| Document Date: 2014-10-23 12:12:04
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City Reference / / Company Forest Laboratories Inc. / / Event FDA Phase / / IndustryTerm antipsychotic drug products / machinery / / MedicalCondition polyuria / oral hypoesthesia / dementia / Seizures / Leukopenia / tachycardia / swollen tongue / Hypersensitivity Reactions Hypersensitivity / schizoaffective disorder / anaphylaxis / cerebrovascular disease / Known hypersensitivity / transient ischemic attack / Syncope / cerebrovascular accidents / obesity / akathisia / oral hypoesthesia / Diabetes Mellitus Hyperglycemia / bradycardia / tachycardia / both serious medical illness / Neuroleptic Malignant Syndrome / Hypersensitivity / myoglobinuria / mg Schizophrenia / heat stroke / muscle rigidity / transient ischemic attacks / bipolar mania / e.g. pneumonia / systemic infection / Agranulocytosis / wheezing / Hyperprolactinemia / hypotension / Concomitant Illness / Schizophrenia SAPHRIS / short-term placebo-controlled schizophrenia / pneumonia / dementia-related psychoses / schizophrenia / I Disorder / dyspnea / chronic treatment / Dysphagia / Carcinogenesis / hyperglycemia / Neutropenia / stroke / dyslipidemia / chronic illness / mania / diabetes / B ipolar Disorder / cardiac dysrhythmia / short-term schizophrenia / rhabdomyolysis / seizure / Orthostatic Hypotension / CONTRAINDICATIONS Hypersensitivity / leukopenia/neutropenia / Tardive Dyskinesia A / Diabetes Mellitus / heart failure / angioedema / hyperosmolar coma / Dizziness / Adult Patients Schizophrenia / rash / Tardive Dyskinesia / acute renal failure / syndrome / bipolar disorder / Chronic antipsychotic treatment / Dehydration / akathisia / / MedicalTreatment adjunctive therapy / drug therapy / / Organization DOSAGE AND ADMINISTRATION / FDA / Tablet Administration / / Person Bipolar Disorder (Monotherapy) / Bipolar Disorder (Adjunctive) / / / Position physician / / Product Administration Instructions SAPHRIS / risperidone / Sublingual tablets / olanzapine / Concomitant Medication / SAPHRIS® (asenapine) / SAPHRIS / / ProgrammingLanguage C / / PublishedMedium Baseline / / 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 SAPHRIS (asenapine) safely and effectively. See full prescribing information for SAPHRIS.