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Generic Name
RisperiDONE
Brand Names
Risperdal, Risperdal Consta, Risperdal M-TAB, Rykindo, UZEDY
FDA approval date: December 29, 1993
Classification: Atypical Antipsychotic
Form: Injection, Tablet, Kit, Solution
What is Risperdal (RisperiDONE)?
RISPERDAL is an atypical antipsychotic indicated for: Treatment of schizophrenia.
Approved To Treat
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Brand Information
RISPERDAL (risperidone)
WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS
Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. RISPERDAL is not approved for the treatment of patients with dementia-related psychosis.
1DOSAGE AND ADMINISTRATION
Severe Renal and Hepatic Impairment in Adults: use a lower starting dose of 0.5 mg twice daily. May increase to dosages above 1.5 mg twice daily at intervals of one week or longer.
1.1Irritability Associated with Autistic Disorder – Pediatrics (Children and Adolescents)
The dosage of RISPERDAL should be individualized according to the response and tolerability of the patient. The total daily dose of RISPERDAL can be administered once daily, or half the total daily dose can be administered twice daily.
For patients with body weight less than 20 kg, initiate dosing at 0.25 mg per day. For patients with body weight greater than or equal to 20 kg, initiate dosing at 0.5 mg per day. After a minimum of four days, the dose may be increased to the recommended dose of 0.5 mg per day for patients less than 20 kg and 1.0 mg per day for patients greater than or equal to 20 kg. Maintain this dose for a minimum of 14 days. In patients not achieving sufficient clinical response, the dose may be increased at intervals of 2 weeks or greater, in increments of 0.25 mg per day for patients less than 20 kg, or increments of 0.5 mg per day for patients greater than or equal to 20 kg. The effective dose range is 0.5 mg to 3 mg per day. No dosing data are available for children who weigh less than 15 kg.
Once sufficient clinical response has been achieved and maintained, consider gradually lowering the dose to achieve the optimal balance of efficacy and safety. The physician who elects to use RISPERDAL for extended periods should periodically re-evaluate the long-term risks and benefits of the drug for the individual patient.
Patients experiencing persistent somnolence may benefit from a once-daily dose administered at bedtime or administering half the daily dose twice daily, or a reduction of the dose.
1.2Dosing in Patients with Severe Renal or Hepatic Impairment
For patients with severe renal impairment (Clcr< 30 mL/min) or hepatic impairment (10–15 points on Child Pugh System), the initial starting dose is 0.5 mg twice daily. The dose may be increased in increments of 0.5 mg or less, administered twice daily. For doses above 1.5 mg twice daily, increase in intervals of one week or greater
1.3Dose Adjustments for Specific Drug Interactions
When RISPERDAL is co-administered with enzyme inducers (e.g., carbamazepine), the dose of RISPERDAL should be increased up to double the patient's usual dose. It may be necessary to decrease the RISPERDAL dose when enzyme inducers such as carbamazepine are discontinued
When fluoxetine or paroxetine is co-administered with RISPERDAL, the dose of RISPERDAL should be reduced. The RISPERDAL dose should not exceed 8 mg per day in adults when co-administered with these drugs. When initiating therapy, RISPERDAL should be titrated slowly. It may be necessary to increase the RISPERDAL dose when enzyme inhibitors such as fluoxetine or paroxetine are discontinued
1.4Administration of RISPERDAL Oral Solution
RISPERDAL Oral Solution can be administered directly from the calibrated oral dosing syringe, 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.
2DOSAGE FORMS AND STRENGTHS
RISPERDAL Tablets are available in the following strengths and colors: 0.5 mg (red-brown), 1 mg (white), 2 mg (orange), 3 mg (yellow), and 4 mg (green). All are capsule shaped, and imprinted with "JANSSEN" on one side and either "Ris 0.5", "R1", "R2", "R3", or "R4" on the other side according to their respective strengths.
RISPERDAL Oral Solution is available in a 1 mg/mL strength.
RISPERDAL M-TAB Orally Disintegrating Tablets are available in the following strengths, colors, and shapes: 0.5 mg (light coral, round), 1 mg (light coral, square), 2 mg (coral, square), 3 mg (coral, round), and 4 mg (coral, round). All are biconvex and etched on one side with "R0.5", "R1", "R2", "R3", or "R4" according to their respective strengths.
3CONTRAINDICATIONS
RISPERDAL is contraindicated in patients with a known hypersensitivity to either risperidone or paliperidone, or to any of the excipients in the RISPERDAL formulation. Hypersensitivity reactions, including anaphylactic reactions and angioedema, have been reported in patients treated with risperidone and in patients treated with paliperidone. Paliperidone is a metabolite of risperidone.
4ADVERSE REACTIONS
The following are discussed in more detail in other sections of the labeling:
- Increased mortality in elderly patients with dementia-related psychosis
- Cerebrovascular adverse events, including stroke, in elderly patients with dementia-related psychosis
- Neuroleptic malignant syndrome
- Tardive dyskinesia
- Metabolic Changes (Hyperglycemia and diabetes mellitus, Dyslipidemia, and Weight Gain)
- Hyperprolactinemia
- Orthostatic hypotension
- Falls
- Leukopenia, neutropenia, and agranulocytosis
- Potential for cognitive and motor impairment
- Seizures
- Dysphagia
- Priapism
- Disruption of body temperature regulation
- Patients with Phenylketonuria
The most common adverse reactions in clinical trials (>5% and twice placebo) were parkinsonism, akathisia, dystonia, tremor, sedation, dizziness, anxiety, blurred vision, nausea, vomiting, upper abdominal pain, stomach discomfort, dyspepsia, diarrhea, salivary hypersecretion, constipation, dry mouth, increased appetite, increased weight, fatigue, rash, nasal congestion, upper respiratory tract infection, nasopharyngitis, and pharyngolaryngeal pain.
The most common adverse reactions that were associated with discontinuation from clinical trials (causing discontinuation in >1% of adults and/or >2% of pediatrics) were nausea, somnolence, sedation, vomiting, dizziness, and akathisia
The data described in this section are derived from a clinical trial database consisting of 9803 adult and pediatric patients exposed to one or more doses of RISPERDAL for the treatment of schizophrenia, bipolar mania, autistic disorder, and other psychiatric disorders in pediatrics and elderly patients with dementia. Of these 9803 patients, 2687 were patients who received RISPERDAL while participating in double-blind, placebo-controlled trials. The conditions and duration of treatment with RISPERDAL varied greatly and included (in overlapping categories) double-blind, fixed- and flexible-dose, placebo- or active-controlled studies and open-label phases of studies, inpatients and outpatients, and short-term (up to 12 weeks) and longer-term (up to 3 years) exposures. Safety was assessed by collecting adverse events and performing physical examinations, vital signs, body weights, laboratory analyses, and ECGs.
4.1Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
4.2Postmarketing Experience
The following adverse reactions have been identified during postapproval use of risperidone. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. These adverse reactions include: alopecia, anaphylactic reaction, angioedema, atrial fibrillation, cardiopulmonary arrest, catatonia, diabetic ketoacidosis in patients with impaired glucose metabolism, dysgeusia, hypoglycemia, hypothermia, ileus, inappropriate antidiuretic hormone secretion, intestinal obstruction, jaundice, mania, pancreatitis, pituitary adenoma, precocious puberty, pulmonary embolism, QT prolongation, sleep apnea syndrome, somnambulism, Stevens-Johnson syndrome and toxic epidermal necrolysis (SJS/TEN), sudden death, thrombocytopenia, thrombotic thrombocytopenic purpura, urinary retention, and water intoxication.
Postmarketing cases of extrapyramidal symptoms (dystonia and dyskinesia) have been reported in patients concomitantly taking methylphenidate and risperidone when there was an increase or decrease in dosage, initiation, or discontinuation of either or both medications.
5DESCRIPTION
RISPERDAL
Risperidone is a white to slightly beige powder. It is practically insoluble in water, freely soluble in methylene chloride, and soluble in methanol and 0.1
RISPERDAL
RISPERDAL is also available as a 1 mg/mL oral solution. RISPERDAL
RISPERDAL
6PATIENT COUNSELING INFORMATION
Advise patients using RISPERDAL oral solution to read the FDA-approved patient labeling (Instructions for Use) for RISPERDAL oral solution.
Physicians are advised to discuss the following issues with patients for whom they prescribe RISPERDAL.
7INSTRUCTIONS FOR USE
RISPERDAL
Read these Instructions for Use before you start using RISPERDAL Oral Solution and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or treatment.
Important information you need to know before taking RISPERDAL Oral Solution:
- Take RISPERDAL Oral Solution exactly as your healthcare provider tells you to take it.
- Each 1 mL contains 1 mg of RISPERDAL Oral Solution.
- Ask your healthcare provider or pharmacist to show you how to measure your prescribed dose using the oral dosing syringe.
- Always use the oral dosing syringe that comes with RISPERDAL Oral Solution. Contact your healthcare provider or pharmacist if you lose or damage the oral dosing syringe, or if your carton does not come with one.
- RISPERDAL Oral Solution can be taken directly from the oral dosing syringe or mixed with water, coffee, orange juice, or low-fat milk.
Gather and check supplies:
- Gather the RISPERDAL Oral Solution bottle and oral dosing syringe.
- Check the expiration date on the bottle. Do not use the bottle of RISPERDAL Oral Solution if the expiration date has passed.
- Check your dose in mLs as prescribed by your healthcare provider. Find this mL marking on the plunger of the oral dosing syringe. If your dose is more than 3 mL, you will need to divide your dose. Follow the instructions given to you by your healthcare provider or pharmacist on how to divide your dose.
Preparing a dose of RISPERDAL Oral Solution:
Storing RISPERDAL Oral Solution:
- Store RISPERDAL Oral Solution at room temperature between 59 °F to 77 °F (15 °C to 25 °C).
- Do not freeze RISPERDAL Oral Solution. Protect from light.
- Keep RISPERDAL Oral Solution and all medicines out of the reach of children.
Manufactured for:
For patent information: www.jansenpatents.com
© Johnson & Johnson and its affiliates 2007
This Instructions for Use has been approved by the U.S. Food and Drug Administration.
8INSTRUCCIONES DE USO
RISPERDAL
Lea estas Instrucciones de uso antes de comenzar a usar RISPERDAL Solución oral y cada vez que renueve su receta. Es posible que este material contenga información nueva. Esta información no reemplaza la consulta con su proveedor de atención médica acerca de su enfermedad o tratamiento.
Información importante que debe saber antes de tomar RISPERDAL Solución oral:
- Tome RISPERDAL Solución oral exactamente como se lo indica su proveedor de atención médica.
- Cada 1 ml contiene 1 mg de RISPERDAL Solución oral.
- Pídale a su proveedor de atención médica o farmacéutico que le muestre cómo medir la dosis recetada con la jeringa de dosificación oral.
- Utilice siempre la jeringa de dosificación oral que viene con RISPERDAL Solución oral. Comuníquese con su proveedor de atención médica o farmacéutico si pierde o daña la jeringa de dosificación oral, o si su caja no viene con una.
- RISPERDAL Solución oral se puede tomar directamente de la jeringa de dosificación oral o se puede mezclar con agua, café, jugo de naranja o leche con bajo contenido de grasa.
Reúna y verifique los suministros:
- Reúna el frasco de RISPERDAL Solución oral y la jeringa de dosificación oral.
- Consulte la fecha de caducidad en el frasco. No utilice el frasco de RISPERDAL Solución oral si ha pasado la fecha de caducidad.
- Verifique su dosis en ml según lo prescrito por su proveedor de atención médica. Busque esta marca de ml en el émbolo de la jeringa de dosificación oral. Si su dosis supera los 3 ml, deberá dividir la dosis. Siga las instrucciones que le dé su proveedor de atención médica o farmacéutico sobre cómo dividir su dosis.
Preparación de una dosis de RISPERDAL Solución oral:
Almacenamiento de RISPERDAL Solución oral
- Almacene RISPERDAL Solución oral a temperatura ambiente entre 59 °F y 77 °F (de 15 °C a 25 °C).
- No congelar RISPERDAL Solución oral. Proteger de la luz.
- Mantenga RISPERDAL Solución oral y todos los medicamentos fuera del alcance de los niños.
Fabricado para:
Janssen Pharmaceuticals, Inc.
Titusville, NJ, 08560, USA
Estas Instrucciones de uso han sido aprobadas por la Administración de Alimentos y Medicamentos (FDA) de los EE. UU.
Para información sobre patentes : www.janssenpatents.com
© Johnson & Johnson y sus afiliados 2007
Revisado: 2/2025