| Document Date: 2009-08-04 13:40:40
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City CONTRAINDICATIONS / / Company Janssen Pharmaceuticals / Inc. / Ortho-McNeil-Janssen Pharmaceuticals Inc. / / Event FDA Phase / / Facility Laboratory Test Abnormalities / Laboratory Tests ADVERSE REACTIONS / / IndustryTerm machinery / food / treatment of schizoaffective disorder / / MedicalCondition polyuria / dementia / Seizures / Leukopenia / Galactorrhea / coma / Thrombotic Thrombocytopenic Purpura / Schizoaffective Disorder / cerebrovascular disease / dyskinesia / infectious / Known hypersensitivity / transient ischemic attack / Syncope / torsade de pointes / cerebrovascular accidents / obesity / bradycardia / hypogonadism / tachycardia / hypersensitivity / anaphylactic reactions / Neuroleptic Malignant Syndrome / myoglobinuria / illness / constipation / muscle rigidity / transient ischemic attacks / breast cancer / Agranulocytosis / gynecomastia / hypotension / Hyperprolactinemia / long QT syndrome / cancers / Priapism / e.g. stroke / pneumonia / adenocarcinomas / adenomas / schizophrenia / gastrointestinal disease / For schizophrenia / nasopharyngitis / Dysphagia / Carcinogenesis / Hyperglycemia / cardiac arrhythmias / Chronic / Neutropenia / Stroke / diabetes / chronic administration / fever / cardiac dysrhythmia / rhabdomyolysis / seizure / Orthostatic Hypotension / leukopenia/neutropenia / Diabetes Mellitus / heart failure / angioedema / infection / hypokalemia / impotence / Tardive Dyskinesia / acute renal failure / syndrome / Dehydration / akathisia / / MedicalTreatment antibiotics / Adjunctive Therapy / drug therapy / / Organization Division of Ortho-McNeil-Janssen Pharmaceuticals / DOSAGE AND ADMINISTRATION / FDA / / / Position physician / Major / / Product INVEGA / divalproex sodium / carbamazepine / risperidone / olanzapine / gatifloxacin / As INVEGA® / INVEGA® / INVEGA® (paliperidone) / INVEGA® (paliperidone) Extended-Release Tablets / / Technology Pharmacokinetics / Pharmacodynamics / / URL www.fda.gov/medwatch / /
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HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use INVEGA® safely and effectively. See full prescribing information for INVEGA®. INVEGA® (paliperidone) Extended-Rel