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ALERT: U.S. Boxed Warning
The FDA-approved labeling includes a boxed warning. See Warnings/Precautions section for a concise summary of this information. For verbatim wording of the boxed warning, consult the product labeling or www.fda.gov.
Medication Safety Issues
Sound-alike/look-alike issues:
Risperidone may be confused with reserpine, ropinirole
Risperdal® may be confused with lisinopril, reserpine, Restoril™
Pronunciation
(ris PER i done)
U.S. Brand Names
Index Terms
Generic Available
Yes: Excludes injection
Canadian Brand Names
Pharmacologic Category
Pharmacologic Category Synonyms
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
Injection: Treatment of schizophrenia; maintenance treatment of bipolar I disorder in adults as monotherapy or in combination with lithium or valproate
Use: Unlabeled/Investigational
Treatment of Tourette's disorder; treatment of pervasive developmental disorder; psychosis/agitation related to Alzheimer's dementia; post-traumatic stress disorder (PTSD)
Pregnancy Risk Factor
C
Pregnancy Considerations
Animal studies indicate an increase in fetal mortality. Reversible EPS symptoms were noted in neonates following use of risperidone during the last trimester. Agenesis of the corpus callosum has also been noted in one case report. There are no adequate and well-controlled studies in pregnant women. 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. Healthcare providers are encouraged to enroll women 18-45 years of age exposed to risperidone during pregnancy in the Atypical Antipsychotics Pregnancy Registry (1-866-961-2388).
Lactation
Enters breast milk/not recommended
Breast-Feeding Considerations
Risperidone and its metabolite are excreted in breast milk; it is recommended that women not breast-feed during therapy or for 12 weeks after the last injection if using Risperdal® Consta®.
Contraindications
Hypersensitivity to risperidone or any component of the formulation
Warnings/Precautions
Boxed warnings:
• Dementia: See “Disease-related concerns” below.
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.
• 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.
• 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 these reactions is generally much lower relative to typical/conventional antipsychotics). Risk of dystonia (and probably other EPS) may be greater with increased doses, use of conventional antipsychotics, males, and younger patients.
• 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: Use is associated with increased prolactin levels; clinical significance of hyperprolactinemia in patients with breast cancer or other prolactin-dependent tumors is unknown.
• 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: [U.S. 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. Risperidone is not approved for the treatment of dementia-related psychosis.
• Hepatic impairment: Use with caution in patients with hepatic disease or impairment; dosage reduction is recommended.
• Parkinson's disease: Use with caution in patients with Parkinson's disease.
• 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:
• Antiemetic effects: May mask toxicity of other drugs or conditions (eg, intestinal obstruction, Reyes syndrome, brain tumor) due to antiemetic effects.
Special populations:
• Pediatrics: Safety and efficacy have not been established in children <5 years of age (<18 years of age for I.M. injection). Long-term effects on growth or sexual maturation have not been evaluated.
Dosage form specific issues:
• Vehicle used in injectable (polylactide-co-glycolide microspheres): Has rarely been associated with retinal artery occlusion in patients with abnormal arteriovenous anastomosis (eg, patent foramen ovale).
Adverse Reactions
The frequency of adverse effects is reported as absolute percentages and is not based upon net frequencies as compared to placebo. Actual frequency may be dependant upon dose and/or indication. Events are reported from placebo-controlled studies and not with combination therapy. Unless otherwise noted, frequency of adverse effects is reported for the oral formulation in adults.
>10%:
Central nervous system: Somnolence (children 12% to 67%; adults 5% to 14%; I.M. injection 5% to 6%), fatigue (children 18% to 42%; adults 1% to 3%), headache (I.M. injection 15% to 21%), fever (children 20%; adults 1% to 2%), dystonia (children 9% to 18%; adults 5% to 11%), anxiety (children ?16%; adults 2% to 16%), dizziness (children 7% to 16%; adults 4% to 10%), Parkinsonism (children 2% to 16%; adults 12% to 20%)
Dermatologic: Rash (children ?11%; adults 2% to 4%)
Gastrointestinal: Appetite increased (children 4% to 49%), vomiting (children 10% to 25%), salivation increased (children ?22%; adults 1% to 3%), constipation (children 21%; adults 8% to 9%), abdominal pain (children 15% to 18%; adults 3% to 4%), nausea (children 8% to 16%; adults 4% to 9%), dyspepsia (children 5% to 16%; adults 4% to 10%), xerostomia (children 13%; adults ?4%)
Genitourinary: Urinary incontinence (children 5% to 22%; adults <2%)
Neuromuscular & skeletal: Tremor (adults 6%; children 10% to 12%)
Respiratory: Rhinitis (children 13% to 36%; adults 7% to 11%), upper respiratory infection (children 34%; adults 2% to 3%), cough (children 34%; adults 3%)
1% to 10%:
Cardiovascular: Tachycardia (children ?7%; adults 1% to 5%), hypertension (I.M. injection 3%), chest pain (1% to 3%), creatine phosphokinase increased (?2%), postural hypotension (?2%), arrhythmia (?1%), edema (?1%), hypotension (?1%), syncope (?1%)
Central nervous system: Akathisia (children ?10%; adults 5% to 9%), automatism (children 7%), confusion (children 5%)
Dermatologic: Seborrhea (up to 2%), acne (1%)
Endocrine & metabolic: Lactation nonpuerperal (children 2% to 5%; adults 1%), ejaculation failure (?1%)
Gastrointestinal: Diarrhea (children 7% to 8%; adults ?3%), anorexia (children 8%; adults ?2%;), weight gain (children 5%; adults ?1%), toothache (I.M. injection 1% to 3%)
Genitourinary: Urinary tract infection (?3%)
Hematologic: Neutropenia (I.M. injection <2%), anemia (I.M. injection <2%; oral ?1%)
Hepatic: Transaminases increased (I.M. injection ?1%; oral 1%)
Neuromuscular & skeletal: Dyskinesia (children 7%; adults 1%), arthralgia (2% to 3%), back pain (2% to 3%), myalgia (?2%), weakness (1%)
Ocular: Abnormal vision (children 4% to 7%; adults 1% to 3%), blurred vision (I.M. injection 2% to 3%)
Otic: Earache (1%)
Respiratory: Dyspnea (children 2% to 5%; adults 2%), epistaxis (?2%)
?1%, postmarketing, and/or case reports (limited to important or life-threatening): Agranulocytosis, allergic reaction, amenorrhea, amnesia, anaphylactic reaction, angina pectoris, angioedema, antidiuretic hormone disorder, aphasia, apnea, ascites, aspiration, asthma, atrial fibrillation, AV block, bronchospasm, cachexia, catatonic reaction, cerebrovascular accident, cerebrovascular disorder, cholecystitis, cholelithiasis, cholestatic hepatitis, cholinergic syndrome, coma, dehydration, delirium, depression, diabetes mellitus, diabetic ketoacidosis, diverticulitis, dysphagia, esophagitis, esophageal dysmotility, fecal incontinence, flu-like syndrome, gastroenteritis, hematemesis, hematuria, hemorrhage, hepatic failure, hepatocellular damage, hyper-/hypoglycemia, hyperphosphatemia, hypertriglyceridemia, hyperuricemia, hypokalemia, hyponatremia, hypoproteinemia, intestinal obstruction, jaundice, leukocytosis, leukopenia, leukorrhea, lymphadenopathy, mastitis, menstrual irregularities, migraine, myocardial infarction, myocarditis, palpitation, pancreatitis, Pelger-Huët anomaly, pituitary adenomas, pneumonia, precocious puberty, premature atrial contractions, priapism, pulmonary embolism, purpura, QTc prolongation, RBC disorders, renal insufficiency, retinal artery occlusion (I.M. formulation), rigors, sarcoidosis, skin exfoliation, skin ulceration, ST depression, stomatitis, stridor, stroke, superficial phlebitis, synostosis, T wave inversions, thrombocytopenia, thrombophlebitis, thrombotic thrombocytopenic purpura, tinnitus, tongue discoloration, tongue edema, tongue paralysis, torticollis, transient ischemic attack, urinary retention, urticaria, ventricular extrasystoles, ventricular tachycardia, water intoxication, withdrawal syndrome, xerophthalmia
Metabolism/Transport Effects
Substrate of CYP2D6 (major), 3A4 (minor); Inhibits CYP2D6 (weak), 3A4 (weak)
Drug Interactions
Acetylcholinesterase Inhibitors (Central): May enhance the neurotoxic (central) effect of Antipsychotics. Severe extrapyramidal symptoms have occurred in some patients. Risk C: Monitor therapy
Alcohol (Ethyl): CNS Depressants may enhance the CNS depressant effect of Alcohol (Ethyl). Risk C: Monitor therapy
Alfuzosin: May enhance the QTc-prolonging effect of QTc-Prolonging Agents. Risk C: Monitor therapy
Amphetamines: Antipsychotics may diminish the stimulatory effect of Amphetamines. Risk C: Monitor therapy
Anticholinergics: May enhance the adverse/toxic effect of other Anticholinergics. Exceptions: Paliperidone. Risk C: Monitor therapy
Anti-Parkinson's Agents (Dopamine Agonist): Antipsychotics (Atypical) may diminish the therapeutic effect of Anti-Parkinson's Agents (Dopamine Agonist). Risk D: Consider therapy modification
Artemether: May enhance the QTc-prolonging effect of QTc-Prolonging Agents. Risk X: Avoid combination
CarBAMazepine: May decrease the serum concentration of Risperidone. Risk C: Monitor therapy
Chloroquine: May enhance the QTc-prolonging effect of QTc-Prolonging Agents. Risk C: Monitor therapy
Ciprofloxacin: May enhance the QTc-prolonging effect of QTc-Prolonging Agents. Risk C: Monitor therapy
CNS Depressants: May enhance the adverse/toxic effect of other CNS Depressants. Risk C: Monitor therapy
CYP2D6 Inhibitors (Moderate): May decrease the metabolism of CYP2D6 Substrates. Risk C: Monitor therapy
CYP2D6 Inhibitors (Strong): May decrease the metabolism of CYP2D6 Substrates. Risk D: Consider therapy modification
Darunavir: May increase the serum concentration of CYP2D6 Substrates. Risk C: Monitor therapy
Dronedarone: QTc-Prolonging Agents may enhance the QTc-prolonging effect of Dronedarone. Risk X: Avoid combination
Gadobutrol: May enhance the QTc-prolonging effect of QTc-Prolonging Agents. Risk D: Consider therapy modification
Lithium formulations: May enhance the neurotoxic effect of Antipsychotics. Lithium formulations may decrease the serum concentration of Antipsychotics. Specifically noted with chlorpromazine. Risk C: Monitor therapy
Lumefantrine: May enhance the QTc-prolonging effect of QTc-Prolonging Agents. Risk X: Avoid combination
Nilotinib: May enhance the QTc-prolonging effect of QTc-Prolonging Agents. Risk X: Avoid combination
Peginterferon Alfa-2b: May decrease the serum concentration of CYP2D6 Substrates. Risk C: Monitor therapy
Pimozide: QTc-Prolonging Agents may enhance the QTc-prolonging effect of Pimozide. Risk X: Avoid combination
Pramlintide: May enhance the anticholinergic effect of Anticholinergics. These effects are specific to the GI tract. Risk D: Consider therapy modification
QTc-Prolonging Agents: May enhance the adverse/toxic effect of other QTc-Prolonging Agents. Their effects can be additive, causing life-threatening ventricular arrhythmias. Risk D: Consider therapy modification
QuiNINE: QTc-Prolonging Agents may enhance the QTc-prolonging effect of QuiNINE. QuiNINE may enhance the QTc-prolonging effect of QTc-Prolonging Agents. Risk X: Avoid combination
Selective Serotonin Reuptake Inhibitors: May decrease the metabolism of Risperidone. Exceptions: Fluvoxamine. Risk C: Monitor therapy
Tetrabenazine: QTc-Prolonging Agents may enhance the QTc-prolonging effect of Tetrabenazine. Risk X: Avoid combination
Tetrabenazine: May enhance the adverse/toxic effect of Antipsychotics. Risk C: Monitor therapy
Thioridazine: QTc-Prolonging Agents may enhance the QTc-prolonging effect of Thioridazine. Risk X: Avoid combination
Valproic Acid: May enhance the adverse/toxic effect of Risperidone. Generalized edema has developed. Risk C: Monitor therapy
Verapamil: May increase the serum concentration of Risperidone. Risk C: Monitor therapy
Ziprasidone: QTc-Prolonging Agents may enhance the QTc-prolonging effect of Ziprasidone. The risk of a severe arrhythmia may be increased. Risk X: Avoid combination
Ethanol/Nutrition/Herb Interactions
Ethanol: Avoid ethanol (may increase CNS depression).
Herb/Nutraceutical: Avoid kava kava, gotu kola, valerian, St John's wort (may increase CNS depression).
Storage
Injection: Risperdal® Consta®: Store in refrigerator at 2°C to 8°C (36°F to 46°F) and protect from light. May be stored at room temperature of 25°C (77°F) for up to 7 days prior to administration. Following reconstitution, store at room temperature and use within 6 hours. Suspension settles in ~2 minutes; shake vigorously to resuspend prior to administration.
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.
Reconstitution
Risperdal® Consta®: Bring to room temperature prior to reconstitution. Reconstitute with provided diluent only. Shake vigorously to mix; will form thick, milky suspension. Following reconstitution, store at room temperature and use within 6 hours. Suspension settles in ~2 minutes; shake vigorously to resuspend prior to administration.
Mechanism of Action
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
Pharmacodynamics/Kinetics
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 4-6 weeks
Distribution: Vd: 1-2 L/kg
Protein binding, plasma: Risperidone 90%; 9-hydroxyrisperidone: 77%
Metabolism: Extensively hepatic via CYP2D6 to 9-hydroxyrisperidone (similar pharmacological activity as risperidone); N-dealkylation is a second minor pathway
Bioavailability: Oral: 70%; Tablet (relative to solution): 94%; orally-disintegrating tablets and oral solution are bioequivalent to tablets
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: 3-6 days; related to microsphere erosion and subsequent absorption of risperidone
Time to peak, plasma: Oral: Risperidone: Within 1 hour; 9-hydroxyrisperidone: Extensive metabolizers: 3 hours; Poor metabolizers: 17 hours
Excretion: Urine (70%); feces (14%)
Dosage
Oral:
Children ?5 years and Adolescents: Autism:
<15 kg: Use with caution; specific dosing recommendations not available
<20 kg: Initial: 0.25 mg/day; may increase dose to 0.5 mg/day after ?4 days, maintain dose for ?14 days. In patients not achieving sufficient clinical response, may increase dose by 0.25 mg/day in ?2-week intervals. Therapeutic effect reached plateau at 1 mg/day in clinical trials. Following clinical response, consider gradually lowering dose. May be administered once daily or in divided doses twice daily.
?20 kg: Initial: 0.5 mg/day; may increase dose to 1 mg/day after ?4 days, maintain dose for ?14 days. In patients not achieving sufficient clinical response, may increase dose by 0.5 mg/day in ?2-week intervals. Therapeutic effect reached plateau at 2.5 mg/day (3 mg/day in children >45 kg) in clinical trials. Following clinical response, consider gradually lowering dose. May be administered once daily or in divided doses twice daily.
Children and Adolescents:
Pervasive developmental disorder (unlabeled use): Initial: 0.25 mg twice daily; titrate up 0.25 mg/day every 5-7 days; optimal dose range: 0.75-3 mg/day
Schizophrenia: Adolescents 13-17 years: Initial: 0.5 mg once daily; dose may be adjusted in increments of 0.5-1 mg/day at intervals ?24 hours to a dose of 3 mg/day. Doses ranging from 1-6 mg/day have been evaluated, however, doses >3 mg/day do not confer additional benefit and are associated with increased adverse events.
Bipolar disorder: Children and Adolescents 10-17 years: Initial: 0.5 mg once daily; dose may be adjusted in increments of 0.5-1 mg/day at intervals ?24 hours to a dose of 2.5 mg/day. Doses ranging from 0.5-6 mg/day have been evaluated, however doses >2.5 mg/day do not confer additional benefit and are associated with increased adverse events.
Tourette's disorder (unlabeled use): Initial: 0.5 mg; titrate to 2-4 mg/day
Adults:
Schizophrenia:
Initial: 1 mg twice daily; may be increased by 1-2 mg/day at intervals ?24 hours to a recommended dosage range of 4-8 mg/day; may be given as a single daily dose once maintenance dose is achieved; daily dosages >6 mg do not appear to confer any additional benefit, and the incidence of extrapyramidal symptoms is higher than with lower doses. Further dose adjustments should be made in increments/decrements of 1-2 mg/day on a weekly basis. Dose range studied in clinical trials: 4-16 mg/day.
Maintenance: Recommended dosage range: 2-8 mg/day
Bipolar mania:
Initial: 2-3 mg once daily; if needed, adjust dose by 1 mg/day in intervals ?24 hours; dosing range: 1-6 mg/day
Maintenance: No dosing recommendation available for treatment >3 weeks duration.
Post-traumatic stress disorder (PTSD) (unlabeled use): 0.5-8 mg/day
Elderly:
Oral: A starting dose of 0.5 mg twice daily, and 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.
Psychosis/agitation related to Alzheimer's dementia (unlabeled use): Initial: 0.25-1 mg/day; if necessary, gradually increase as tolerated not to exceed 1.5-2 mg/day
I.M. (Risperdal® Consta®): 25 mg every 2 weeks; a lower initial dose of 12.5 mg may be appropriate in some patients
Note: Additional monitoring of renal function and orthostatic blood pressure may be warranted. If once-a-day dosing in the elderly or debilitated patient is considered, a twice daily regimen should be used to titrate to the target dose, and this dose should be maintained for 2-3 days prior to attempts to switch to a once-daily regimen.
I.M.: Adults: Schizophrenia, bipolar I maintenance (Risperdal® Consta®): 25 mg every 2 weeks; some patients may benefit from larger doses; maximum dose not to exceed 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.
Note: Oral risperidone (or other antipsychotic) should be administered with the initial injection of Risperdal® Consta® and continued for 3 weeks (then discontinued) to maintain adequate therapeutic plasma concentrations prior to main release phase of risperidone from injection site. When switching from depot administration to a short-acting formulation, administer short-acting agent in place of the next regularly-scheduled depot injection.
Dosing adjustment in renal impairment:
Oral: Starting dose of 0.5 mg twice daily; titration should progress slowly in increments of no more than 0.5 mg twice daily; increases to dosages >1.5 mg twice daily should occur at intervals of ?1 week. Clearance of the active moiety is decreased by 60% in patients with moderate-to-severe renal disease compared to healthy subjects.
I.M.: An initial dose of 12.5 mg may be considered
Dosing adjustment in hepatic impairment:
Oral: Starting dose of 0.5 mg twice daily; titration should progress slowly in increments of no more than 0.5 mg twice daily; increases to dosages >1.5 mg twice daily should occur at intervals of ?1 week. The mean free fraction of risperidone in plasma was increased by 35% in patients with hepatic impairment compared to healthy subjects.
I.M.: An initial dose of 12.5 mg may be considered
Administration: Oral
Oral solution can be mixed with water, coffee, orange juice, or low-fat milk, but is not compatible with cola or tea. May be administered with or without food.
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.
When reinitiating treatment after discontinuation, the initial titration schedule should be followed.
Risperdal® M-Tabs® should not be removed from blister pack until administered. 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.
Administration: I.M.
Risperdal® Consta® should be administered I.M. into either the deltoid muscle or the upper outer quadrant of the gluteal area. 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).
Monitoring Parameters
Vital signs; fasting lipid profile and fasting blood glucose/Hgb A1c (prior to treatment, at 3 months, then annually); BMI, personal/family history of obesity, waist circumference; blood pressure; mental status, abnormal involuntary movement scale (AIMS), extrapyramidal symptoms; orthostatic blood pressure changes for 3-5 days after starting or increasing dose. Weight should be assessed prior to treatment, at 4 weeks, 8 weeks, 12 weeks, and then at quarterly intervals. Consider titrating to a different antipsychotic agent for a weight gain ?5% of the initial weight.
Dietary Considerations
May be taken with or without food. Risperdal® M-Tabs® contain phenylalanine.
Patient Education
Do not take any new medication during therapy unless approved by prescriber. Use exactly as directed; do not increase dose or frequency. It may take several weeks to achieve desired results; do not discontinue without consulting prescriber. Dilute solution with water, milk, or orange juice; do not dilute with beverages containing tannin or pectinate (eg, colas, tea). Avoid alcohol or caffeine unless approved by prescriber. Maintain adequate hydration unless instructed to restrict fluid intake. If you have diabetes, you may experience increased blood sugars. Monitor blood sugars closely. You may experience excess sedation, drowsiness, restlessness, dizziness, or blurred vision (use caution driving or when engaging in tasks requiring alertness until response to drug is known); dry mouth, nausea, or GI upset (small frequent meals, frequent mouth care, chewing gum, or sucking lozenges may help); postural hypotension (use caution climbing stairs or when changing position from lying or sitting to standing); or urinary retention (void before taking medication). Report persistent CNS effects (eg, trembling fingers, altered gait or balance, excessive sedation, seizures, unusual muscle or skeletal movements, anxiety, abnormal thoughts [especially thoughts of suicide], confusion, personality changes); chest pain, palpitations, rapid heartbeat, severe dizziness; swelling or pain in breasts (male and female), altered menstrual pattern, sexual dysfunction; pain or difficulty on urination; vision changes; skin rash or yellowing of skin; respiratory difficulty; or worsening of condition. Pregnancy/breast-feeding precautions: Inform prescriber if you are or intend to become pregnant. Do not breast-feed.
Geriatric Considerations
Any changes in disease status in any organ system can result in behavior changes.
Extrapyramidal syndrome symptoms occur less with this agent when total daily dose remains <6 mg as compared with phenothiazines and butyrophenone classes of antipsychotics. Many elderly patients receive antipsychotic medications for inappropriate nonpsychotic behavior. Before initiating antipsychotic medication, the clinician should investigate any possible reversible cause; any stress or stress from any disease can cause acute “confusion” or worsening of baseline nonpsychotic behavior. Most commonly acute changes in behavior are due to increases in drug dose or addition of new drug to regimen; fluid electrolyte loss; infections; and changes in environment.
In the treatment of agitated, demented, elderly patients, authors of meta-analysis of controlled trials of the response to the traditional antipsychotics (phenothiazines, butyrophenones) in controlling agitation have concluded that the use of neuroleptics results in a response rate of 18%. Clearly neuroleptic therapy for behavior control should be limited with frequent attempts to withdraw the agent given for behavior control. In light of significant risks and adverse effects in elderly population compared with limited data demonstrating efficacy in the treatment of dementia related psychosis, aggression, and agitation, an extensive risk:benefit analysis should be performed prior to use.
Additional Information
Risperdal® Consta® is an injectable formulation of risperidone using the extended release Medisorb® drug-delivery system; small polymeric microspheres degrade slowly, releasing the medication at a controlled rate.
Anesthesia and Critical Care Concerns/Other Considerations
Clinical Pearls/Comments: Risperidone may cause orthostatic hypotension and tachycardia but to a degree which may be less than is seen with other agents (eg, phenothiazines [chlorpromazine, thioridazine]).
Cardiovascular Considerations
Risperidone may cause orthostatic hypotension and tachycardia but to a degree which may be less than is seen with other agents (eg, phenothiazines: chlorpromazine, thioridazine). Risperidone may also prolong the QT interval. For these reasons, patient's with cardiovascular disease should be monitored closely while on therapy.
Dental Health: Effects on Dental Treatment
Key adverse event(s) related to dental treatment: Significant xerostomia (normal salivary flow resumes upon discontinuation) and toothache.
Dental Health: Vasoconstrictor/Local Anesthetic Precautions
No information available to require special precautions
Mental Health: Child/Adolescent Considerations
Aggression: In a randomized, double-blind, placebo-controlled study, 10 children and adolescents 6-14 years of age (mean: 9.2 ± 2.9 years) with conduct disorder and prominent aggressive behavior received risperidone in the following doses: Patients <50 kg: Initial: 0.25 mg once daily; doses were increased as needed by 0.25 mg/day increments each week to a maximum of 1.5 mg/day; patients ?50 kg: Initial: 0.5 mg once daily; doses were increased as needed by 0.5 mg/day increments each week to a maximum of 3 mg/day; final dose: 0.75-1.5 mg/day; mean: 0.028 ± 0.004 mg/kg/day (Findling, 2000). In another randomized, double-blind, placebo-controlled study, 19 adolescents (mean age: 14 ± 1.5 years; 7 with borderline IQ and 6 with mild mental retardation) received initial risperidone doses of 0.5 mg twice daily; doses were increased as needed by 1 mg/day increments up to a planned maximum of 5 mg twice daily; final doses: Range: 1.5-4 mg/day (0.019-0.08 mg/kg/day); mean: 2.9 mg/day (0.044 mg/kg/day); the authors recommend the following initial doses for clinical practice: Patients <25 kg: 0.25 mg/day; patients ?25 kg: 0.5 mg/day (Buitelaar, 2001).
In an open trial, 26 children and adolescents 10-18 years of age (mean: 15 ± 1.9 years) with a borderline IQ (n=19) or mild mental retardation (n=5) received initial risperidone doses of 0.5 mg/day; doses were increased by 0.5-1 mg/day increments every 3 days up to a planned maximum of 6 mg/day and given in twice daily doses; final dose: 0.5-4 mg/day; mean: 2.1 ± 1 mg/day (Buitelaar, 2000). Eleven children and adolescents 5.5-16 years of age (mean: 9.8 years) with mood disorders and aggressive behavior received risperidone in titrated doses in an open trial; final dose: 0.75-2.5 mg/day given in 2-3 divided doses (Schreier, 1998).
Autism: A multicenter double-blind, placebo-controlled trial of risperidone in children and adolescents 5-17 years of age (mean: 8.8 ± 2.7 years) with autism and serious behavioral problems demonstrated the short-term efficacy of risperidone for the treatment of aggression, tantrums, or self-injurious behavior. The following doses were used: Children 15-20 kg: Initial: 0.25 mg/day. Children 20-45 kg: Initial: 0.5 mg at bedtime on days 1-3 and 0.5 mg twice daily on day 4; dose was gradually increased in 0.5 mg increments to a maximum dose of 2.5 mg/day. Children >45 kg: Maximum dose: 3.5 mg/day; mean effective dose: 1.8 ± 0.7 mg/day (range: 0.5-3.5 mg/day) (McCracken, 2002).
In an open-labeled prospective study, 10 boys 4.5-10.8 years of age (mean: 7.2 ± 2.2 years) with autistic disorder were started on risperidone 0.5 mg/day; final dose: range: 1-2.5 mg/day (0.03-0.08 mg/kg/day); mean: 1.3 ± 0.5 mg/day (0.05 ± 0.2 mg/kg/day) (Nicolson, 1998). In an open clinical trial, 6 children 5-9 years of age (mean: 7.33 years) with autistic disorder were started on risperidone monotherapy 0.25 mg at bedtime; final dose: range: 0.75-1.5 mg/day (0.03-0.06 mg/kg/day); mean: 1.1 mg (0.04 mg/kg/day) (Findling, 1997).
Bipolar disorder: In a retrospective chart review, 28 children and adolescents 4-17 years of age (mean: 10.4 ± 3.8 years) were treated for bipolar disorder; optimal mean dose: 1.7 ± 1.3 mg/day (Frazier 1999).
Pervasive developmental disorders (PDDs): In a prospective open-labeled study, children and adolescents 5-18 years of age (mean 10.2 ± 3.7 years) were treated for PDDs (11 with autistic disorder) with initial doses of 0.5 mg at night; optimal dose: 1-4 mg/day (mean: 1.8 ± 1 mg/day) (McDougle, 1997). Fourteen children and adolescents 9-17 years of age (mean: 12.7 ± 4 years) were treated in an open case series, for PDDs (4 with autistic disorder) with initial doses of 0.25 mg twice daily; optimal dose: 0.75-1.5 mg/day given in divided doses (Fisman, 1996). In an open trial, 6 children and adolescents 7-14 years of age (mean: 10.7 ± 3.3 years) were treated for PDDs (5 with autistic disorder; all 6 with severe behavioral problems) with initial doses of 0.5 mg once or twice daily; optimal dose: 1-6 mg/day (mean 2.7 ± 2.2 mg/day) (Perry, 1997). Twenty children and adolescents (age: 8-17 years) with developmental disorders refractory to previous psychotropic agents were treated in an open clinical trial with risperidone; final doses: 1.5-10 mg/day; responders: 1-4 mg/day; nonresponders: 4.5-10 mg/day (Hardan, 1996).
Schizophrenia: In a prospective, open-labeled pilot study, 10 children and adolescents 11-18 years of age (mean: 15.1 years) were treated for schizophrenia with initial doses of 1 mg twice daily; final dose: Range: 4-10 mg/day (0.05-0.17 mg/kg/day); mean: 6.6 mg/day (0.095 mg/kg/day) (Armenteros, 1997). In a retrospective study, 16 children and adolescents 9-20 years of age (mean 14.9 ± 2.73 years) were treated for psychotic disorders with initial doses of 1 mg twice daily; optimal dose: 2-10 mg/day (mean: 5.9 ± 2.8 mg/day) divided and given in 2-3 doses/day (Grcevich, 1996).
Tourette's syndrome: In a multicenter, double-blind, parallel-group comparative study, 50 patients 11-50 years of age were treated for Tourette's syndrome with risperidone versus pimozide; final dose: 0.5-6 mg/day (mean: 3.8 mg/day) (Bruggeman, 2001).
Seven children and adolescents 11-16 years of age (mean: 12.9 ± 1.9 years) were treated in a prospective open-labeled trial for chronic tic disorders (5 with Tourette's syndrome) with initial doses of 0.5 mg at bedtime; final dose: 1-2.5 mg/day (Lombroso, 1995). In a retrospective review, 28 children and adolescents 5-18 years of age (mean 11.1 ± 3.6 years) with Tourette's syndrome and aggressive behavior were treated with risperidone; final dose: 0.5-9 mg/day (mean: 2 mg/day) (Sandor, 2000).
Armenteros JL, Whitaker AH, Welikson M, et al, “Risperidone in Adolescents With Schizophrenia: An Open Pilot Study,” J Am Acad Child Adolesc Psychiatry, 1997, 36(5):694-700.
Bruggeman R, van der Linden C, Buitelaar JK, et al, “Risperidone Versus Pimozide in Tourette's Disorder: A Comparative Double-Blind Parallel-Group Study,” J Clin Psychiatry, 2001, 62(1):50-6.
Buitelaar JK, “Open-Label Treatment With Risperidone of 26 Psychiatrically-Hospitalized Children and Adolescents With Mixed Diagnoses and Aggressive Behavior,” J Child Adolesc Psychopharmacol, 2000, 10(1):19-26.
Buitelaar JK, van der Gaag RJ, Cohen-Kettenis P, et al, “A Randomized Controlled Trial of Risperidone in the Treatment of Aggression in Hospitalized Adolescents With Subaverage Cognitive Abilities,” J Clin Psychiatry, 2001, 62(4):239-48.
Findling RL, Maxwell K, and Wiznitzer M, “An Open Clinical Trial of Risperidone Monotherapy in Young Children With Autistic Disorder,” Psychopharmacol Bull, 1997, 33(1):155-9.
Findling RL, McNamara NK, Branicky LA, et al, “A Double-Blind Pilot Study of Risperidone in the Treatment of Conduct Disorder,” J Am Acad Child Adolesc Psychiatry, 2000, 39(4):509-16.
Fisman S and Steele M, “Use of Risperidone in Pervasive Developmental Disorders: A Case Series,” J Child Adolesc Psychopharmacol, 1996, 6(3):177-90.
Frazier JA, Meyer MC, Biederman J, et al, “Risperidone Treatment for Juvenile Bipolar Disorder: A Retrospective Chart Review,” J Am Acad Child Adolesc Psychiatry, 1999, 38(8):960-5.
Grcevich SJ, Findling RL, Rowane WA, et al, “Risperidone in the Treatment of Children and Adolescents With Schizophrenia: A Retrospective Study,” J Child Adolesc Psychopharmacol, 1996, 6(4):251-7.
Hardan A, Johnson K, Johnson C, et al, “Case Study: Risperidone Treatment of Children and Adolescents With Developmental Disorders,” J Am Acad Child Adolesc Psychiatry, 1996, 35(11):1551-6.
Lombroso PJ, Scahill L, King RA, et al, “Risperidone Treatment of Children and Adolescents With Chronic Tic Disorders: A Preliminary Report,” J Am Acad Child Adolesc Psychiatry, 1995, 34(9):1147-52.
McCracken JT, McGough J, Shah B, et al, “Risperidone in Children With Autism and Serious Behavioral Problems,” N Engl J Med, 2002, 347(5):314-21.
McDougle CJ, Holmes JP, Bronson MR, et al, “Risperidone Treatment of Children and Adolescents With Pervasive Developmental Disorders: A Prospective Open-Label Study,” J Am Acad Child Adolesc Psychiatry, 1997, 36(5):685-93.
Nicolson R, Awad G, and Sloman L, “An Open Trial of Risperidone in Young Autistic Children,” J Am Acad Child Adolesc Psychiatry, 1998, 37(4):372-6.
Perry R, Pataki C, Munoz-Silva DM, et al, “Risperidone in Children and Adolescents With Pervasive Developmental Disorder: Pilot Trial and Follow-Up,” J Child Adolesc Psychopharmacol, 1997, 7(3):167-79.
Sandor P and Stephens RJ, “Risperidone Treatment of Aggressive Behavior in Children With Tourette Syndrome,” J Clin Psychopharmacol, 2000, 20(6):710-2.
Schreier HA, “Risperidone for Young Children With Mood Disorders and Aggressive Behavior,” J Child Adolesc Psychopharmacol, 1998, 8(1):49-59.
Mental Health: Comment
Risperidone is an antipsychotic agent of a class often referred to as atypical. It should be noted that the definition of the term “atypical” is not universally agreed upon. Some prefer to describe antipsychotics based on their pharmacological properties. A common feature of all definitions used to describe “atypical” antipsychotics is the lack of significant acute or subacute EPS, at dosages generally associated with antipsychotic actions. Other experts have included definitions of atypicality that include a) failure to increase serum prolactin levels; b) superior efficacy for positive, negative, and cognitive symptoms; and c) lack of evidence of tardive dyskinesia or dystonia following chronic administration.
Risperidone is associated with a dose dependent increase in EPS. Optimal dosage for most patients is ~4 mg/day. EPS is low when dosed ?6 mg/day. Dosages >6 mg/day give a clinical picture similar to haloperidol.
Tardive dyskinesia (TD) secondary to typical antipsychotics has an estimated incidence of 3% to 5% per year for the first 5 years of treatment. The incidence of TD associated with the atypical antipsychotics is estimated to be 0.5% to 1%. It is not clear if this estimate represents a risk associated with mental illness or to what extent drug therapy can be implicated. Atypical antipsychotics appear less likely to cause tardive dyskinesia than typical antipsychotics (fluphenazine, haloperidol).
Coadministration of two or more antipsychotics does not generally improve clinical response and may increase the potential for adverse effects.
The long acting dosage form of risperidone is formed by cross-linking polylactide and glycolide molecules into a polymer, then exposing that polymer to risperidone to create microspheres that are 25-150 microns in diameter. The microspheres must be suspended in the water-based diluent (provided in the kit) prior to injection. Since the microspheres may not be uniformly distributed in the diluent, the entire contents of the vial must be injected to ensure accurate dosing (dividing a dose is not accurately possible). Further, the bore of the needle (included in the kit) is Teflon® coated to prevent destruction of the microspheres and loss of drug due to sticking to the interior surface during injection.
Approximately 1% of the drug is released for the first 3 weeks after an injection. Therefore, one must overlap with oral therapy for at least 3 weeks and often 4-6 weeks or longer. This dosage form is not amenable to loading dose strategies. However, it is water-based (as opposed to oil) and is associated with less pain after injection than haloperidol decanoate or fluphenazine decanoate. The vials can be stored at room temperature for ?7 days total prior to reconstitution and should be stored in a refrigerator until the day of injection.
In 2008, the FDA issued a warning regarding increased mortality risk with typical and atypical antipsychotic drugs when used in elderly patients with dementia-related psychosis.
Nursing: Physical Assessment/Monitoring
Assess potential for interactions with other prescriptions, OTC medications, or herbal products patient may be taking. Monitor results of periodic ophthalmic exams. Assess therapeutic effectiveness and adverse reactions at beginning of therapy and periodically with long-term use. Monitor weight prior to initiating therapy and at least monthly. Be alert to the potential for orthostatic hypotension, especially during the titration phase. Initiate at lower doses and titrate to target dose. Taper dosage slowly when discontinuing. Teach patient appropriate use, possible side effects, interventions to reduce side effects, and adverse symptoms to report.
Dosage Forms
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Injection, microspheres for reconstitution, extended release:
Risperdal® Consta®: 12.5 mg, 25 mg, 37.5 mg, 50 mg [contains polylactide-co-glycolide; supplied in a dose-pack containing vial with active ingredient in microsphere formulation, prefilled syringe with diluent, needle-free vial access device, and 2 safety needles (a 21 G UTW 1-inch and a 20 G TW 2-inch)]
Solution, oral: 1 mg/mL (30 mL)
Risperdal®: 1 mg/mL (30 mL) [contains benzoic acid]
Tablet: 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, 4 mg
Risperdal®: 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, 4 mg
Tablet, orally disintegrating: 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, 4 mg
Risperdal® M-Tabs®: 0.5 mg [contains phenylalanine 0.14 mg]; 1 mg [contains phenylalanine 0.28 mg]; 2 mg [contains phenylalanine 0.42 mg]; 3 mg [contains phenylalanine 0.63 mg]; 4 mg [contains phenylalanine 0.84 mg]
Pricing: U.S. (www.drugstore.com)
Solution (Risperdal)
1 mg/mL (60): $310.22
Solution (Risperidone)
1 mg/mL (30): $125.99
Tablet, orally-disintegrating (Risperdal M-TAB)
0.5 mg (28): $144.42
1 mg (28): $163.25
Tablets (Risperdal)
0.25 mg (30): $124.52
0.5 mg (30): $135.09
1 mg (30): $159.77
2 mg (30): $246.70
3 mg (30): $318.69
4 mg (30): $364.18
Tablets (Risperidone)
0.25 mg (60): $145.99
0.5 mg (60): $179.98
1 mg (60): $195.98
2 mg (60): $289.96
3 mg (60): $299.99
4 mg (60): $399.98
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Buitelaar JK, “Open-Label Treatment With Risperidone of 26 Psychiatrically-Hospitalized Children and Adolescents With Mixed Diagnoses and Aggressive Behavior,” J Child Adolesc Psychopharmacol, 2000, 10(1):19-26.
Buitelaar JK, van der Gaag RJ, Cohen-Kettenis P, et al, “A Randomized Controlled Trial of Risperidone in the Treatment of Aggression in Hospitalized Adolescents With Subaverage Cognitive Abilities,” J Clin Psychiatry, 2001, 62(4):239-48.
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Frazier JA, Meyer MC, Biederman J, et al, “Risperidone Treatment for Juvenile Bipolar Disorder: A Retrospective Chart Review,” J Am Acad Child Adolesc Psychiatry, 1999, 38(8):960-5.
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International Brand Names
Lexi-Comp.com
Last full review/revision September 2009
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