (<4%), gastroenteritis (<4%), toothache (≤3%)

Genitourinary: Menstruation (≤4%), cystitis (<4%), ejaculatory disorder (<4%), erectile dysfunction (<4%), glycosuria (<4%), irregular menses (<4%), mastalgia (<4%), sexual disorder (<4%), urinary tract infection (<4%)

Hematologic & oncologic: Anemia (<4%), neutropenia (<4%)

Hepatic: Increased serum ALT (<4%), increased serum AST (<4%)

Hypersensitivity: Hypersensitivity (<4%)

Infection: Infection (<4%), influenza (<4%), localized infection (<4%), subcutaneous abscess (<4%), viral infection (<4%)

Local: Induration at injection site (<4%), injection site reaction (<4%), pain at injection site (<4%), swelling at injection site (<4%)

Neuromuscular & skeletal: Limb pain (2% to 6%), dyskinesia (adults ≤6%; children <1%), back pain (≤4%), arthralgia (2% to 4%), abnormal posture (<4%), akinesia (<4%), hypokinesia (<4%), musculoskeletal chest pain (<4%), myalgia (<4%), neck pain (<4%), weakness (<4%), increased creatine phosphokinase (≤2%)

Ophthalmic: Blurred vision (2% to 7%), conjunctivitis (<4%), reduced visual acuity (<4%)

Otic: Otalgia (≤4%), otic infection (<4%)

Respiratory: Nasal congestion (≤6% to 10%), pharyngolaryngeal pain (3% to 10%), rhinitis (<4% to 9%), respiratory tract infection (≤6% to 8%), bronchitis (<4%), dyspnea (<4%), flu-like symptoms (<4%), pharyngitis (<4%), pneumonia (<4%), sinusitis (<4%), epistaxis (≤2%), sinus congestion (≤2%)

<1% (Limited to important or life-threatening): Abnormal erythrocytes, abscess at injection site, acariasis, agranulocytosis, alopecia, anaphylaxis, angioedema, apnea, aspiration, atrial fibrillation, atrial premature contractions, cardiorespiratory arrest, cerebral ischemia, cerebrovascular accident, cholestatic hepatitis, cholinergic syndrome, coma, cyst, delirium, depression of ST segment on ECG, dermal ulcer, diabetes mellitus, diabetic coma, diabetic ketoacidosis, disruption of body temperature regulation, diverticulitis, esophageal motility disorder, eye infection, fecal incontinence, fecaloma, glaucoma, granulocytopenia, hematoma, hemorrhage, hepatic failure, hepatic injury, hyperkeratosis, hyperthermia, hypertonia, hypertriglyceridemia, hyperuricemia, hypoglycemia, hypokalemia, hyponatremia, hypothermia, impaired consciousness, increased serum cholesterol, intestinal obstruction, intraoperative floppy iris syndrome, leukocytosis, leukopenia, leukorrhea, lower respiratory tract infection, lymphadenopathy, mania, migraine, myocardial infarction, myocarditis, neuroleptic malignant syndrome, nystagmus, ocular hyperemia, pancreatitis, Pelger-Huët anomaly, phlebitis, pituitary neoplasm, precocious puberty, priapism, pulmonary embolism, renal insufficiency, retinal artery occlusion, retrograde ejaculation, rhabdomyolysis, SIADH, sleep apnea, swelling of eye, synostosis, thrombocytopenia, thrombophlebitis, thrombotic thrombocytopenic purpura, tissue necrosis, tongue paralysis, torticollis, transient ischemic attacks, unresponsive to stimuli, urinary retention, ventricular premature contractions, ventricular tachycardia, water intoxication, withdrawal syndrome

ALERT: U.S. 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. Analyses of 17 placebo-controlled trials (modal duration of 10 weeks), largely in patients taking atypical antipsychotic drugs, revealed a risk of death in the drug-treated patients of between 1.6 and 1.7 times that seen in placebo-treated patients. Over the course of a typical 10-week controlled trial, the rate of death in drug-treated patients was approximately 4.5% compared with a rate of approximately 2.6% in the placebo group. Although the causes of death were varied, most of the deaths appeared to be either cardiovascular (eg, heart failure, sudden death) or infectious (eg, pneumonia) in nature. Observational studies suggest that similar to atypical antipsychotic drugs, treatment with conventional antipsychotic drugs may increase mortality. The extent to which the findings of increased mortality in observational studies may be attributed to the antipsychotic drug as opposed to some characteristic(s) of the patients is not clear. Risperidone is not approved for the treatment of patients with dementia-related psychosis.

Warnings/Precautions

Concerns related to adverse effects:

• Altered cardiac conduction: May alter cardiac conduction; life-threatening arrhythmias have occurred with therapeutic doses of antipsychotics. Use caution with history of conduction abnormalities. Relative to other neuroleptics, risperidone has a low risk of arrhythmias.

• Anticholinergic effects: May cause anticholinergic effects (confusion, agitation, constipation, xerostomia, blurred vision, urinary retention); use with caution in patients with decreased gastrointestinal motility, urinary retention, BPH, xerostomia, or visual problems. Relative to other neuroleptics, risperidone has a low potency of cholinergic blockade.

• Antiemetic effects: May mask toxicity of other drugs or conditions (eg, intestinal obstruction, Reyes syndrome, brain tumor) due to antiemetic effects.

• Blood dyscrasias: Leukopenia, neutropenia, and agranulocytosis (sometimes fatal) have been reported in clinical trials and postmarketing reports with antipsychotic use; presence of risk factors (eg, pre-existing low WBC or history of drug-induced leuko-/neutropenia) should prompt periodic blood count assessment. Discontinue therapy at first signs of blood dyscrasias or if absolute neutrophil count <1,000/mm3.

• Cerebrovascular effects: An increased incidence of cerebrovascular effects (eg, transient ischemic attack, stroke), including fatalities, has been reported in placebo-controlled trials of risperidone for the unapproved use in elderly patients with dementia-related psychosis.

• Dyslipidemia: Has been reported with atypical antipsychotics; risk profile may differ between agents. Discrepant results have been reported in clinical trials, regarding lipid changes associated with risperidone (American Diabetes Association, 2004).

• Esophageal dysmotility/aspiration: Antipsychotic use has been associated with esophageal dysmotility and aspiration; use with caution in patients at risk of pneumonia (eg, Alzheimer's disease).

• Extrapyramidal symptoms (EPS): May cause extrapyramidal symptoms, including pseudoparkinsonism, acute dystonic reactions, akathisia, and tardive dyskinesia. Risk of dystonia (and possibly other EPS) may be greater with increased doses, use of conventional antipsychotics, males, and younger patients. Risk of tardive dyskinesia and potential for irreversibility may be increased in elderly patients (particularly women), prolonged therapy, and higher total cumulative dose; antipsychotics may also mask signs/symptoms of tardive dyskinesia. Consider therapy discontinuation with signs/symptoms of tardive dyskinesia.

• Hyperglycemia: Atypical antipsychotics have been associated with development of hyperglycemia; in some cases, may be extreme and associated with ketoacidosis, hyperosmolar coma, or death. Use with caution in patients with diabetes or other disorders of glucose regulation; monitor for worsening of glucose control.

• Hyperprolactinemia: Risperidone is associated with greater increases in prolactin levels as compared to other antipsychotic agents; clinical significance of hyperprolactinemia in patients with breast cancer or other prolactin-dependent tumors is unknown.

• Intraoperative floppy iris syndrome: Few case reports describe intraoperative floppy iris syndrome (IFIS) in patients receiving risperidone and undergoing cataract surgery (Ford, 2011). Prior to cataract surgery, evaluate for prior or current risperidone use. The benefits or risks of interrupting risperidone prior to surgery have not been established; clinicians are advised to proceed with surgery cautiously.

• Leukopenia: Neutropenia has been reported with antipsychotic use, including fatal cases of agranulocytosis. Pre-existing myelosuppression (disease or drug-induced) increases risk and these patients should have frequent CBC monitoring; decreased blood counts in absence of other causative factors should prompt discontinuation of therapy.

• Neuroleptic malignant syndrome (NMS): Use may be associated with neuroleptic malignant syndrome (NMS); monitor for mental status changes, fever, muscle rigidity and/or autonomic instability (risk may be increased in patients with Parkinson's disease or Lewy body dementia).

• Orthostatic hypotension: May cause orthostatic hypotension; use with caution in patients at risk of this effect (eg, concurrent medication use which may predispose to hypotension/bradycardia or presence of hypovolemia) or in those who would not tolerate transient hypotensive episodes. Use caution with history of cerebrovascular or cardiovascular disease (MI, heart failure, or ischemic disease).

• Priapism: Rare cases of priapism have been reported.

• Sedation: May be low to moderately sedating, use with caution in disorders where CNS depression is a feature; patients must be cautioned about performing tasks which require mental alertness (eg, operating machinery or driving).

• Suicidal ideation: The possibility of a suicide attempt is inherent in psychotic illness or bipolar disorder; use with caution in high-risk patients during initiation of therapy. Prescriptions should be written for the smallest quantity consistent with good patient care.

• Temperature regulation: Impaired core body temperature regulation may occur; caution with strenuous exercise, heat exposure, dehydration, and concomitant medication possessing anticholinergic effects.

• Weight gain: Significant weight gain has been observed with antipsychotic therapy; incidence varies with product. Monitor waist circumference and BMI.

Disease-related concerns:

• Cardiovascular disease: Use with caution in patients with severe cardiac disease, hemodynamic instability, prior myocardial infarction or ischemic heart disease.

• Dementia: [US Boxed Warning]: Elderly patients with dementia-related psychosis treated with antipsychotics are at an increased risk of death compared to placebo. Most deaths appeared to be either cardiovascular (eg, heart failure, sudden death) or infectious (eg, pneumonia) in nature. Use with caution in dementia with Lewy bodies; antipsychotics may worsen dementia symptoms and patients with dementia with Lewy bodies are more sensitive to the extrapyramidal side effects (APA [Rabins, 2007]). Risperidone is not approved for the treatment of dementia-related psychosis. The Canadian labeling indicates risperidone (oral) for short-term use in severe Alzheimer dementia to manage aggression and psychotic symptoms. Careful assessment of risk factors for stroke or existing cardiovascular morbidities is required prior to initiation.

• Hepatic impairment: Use with caution in patients with hepatic disease or impairment; dosage reduction is recommended.

• Parkinson disease: Use with caution in patients with Parkinson disease; antipsychotics may aggravate the motor disturbances of Parkinson disease (APA [Rabins, 2007]).

• Renal impairment: Use with caution in patients with renal disease; dosage reduction is recommended.

• Seizures: Use with caution in patients at risk of seizures, including those with a history of seizures, head trauma, brain damage, alcoholism, or concurrent therapy with medications which may lower seizure threshold. Elderly patients may be at increased risk of seizures due to an increased prevalence of predisposing factors.

Concurrent drug therapy issues:

• Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information.

Special populations:

• Elderly: Use in patients with dementia is associated with an increased risk of mortality and cerebrovascular accidents. Avoid antipsychotic use for behavioral problems associated with dementia unless alternative nonpharmacologic therapies have failed and patient may harm self or others; careful assessment of risk factors for stroke or existing cardiovascular morbidities is required prior to initiation. In addition, use may cause or exacerbate syndrome of inappropriate antidiuretic hormone secretion or hyponatremia; monitor sodium closely with initiation or dosage adjustments in older adults (Beers Criteria).

Dosage form specific issues:

• Benzyl alcohol and derivatives: Some dosage forms may contain sodium benzoate/benzoic acid; benzoic acid (benzoate) is a metabolite of benzyl alcohol; large amounts of benzyl alcohol (≥99 mg/kg/day) have been associated with a potentially fatal toxicity (“gasping syndrome”) in neonates; the “gasping syndrome” consists of metabolic acidosis, respiratory distress, gasping respirations, CNS dysfunction (including convulsions, intracranial hemorrhage), hypotension, and cardiovascular collapse (AAP ["Inactive" 1997]; CDC, 1982); some data suggests that benzoate displaces bilirubin from protein binding sites (Ahlfors, 2001); avoid or use dosage forms containing benzyl alcohol derivative with caution in neonates. See manufacturer’s labeling.

• Injectable suspension: Vehicle used (polylactide-co-glycolide microspheres) has rarely been associated with retinal artery occlusion in patients with abnormal arteriovenous anastomosis (eg, patent foramen ovale). Not for intravenous use; administer only as an intramuscular injection.

Special handling:

• Hazardous agent: Use appropriate precautions for handling and disposal (NIOSH 2014 [group 2]).

Monitoring Parameters

Mental status; vital signs (as clinically indicated); blood pressure (baseline; repeat 3 months after antipsychotic initiation, then yearly); weight, height, BMI, waist circumference (baseline; repeat at 4, 8, and 12 weeks after initiating or changing therapy, then quarterly; consider switching to a different antipsychotic for a weight gain ≥5% of initial weight); CBC (as clinically indicated; monitor frequently during the first few months of therapy in patients with pre-existing low WBC or history of drug-induced leukopenia/neutropenia); electrolytes, renal and liver function (annually and as clinically indicated); personal and family history of obesity, diabetes, dyslipidemia, hypertension, or cardiovascular disease (baseline; repeat annually); fasting plasma glucose level/HbA1c (baseline; repeat 3 months after starting antipsychotic, then yearly); fasting lipid panel (baseline; repeat 3 months after initiation of antipsychotic; if LDL level is normal repeat at 2 to 5 year intervals or more frequently if clinical indicated); changes in menstruation, libido, development of galactorrhea, erectile and ejaculatory function (at each visit for the first 12 weeks after the antipsychotic is initiated or until the dose is stable, then yearly); abnormal involuntary movements or parkinsonian signs (baseline; repeat weekly until dose stabilized for at least 2 weeks after introduction and for 2 weeks after any significant dose increase); tardive dyskinesia (every 12 months; high-risk patients every 6 months); ocular examination (yearly in patients >40 years; every 2 years in younger patients) (ADA, 2004; Lehman, 2004; Marder, 2004).

Pregnancy Risk Factor

C

Pregnancy Considerations

Adverse events were observed in animal reproduction studies. In human studies, risperidone and its metabolite cross the placenta (Newport, 2007). An increased risk of teratogenic effects has not been observed following maternal use of risperidone (limited data) (Coppola, 2007). Agenesis of the corpus callosum has been noted in one case report of an infant exposed in utero; relationship to risperidone exposure is not known. Antipsychotic use during the third trimester of pregnancy has a risk for extrapyramidal symptoms (EPS) and/or withdrawal symptoms in newborns following delivery. Symptoms in the newborn may include agitation, feeding disorder, hypertonia, hypotonia, respiratory distress, somnolence, and tremor. These effects may be self-limiting and allow recovery within hours or days with no specific treatment, or they may be severe requiring prolonged hospitalization. When using Risperdal® Consta®, patients should notify healthcare provider if they become or intend to become pregnant during therapy or within 12 weeks of last injection. Risperidone may cause hyperprolactinemia, which may decrease reproductive function in both males and females.

The ACOG recommends that therapy during pregnancy be individualized; treatment with psychiatric medications during pregnancy should incorporate the clinical expertise of the mental health clinician, obstetrician, primary healthcare provider, and pediatrician. Safety data related to atypical antipsychotics during pregnancy is limited and routine use is not recommended. However, if a woman is inadvertently exposed to an atypical antipsychotic while pregnant, continuing therapy may be preferable to switching to a typical antipsychotic that the fetus has not yet been exposed to; consider risk:benefit (ACOG, 2008).

Healthcare providers are encouraged to enroll women 18 to 45 years of age exposed to risperidone during pregnancy in the Atypical Antipsychotics Pregnancy Registry (1-866-961-2388 or http://www.womensmentalhealth.org/pregnancyregistry).

Patient Education

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience weight gain, akathisia, fatigue, anxiety, nausea, dyspepsia, diarrhea, constipation, xerostomia, polyphagia, asthenia, rhinitis, rhinorrhea, pharyngitis, headache, or insomnia. Have patient report immediately to prescriber significant injection site irritation, signs of hyperglycemia, suicidal ideation, severe dizziness, syncope, behavioral changes, mood changes, tremors, difficulty moving, rigidity, dysphagia, difficulty speaking, difficulty focusing, vision changes, dyspnea, sialorrhea, macromastia, sexual dysfunction, nipple discharge, amenorrhea, priapism, signs of neuroleptic malignant syndrome, or signs of tardive dyskinesia (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for healthcare professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience and judgment in diagnosing, treating and advising patients.

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