risperidone (Rx)

Brand and Other Names:Risperdal, Risperdal Consta, more...Risperdal M-Tab, Perseris
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Dosing & Uses

AdultPediatricGeriatric

Dosage Forms & Strengths

tablet (Risperdal)

  • 0.25mg
  • 0.5mg
  • 1mg
  • 2mg
  • 3mg
  • 4mg

tablet, orally disintegrating (Risperdal M- Tabs)

  • 0.5mg
  • 1mg
  • 2mg
  • 3mg
  • 4mg

oral solution (Risperidal)

  • 1mg/mL

IM injection kit, long-acting injectable suspension (Risperdal Consta)

  • Kit contains prefilled 2-mL diluent syringe, vial containing risperidone microspheres, vial adapter, and needles for deltoid or gluteal IM administration
  • 12.5mg
  • 25mg
  • 37.5mg
  • 50mg

SC injection kit, extended-release injectable suspension (Perseris)

  • Kit includes a prefilled syringe containing risperidone powder, a syringe prefilled with the delivery system and desiccant, and needle for SC administration into the abdomen
  • 90mg
  • 120mg
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Schizophrenia

Also see Administration

PO (Risperdal or Risperidal M-Tabs)

  • 2 mg/day initially; may increase in increments of 1-2 mg/day at intervals ≥24 hr
  • Recommended target dosage: 2-8 mg/day once daily or divided q12hr (efficacy follows bell-shaped curve; 4-8 mg/day more effective than 12-16 mg/day)

IM (Risperdal Consta)

  • 12.5-50 mg injected into deltoid or gluteal muscle every 2 weeks; dosage should not be adjusted more frequently than every 4 weeks
  • Recommended to establish tolerability of PO risperidone before initiating treatment with IM risperidone

SC (Perseris)

  • 90 mg or 120 mg SC once monthly initially
  • Supplementation with oral risperidone is not recommended
  • Based on average plasma concentration of risperidone and total active moiety, 90-mg dose corresponds to 3 mg/day oral risperidone and 120-mg dose corresponds to 4 mg/day oral risperidone
  • Patients who are on stable oral risperidone doses <3 mg/day or >4 mg/day may not be candidates for risperidone ER suspension

Bipolar Mania

PO (Risperdal or Risperidal M-Tabs)

  • 2-3 mg/day initially; may be increased if necessary in increments of 1 mg/day at intervals of 24 hours to 6 mg/day; dosage recommendations not available for treatment duration >3 weeks

Bipolar Disorder

IM (Risperdal Consta)

  • Recommended dose for monotherapy or adjunctive therapy to lithium or valproate for the maintenance treatment of bipolar I disorder: 25 mg IM q2Weeks; some patients may benefit from a higher dose of 37.5 mg or 50 mg
  • Dosages above 50 mg have not been studied in this population
  • Periodically re-evaluate the long-term risks and benefits of the drug for the individual patient

Tourette Syndrome (Off-label)

0.5-1 mg/day PO; may be increased or decreased in increments of 0.5 mg q12hr at intervals >3 days; not to exceed 6 mg/day

Posttraumatic Stress Disorder (Off-label)

0.5-8 mg/day PO

Dosing Modifications

Renal impairment

  • SC
    • Not studied, use with caution
    • Prior to initiating treatment, it is recommended that patients be carefully titrated up to at least 3 mg/day or oral risperidone; if patients tolerate 3 mg oral and are psychiatrically stable, consider a 90-mg dose
  • CrCl <30 mL/min (PO)
    • 0.5 mg q12hr initially; consider longer titration intervals; may be increased by up to 0.5 mg/day PO divided q12hr; dosage increase >1.5 mg q12hr should occur no more frequently than once weekly
  • CrCl <30 mL/min (IM)
    • If 2-mg total daily dose of PO risperidone is well tolerated, may start with 12.5-25 mg IM every 2 weeks; continue PO supplementation for 3 weeks after first injection until main release of risperidone from injection has begun

Hepatic impairment

  • SC
    • Not studied, use with caution
    • Prior to initiating treatment, it is recommended that patients be carefully titrated up to at least 3 mg/day or oral risperidone; if patients tolerate 3 mg oral and are psychiatrically stable, consider a 90-mg dose
  • Child-Pugh 10-15 points (PO)
    • 0.5 mg q12hr initially; consider longer titration intervals; may be increased by up to 0.5 mg/day PO divided q12hr; dosage increase >1.5 mg q12hr should occur no more frequently than once weekly
  • Child-Pugh 10-15 points (IM)
    • If 2-mg total daily dose of PO risperidone is well tolerated, may start with 25 mg IM every 2 weeks; continue PO supplementation for 3 weeks after first injection until main release of risperidone from injection has begun

Coadministration with strong CYP2D6 inhibitors

  • SC, ER suspension
    • When initiation of a strong CYP2D6 inhibitor (eg, fluoxetine, paroxetine) is considered, patient may be placed on the lowest dose (90 mg) of risperidone ER suspension between 2-4 weeks before the planned start of the CYP2D6 inhibitor to adjust for the expected increase in plasma risperidone concentrations
    • When the CYP2D6 inhibitor is initiated in patients receiving risperidone ER suspension 90 mg, it is recommended to continue treatment with 90 mg unless clinical judgment necessitates interruption of risperidone treatment
  • IM, long-acting injectable suspension
    • When initiation of a strong CYP2D6 inhibitor (eg, fluoxetine, paroxetine) is considered, patient may be placed on a lower dose between 2-4 weeks before the planned start of the CYP2D6 inhibitor to adjust for the expected increase in plasma risperidone concentrations
    • When a CYP2D6 inhibitor initiated in patients receiving 25 mg IM of long-acting risperidone suspension, it is recommended to continue this dose unless clinical judgment necessitates lowering to 12.5 mg IM or interrupting treatment
    • If long-acting risperidone suspension is initiated in patients already receiving a strong CYP2D6 inhibitor, consider using a starting dose of 12.5 mg IM; efficacy of the 12.5 mg dose has not been investigated in clinical trials
  • PO
    • When a strong CYP2D6 inhibitor (eg, fluoxetine, or paroxetine) is coadministered with oral risperidone, reduce oral risperidone dose; dose should not exceed 8 mg/day in adults when coadministered with these drugs
    • When initiating therapy, titrate oral risperidone slowly If enzyme inhibitor is discontinued, assess risperidone dose and increase if necessary

Coadministration with strong CYP3A4 inducers

  • SC, ER injectable suspension
    • At initiation of therapy with CYP3A4 inducers (eg, carbamazepine, phenytoin, rifampin, phenobarbital), closely monitor during the first 4-8 weeks In patients receiving risperidone ER suspension 90 mg, consider increasing the dose to 120 mg
    • In patients receiving risperidone ER suspension 120 mg, consider additional oral risperidone therapy
    • On discontinuation of the strong CYP3A4 inducers, re-evaluated dosage of ER suspension or any additional oral risperidone therapy and if necessary, decreased to adjust for the expected increase in plasma concentration of risperidone
    • For patients treated with risperidone ER 90 mg and discontinuing from a strong CYP3A4 inducer, continue treatment with the 90-mg dose unless clinical judgment necessitates interruption of risperidone ER suspension treatment
  • IM, long-acting injectable suspension
    • Coadministration with strong CYP3A4 inducers (eg, carbamazepine, phenytoin, rifampin, phenobarbital) with risperidone would be expected to cause decreases in the plasma concentrations of the sum of risperidone and 9-hydroxyrisperidone combined, which could lead to decreased efficacy of IM risperidone; titrate accordingly for patients receiving these enzyme inducers, especially during initiation or discontinuation of therapy with these inducers
    • At the initiation of therapy with CYP3A4 inducers, patients should be closely monitored during the first 4-8 weeks, since the dose of IM risperidone may need to be adjusted; a dose increase, or additional oral risperidone, may need to be considered
    • If enzyme inducer is discontinued, assess risperidone dose and decrease if necessary
    • Patients may be placed on a lower dose of IM risperidone between 2-4 weeks before the planned discontinuation CYP3A4 inducers to adjust for the expected increase in plasma concentrations of risperidone plus 9-hydroxyrisperidone
    • For patients treated with the recommended dose of 25 mg and discontinuing from CYP3A4 inducers, continue treatment with the 25-mg dose unless clinical judgment necessitates lowering dose to 12.5 mg or necessitates interruption of IM risperidone treatment
    • The efficacy of the 12.5 mg dose has not been investigated in clinical trials
  • PO
    • Coadministered with enzyme inducers (eg, carbamazepine), the risperidone dose should be increased up to double the patient’s usual dose If enzyme inducer is discontinued, assess risperidone dose and decrease if necessary

Dosing Considerations

For patient who have never taken risperidone, establish tolerability with PO risperidone before initiating the IM or SC dosage forms

Switching from other antipsychotics to IM risperidone

  • There are no systematically collected data to specifically address switching patients from other antipsychotics to IM risperidone or concerning concomitant administration with other antipsychotics
  • Previous antipsychotics should be continued for 3 weeks after the first injection of IM risperidone to ensure that therapeutic concentrations are maintained until the main release phase of risperidone from the injection site has begun
  • As recommended with other antipsychotic medications, the need for continuing existing EPS medication should be re-evaluated periodically

Dosage Forms & Strengths

tablet

  • 0.25mg
  • 0.5mg
  • 1mg
  • 2mg
  • 3mg
  • 4mg

tablet, orally disintegrating

  • 0.5mg
  • 1mg
  • 2mg
  • 3mg
  • 4mg

oral solution

  • 1mg/mL
more...

Schizophrenia

<13 years: Safety and efficacy not established

>13 years: 0.5 mg/day PO in morning or evening initially; may be increased in increments of 0.5-1 mg/day at intervals ≥24 hr to recommended dosage of 3 mg/day; dosage range: 1-6 mg/day (dosages >3 mg/day have not been proved more effective and are associated with increased incidence of adverse effects)

If persistent somnolence occurs, daily dose may be divided q12hr 

Bipolar Mania

<10 years: Safety and efficacy not established 

>10 years: 0.5 mg/day PO in morning or evening initially; may be increased in increments of 0.5-1 mg/day at intervals ≥24 hr to recommended dosage of 2.5 mg/day; dosage range: 0.5-6 mg/day (dosages >2.5 mg/day have not been proved more effective and are associated with increased incidence of adverse effects)

If persistent somnolence occurs, daily dose may be divided q12hr

Autism

Irritability associated with autistic disorder in children aged 5-16 years

<5 years: Safety and efficacy not established

5-16 years (<20 kg): 0.25 mg/day PO initially; may be increased after ≥4 days to recommended dosage of 0.5 mg/day

5-16 years (≥20 kg): 0.5 mg/day PO initially; may be increased after ≥4 days to recommended dosage of 1 mg/day

Insufficient response to recommended dosage

  • If response to recommended dosage insufficient, dosage may be adjusted as follows after minimum of 14 days and at least every 2 weeks thereafter
  • <20 kg: Adjusted in increments of 0.25 mg/day; not to exceed 1 mg/day
  • ≥20 kg: Adjusted in increments of 0.5 mg/day; not to exceed 2.5 mg/day

Not approved for dementia-related psychosis, because of increased risk of cardiovascular or infectious related deaths (see Black Box Warnings)

Risk of orthostatic hypotension higher in elderly; monitoring of renal function and orthostatic blood pressure may be necessary; for titrating to target dose, twice-daily regimen should be used and dosage maintained for 2-3 days before change is made to once-daily dose regimen

Schizophrenia, Bipolar Mania

Use lower initial dose, and adjust more gradually

PO: 0.5 mg q12hr; may be increased in increments ≤0.5 mg q12hr; increases to dosages >1.5 mg q12hr should occur at intervals ≥1 week

IM: 12.5-25 mg injected into deltoid or gluteal muscle every 2 weeks; dosage should not be adjusted more frequently than every 4 weeks

Recommended to establish tolerability of PO risperidone before initiating treatment with IM risperidone

Psychosis, Agitation Related to Alzheimer Dementia (Off-label)

0.25-1 mg/day PO initially; may be increased gradually as tolerated; not to exceed 1.5-2 mg/day

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Interactions

Interaction Checker

and risperidone

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      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            >10%

            Somnolence (40-45%)

            Insomnia (26-30%)

            Agitation (20-25%)

            Anxiety (10-15%)

            Headache (10-15%)

            Rhinitis (10-15%)

            Fatigue (18-31%)

            Parkinsonism (28-62%)

            Akathisia (5-11%)

            Increased appetite (4-44%)

            Vomiting (10-20%)

            Drooling (<12%)

            Urinary incontinence (5-22%)

            Tremor (11-24%)

            Nasopharyngitis (4-19%)

            Rhinorrhea (4-12%)

            Enuresis (1-16%)

            ER suspension

            • Increased weight (12.8-13%)

            1-10%

            Constipation (5-10%)

            Dyspepsia (5-10%)

            Nausea (5-10%)

            Abdominal pain (1-5%)

            Aggressive reaction (1-5%)

            Facial edema (<4%)

            QT prolongation (<4%)

            Dizziness (1-5%)

            Extrapyramidal symptoms (EPS; 1-5%)

            Gynecomastia in children (1-5%)

            Rash (1-5%)

            Tachycardia (1-5%)

            Syncope (1-2%)

            Bradycardia (<4%)

            Palpitation (<4%)

            Chest pain (<4%)

            Agitation (<4%)

            Postural dizziness (<4%)

            Pruritus (<4%)

            Acne (1-2%)

            Hyperprolactinemia (<4%)

            Sexual dysfunction (<4%)

            Xerostomia (7-10%)

            ER suspension

            • Sedation (7-7.7%)
            • Pain in extremity (0.9-7.7%)
            • Constipation (7-7/7%)
            • Anxiety (2.6-6.8%)
            • Akathisia (2.6-6.8%)
            • Back pain (3.5-6.8%)
            • Musculoskeletal pain (5.2%)
            • Extrapyramidal disorder (1.7-4.3%)
            • Increased appetite (1.7-3.4%)
            • Musculoskeletal stiffness (0.9-2.6%)
            • Abdominal discomfort (2.6%)
            • Muscle spasms (0-2.6%)
            • Dry mouth (1.7-2.6%)

            <1%

            Agranulocytosis

            Cholesterol increased

            Delirium

            Ketoacidosis

            Orthostatic hypotension

            Seizures

            Frequency Not Defined

            Diabetes mellitus

            Hyperthermia

            Hypoglycemia

            Hypothermia

            Myelosuppression

            Neuroleptic malignant syndrome (NMS)

            Priapism

            Prolonged QT interval

            Tardive dyskinesia

            Thrombotic thrombocytopenic purpura (TTP)

            Sleep apnea syndrome

            Urinary retention

            Blood and lymphatic system disorders: Anemia, granulocytopenia

            Cardiac disorders: Tachycardia, sinus bradycardia, sinus tachycardia, atrioventricular block first degree, bundle branch block left, bundle branch block right, atrioventricular block

            Ear and labyrinth disorders: Ear pain, tinnitus

            Eye Disorders: Vision blurred, oculogyration, ocular hyperemia, eye discharge, conjunctivitis, eye rolling, eyelid edema, eye swelling, eyelid margin crusting, dry eye, lacrimation increased, photophobia, glaucoma, visual acuity reduced

            Gastrointestinal disorders: Dysphagia, fecaloma, fecal incontinence, gastritis, lip swelling, cheilitis, aptyalism

            General disorders: Thirst, gait disturbance, chest pain, influenza-like illness, pitting edema, edema, chills, sluggishness, malaise, face edema, discomfort, generalized edema, drug withdrawal syndrome, peripheral coldness, feeling abnormal

            Immune system disorders: Drug hypersensitivity

            Infections and infestations: Nasopharyngitis, upper respiratory tract infection, sinusitis, urinary tract infection, pneumonia, influenza, ear infection, viral infection, pharyngitis, tonsillitis, bronchitis, eye infection, localized infection, cystitis, cellulitis, otitis media, onychomycosis, acarodermatitis, bronchopneumonia, respiratory tract infection, tracheobronchitis, otitis media chronic

            Investigations: Body temperature increased, alanine aminotransferase increased, heart rate increased, eosinophil count increased, white blood cell count decreased, hemoglobin decreased, blood creatine phosphokinase increased, hematocrit decreased, body temperature decreased, blood pressure decreased, transaminases increased

            Metabolism and nutrition disorders: Polydipsia, anorexia

            Musculoskeletal, connective tissue, and bone disorders: Joint swelling, musculoskeletal chest pain, posture abnormal, myalgia, neck pain, muscular weakness, muscle rigidity, muscle contracture, rhabdomyolysis

            Nervous system disorders: Dizziness postural, disturbance in attention, unresponsive to stimuli, depressed level of consciousness, movement disorder, hypokinesia, bradykinesia, transient ischemic attack, coordination abnormal, cerebrovascular accident, masked facies, speech disorder, syncope, loss of consciousness, muscle contractions involuntary, Parkinson disease, tongue paralysis, akinesia, cerebral ischemia, cerebrovascular disorder, neuroleptic malignant syndrome, diabetic coma, head titubation

            Psychiatric disorders: Agitation, blunted affect, confusional state, middle insomnia, nervousness, sleep disorder, listlessness

            Renal and urinary disorders: Enuresis, dysuria, pollakiuria, urinary incontinence Reproductive system and breast disorders: Vaginal discharge, menstrual disorder, retrograde ejaculation, sexual dysfunction

            Postmarketing Reports

            Falls

            Alopecia, anaphylactic reaction, angioedema, atrial fibrillation, cardiopulmonary arrest, diabetic ketoacidosis in patients with impaired glucose metabolism, dysgeusia, hypoglycemia, hypothermia, ileus, inappropriate antidiuretic hormone secretion, intestinal obstruction, jaundice, mania, pancreatitis, pituitary adenoma, precocious puberty, pulmonary embolism, QT prolongation, sleep apnea syndrome, sudden death, thrombocytopenia, thrombotic thrombocytopenic purpura, urinary retention, and water intoxication

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            Warnings

            Black Box Warnings

            Elderly patients with dementia-related psychosis

            • Not approved for dementia-related psychosis
            • Elderly patients with dementia-related psychosis who are treated with antipsychotic drugs are at increased risk of death, as shown in short-term controlled trials; deaths in these trials appeared to be either cardiovascular (eg, heart failure, sudden death) or infectious (eg, pneumonia) in nature

            Contraindications

            Documented hypersensitivity

            Cautions

            Increased incidence of cerebrovascular disease reported; may alter cardiac conduction; life threatening arrhythmias reported with therapeutic doses of antipsychotics

            May cause anticholinergic effects including blurred vision, urinary retention, agitation, confusion, blurred vision, and xerostomia

            Use with caution in patients with history of seizures, Parkinson disease, Lewy body dementia, cardiovascular disease, hypovolemia, dehydration

            Leukopenia/neutropenia and agranulocytosis reported; possible risk factors for leukopenia/neutropenia include preexisting low white blood cell (WBC) count and history of drug-induced leukopenia/neutropenia

            If patient has history of clinically significant low WBC count or drug-induced leukopenia/neutropenia, monitor complete blood count (CBC) frequently during first few months of therapy; discontinue drug at first sign of clinically significant WBC decline <1000/μL in absence of other causative factors, and continue monitoring WBC count until recovery

            May cause somnolence, postural hypotension, motor and sensory instability, which may lead to falls and, consequently, fractures or other injuries; perform complete fall risk assessments when initiating antipsychotic treatment and recurrently for patients on long-term antipsychotic therapy

            Use caution in patients at risk of pneumonia; esophageal dysmotility and aspiration reported with antipsychotic use

            May cause extrapyramidal symptoms including acute dystonic reactions, akathisia, pseudoparkinsonism, and tardive dyskinesia

            Intraoperative floppy iris syndrome reported in patients receiving risperidone therapy

            Monitor for fever, mental status changes, muscle rigidity and or autonomic instability; neuroleptic malignant syndrome associated with risperidone use

            Use with caution in children <15 kg

            Cases of priapism reported with therapy

            Prolactin elevations occur and persist during chronic administration; risperidone is associated with higher levels of prolactin elevation than other antipsychotic agents

            Use caution when operating heavy machinery

            FDA warning regarding off-label use for dementia in elderly

            Seizures observed during premarketing studies of risperidone in adult patients with schizophrenia

            Esophageal dysmotility and aspiration have been associated with antipsychotic use

            Disruption of body temperature regulation has been attributed to antipsychotic agents

            Metabolic changes

            • Atypical antipsychotic drugs have been associated with metabolic changes that may increase cardiovascular or cerebrovascular risk (eg, hyperglycemia, dyslipidemia, and body weight gain)
            • In some cases, hyperglycemia concomitant with use of atypical antipsychotics has been associated with ketoacidosis, hyperosmolar coma, or death
            • In some cases, hyperglycemia has resolved when the atypical antipsychotic, including risperidone, was discontinued; however, some patients required continuation of antidiabetic treatment despite discontinuation of risperidone
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            Pregnancy & Lactation

            Pregnancy

            There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to atypical antipsychotics, including risperidone, during pregnancy

            Healthcare professionals are encouraged to register patients by contacting the National Pregnancy Registry for Atypical Antipsychotics at 1-866-961-2388 or online at http://womensmentalhealth.org/clinical-and-research programs/ pregnancyregistry/

            Infertility

            • Based on the pharmacologic action of risperidone, treatment may result in an increase in serum prolactin levels, which may lead to reversible reduction in fertility in females of reproductive potential

            Disease-associated maternal and/or embryo/fetal risk

            • There is a risk to the mother from untreated schizophrenia, including increased risk of relapse, hospitalization, and suicide
            • Schizophrenia is associated with increased adverse perinatal outcomes, including preterm birth It is not known if this is a direct result of the illness or other comorbid factors

            Fetal/neonatal adverse reactions

            • Extrapyramidal and/or withdrawal symptoms, including agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress, and feeding disorder reported in neonates who were exposed to antipsychotic drugs, including risperidone, during the third trimester of pregnancy; symptoms varied
            • Monitor neonates for extrapyramidal and/or withdrawal symptoms and manage symptoms appropriately

            Lactation

            Limited data from published literature reports the presence of risperidone and its metabolite, 9- hydroxyrisperidone, in human breast milk at relative infant dose ranging between 2.3 and 4.7% of the maternal weight-adjusted dosage

            Reports of sedation, failure to thrive, jitteriness, and extrapyramidal symptoms (tremors and abnormal muscle movements) in breastfed infants exposed to risperidone

            Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for the drug, and any potential adverse effects on the breastfed infant from the drug or from the underlying maternal condition

            Pregnancy Categories

            A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA:Information not available.

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            Pharmacology

            Mechanism of Action

            Improves negative symptoms of psychoses and reduces incidence of EPS

            Has high affinity for serotonin type 2 (5-HT2) receptors; binds to dopamine D2 receptors with 20 times lower affinity than that for 5-HT2 receptors; antagonizes alpha1-adrenergic, alpha2-adrenergic, and histaminergic receptors; has moderate affinity for serotonin type 1 (5-HT1C, 5-HT1D, 5-HT1A) receptors; has weak affinity for dopamine D1 receptors; has no affinity for muscarinic, beta1-adrenergic, and beta2-adrenergic receptors

            Absorption

            Peak plasma time, steady-state: 4-6 hr (SC)

            Peak plasma concentration: 6.33-10.9 ng/mL (risperidone, 9-hydroxyrisperidone)

            AUC: 2262-3891 ng·hr/mL

            Bioavailability: 70%

            Peak plasma time: Extensive metabolizers, 3 hr; poor metabolizers, 17 hr

            Distribution

            Protein bound: Risperidone, 90%; metabolite, 77%

            Vd: 1-2 L/kg

            Metabolism

            Metabolized in liver by CYP2D6

            Metabolite: 9-hydroxyrisperidone (paliperidone)

            Elimination

            Half-life: Extensive metabolizers, 3 hr (parent and metabolite combined); poor metabolizers, 20 hr (parent and metabolite combined); prolonged in renal impairment; free fraction increase in hepatic disease

            Half-life: 8-9 days (9-hydroxyrisperidone and total active moiety)

            Excretion: Urine (70%), feces (14%)

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            Administration

            Oral Administration

            Oral solution

            • Administer directly from the calibrated pipette, or can be mixed with a beverage prior to administration
            • Compatible in the following beverages: Water, coffee, orange juice, and low-fat milk; it is NOT compatible with either cola or tea

            Orally disintegrating tablets

            • Do not open the blister until ready to administer
            • For single tablet removal, separate one of the four blister units by tearing apart at the perforations
            • Bend the corner where indicated
            • Peel back foil to expose the tablet
            • DO NOT push the tablet through the foil because this could damage the tablet
            • The child-resistant pouch should be torn open at the notch to access the blister; do not open the blister until ready to administer
            • Peel back foil from the side to expose the tablet
            • DO NOT push the tablet through the foil, because this could damage the tablet
            • Using dry hands, remove the tablet from the blister unit and immediately place the entire oral disintegration on the tongue; consumed immediately, as the tablet cannot be stored once removed from the blister unit
            • Disintegrate in the mouth within seconds and can be swallowed subsequently with or without liquid; patients should not attempt to split or to chew the tablet

            SC Preparation

            Visually inspect for particulate matter and discoloration prior to administration

            Hold powder syringe upright tap the barrel of the syringe to unpack the powder

            Remove caps from both powder syringe and diluent syringe

            Connect both syringes; do not over tighten

            Keep your fingers off the plunger to avoid drug spillage

            Mix product

            • Failure to fully mix the product could result in incorrect dosage
            • Premixing
              • Transfer contents of the liquid syringe into the powder syringe
              • Gently push the powder syringe plunger until you feel resistance (to wet powder and avoid compacting)
              • Repeat this gentle back-and-forth process for 5 cycles
            • Complete mixing
              • Continue mixing the syringes for an additional 55 cycles; mixing can be more vigorous than when premixing
              • When fully mixed, the product should be a cloudy suspension that is uniform in color; varies between white to yellow-green in color
              • If mixed drug appears any clear areas in the mixture, continue to mix until the distribution of the color is uniform

            SC Administration

            For abdominal SC injection, only

            Do not administer by any other route

            To be administered by a healthcare professional only

            Choose an injection site on the abdomen with adequate SC tissue that has no skin conditions (eg, nodules, lesions, excessive pigment); recommended patient be in the supine position; rotate injection sites (refer to prescribing information)

            Allow package to come to room temperature for at least 15 minutes prior to preparation

            Only prepare medication when you are ready to administer the dose

            As a universal precaution, always wear gloves

            IM preparation

            Remove dose pack from refrigerator; allow to sit at room temperature at least 30 minutes before reconstituting; do not warm any other way

            Remove vial cap; connect vial adapter

            Keep vial vertical to prevent leakage

            Hold base of vial and pull up on the sterile blister to remove; do not shake; do not touch exposed luer opening on vial adapter; this will result in contamination

            Remove cap from liquid cap; connect liquid syringe to the vial adapter

            Do not hold glass syringe barrel; may cause the white collar to loose or detach Inject diluent, suspend microspheres in diluent

            Continuing to hold down the plunger rod, shake vigorously for at least 10 seconds, as shown; check the suspension

            Microspheres will be visible in the liquid; immediately proceed to the next step so suspension does not settle

            IM Administration

            Immediately inject entire contents of syringe IM into the gluteal or deltoid muscle of the patient

            Gluteal injection should be made into the upper-outer quadrant of the gluteal area

            Do not IV administer

            Storage

            Tablets and oral disintegrating tablets

            • Store at room temperature 15-25°C (59-77°F); protect from light and moisture

            Oral solution

            • Store at controlled room temperature 15- 25°C (59-77°F); protect from light and freezing

            SC and IM kits

            • Unopened: Refrigerate 2-8°C (36-46°F); may store at room temperature in its original packaging at 20-25°C (68-77°F) for up to 7 days
            • After removal from the refrigerator, discard after 7 days
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            Images

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            Formulary

            FormularyPatient Discounts

            Adding plans allows you to compare formulary status to other drugs in the same class.

            To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

            Adding plans allows you to:

            • View the formulary and any restrictions for each plan.
            • Manage and view all your plans together – even plans in different states.
            • Compare formulary status to other drugs in the same class.
            • Access your plan list on any device – mobile or desktop.

            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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            Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.