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U.S. Department of Health and Human Services

New Pediatric Labeling Information Database - Detail

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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 years* Safety 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-related* In 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 studies* Adverse reactions in the adolescent trial included somnolence, akathisia, tremor, dystonia, cogwheel rigidity, anxiety, weight gain, and tachycardia* Information 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
Therapeutic Category:  Antipsychotic