Risperidone

What is Risperidone?

• Risperidone (Risperdal) is an atypical antipsychotic agent used to treat schizophrenia, bipolar disorder and irritability associated with autistic disorder.

Risperidone

Risperidone-3D-balls

What are the uses of this medicine?

Risperidone (Risperdal) is used for:

• Treatment of schizophrenia in adults and adolescents aged 13–17 years.
• Alone, or in combination with lithium or valproate, for the short-term treatment of acute manic or mixed episodes associated with Bipolar I Disorder in adults, and alone in children and adolescents aged 10–17 years.
• Treatment of irritability associated with autistic disorder in children and adolescents aged 5–16 years.

How does this medicine work?

• Risperidone (ris per' i done) is a benzisoxazole derivative which appears to act as a dopamine type 2 (D2) and serotonin (5-HT2) receptor antagonist.
• Risperidone is indicated for treatment of schizophrenia and as monotherapy or combination therapy for acute manic or mixed episodes of bipolar I disorder in adults. Risperidone is also used for management of irritability with autistic disorder in children and adolescents.

Who Should Not Use this medicine ?

This medicine cannot be used in patients with:

• Known hypersensitivity to the product.

What drug interactions can this medicine cause?

• Due to CNS effects, use caution when administering with other centrally-acting drugs. Avoid alcohol.
• Due to hypotensive effects, hypotensive effects of other drugs with this potential may be enhanced.
• Risperdal® may antagonize the effects of levodopa and dopamine agonists.
• Cimetidine and ranitidine increased the bioavailability of risperidone.
• Chronic administration of clozapine with Risperdal® may decrease the clearance of risperidone.
• Fluoxetine and paroxetine increase plasma concentrations of risperidone.
• Carbamazepine and other enzyme inducers decrease plasma concentrations of risperidone which could lead to decreased efficacy of Risperdal® treatment.

Is this medicine FDA approved?

• Risperidone was approved for use in the United States in 1993 and it is still widely used.
• Risperidone is available as tablets of 0.25, 0.5, 1, 2, 3 and 4 mg generically and under the brand name of Risperdal. Oral solutions for pediatric use are available as are orally disintegrating tablets and formulations for parenteral administration.

How should this medicine be used?

Recommended dosage: Schizophrenia

• Adults:
• Risperdal® can be administered once or twice daily. Initial dosing is generally 2 mg/day.
• Dose increases should then occur at intervals not less than 24 hours, in increments of 1–2 mg/day, as tolerated, to a recommended dose of 4–8 mg/day.
• Efficacy has been demonstrated in a range of 4–16 mg/day.
• The safety of doses above 16 mg/day has not been evaluated in clinical trials.

• Adolescents:
• The dosage of Risperdal® should be initiated at 0.5 mg once daily, administered as a single-daily dose in either the morning or evening.
• Dosage adjustments, if indicated, should occur at intervals not less than 24 hours, in increments of 0.5 or 1 mg/day, as tolerated, to a recommended dose of 3 mg/day.
• Doses higher than 6 mg/day have not been studied.
• There are no controlled data to support the longer term use of Risperdal® beyond 8 weeks in adolescents with schizophrenia.

Bipolar Mania:

• Adults:
• Risperdal® should be administered on a once-daily schedule, starting with 2 mg to 3 mg per day.
• Dosage adjustments, if indicated, should occur at intervals of not less than 24 hours and in dosage increments/decrements of 1 mg per day.

Pediatrics:

• The dosage of Risperdal® should be initiated at 0.5 mg once daily, administered as a single-daily dose in either the morning or evening.
• Dosage adjustments, if indicated, should occur at intervals not less than 24 hours, in increments of 0.5 or 1 mg/day, as tolerated, to a recommended dose of 2.5 mg/day.

Irritability Associated with Autistic Disorder – Pediatrics (Children and Adolescents):

• Dosing should be initiated at 0.25 mg per day for patients < 20 kg and 0.5 mg per day for patients ≥ 20 kg.
• After a minimum of four days from treatment initiation, the dose may be increased to the recommended dose of 0.5 mg per day for patients < 20 kg and 1 mg per day for patients ≥ 20 kg.
• This dose should be maintained for a minimum of 14 days.
• In patients not achieving sufficient clinical response, dose increases may be considered at ≥ 2-week intervals in increments of 0.25 mg per day for patients < 20 kg or 0.5 mg per day for patients ≥ 20 kg.
• Caution should be exercised with dosage for smaller children who weigh less than 15 kg.

Administration:

• Risperdal® Oral Solution can be administered directly from the calibrated pipette, or can be mixed with a beverage prior to administration.
• Risperdal® Oral Solution is compatible in the following beverages: water, coffee, orange juice, and low-fat milk; it is NOT compatible with either cola or tea.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Tablets: 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, and 4 mg
• Oral solution: 1 mg/mL
• Orally disintegrating tablets: 0.5 mg, 1 mg, 2 mg, 3 mg, and 4 mg

This medicine is available in fallowing brand namesː

• Risperdal

What side effects can this medication cause?

The most common side effects of this medicine include:

• somnolence, appetite increased, fatigue, rhinitis, upper respiratory tract infection, vomiting, coughing, urinary incontinence, saliva increased, constipation, fever, Parkinsonism, dystonia, abdominal pain, anxiety, nausea, dizziness, dry mouth, tremor, rash, akathisia, and dyspepsia

The most common side effects that were associated with discontinuation:

• somnolence, nausea, abdominal pain, dizziness, vomiting, agitation, and akathisia.

What special precautions should I follow?

• Cerebrovascular events, including stroke, in elderly patients with dementia-related psychosis. Risperdal® is not approved for use in patients with dementia-related psychosis.
• A potentially fatal symptom complex sometimes referred to as Neuroleptic Malignant Syndrome (NMS) has been reported in association with antipsychotic drugs. The patient should be carefully monitored, since recurrences of NMS have been reported.
• A syndrome of potentially irreversible, involuntary, dyskinetic movements may develop in patients treated with antipsychotic drugs. If signs and symptoms of tardive dyskinesia appear in a patient treated with Risperdal®, drug discontinuation should be considered. However, some patients may require treatment with Risperdal® despite the presence of the syndrome.
• Hyperglycemia, in some cases extreme and associated with ketoacidosis or hyperosmolar coma or death, has been reported in patients treated with atypical antipsychotics including Risperdal. Patients with an established diagnosis of diabetes mellitus who are started on atypical antipsychotics should be monitored regularly for worsening of glucose control.
• Risperdal® is associated with higher levels of prolactin elevation than other antipsychotic agents. Risperdal® may induce orthostatic hypotension associated with dizziness, tachycardia, and in some patients, syncope. A dose reduction should be considered if hypotension occurs.
• Events of leukopenia/neutropenia have been reported temporally related to antipsychotic agents, including Risperdal. Patients with clinically significant neutropenia should be carefully monitored for fever or other symptoms or signs of infection and treated promptly if such symptoms or signs occur.
• Risperdal® has the potential to impair judgment, thinking, or motor skills, patients should be cautioned about operating hazardous machinery, including automobiles, until they are reasonably certain that Risperdal® therapy does not affect them adversely.
• Risperdal® should be used cautiously in patients with a history of seizures.
• Esophageal dysmotility and aspiration have been associated with antipsychotic drug use. Antipsychotic drugs should be used cautiously in patients at risk for aspiration pneumonia.
• Rare cases of priapism have been reported. While the relationship of the events to Risperdal. Severe priapism may require surgical intervention.
• Thrombotic Thrombocytopenic Purpura (TTP) may occur. The relationship to Risperdal® therapy is unknown.
• Disruption of body temperature regulation has been attributed to antipsychotic agents. Caution is advised when prescribing for patients who will be exposed to temperature extremes.
• Risperidone has an antiemetic effect.
• The possibility of a suicide attempt is inherent in patients with schizophrenia and bipolar mania, including children and adolescent patients, and close supervision of high-risk patients should accompany drug therapy.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• drowsiness and sedation
• tachycardia and hypotension
• extrapyramidal symptoms
• hyponatremia
• hypokalemia
• prolonged QT
• widened QRS
• seizure
• convulsions
• Torsade de pointes

Treatment of overdosage:

• There is no specific antidote to Risperdal®.
• Therefore, appropriate supportive measures should be instituted.
• The possibility of multiple drug involvement should be considered.
• Hypotension and circulatory collapse should be treated with appropriate measures, such as intravenous fluids and/or sympathomimetic agents (epinephrine and dopamine should not be used, since beta stimulation may worsen hypotension in the setting of risperidone-induced alpha blockade).
• In cases of severe extrapyramidal symptoms, anticholinergic medication should be administered.

Can this medicine be used in pregnancy?

• There are no adequate and well-controlled studies in pregnant women.
• Risperdal® should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Can this medicine be used in children?

• Safety and effectiveness of Risperdal® in children less than 13 years of age with schizophrenia have not been established.
• Safety and effectiveness of Risperdal® in children less than 10 years of age with bipolar disorder have not been established.
• The safety and effectiveness of Risperdal® in pediatric patients less than 5 years of age with autistic disorder have not been established.

What are the active and inactive ingredients in this medicine?

Active ingredient:

• risperidone

Inactive ingredients:

• silicon dioxide
• HYPROMELLOSES
• anhydrous lactose
• magnesium stearate
• cellulose, microcrystalline
• propylene glycol
• sodium lauryl sulfate
• starch, corn

Who manufactures and distributes this medicine?

Manufactured by: Janssen Pharmaceutica N.V. Beerse, Belgium

Manufactured for:

• Janssen, Division of Ortho-McNeil-Janssen
• Pharmaceuticals, Inc.
• Titusville, NJ, United States

What should I know about storage and disposal of this medication?

• Store bottle at controlled room temperature (59°-77°F/15°–25°C) away from children; avoid freezing and protect from light.

Antipsychotic agents

First Generation

• Phenothiazines
  • Chlorpromazine, Fluphenazine, Perphenazine, Prochlorperazine, Thioridazine, Trifluoperazine

• Other
  • Haloperidol, Lithium, Loxapine, Molindone, Pimozide

Second Generation (Atypicals)

• Aripiprazole, Asenapine, Brexpiprazole, Cariprazine, Clozapine, Iloperidone, Lurasidone, Olanzapine, Paliperidone, Pimavanserin, Quetiapine, Risperidone, Ziprasidone

• Dailymed label info on Risperidone
• FDA Risperidone

Risperidone Resources
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