Risperidone

Risperidone is used to treat certain mental/mood disorders (such as schizophrenia, bipolar disorder, irritability associated with autistic disorder). This medication can help you to think clearly and take part in everyday life.

Risperidone belongs to a class of drugs called atypical antipsychotics. It works by helping to restore the balance of certain natural substances in the brain.

Risperidone may also be used in combination with other medication to treat depression.

Risperidone is available under the following different brand names: Risperdal, Risperdal Consta, and Risperdal M-Tab.

Adult and Pediatric Dosage Forms and Strengths

Tablet

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

Tablet, orally disintegrating

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

Oral solution

• 1 mg
• /mL

Powder for injection (adult only)

• 12.5 mg
• 25 mg
• 37.5 mg
• 50 mg

Dosage Considerations – Should be Given as Follows:

Schizophrenia

Oral

• 2 mg/day initially; may be increased in increments of 1-2 mg/day at intervals of 24 hours or more
• Recommended target dosage: 2-8 mg/day once daily or divided every 12 hours (efficacy follows bell-shaped curve; 4-8 mg/day more effective than 12-16 mg/day)

Intramuscular (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 oral risperidone before initiating treatment with IM risperidone

Pediatric

• Children under 13 years: Safety and efficacy not established
• Children over13 years: 0.5 mg/day orally in morning or evening initially; may be increased in increments of 0.5-1 mg/day at intervals 24 hours or more to recommended dosage of 3 mg/day; dosage range: 1-6 mg/day (dosages greater than 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 every 12 hours

Geriatric

• Use lower initial dose, and adjust more gradually
• Oral: 0.5 mg every 12 hours; may be increased in increments up to 0.5 mg every 12 hours; increases to dosages greater than 1.5 mg every 12 hours should occur at intervals of 1 week or more
• Intramuscular (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 oral risperidone before initiating treatment with IM risperidone

Bipolar Mania

Oral

• 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 greater than 3 weeks

Intramuscular (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 oral risperidone before initiating treatment with IM risperidone

Pediatric

• Children under 10 years: Safety and efficacy not established
• Children over 10 years: 0.5 mg/day orally in morning or evening initially; may be increased in increments of 0.5-1 mg/day at intervals of 24 hours or more to recommended dosage of 2.5 mg/day; dosage range: 0.5-6 mg/day (dosages greater than 2.5 mg/day have not been proven more effective and are associated with increased incidence of adverse effects)
• If persistent somnolence occurs, daily dose may be divided every 12 hours

Geriatric

• Use lower initial dose, and adjust more gradually
• Oral: 0.5 mg every 12 hours; may be increased in increments up to 0.5 mg every 12 hours; increases to dosages greater than 1.5 mg every 12 hours should occur at intervals 1 week or more
• Intramuscular (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 oral risperidone before initiating treatment with IM risperidone

Autism (Pediatric)

Irritability associated with autistic disorder in children aged 5-16 years

Children under 5 years: Safety and efficacy not established

Children 5-16 years (less than 20 kg): 0.25 mg/day orally initially; may be increased after 4 days or more to recommended dosage of 0.5 mg/day

Children 5-16 years (20 kg or more): 0.5 mg/day orally initially; may be increased after 4 days or more 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
• Less than 20 kg: Adjusted in increments of 0.25 mg/day; not to exceed 1 mg/day
• 20 kg or more: Adjusted in increments of 0.5 mg/day; not to exceed 2.5 mg/day

Tourette Syndrome (Off-label)

• 0.5-1 mg/day orally; may be increased or decreased in increments of 0.5 mg every 12 hours at intervals more than 3 days; not to exceed 6 mg/day

Posttraumatic Stress Disorder (Off-label)

• 0.5-8 mg/day orally

Psychosis, Agitation Related to Alzheimer Dementia (Off-label)

• Gertiatric: 0.25-1 mg/day orally initially; may be increased gradually as tolerated; not to exceed 1.5-2 mg/day

Administration

Intramuscular (IM) Administration

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

Dosing Modificationsn

Renal impairment

• CrCl less than 30 mL/min
• Oral: 0.5 mg every 12 hours initially; consider longer titration intervals; may be increased by up to 0.5 mg/day orally divided every 12 hours; dosage increase greater than 1.5 mg every 12 hours should occur no more frequently than once weekly
• IM: If 2-mg total daily dose of oral resperidone is well tolerated, may start with 12.5-25 mg IM every 2 weeks; continue oral supplementation for 3 weeks after first injection until main release of risperidone from injection has begun

Hepatic impairment

• Oral: 0.5 mg every 12 hours initially; consider longer titration intervals; may be increased by up to 0.5 mg/day orally divided every 12 hours; dosage increase greater than 1.5 mg every 12 hours should occur no more frequently than once weekly
• Intramuscular (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

Not approved for dementia-related psychosis, because of increased risk of cardiovascular or infectious related deaths.

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.

Common side effects of risperidone include:

• Drowsiness
• Insomnia
• Agitation
• Anxiety
• Headache
• Runny or stuffy nose
• Fatigue
• Parkinsonism
• Restlessness
• Increased appetite
• Vomiting
• Drooling
• Urinary incontinence
• Tremor
• Bedwetting
• Constipation
• Indigestion
• Nausea
• Abdominal pain
• Aggressive reaction
• Facial swelling
• QT prolongation
• Dizziness
• Extrapyramidal symptoms (EPS) (muscle spasms, restlessness, muscle rigidity, slowness of movement, tremor, and jerky movements)
• Male breast enlargement in children
• Rash
• Fast heart rate
• Lightheadedness or fainting
• Slow heart rate
• Palpitation
• Chest pain
• Agitation
• Dizziness upon standing
• Itching
• Acne
• Hyperprolactinemia
• Sexual dysfunction
• Dry mouth

Less common side effects of risperidone include:

• Agranulocytosis
• Cholesterol increased
• Delirium
• Ketoacidosis
• Seizures

Other side effects of risperidone include:

• Diabetes mellitus
• Elevated core body temperature (hyperthermia)
• Dangerously low body temperature (hypothermia)
• Low blood sugar (hypoglycemia)
• Myelosuppression
• Neuroleptic malignant syndrome (NMS)
• Prolonged erection
• Prolonged QT interval
• Repetitive, involuntary movements (tardive dyskinesia)
• Thrombotic thrombocytopenic purpura (TTP)
• Sleep apnea syndrome
• Urinary retention

This is not a complete list of side effects and other serious side effects may occur. Call your doctor for information and medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

If your doctor has directed you to use this medication for your condition, your doctor or pharmacist may already be aware of any possible drug interactions or side effects and may be monitoring you for them. Do not start, stop, or change the dosage of this medicine or any medicine before getting further information from your doctor, healthcare provider or pharmacist first.

Risperidone has no known severe interactions with other drugs.

Risperidone has serious interactions with at least 31 different drugs.

Risperidone has moderate interactions with at least 355 different drugs.

Risperidone has mild interactions with at least 29 different drugs.

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist. Check with your physician if you have health questions or concerns.

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 (e.g., heart failure, sudden death) or infectious (e.g., pneumonia) in nature.

This medication contains risperidone. Do not take Risperdal, Risperdal Consta, or Risperdal M-Tab if you are allergic to risperidone or any ingredients contained in this drug.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately.

Contraindications

• Documented hypersensitivity

Effects of Drug Abuse

• No information available

Short-Term Effects

• See "What Are Side Effects Associated with Using Risperidone?"

Long-Term Effects

• Prolactin elevations occur and persist during chronic administration.
• See "What Are Side Effects Associated with Using Risperidone?"

Cautions

• Increased incidence of cerebrovascular disease reported; may alter cardiac conduction; life threatening arrhythmias reported with therapeutic doses of antipsychotics.
• May cause anticholinergic 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 white blood cell (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 less than 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 rigidity and or autonomic instability; neuroleptic malignant syndrome associated with resperidone use.
• Use with caution in children less than 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 (e.g., 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

Pregnancy and Lactation

• Use risperidone with caution during pregnancy if benefits outweigh risks. Animal studies show risk and human studies are not available or neither animal nor human studies were done.
• Neonates exposed to antipsychotic drugs during 3rd trimester of pregnancy are at risk for extrapyramidal symptoms (EPS) or withdrawal symptoms after delivery; these complications vary in severity, with some being self-limited and others requiring ICU support and prolonged hospitalization.
• Risperidone is distributed in breast milk; do not nurse.