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Pharmacology / Benzimidazoles / Pyridines / Sulfoxides / Organofluorides / Lansoprazole / Clopidogrel / Dexlansoprazole / Rabeprazole / Chemistry / Organic chemistry / Proton pump inhibitors


Page 1 of 13 HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use DEXILANT safely and effectively. See full prescribing information for DEXILANT. DEXILANT (dexlansoprazo
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Document Date: 2011-11-01 12:14:12


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City

Reference / /

Company

Patients (N) 1 2 Treatment Group / Takeda Pharmaceuticals America Inc. / Ames / Alteon Inc. / /

Currency

pence / /

Event

Product Issues / FDA Phase / /

Facility

Laboratory Investigations / /

IndustryTerm

food-effect studies / food / /

MedicalCondition

vulvo-vaginal infection Injury / Symptomatic non-erosive GERD / hypercalcemia / hypokalemia Musculoskeletal / enteritis / hepatocellular adenoma / paresthesia oral / viral infection / HIV / Lymphatic System Disorders / cholelithiasis / Healed Erosive Esophagitis A / seizures / herpes zoster / ear and labyrinth disorders / arthritis / esophagitis / convulsion / hemorrhoids / bursitis / pruritis / anaphylaxis / toxic epidermal necrolysis / rash / leucocytoclastic vasculitis / gout / Symptomatic Non-Erosive GERD A / bradycardia / Poisoning / angina / diarrhea / hematemesis / muscle cramps / upper respiratory tract infection / asthma / Nutrition Disorders / abdominal pain / tumor / adenoma / autoimmune hemolytic anemia / arthralgia / Urinary Disorders / nasopharyngitis / hypothyroidism / ECL cell carcinoids / eye swelling Gastrointestinal Disorders / dysphagia / Carcinogenesis / tetany / folliculitis / mg GERD / ear pain / candida infections / vertigo Endocrine Disorders / pancreatitis General Disorders / vomiting / deep vein thrombosis / erosive esophagitis / Immune System Disorders / tonsillitis / dizziness / irritable bowel syndrome / depression / rash / Breast Disorders / proctitis / tinnitus / oral herpes / hypomagnesemia / hyponatremia Musculoskeletal System Disorders / testicular interstitial cell adenomas / cholecystitis / anaphylactic shock / facial edema Hepatobiliary Disorders / headaches / symptomatic GERD / chest pain / duodenitis / bronchitis / mucosal inflammation / dermatitis / cerebrovascular accident / nausea / gastrointestinal hypermotility disorders / carcinoma / colitis / Stevens-Johnson syndrome / tremor / urticaria Vascular Disorders / Healed Erosive Esophagitis / liver tumors / auditory hallucination / myalgia Nervous System Disorders / lymphadenopathy Cardiac Disorders / gastritis / goiter Eye Disorders / hypersensitivity / trigeminal neuralgia Psychiatric Disorders / hepatitis Immune System Disorders / sinusitis / pyrexia Hepatobiliary Disorders / constipation / gastrointestinal disorders / influenza / neutropenia / rectal tenesmus / skin and subcutaneous tissue disorders / arrhythmia / Mediastinal Disorders / insomnia / epistaxis / hematochezia / General Disorders / central obesity / adenomas / hypertension / acne / disease / restless legs syndrome / carcinoid tumors / gastroenteritis / paresthesia / psychomotor hyperactivity / migraine / bone fracture Nervous System Disorders / symptomatic non-erosive gastroesophageal reflux disease / hyperlipidemia / erythema / hypersensitivity Infections / exfoliative dermatitis / eye irritation / dysphonia / pain / GERD / myocardial infarction / dyspareunia / diabetes mellitus / hyperventilation / Connective Tissue Disorders / cough / inflammation / deafness Eye Disorders / pharyngitis / B-cell lymphoma / anemia / dehydration / /

MedicalTreatment

hemodialysis / /

Organization

Clopidogrel Concomitant administration / After Administration of DEXILANT Dose / US Federal Reserve / DOSAGE AND ADMINISTRATION / FDA / DEXILANT / Tacrolimus Concomitant administration / administration of DEXILANT / Size Unit / Profile Following Oral Administration / /

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Position

General / treating physician / /

Product

ampicillin / diazepam / phenytoin / Delayed-Release Capsules / theophylline / digoxin / potassium chloride / polyethylene glycol / CL / talc / DEXILANT capsules / Clopidogrel / lansoprazole / ketoconazole / DEXILANT / fertility / /

Technology

Pharmacokinetics / DNA synthesis / Pharmacodynamics / /

URL

www.fda.gov/medwatch / /

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