Wyoming Finance

Dec 31 2017

Risperdal, Risperdal Consta (risperidone) dosing, indications, interactions, adverse effects, and more

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risperidone (Rx)

  • 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)
  • 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

  • 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
  • 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)

Administration

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

Dosing Modifications

  • 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
  • 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, orally disintegrating

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

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

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

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 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

FDA warning regarding off-label use for dementia in elderly

  • 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

Prior Authorization
Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.

Quantity Limits
Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.

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.

Other Restrictions
Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.


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