| Document Date: 2014-06-17 17:13:23
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Company Dyskinesia / EPS Group / Human Experience / Janssen Pharmaceuticals Inc. / Akathisia / / Event FDA Phase / / Facility Laboratory Test Abnormalities In / Laboratory Test Abnormalities / Laboratory Tests No / / IndustryTerm antipsychotic drug products / machinery / food / Treatment of schizoaffective disorder / / MedicalCondition polyuria / Neuroleptic Malignant Syndrome A / dysarthria / dementia / trismus / For Parkinsonism / Seizures / congenital long QT syndrome / coma / Thrombotic Thrombocytopenic Purpura / schizoaffective disorder / EPS-related AE Dyskinesia Dystonia Hyperkinesia Parkinsonism Tremor / extrapyramidal disorder / cerebrovascular disease / dyskinesia / cogwheel rigidity / cerebrovascular accidents / bradykinesia / bradycardia / anaphylactic reactions / Neuroleptic Malignant Syndrome / diarrhea / muscle rigidity / breast cancer / brain tumor / muscle contracture / adolescent schizophrenia / Hyperprolactinemia / Abdominal pain / muscle rigidity Dyskinesia / Aspiration pneumonia / pneumonia / restlessness Parkinsonism / schizophrenia / parkinsonism / above schizophrenia / gastrointestinal disease / arthralgia / anaphylactic reaction Infections / mg/day Schizoaffective disorder / nasopharyngitis / akathisia / extrapyramidal symptoms / extremity Nervous system disorders / chronic treatment / Dysphagia / Carcinogenesis / Hyperglycemia / chronic / Neutropenia / dyslipidemia / Stroke / acute dystonia / diabetes / intestinal pseudoobstruction / chronic administration / fever / Lethargy / seizure / orthostatic hypotension / CONTRAINDICATIONS Hypersensitivity / vomiting / psychoses / drooling / established tardive dyskinesia / Tardive Dyskinesia A / torticollis Tremor / muscle twitching Dystonia / torticollis / Diseases / infection / dystonia / Dizziness / Hyperkinesia / hypokalemia / For Akathisia / Tardive Dyskinesia / breast disorders / acute renal failure / inflammatory / disorders / Chronic antipsychotic treatment / tardive dyskinesia Dystonia / nuchal rigidity / Headache / Schizophrenia INVEGA / Skin disorders / rthostatic Hypotension / Leukopenia / Galactorrhea / subcutaneous tissue disorders / nausea / muscle spasms / heart disease / rhinitis / Tremor Parkinsonism / Known hypersensitivity / transient ischemic attack / hypersomnia / tremor / Syncope / torsade de pointes / Fatigue / peritonitis / pooled schizoaffective disorder / Atrioventricular block / obesity / Cardiac disorders / both serious medical illness / tachycardia / myoglobinuria / hypersensitivity / restlessness / heat stroke / parkinsonism Tremor / esophageal motility disorders / hypokinesia / cystic fibrosis / constipation / pruritus / transient ischemic attacks / Infections / systemic infection / Agranulocytosis / gynecomastia / hypotension / Concomitant Illness / intestinal obstruction / cancers / Insomnia / involuntary Dyskinesia / Priapism / Epistaxis / e.g. stroke / gastroparesis / adenomas / adenocarcinomas / Hypertension / disease / nervous system disorders / drug-induced leukopenia/ neutropenia / tongue paralysis / sinus tachycardia / Recommended Dose Maximum Dose Schizophrenia / cardiac arrhythmias / chronic illness / cardiovascular disease / cardiac dysrhythmia / rhabdomyolysis / pain / myocardial infarction / oculogyration Hyperkinesia / Diabetes Mellitus / edema Immune system disorders / thoracic and mediastinal disorders / heart failure / angioedema / Schizoaffective Disorder INVEGA / connective tissue disorders / spasm / cough / impotence / syndrome / Dehydration / akathisia / / MedicalTreatment Adjunctive Therapy / antidepressant therapy / antibiotics / drug therapy / / Organization DOSAGE AND ADMINISTRATION / FDA / / / Position physician / General / / Product Anticholinergic Medication / INVEGA / divalproex sodium / lamotrigine / carbamazepine / risperidone / olanzapine / Extended-Release Tablets / gatifloxacin / Concomitant Medication / As INVEGA® / INVEGA® (paliperidone) Extended-Release Tablets / / Technology alpha / Pharmacokinetics / Pharmacodynamics / / URL www.fda.gov/medwatch / /
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INVEGA® Revised: [removed][removed]paliperidone) Extended-Release Tablets