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Risperdal Consta (Risperidone) - Summary

 


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Increased Mortality in Elderly Patients with Dementia –Related Psychosis

Elderly patients with dementia-related psychosis treated with atypical antipsychotic drugs are at an increased risk of death compared to placebo. Analyses of seventeen placebo controlled trials (modal duration of 10 weeks) in these patients revealed a risk of death in the drug-treated patients of between 1.6 to 1.7 times that seen in placebo-treated patients. Over the course of a typical 10 week controlled trial, the rate of death in drug-treated patients was about 4.5%, compared to a rate of about 2.6% in the placebo group. Although the causes of death were varied, most of the deaths appeared to be either cardiovascular (e.g., heart failure, sudden death) or infectious (e.g., pneumonia) in nature. RISPERDAL ® CONSTA ® (risperidone) is not approved for the treatment of patients with Dementia-Related Psychosis.

 

SUMMARY

JANSSEN, L.P.
RISPERDAL® CONSTA®
(risperidone)
LONG-ACTING INJECTION

RISPERDAL® (risperidone) is a psychotropic agent belonging to the chemical class of benzisoxazole derivatives. The chemical designation is 3-[2-[4-(6-fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl]ethyl]-6,7,8,9-tetrahydro-2-methyl-4H-pyrido[1,2-a]pyrimidin-4-one.

RISPERDAL® CONSTA®(risperidone) is indicated for the treatment of schizophrenia.

The efficacy of RISPERDAL® CONSTA® is based in part on a 12-week, placebo-controlled trial in schizophrenic inpatients or outpatients, along with extrapolation from the established efficacy of oral RISPERDAL® in this population.

The effectiveness of RISPERDAL® CONSTA® in longer-term use, that is, more than 12 weeks, has not been systematically evaluated in controlled trials. However, oral risperidone has been shown to be effective in delaying time to relapse in longer-term use. Patients should be periodically reassessed to determine the need for continued treatment (see DOSAGE AND ADMINISTRATION ).


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NEWS HIGHLIGHTS RELATED TO RISPERDAL CONSTA

Media Articles Related to Risperdal Consta (Risperidone)

Teva Announces Appellate Court Reverses Generic Risperdal(R) Exclusivity Decision
Source: Bipolar News From Medical News Today [2008.09.15]

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Published Studies Related to Risperdal Consta (Risperidone)

Short-term treatment with risperidone or haloperidol in first-episode schizophrenia: 8-week results of a randomized controlled trial within the German Research Network on Schizophrenia. [2008.11]

A 12-week, double-blind, placebo-controlled trial of donepezil adjunctive treatment to risperidone in chronic and stable schizophrenia. [2008.08.07]

Effects of warm-supplementing kidney yang (WSKY) capsule added on risperidone on cognition in chronic schizophrenic patients: a randomized, double-blind, placebo-controlled, multi-center clinical trial. [2008.08]

A randomized, double-blind, placebo-controlled trial of metformin treatment for weight gain associated with initiation of risperidone in children and adolescents. [2008.08]

Efficacy of risperidone augmentation to antidepressants in the management of suicidality in major depressive disorder: a randomized, double-blind, placebo-controlled pilot study. [2008.08]

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Clinical Trials Related to Risperdal Consta (Risperidone)

Evaluation of the Usefulness to Doctors of the Risperdal® Consta® Treatment Guidebook Over a Three-Month Period During Which Adult Patients With Schizophrenia or Schizoaffective Disorder Are Switching From Daily Doses or Risperidone Tablets to Long-Acting Risperidone by Injection [Completed]

Risperdal Consta for Bipolar Disorder [Active, not recruiting]

A Study of How Long it Takes a Patient to Relapse After Switching From an Oral Antipsychotic to One of Two Doses of Long-Acting Risperidone Injections in Patients With Schizophrenia or Schizoaffective Disorder [Completed]

A Prospective Study of Risperdal® (Risperidone) for the Treatment of Behavioral Disorder Following Psychological Therapy for Challenging Behavior in Learning Disabled Children [Completed]

Risperidone (Risperdal) Augmentation in Depressed Partial Responders to SRI Treatment [Withdrawn]

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Page last updated: 2008-11-03

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