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Risperdal

(risperidone)

Full Prescribing Information DailyMed Drug Information

Forms/Strengths

  • Tablets: 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, 4 mg
  • ODT: 0.5 mg, 1 mg, 2 mg, 3 mg, 4 mg

Dosing

  • Age: Adults and pediatric patients (pediatric use approved for irritability in autism, typically ages 5–16
  • Considerations: Start low (especially in pediatric patients); titrate gradually based on response and tolerability; monitor metabolic parameters and prolactin levels.
  • Initial Dose:
    • Adults (schizophrenia, bipolar disorder): 1–2 mg/day
    • Pediatrics (irritability): 0.25–0.5 mg/day
  • Titration:
    • Increase by 1 mg increments in adults
    • Increase by 0.25–0.5 mg increments in children
    • Adjust dosing every few days to weekly based on response and side effects
  • Max Dose: Approximately 6 mg/day in adults; pediatric maximum is weight dependent (often lower than adult maximum)

Quick Facts

  • Atypical antipsychotic; blocks dopamine D2 and serotonin 5-HT2A receptors
  • Modulates neurotransmission; improves psychotic symptoms, mood, and reduces irritability
  • Available as oral tablets (including orally disintegrating options)
  • Common side effects: weight gain, sedation, extrapyramidal symptoms, hyperprolactinemia
  • Required bloodwork: baseline and periodic fasting glucose, lipid panel, and prolactin levels
  • Unique dual receptor mechanism provides broad therapeutic effects in psychotic and mood disorders

Indications

  • Irritability Associated with Autistic Disorder (ICD-10: F84.0): Reduces aggression, self-injury, and tantrums.
  • Schizophrenia (ICD-10: F20.x): Reduces psychotic symptoms, such as delusions and hallucinations.
  • Bipolar Disorder (ICD-10: F31.x): Controls manic symptoms and helps stabilize mood.

Off-Label Uses

  • Generalized Anxiety Disorder (ICD-10: F41.1): Sometimes used adjunctively in treatment-refractory cases.
  • Post-Traumatic Stress Disorder (ICD-10: F43.10): Occasionally employed off-label in patients not responding to first-line treatments.
  • Borderline Personality Disorder (ICD-10: F60.3): May help reduce impulsivity and emotional dysregulation.
  • Tourette’s Disorder (ICD-10: F95.2): Occasionally used off-label to reduce motor and vocal tics.

How to Take

  • Take once or twice daily, as directed.
  • Can be taken with or without food.
  • Swallow the tablet whole; do not crush or chew.
  • If using the orally disintegrating tablet (ODT), place it on the tongue and let it dissolve completely—do not chew.
  • If using the oral solution, measure with a provided dosing syringe or cup—do not mix with tea or cola.
  • Do not abruptly stop taking; tapering may be required to avoid withdrawal effects.

Side Effects

  • Extrapyramidal symptoms (e.g., tremor, rigidity, akathisia)
  • Hyperprolactinemia (which may cause galactorrhea, menstrual disturbances)
  • Weight gain and metabolic abnormalities
  • Sedation and dizziness
  • Orthostatic hypotension
  • Potential risk for tardive dyskinesia with long-term use

Monitoring / Labs

Metabolic Monitoring:

    • Baseline and periodic fasting glucose and lipid profile
    • Regular weight checks and assessment of body mass index (BMI)

Prolactin Levels:

    • Check baseline levels and monitor if symptoms suggest hyperprolactinemia (e.g., galactorrhea, menstrual irregularities)

  • Neurological Monitoring:

    • Regular assessment for extrapyramidal symptoms and tardive dyskinesia
    • Monitor blood pressure, particularly during dose adjustments

  • Other Considerations:

    • In elderly patients with dementia-related psychosis, close monitoring is necessary due to increased mortality risk (not applicable in pediatric use)
    • Routine laboratory monitoring should be individualized based on clinical status

Education

  • When to Call the Doctor:

    • Severe mood changes, aggression, or suicidal thoughts.
    • Uncontrollable muscle movements (tardive dyskinesia).
    • Fever, muscle stiffness, confusion (possible neuroleptic malignant syndrome).
    • Sudden dizziness, fainting, or irregular heartbeats.
    • Signs of high blood sugar (excessive thirst, frequent urination, blurred vision).

  • Safety Tips:

    • Monitor blood sugar levels, especially in patients with diabetes.
    • Use caution in patients with dementia-related psychosis, as it may increase the risk of stroke.
    • Avoid alcohol and sedatives, which may increase drowsiness.
    • Rise slowly from sitting or lying positions to prevent dizziness.
    • Weight gain and metabolic changes may occur; monitor diet and physical activity.

  • Parent Tips for Pediatric Patients:

    • Monitor for changes in mood, irritability, or aggression.
    • Watch for increased appetite and weight gain; encourage balanced nutrition.
    • Observe for sedation or drowsiness affecting school performance.
    • Keep regular follow-up appointments to track effectiveness and side effects.
    • Report any unusual movements or muscle stiffness to the healthcare provider.

Additional Information

  • Contraindications:

    • Hypersensitivity to risperidone or formulation components.
    • Use with caution in patients with cardiovascular disease, seizure disorders, or history of stroke.

  • Pregnancy:

    • Category C; use only if benefits outweigh risks.
    • May cause withdrawal symptoms in newborns if taken in the third trimester.

  • Lactation:

    • Excreted in breast milk; not recommended due to potential adverse effects on the infant.

  • Drug Interactions:

    • CNS depressants (e.g., alcohol, benzodiazepines) may increase sedation.
    • Serotonergic drugs (e.g., SSRIs, SNRIs, MAOIs) may increase the risk of serotonin syndrome.
    • Antihypertensive medications may increase the risk of low blood pressure and dizziness.
    • CYP2D6 inhibitors (e.g., fluoxetine, paroxetine) may increase risperidone levels, requiring dose adjustments.
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