In this trial, symptoms reported by >5% of patients included fatigue, dizziness, dystonia, parkinsonism, akathisia, abdominal pain, dyspepsia, nausea, vomiting, and diarrhea.Dr. It did not demonstrate efficacy for low-dose Risperidone. The results of the trials follow:The efficacy of Risperidone in the treatment of mania in children or adolescents with Bipolar I disorder was demonstrated in a 3-week, randomized, double-blind, placebo-controlled, multicenter trial including patients ranging in ages from 10 to 17 years who were experiencing a manic or mixed episode of bipolar I disorder. Data sources include IBM Watson Micromedex (updated 2 Sep 2020), Cerner Multum™ (updated 1 Sep 2020), Wolters Kluwer™ … The main metabolite, 9-hydroxyRisperidone, has similar pharmacological activity as Risperidone. A Cochran-Armitage Test for trend in these data revealed a positive trend (p<0.05) for the following adverse reactions: somnolence, vision abnormal, dizziness, palpitations, weight increase, erectile dysfunction, ejaculation disorder, sexual function abnormal, fatigue, and skin discoloration.Weight gain was observed in short-term, controlled trials and longer-term uncontrolled studies in adult and pediatric patients Between-group comparisons for pooled placebo-controlled trials in adults revealed no statistically significant differences between Risperidone and placebo in mean changes from baseline in ECG parameters, including QT, QTc, and PR intervals, and heart rate. As illustrated by a mass balance study of a single 1 mg oral dose of The apparent half-life of Risperidone was 3 hours (CV=30%) in extensive metabolizers and 20 hours (CV=40%) in poor metabolizers. In patients who do require chronic treatment, the smallest dose and the shortest duration of treatment producing a satisfactory clinical response should be sought. In all cases, study medication was initiated at 0.5 mg/day and titrated to the target dosage range by Day 7, with further increases in dosage to the maximum tolerated dose within the targeted dose range by Day 10. Kowatch is professor of psychiatry and pediatrics at Cincinnati Children’s Hospital Medical Center and a Section Editor for Current Psychiatry. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. The mean changes in ABC-I scores were -3.5, -7.4, and -12.4 in the placebo, low-dose, and high-dose group respectively. Current evidence supports the use of risperidone for children and adolescents. However, doses above 6 mg per day for twice daily dosing were not demonstrated to be more efficacious than lower doses, were associated with more extrapyramidal symptoms and other adverse effects, and are generally not recommended. All patients met DSM-IV diagnostic criteria for schizophrenia and were experiencing an acute episode at time of enrollment. In 103 adolescent patients with schizophrenia, a mean increase of 9 kg was observed after 8 months of Risperidone treatment. Dystonia includes dystonia, laryngospasm, and muscle spasms. In arriving at a diagnosis, it is important to identify cases in which the clinical presentation includes both serious medical illness (e.g., pneumonia, systemic infection, etc.) Akathisia includes hyperkinesia and akathisia.Table 12 lists the adverse reactions reported in 5% or more of Risperidone-treated pediatric patients with bipolar mania in a 3-week double-blind, placebo-controlled trial. Although efficacy has been demonstrated in studies of adolescent patients with schizophrenia at doses between 1 mg to 6 mg per day, no additional benefit was observed above 3 mg per day, and higher doses were associated with more adverse events. However, epidemiological studies suggest an increased risk of treatment-emergent hyperglycemia-related adverse events in patients treated with the atypical antipsychotics. Dystonia includes dystonia and oculogyration.Table 10 lists the adverse reactions reported in 2% or more of Risperidone-treated adult patients with bipolar mania in four 3-week, double-blind, placebo-controlled monotherapy trials. After removal from its blister, the orally-disintegrating tablets should be consumed immediately as it can not be stored once removed. Risperidone tablets are indicated for the treatment of acute manic or mixed episodes associated with Bipolar I Disorder.