Quick Links: Skip to main page content
Skip to Search
Skip to Topics Menu
Skip to Common Links
U.S. Food & Drug Administration
Follow FDA
En Español
Search FDA
Home
Food
Drugs
Medical Devices
Radiation-Emitting Products
Vaccines, Blood & Biologics
Animal & Veterinary
Cosmetics
Tobacco Products
New Pediatric Labeling Information Database - Detail
FDA Home
Pediatrics
New Pediatric Labeling Information Database
Detail
-
Please note:
JavaScript must be enabled for this application to work properly.
Check your settings
if you are unsure if your JavaScript is enabled.
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
BPCA(B) and PREA(P):
B, P
Sponsor:
Ortho McNeil
Pediatric Exclusivity Granted Date:
01/05/2011
NNPS:
FALSE'
Therapeutic Category:
Antipsychotic
-
-