Special Populations Renal Impairment In patients with moderate to severe renal disease, clearance of the sum of risperidone and its active metabolite decreased by 60% compared to young healthy subjects. RISPERDAL ® doses should be reduced in patients with renal disease ( see PRECAUTIONS and DOSAGE AND ADMINISTRATION) . Hepatic Impairment While the pharmacokinetics of risperidone in subjects with liver disease were comparable to those in young healthy subjects, the mean free fraction of risperidone in plasma was increased by about 35% because of the diminished concentration of both albumin and 1 -acid glycoprotein. RISPERDAL ® doses should be reduced in patients with liver disease ( see PRECAUTIONS and DOSAGE AND ADMINISTRATION) . Elderly In healthy elderly subjects, renal clearance of both risperidone and 9-hydroxyrisperidone was decreased, and elimination half-lives were prolonged compared to young healthy subjects. Dosing should be modified accordingly in the elderly patients ( see DOSAGE AND ADMINISTRATION) . Race and Gender Effects No specific pharmacokinetic study was conducted to investigate race and gender effects, but a population pharmacokinetic analysis did not dentify mportant differences in the disposition of risperidone due to gender ( whether corrected for body weight or not) or race. Clinical Trials Schizophrenia Short-Term Efficacy The efficacy of RISPERDAL ® in the treatment of schizophrenia was established in four short-term ( 4-to 8-week) controlled trials of psychotic inpatients who met DSM-III-R criteria for schizophrenia. Several instruments were used for assessing psychiatric signs and symptoms in these studies, among them the Brief Psychiatric Rating Scale ( BPRS) , a multi-item inventory of general psychopathology traditionally used to evaluate the effects of drug treatment in schizophrenia. The BPRS psychosis cluster ( conceptual disorganization, hallucinatory behavior, suspiciousness, and unusual thought content) is considered a particularly useful subset for assessing actively psychotic schizophrenic patients. A second traditional assessment, the Clinical Global Impression ( CGI) , reflects the impression of a skilled observer, fully familiar with the manifestations of schizophrenia, about the overall clinical state of the patient. In addition, the Positive and Negative Syndrome Scale ( PANSS) and the Scale for Assessing Negative Symptoms ( SANS) were employed. The results of the trials follow: | ||||
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