| Document Date: 2014-05-13 17:04:46
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City Mountain View / Brands Horsham / / Company Teva Pharmaceuticals USA Inc. / Teva Pharmaceuticals / Alexza Pharmaceuticals Inc. / CA 94043 / Ames / / Event FDA Phase / Product Issues / Product Recall / / IndustryTerm machinery / hazardous machinery / advance airway management / drugdevice combination product / heavy machinery / treatment of agitation associated with bipolar I disorder / healthcare professional / healthcare facility / airway management / healthcare / healthcare facilities / enrolled healthcare facilities / drug-device combination product / enrolled healthcare facility / Monitor for signs and symptoms / / MedicalCondition fetal resorptions / dementia / seizures / ischemic heart disease / cerebrovascular disease / Seizures ADASUVE / disorder / Neuroleptic Malignant Syndrome / pulmonary diseases / memory loss / severe disease / muscle rigidity / high fever / asthma / acute bronchospasm / neck dystonia / pneumonia / pulmonary safety trials / moderate COPD / schizophrenia / fainting / hydronephrosis / shortness of breath / dysgeusia / pulmonary function / emphysema / Carcinogenesis / stroke / Acute dystonia / DEMENTIA-RELATED PSYCHOSIS Bronchospasm ADASUVE / Seizure / orthostatic hypotension / Urinary Retention ADASUVE / respiratory depression / hypotonia / Dystonia / renal failure / disorders / Glaucoma / ovarian follicular cysts / COPD / CNS depression / Urinary Retention / unconsciousness / lung diseases / Syncope ADASUVE / Known hypersensitivity / transient ischemic attack / tremor / Syncope / low blood pressure / Mitigate Bronchospasm / severe COPD / lung disease / mild disease / tachycardia / Hypersensitivity / chronic pulmonary disease / heat stroke / transient ischemic attacks / profound hypotension / mild-moderate persistent asthma / systemic infection / chronic bronchitis / wheezing / Hypotension / presyncope / hypertension / bronchospasm / I disorder / dyspnea / chronic obstructive pulmonary disease / Bronchospasm ADASUVE / cardiovascular disease / coughing / cardiac dysrhythmia / pulmonary disease / rhabdomyolysis / myocardial infarction / clinical pulmonary safety trials / heart failure / metallic taste / chest tightness / spasm / cough / withdrawal symptoms / motor restlessness / Fertility Carcinogenesis / lightheadedness / syndrome / Bipolar Disorder / respiratory distress / throat irritation / Psychomotor agitation / Akathisia / dehydration / / MedicalTreatment mechanical ventilation / drug therapy / / Movie Half-life / / Organization ADASUVE administration / Administration of ADASUVE / DOSAGE AND ADMINISTRATION / FDA / After administration / U.S. Food and Drug Administration / / / Position Pregnancy Counsel / Nursing Mothers Counsel / pharmacist / Anticholinergic Reactions Counsel / / Product symptoms / loxapine / albuterol / amoxapine / Neuroleptic Malignant Syndrome Antipsychotic / Epinephrine / This Medication / ADASUVE® (loxapine) / ADASUVE / / ProvinceOrState Pennsylvania / / PublishedMedium Baseline / / Technology CGI / flash / alpha / Pharmacokinetics / Pharmacodynamics / / URL www.adasuverems.com / www.poison.org / www.fda.gov/medwatch / www.ADASUVE.com / /
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HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use ADASUVE safely and effectively. See full prescribing information for ADASUVE. ADASUVE® (loxapine) inhalation powder