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risperidone (Rx)Brand and Other Names:Risperdal, Risperdal Consta, more...Risperdal M-Tab

 
 
 

Dosing & Uses

AdultPediatricGeriatric

Dosage Forms & Strengths

tablet

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

tablet, orally disintegrating

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

oral solution

  • 1mg/mL

powder for injection

  • 12.5mg
  • 25mg
  • 37.5mg
  • 50mg
more...

Schizophrenia

PO

  • 2 mg/day initially; may be increased in increments of 1-2 mg/day at intervals ≥24 hours
  • 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

  • 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

Bipolar Mania

PO

  • 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

IM

  • 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

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

Administration

IM Administration

  • Use supplied diluent for resuspension only
  • Administer within 2 minutes of resuspension; if this is not done, shake vigorously to resuspend

Dosing Modifications

Renal impairment

  • 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
  • IM: If 2-mg total daily dose of PO resperidone 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

  • 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
  • IM: If 2-mg total daily dose of PO resperidone 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

Dosage Forms & Strengths

tablet

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

tablet, orally disintegrating

  • 0.25mg
  • 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

risperidone and

No Results

     
     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

            Sort by :  
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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%)

            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%)

            <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

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            Warnings

            Black Box Warnings

            Not approved for dementia-related psychosis; 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 anicholinergic 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

            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 regidity and or autonomic instability; neuroleptic malignant syndrome associated with resperidone use

            Use with caution in children <15 kg

            Cases of priapism reported with therapy

            Prolactin elevations occur and persist during chronic administration

            Use caution when operating heavy machinery

            Risk of orthostatic hypotension

            FDA warning regarding off-label use for dementia in elderly

            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
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            Pregnancy & Lactation

            Pregnancy category: C

            Neonates exposed to antipsychotic drugs during 3rd trimester of pregnancy are at risk for EPS or withdrawal symptoms after delivery; these complications vary in severity, with some being self-limited and others requiring ICU support and prolonged hospitalization

            Lactation: Drug distributed in breast milk; do not nurse

            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.

            more...
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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

            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

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

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            Images

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            Formulary

            FormularyPatient Discounts

            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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