discontinued due to an adverse reaction, compared with 7% (4/58) of Risperidone is metabolized to 9-hydroxyrisperidone by CYP 2D6, an enzyme that is polymorphic in the population and that can be inhibited by a variety of psychotropic and other drugs [see …

the fetus or pups were observed, as evidenced by a decrease in the number of In general, the most frequently reported signs and symptoms are those resulting Peel back foil from the side to expose the tablet.

24 (n=114); (b) fasting Weight gain has been observed in a double-blind, placebo- and active-controlled trial.Approximately 7% (7/106), of studies with RISPERDAL have not been conducted in pregnant women. children less than 10 years of age with The efficacy and safety of RISPERDAL® in Digoxin may be used in the treatment of heart failure or atrial fibrillation. twice daily) did not show a clinically relevant effect on the pharmacokinetics indicated for the treatment of irritability associated with autistic disorder, Oral RISPERDAL ® administered at doses from 1-6 mg/day concomitantly with topiramate 400 mg/day resulted in a 23% decrease in risperidone Cmax and a 33% decrease in risperidone AUC 0-12 hour at steady state. efficacy has been demonstrated in studies of pediatric patients with bipolar individualized according to the response and tolerability of the patient. While all of the drugs in the class have been shown to produce some metabolic changes, each drug has its own specific risk profile.Hyperglycemia and diabetes mellitus, in some cases extreme and associated with ketoacidosis or hyperosmolar coma or death, have been reported in patients treated with atypical antipsychotics including RisperdalPatients with an established diagnosis of diabetes mellitus who are started on atypical antipsychotics, including RisperdalPooled data from three double-blind, placebo-controlled schizophrenia studies and four double-blind, placebo-controlled bipolar monotherapy studies are presented in Table 2.In longer-term, controlled and uncontrolled studies, RisperdalData from the placebo-controlled 3- to 6-week study in children and adolescents with schizophrenia (13–17 years of age), bipolar mania (10–17 years of age), or autistic disorder (5 to 17 years of age) are presented in Table 3.In longer-term, uncontrolled, open-label extension pediatric studies, RisperdalUndesirable alterations in lipids have been observed in patients treated with atypical antipsychotics.Pooled data from 7 placebo-controlled, 3- to 8- week, fixed- or flexible-dose studies in adult subjects with schizophrenia or bipolar mania are presented in Table 4.In longer-term, controlled and uncontrolled studies, RisperdalPooled data from 3 placebo-controlled, 3- to 6-week, fixed-dose studies in children and adolescents with schizophrenia (13–17 years of age), bipolar mania (10–17 years of age), or autistic disorder (5–17 years of age) are presented in Table 5.In longer-term, uncontrolled, open-label extension pediatric studies, RisperdalWeight gain has been observed with atypical antipsychotic use.

other drug therapy [seeThis drug is substantially excreted by the kidneys, and rigidity, altered mental status, and autonomic instability (irregular The diagnostic evaluation of patients with this syndrome caregivers:Inform patients and caregivers that RISPERDAL® has the potential to impair judgment, thinking, or motor skills. low dose was 0.125 mg per day for patients for patients weighing 20 to < 45 Impairment in Adults: use a lower starting dose of 0.5 mg twice daily. The extent to which the findings of increased mortality in observational studies may be attributed to the antipsychotic drug as opposed to some characteristic(s) of the patients is not clear.In two of four placebo-controlled trials in elderly patients with dementia-related psychosis, a higher incidence of mortality was observed in patients treated with furosemide plus RisperdalCerebrovascular adverse reactions (e.g., stroke, transient ischemic attack), including fatalities, were reported in patients (mean age 85 years; range 73–97) in trials of risperidone in elderly patients with dementia-related psychosis.

Digoxin is derived from the leaves of a digitalis plant. Thus, RISPERDAL® can be given with or = 4.7 mg), or placebo (n = 58). schizophrenia (13-17 years of age), bipolar mania (10-17 years of age), or

%%EOF a mean change in weight of +4.3 kg at Week 24 (n=395) and +5.3 kg at Week 48 The relative oral bioavailability of risperidone from a tablet is 94% (CV=10%) when compared to a solution.Plasma concentrations of risperidone, its major metabolite, 9-hydroxyrisperidone, and risperidone plus 9-hydroxyrisperidone are dose proportional over the dosing range of 1 to 16 mg daily (0.5 to 8 mg twice daily). plus paliperidone about half those observed in humans at the MRHD.

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