| Document Date: 2011-08-11 15:17:32
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City Reference / / Company SUSPECTED ADVERSE REACTIONS / Schering Corporation / Merck & Co. Inc. / / Event FDA Phase / / IndustryTerm antipsychotic drug products / machinery / / MedicalCondition polyuria / Neuroleptic Malignant Syndrome A / oral hypoesthesia / dementia / Seizures / Leukopenia / tachycardia / swollen tongue / Galactorrhea / Hypersensitivity Reactions Hypersensitivity / ischemic heart disease / schizoaffective disorder / anaphylaxis / cerebrovascular disease / Known hypersensitivity / transient ischemic attack / Syncope / Torsade de Pointes / obesity / akathisia / oral hypoesthesia / Diabetes Mellitus Hyperglycemia / bradycardia / hypogonadism / tachycardia / both serious medical illness / Neuroleptic Malignant Syndrome / Hypersensitivity / myoglobinuria / central nervous system depression / heat stroke / muscle rigidity / transient ischemic attacks / bipolar mania / e.g. pneumonia / systemic infection / Agranulocytosis / wheezing / gynecomastia / Hyperprolactinemia / hypotension / Concomitant Illness / Schizophrenia SAPHRIS / pneumonia / dementia-related psychoses / C ONTRAINDICATIONS Hypersensitivity / Schizophrenia / I Disorder / dyspnea / chronic treatment / Dysphagia / Carcinogenesis / Hyperglycemia / cardiac arrhythmias / chronic / Neutropenia / stroke / chronic illness / mania / diabetes / cardiovascular disease / fever / cardiac dysrhythmia / short-term schizophrenia / rhabdomyolysis / seizure / Orthostatic Hypotension / leukopenia/neutropenia / myocardial infarction / Tardive Dyskinesia A / Diabetes Mellitus / heart failure / angioedema / infection / hyperosmolar coma / Dizziness / hypokalemia / impotence / rash / Tardive Dyskinesia / acute renal failure / syndrome / Bipolar Disorder / Chronic antipsychotic treatment / Dehydration / akathisia / / MedicalTreatment cardiac massage / antibiotics / 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 / gatifloxacin / Concomitant Medication / SAPHRIS / / 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. SAPHRIS (asenapine) sub