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.