Risperidone (7 brand names, 6 dosage forms, 3 routes)
Available dosage forms: TABLET, TABLET, ORALLY DISINTEGRATING, SUSPENSION, EXTENDED RELEASE, FOR SUSPENSION, EXTENDED RELEASE, SOLUTION, POWDER.
Routes of administration: ORAL, SUBCUTANEOUS, INTRAMUSCULAR.
Brand Names
- PERSERIS KIT
- RISPERDAL
- RISPERDAL CONSTA
- RISPERIDONE
- RISVAN
- RYKINDO
- UZEDY
Boxed Warning
Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Risperidone tablets are not approved for the treatment of patients with dementia-related psychosis. [see Warnings and Precautions (5.1)]
Dosage and Administration
Table 1. Recommended Daily Dosage by Indication Initial Dose Titration (Increments) Target Dose Effective Dose Range Schizophrenia: adults ( 2.1) 2 mg 1 to 2 mg 4 to 8 mg 4 to 16 mg Schizophrenia: adolescents ( 2.2) 0.5 mg 0.5 to 1 mg 3 mg 1 to 6 mg Bipolar mania: adults ( 2.2) 2 to 3 mg 1 mg 1 to 6 mg 1 to 6 mg Bipolar mania: children and adolescents ( 2.2) 0.5 mg 0.5 to 1 mg 1 to 2.5 mg 1 to 6 mg Irritability in autistic disorder ( 2.3) 0.25 mg Can increase to 0.5 mg by Day 4: (body weight less than 20 kg) 0.5 mg Can increase to 1 mg by Day 4: (body weight greater than or equal to 20 kg) After Day 4, at intervals of > 2 weeks: 0.25 mg (body weight less than 20 kg) 0.5 mg (body weight greater than or equal to 20 kg) 0.5 mg: (body weight less than 20 kg) 1 mg: (body weight greater than or equal to 20 kg) 0.5 to 3 mg 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.
Contraindications
Risperidone tablets are contraindicated in patients with a known hypersensitivity to either risperidone or paliperidone, or to any of the excipients in the risperidone tablets 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.
Adverse Reactions
The following are discussed in more detail in other sections of the labeling: • Increased mortality in elderly patients with dementia-related psychosis [see Boxed Warningand Warnings and Precautions ( 5.1)] • Cerebrovascular adverse events, including stroke, in elderly patients with dementia-related psychosis [see Warnings and Precautions ( 5.2)] • Neuroleptic malignant syndrome [see Warnings and Precautions ( 5.3)] • Tardive dyskinesia [see Warnings and Precautions ( 5.4)] • Metabolic Changes (Hyperglycemia and diabetes mellitus, Dyslipidemia, and Weight Gain) [see Warnings and Precautions ( 5.5)] • Hyperprolactinemia [see Warnings and Precautions ( 5.6)] • Orthostatic hypotension [see Warnings and Precautions ( 5.7)] • Falls [see Warnings and Precautions ( 5.8)] • Leukopenia, neutropenia, and agranulocytosis [see Warnings and Precautions ( 5.9)] • Potential for cognitive and motor impairment [see Warnings and Precautions ( 5.10)] • Seizures [see Warnings and Precautions ( 5.11)] • Dysphagia [see Warnings and Precautions ( 5.12)] • Priapism [see Warnings and Precautions ( 5.13)] • Disruption of body temperature regulation [see Warnings and Precautions ( 5.14)] 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 [see Adverse Reactions, Discontinuations Due to Adverse Reactions ( 6.1)] . The data described in this section are derived from a c
Mechanism of Action
The mechanism of action of risperidone in schizophrenia is unclear. The drug’s therapeutic activity in schizophrenia could be mediated through a combination of dopamine Type 2 (D 2) and serotonin Type 2 (5HT 2) receptor antagonism. The clinical effect from risperidone results from the combined concentrations of risperidone and its major metabolite, 9-hydroxyrisperidone (paliperidone) [see Clinical Pharmacology ( 12.3)] . Antagonism at receptors other than D 2and 5HT 2may explain some of the other effects of risperidone [see Clinical Pharmacology ( 12.1)] .