In patients not achieving sufficient clinical response, the dose may be increased at intervals of 2 weeks or greater, in increments of 0.
Data from the placebo-controlled 3- to 6-week study in children and adolescents with schizophrenia years of agebipolar mania years of ageor autistic disorder 5 to 17 years of age are presented in Table 3. As monotherapy or as adjunctive therapy with lithium or valproate for the treatment of acute manic or mixed episodes associated with Bipolar I Disorder.
Four patients discontinued the study due to lack of response, 4 due to side-effects, 2 due to withdrawal of consent, and 3 were lost to follow-up. Most efficacy and safety assessments were made weekly; treatment-emergent adverse events and vital signs were assessed more frequently. In more severely ill hospitalized patients such as those included in pivotal trials higher doses may sometimes be required.
Your doctor may check these levels before starting and during treatment with this drug. Severe hepatic impairment Child-Pugh 10 to Risperidone was administered in the diet at doses of 0.
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 ]. Hypersensitivity reactions, including anaphylactic reactions and angioedemahave been reported in patients treated with risperidone and in patients treated with paliperidone.
Risperidone may pass into breast milk and may cause side effects in a child who is breastfed. Early and substantial patient response In summary, patients with bipolar disorder and severe manic symptoms who received risperidone monotherapy improved on all measures of efficacy. Risperidone is well absorbed. Cardio- or cerebrovascular disease; increased risk with metabolic changes eg, hyperglycemia, dyslipidemia, weight gain ; monitor.
Elderly, debilitated, hypotensive, severe renal or hepatic impairment: Risperidone is well absorbed. Interactions that increase your risk of side effects Taking risperidone with certain medications raises your risk of side effects from risperidone.
More about Risperdal (risperidone)
Respond to this article. If you have an allergic reaction, call your doctor or local poison control center right away. Acute manic or mixed bipolar I disorder episodes: Skip to main content. Risperdal, Risperdal Consta, more Geriatric and child populations Elderly Psychopharmacological treatment of the elderly patient with bipolar disorder is complicated by the various pharmaco-kinetic and pharmacodynamic vulnerabilities of the elderly, concurrent medications, and concomitant medical conditions.
Rare adverse effects reported in open-label trials of risperidone therapy adjunct or combination included seizures in two individuals Bahk et aland single-case reports of neuroleptic malignant syndrome, dysuria, dyskinesia, and confusion Bahk et al ; Bowden et al ; Vieta et al Risk of aspiration pneumonia.
For people with hyperprolactinemia high prolactin levels: Conclusions Risperidone is an atypical antipsychotic medication with demonstrated efficacy and relatively good tolerability in the treatment of patients with acute bipolar mania. The effect appeared to be in females, since impaired mating behavior was not noted in the Segment I study in which males only were treated.
This remained significant at the week 8 although there was no additional improvement during Phase II.