Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

New Pediatric Labeling Information Database - Detail
  • Print
  • Share
  • E-mail
-
 
Pediatric Labeling Date:  04/06/2011
 
Trade Name:  Invega
 
Generic Name or Proper Name (*):  paliperidone
 
Indications Studied:  Treatment of schizophrenia
 
Label Changes Summary:  Extended treatment of schizophrenia indication from adults to adolescents 12-17 yearsSafety and effectiveness for the treatment of schizophrenia in patients < 12 years have not been established. Safety and effectiveness for the treatment of schizoaffective disorder in patients < 18 years have not been studied In the adolescent schizophrenia trial, there was no clear enhancement to efficacy at escalation to higher doses (e.g., 6 mg for patients weighing less than 51 kg and 12 mg for patients weighing 51 kg or greater) while adverse events were dose-relatedIn the 6-week, placebo-controlled study in adolescents with schizophrenia, the incidences of extrapyramidal symptoms related adverse events showed a similar dose-related pattern to those in the adult studies. There were notably higher incidences of dystonia, hyperkinesia, tremor, and parkinsonism in adolescents as compared to the adult studiesAdverse reactions in the adolescent trial included somnolence, akathisia, tremor, dystonia, cogwheel rigidity, anxiety, weight gain, and tachycardiaInformation on dosing, adverse events, clinical trial
 
Product Labeling:  Labeling  Opens a new window
 
BPCA(B) and PREA(P):  B, P
 
Sponsor:  Ortho McNeil
 
Pediatric Exclusivity Granted Date:  01/05/2011
 
NNPS:  FALSE'
 
Therapeutic Category:  Antipsychotic
 
-
-