RISPERDAL 2/MG FC TAB 20/FC TAB

Indications

Approved Uses

Schizophrenia (adults; adolescents 13-17 years); Bipolar I disorder-acute manic or mixed episodes (adults; pediatric patients 10-17 years); Bipolar I disorder-adjunctive therapy with lithium or valproate for acute manic or mixed episodes (adults); Irritability associated with autistic disorder (pediatric patients 5-16 years).

Off-Label Uses

Common off-label uses include: agitation/aggression in dementia (not FDA-approved; increased mortality warning), Tourette syndrome/tic disorders, augmentation in treatment-resistant depression or OCD, PTSD-related symptoms, delirium/agitation; ADHD is not a standard evidence-based off-label indication.

Dosage & Administration

Dosing by Condition

Schizophrenia (adults): start 2 mg/day (once daily or divided), usual target 4-8 mg/day; avoid routine doses >8 mg/day; absolute max 16 mg/day. Bipolar I acute mania/mixed (adults): start 2-3 mg/day, adjust by ~1 mg/day, usual range 1-6 mg/day (max 6 mg/day). Schizophrenia (adolescents 13-17): start 0.5 mg/day, target ~3 mg/day, max 6 mg/day. Bipolar mania (pediatrics 10-17): start 0.5 mg/day, titrate to 1-2.5 mg/day typical, max 6 mg/day. Autism irritability (pediatrics 5-16): <20 kg start 0.25 mg/day (target ~0.5 mg/day); ≥20 kg start 0.5 mg/day (target ~1 mg/day); effective range up to ~3 mg/day depending on response/tolerability.

Initial Dose

2 mg/day (schizophrenia in adults); may be given once daily or in two divided doses

Maintenance Dose

4-8 mg/day for schizophrenia; 1-6 mg/day for bipolar mania

Maximum Dose

16 mg/day (schizophrenia); 6 mg/day (bipolar mania)

Children's Dosage

Schizophrenia (13-17 years): 0.5 mg/day initial, target 3 mg/day, max 6 mg/day. Bipolar mania (10-17 years): 0.5 mg/day initial, target 1-2.5 mg/day, max 6 mg/day. Autism irritability (5-16 years): 0.25-0.5 mg/day initial depending on weight, titrate to 0.5-3 mg/day

Dose Adjustment Notes

Elderly and renal/hepatic impairment: start low and titrate slowly (commonly 0.5 mg twice daily for adults) due to higher exposure/orthostasis risk; strong CYP2D6 inhibitors (e.g., fluoxetine/paroxetine) can increase active moiety-consider dose reduction; enzyme inducers (e.g., carbamazepine) can lower levels-may require dose increase with close monitoring; doses >6 mg/day generally add adverse effects with limited added benefit.

How to Take

Swallow tablet whole with water. Can be taken with or without food. May be administered once daily or in two divided doses.

Side Effects

Common Side Effects

Somnolence/sedation, extrapyramidal symptoms (parkinsonism, akathisia, tremor), weight gain/increased appetite, dizziness/orthostatic hypotension, hyperprolactinemia, gastrointestinal effects (nausea, constipation), fatigue; rhinitis can occur.

Side Effect Frequency

Very common/common adverse effects include somnolence/sedation, headache, insomnia, extrapyramidal symptoms (e.g., parkinsonism/akathisia), weight gain/increased appetite, dizziness, GI upset (nausea/vomiting/dyspepsia), fatigue, anxiety; clinically important but less frequent/rare risks include hyperprolactinemia, orthostatic hypotension/tachycardia, QT prolongation, NMS, tardive dyskinesia, seizures, and thromboembolism

Safety & Warnings

Contraindications

Known hypersensitivity to risperidone or to any component of the formulation (often also listed: hypersensitivity to paliperidone).

Warnings & Precautions

Key warnings/precautions: boxed warning-↑ mortality in elderly with dementia-related psychosis (not approved); cerebrovascular events in elderly dementia; NMS; tardive dyskinesia; metabolic changes (hyperglycemia/diabetes, dyslipidemia, weight gain); orthostatic hypotension/syncope; leukopenia/neutropenia; seizures; hyperprolactinemia; caution in cardiovascular disease/QT risk; and for orally disintegrating tablets specifically, phenylalanine content (PKU caution).

Age Restriction

Schizophrenia: ≥13 years; Bipolar I acute manic/mixed episodes: ≥10 years; Irritability associated with autistic disorder: ≥5 years.

Driving Warning

May Cause Drowsiness

Drug Interactions

Drug Interactions

Key interactions: CYP2D6 inhibitors (e.g., fluoxetine/paroxetine) ↑ risperidone exposure; strong enzyme inducers (e.g., carbamazepine, rifampin) ↓ exposure; additive CNS depression with alcohol/benzodiazepines/opioids; additive hypotension with antihypertensives; antagonizes levodopa/dopamine agonists; caution with other QT-prolonging drugs (additive QT risk).

Interaction Severity

MAJOR/clinically significant: strong CYP inducers (e.g., carbamazepine) ↓ risperidone/active moiety; strong CYP2D6 inhibitors (fluoxetine/paroxetine) ↑ exposure; additive CNS depression with alcohol/benzodiazepines/opioids; additive hypotension with antihypertensives; additive QT-risk with other QT-prolonging drugs in at-risk patients. MODERATE: dopamine agonists/levodopa (pharmacodynamic antagonism); other EPS-promoting drugs (e.g., metoclopramide) increase EPS risk.

Food Interaction

No restriction

Alcohol Interaction

Avoid

Special Populations

Pregnancy

Category C (Risk cannot be ruled out

Breastfeeding

Caution

Children

Schizophrenia (13-17 years): 0.5 mg/day initial, target 3 mg/day, max 6 mg/day. Bipolar mania (10-17 years): 0.5 mg/day initial, target 1-2.5 mg/day, max 6 mg/day. Autism irritability (5-16 years): 0.25-0.5 mg/day initial depending on weight, titrate to 0.5-3 mg/day

Elderly

Start at 0.5 mg twice daily; increase by 0.5 mg twice daily increments; target 1-2 mg twice daily. Monitor for orthostatic hypotension, falls, and extrapyramidal symptoms. Not approved for dementia-related psychosis.

Kidney Impairment

Severe renal impairment (CrCl <30 mL/min): start 0.5 mg twice daily; may increase by 0.5 mg per dose to 1.5 mg twice daily; increases above 1.5 mg twice daily should be at ≥1-week intervals.

Liver Impairment

Severe hepatic impairment: start 0.5 mg twice daily; may increase by 0.5 mg per dose to 1.5 mg twice daily; increases above 1.5 mg twice daily should be at ≥1-week intervals (use cautious titration in any hepatic impairment).

Storage & Patient Advice

Missed Dose

Take the missed dose as soon as remembered unless it is close to the next scheduled dose; if close, skip the missed dose and resume the regular schedule-do not double doses.

Stopping the Medicine

Do not stop abruptly; taper gradually under medical supervision to reduce withdrawal symptoms and relapse risk.

Overdose

Symptoms: drowsiness/sedation, tachycardia, hypotension, extrapyramidal symptoms; may include QT prolongation/arrhythmias and rarely seizures. Management: airway/ventilation support, consider activated charcoal (± gastric lavage if appropriate), continuous cardiovascular/ECG monitoring, and supportive/symptomatic care; no specific antidote; urgent emergency evaluation required.

Patient Counseling

Key counseling: take exactly as prescribed and do not stop abruptly without clinician advice; may cause drowsiness/dizziness-avoid driving until effects known and rise slowly; avoid alcohol and other sedatives unless approved; report EPS (tremor, stiffness, restlessness), signs of NMS (fever, rigidity, confusion), or abnormal movements; attend monitoring for weight and metabolic labs; check with a clinician before new medicines; store below 25°C (per SFDA storage conditions).

Monitoring Requirements

Baseline and periodic: weight/BMI (and often waist circumference), blood pressure/orthostasis, fasting glucose or HbA1c, fasting lipids; assess for EPS/tardive dyskinesia; monitor prolactin if symptomatic; CBC if history of low WBC/ANC or clinically indicated; consider ECG/QTc in patients with cardiac risk factors or on QT-prolonging drugs; renal/hepatic function as clinically indicated.

Pharmacology

Mechanism of Action

Selective monoaminergic antagonist with high affinity antagonism at serotonin 5‑HT2A and dopamine D2 receptors; also antagonizes α1/α2-adrenergic and H1 histamine receptors (minimal anticholinergic activity).

Duration of Effect

Approximately 24 hours per dose for many effects (supports once-daily dosing; some patients may require twice-daily dosing). Full therapeutic effect is maintained with continued daily administration.

Half-Life

Risperidone: ~3 hours (CYP2D6 extensive metabolizers) and ~20 hours (poor metabolizers); 9-hydroxyrisperidone: ~21 hours; active moiety (risperidone + 9-hydroxyrisperidone): ~20 hours

Bioavailability

Approximately 70% (oral risperidone tablets)

Metabolism

Hepatic metabolism mainly via CYP2D6 to 9-hydroxyrisperidone (paliperidone); minor contribution via CYP3A4

Excretion

Primarily renal: ~70% recovered in urine; ~14% recovered in feces (after oral dosing)

Protein Binding

Risperidone: ~90% (commonly cited range ~88-90%); 9-hydroxyrisperidone: ~77%

Product Information

Available Dosage Forms

Tablet (including film-coated); Orally disintegrating tablet (M-TAB); Oral solution; Long-acting intramuscular injection (extended-release microspheres; RISPERDAL CONSTA).

Composition per Dose

Each film-coated tablet: 2 mg risperidone

Generic Availability

Yes

OTC Alternatives

No OTC alternative

Psych Class

Antipsychotic-Atypical

Controlled Substance

No

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