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RISPERDAL® Safely and Effectively

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RISPERDAL® Safely and Effectively HIGHLIGHTS OF PRESCRIBING INFORMATION ---------------------------WARNINGS AND PRECAUTIONS-------------------- These highlights do not include all the information needed to use • Cerebrovascular events, including stroke, in elderly patients with RISPERDAL® safely and effectively. See full prescribing information for dementia-related psychosis: RISPERDAL® is not approved for use in RISPERDAL®. patients with dementia-related psychosis. (5.2) • Neuroleptic Malignant Syndrome: Manage with immediate RISPERDAL® (risperidone) tablets, for oral use discontinuation of RISPERDAL® and close monitoring. (5.3) RISPERDAL® (risperidone) oral solution • Tardive dyskinesia: Consider discontinuing RISPERDAL® if clinically RISPERDAL® M-TAB® (risperidone) orally disintegrating tablets indicated. (5.4) Initial U.S. Approval: 1993 • Metabolic Changes: Atypical antipsychotic drugs have been associated WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS with metabolic changes that may increase cardiovascular/ WITH DEMENTIA-RELATED PSYCHOSIS cerebrovascular risk. These metabolic changes include hyperglycemia, See full prescribing information for complete boxed warning. dyslipidemia, and weight gain. (5.5) Elderly patients with dementia-related psychosis treated with o Hyperglycemia and Diabetes Mellitus: Monitor patients for antipsychotic drugs are at an increased risk of death. RISPERDAL® is symptoms of hyperglycemia including polydipsia, polyuria, not approved for use in patients with dementia-related psychosis. (5.1) polyphagia, and weakness. Monitor glucose regularly in patients with diabetes or at risk for diabetes. (5.5) Dyslipidemia: Undesirable alterations have been observed in patients ----------------------------INDICATIONS AND USAGE---------------------------- o treated with atypical antipsychotics. (5.5) RISPERDAL® is an atypical antipsychotic indicated for: Weight Gain: Significant weight gain has been reported. Monitor • Treatment of schizophrenia (1.1) o weight gain. (5.5) • As monotherapy or adjunctive therapy with lithium or valproate, for the • Hyperprolactinemia: Prolactin elevations occur and persist during treatment of acute manic or mixed episodes associated with Bipolar I chronic administration. (5.6) Disorder (1.2) • Orthostatic hypotension: For patients at risk, consider a lower starting • Treatment of irritability associated with autistic disorder (1.3) dose and slower titration. (5.7) • Leukopenia, Neutropenia, and Agranulocytosis: Perform complete blood -----------------------DOSAGE AND ADMINISTRATION----------------------- counts in patients with a history of clinically significant low white blood • Recommended daily dosage: cell count (WBC). Consider discontinuing RISPERDAL® if a clinically Initial Dose Target Effective significant decline in WBC occurs in the absence of other causative Dose Dose Range factors. (5.9) Schizophrenia 2 mg 4 to 8 mg 4 to 16 mg • Potential for cognitive and motor impairment: Use caution when : adults (2.1) operating machinery. (5.10) • Seizures: Use cautiously in patients with a history of seizures or with Schizophrenia 0.5 mg 3 mg 1 to 6 mg conditions that lower the seizure threshold. (5.11) : adolescents (2.1) ------------------------------ADVERSE REACTIONS------------------------------ Bipolar 2 to 3 mg 1 to 6 mg 1 to 6 mg The most common adverse reactions in clinical trials (>5% and twice placebo) mania: Adults were parkinsonism, akathisia, dystonia, tremor, sedation, dizziness, anxiety, (2.2) blurred vision, nausea, vomiting, upper abdominal pain, stomach discomfort, Bipolar 0.5 mg 1 to 2.5 1 to 6 mg dyspepsia, diarrhea, salivary hypersecretion, constipation, dry mouth, mania: in mg increased appetite, increased weight, fatigue, rash, nasal congestion, upper children and respiratory tract infection, nasopharyngitis, and pharyngolaryngeal pain. (6) adolescents To report SUSPECTED ADVERSE REACTIONS, contact Janssen (2.2) Pharmaceuticals, Inc. at 1-800-JANSSEN (1-800-526-7736) or FDA at 1- Irritability 0.25 mg 0.5 mg 0.5 to 3 mg 800-FDA-1088 or www.fda.gov/medwatch associated (Weight < (<20 kg) with autistic 20 kg) ---------------------------------DRUG INTERACTIONS---------------------------- disorder (2.3) 1 mg • Carbamazepine and other enzyme inducers decrease plasma concentrations ® 0.5 mg (≥20 kg) of risperidone. Increase the RISPERDAL dose up to double the patient’s (Weight usual dose. Titrate slowly. (7.1) ≥20 kg) • Fluoxetine, paroxetine, and other CYP 2D6 enzyme inhibitors increase • plasma concentrations of risperidone. Reduce the initial dose. Do not Severe Renal or 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 exceed a final dose of 8 mg per day of RISPERDAL . (7.1) intervals of at least one week. (2.4) • Oral Solution: Can be administered directly from calibrated pipette or -----------------------USE IN SPECIFIC POPULATIONS----------------------- mixed with beverage (water, coffee, orange juice, or low-fat milk). (2.6) • Pregnancy: May cause extrapyramidal and/or withdrawal symptoms in • M-TAB Orally Disintegrating Tablets: Open the blister only when ready to neonates with third trimester exposure. (8.1) administer, and immediately place tablet on the tongue. Can be swallowed with or without liquid. (2.7) See 17 for PATIENT COUNSELING INFORMATION --------------------DOSAGE FORMS AND STRENGTHS---------------------- • Tablets: 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, and 4 mg (3) Revised: 1/2020 • Oral solution: 1 mg per mL (3) • Orally disintegrating tablets: 0.5 mg, 1 mg, 2 mg, 3 mg, and 4 mg (3) -------------------------------CONTRAINDICATIONS------------------------------- • Known hypersensitivity to risperidone, paliperidone, or to any excipients in RISPERDAL®. (4) 1 Reference ID: 4557059 FULL PRESCRIBING INFORMATION: CONTENTS* 7.2 Pharmacodynamic-related Interactions 8 USE IN SPECIFIC POPULATIONS WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS 8.1 Pregnancy WITH DEMENTIA-RELATED PSYCHOSIS 8.2 Lactation 1 INDICATIONS AND USAGE 8.3 Females and Males of Reproductive Potential 1.1 Schizophrenia 8.4 Pediatric Use 1.2 Bipolar Mania 8.5 Geriatric Use 1.3 Irritability Associated with Autistic Disorder 8.6 Renal Impairment 2 DOSAGE AND ADMINISTRATION 8.7 Hepatic Impairment 2.1 Schizophrenia 8.8 Patients with Parkinson’s Disease or Lewy Body 2.2 Bipolar Mania Dementia 2.3 Irritability Associated with Autistic Disorder – 9 DRUG ABUSE AND DEPENDENCE Pediatrics (Children and Adolescents) 9.1 Controlled Substance 2.4 Dosing in Patients with Severe Renal or Hepatic 9.2 Abuse Impairment 9.3 Dependence 2.5 Dose Adjustments for Specific Drug Interactions 10 OVERDOSAGE 2.6 Administration of RISPERDAL® Oral Solution 10.1 Human Experience 2.7 Directions for Use of RISPERDAL® M-TAB® 10.2 Management of Overdosage Orally Disintegrating Tablets 11 DESCRIPTION 3 DOSAGE FORMS AND STRENGTHS 12 CLINICAL PHARMACOLOGY 4 CONTRAINDICATIONS 12.1 Mechanism of Action 5 WARNINGS AND PRECAUTIONS 12.2 Pharmacodynamics 5.1 Increased Mortality in Elderly Patients with 12.3 Pharmacokinetics Dementia-Related Psychosis 13 NONCLINICAL TOXICOLOGY 5.2 Cerebrovascular Adverse Reactions, Including 13.1 Carcinogenesis, Mutagenesis, Impairment of Stroke, in Elderly Patients with Dementia- Fertility Related Psychosis 14 CLINICAL STUDIES 5.3 Neuroleptic Malignant Syndrome 14.1 Schizophrenia 5.4 Tardive Dyskinesia 14.2 Bipolar Mania - Monotherapy 5.5 Metabolic Changes 14.3 Bipolar Mania – Adjunctive Therapy with Lithium 5.6 Hyperprolactinemia or Valproate 5.7 Orthostatic Hypotension 14.4 Irritability Associated with Autistic Disorder 5.8 Falls 16 HOW SUPPLIED/STORAGE AND HANDLING 5.9 Leukopenia, Neutropenia, and Agranulocytosis 16.1 How Supplied 5.10 Potential for Cognitive and Motor Impairment 16.2 Storage and Handling 5.11 Seizures 17 PATIENT COUNSELING INFORMATION 5.12 Dysphagia 5.13 Priapism 5.14 Body Temperature Regulation *Sections or subsections omitted from the full prescribing information are not 5.15 Patients with Phenylketonuria listed. 6 ADVERSE REACTIONS 6.1 Clinical Trials Experience 6.2 Postmarketing Experience 7 DRUG INTERACTIONS 7.1 Pharmacokinetic-related Interactions 2 Reference ID: 4557059 FULL PRESCRIBING INFORMATION 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. [see Warnings and Precautions (5.1)] 1 INDICATIONS AND USAGE 1.1 Schizophrenia RISPERDAL (risperidone) is indicated for the treatment of schizophrenia. Efficacy was established in 4 short-term trials in adults, 2 short-term trials in adolescents (ages 13 to 17 years), and one long-term maintenance trial in adults [see Clinical Studies (14.1)]. 1.2 Bipolar Mania Monotherapy RISPERDAL is indicated for the treatment of acute manic or mixed episodes associated with Bipolar I Disorder. Efficacy was established in 2 short-term trials in adults and one short-term trial in children and adolescents (ages 10 to 17 years) [see Clinical Studies (14.2)]. Adjunctive Therapy RISPERDAL adjunctive therapy with lithium or valproate is indicated for the treatment of acute manic or mixed episodes associated with Bipolar I Disorder. Efficacy was established in one short-term trial in adults [see Clinical Studies (14.3)]. 1.3 Irritability Associated with Autistic Disorder RISPERDAL is indicated for the treatment of irritability associated with autistic
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