| Document Date: 2013-01-25 11:47:26
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City San Diego / / Company Prometheus Laboratories Inc. / LX002D 5 Prometheus Laboratories Inc. / Ames / Alteon Inc. / / Country United States / / Currency pence / / Event FDA Phase / Product Recall / Product Issues / / Facility I store LOTRONEX / Store LOTRONEX / / IndustryTerm food / healthcare professionals / healthcare / chemical / / MedicalCondition polyuria / tremors / allergies / gastrointestinal intussusception / Bladder inflammation / severe diarrhea-predominant irritable bowel syndrome / Constipation LOTRONEX / diarrhea / hepatitis / Women With Severe DiarrheaPredominant Irritable Bowel Syndrome / cognitive function disorders / bloody diarrhea / end-stage renal disease / illness / less tiredness / hypoglycemia / cramps / fungal infections / upper respiratory tract infection / toxic megacolon / abdominal pain / Sexual function disorders / nasopharyngitis / Carcinogenesis / hyperglycemia / folliculitis / IBS abdominal pain / eczema / fecal incontinence / functional abdominal pain / nail disorders / Muscle pain / ulcerative colitis / vomiting / Women With Severe Diarrhea-Predominant Irritable Bowel Syndrome / dermatosis / Irritable Bowel Syndrome / Women With Irritable Bowel Syndrome / Rash / proctitis / Disorders / Hyposalivation / cholecystitis / headaches / Headache / gastrointestinal spasms / mouse lymphoma cell / dermatitis / urinary tract infection / nausea / muscle spasms / bloating / alopecia / colitis / blood clots / severe chronic irritable bowel syndrome / fatigue / Functional bowel disease / gastritis / skin infections / hypoesthesia / frequent and severe abdominal pain / laryngitis / hypersensitivity / severe liver disease / pain in your stomach / sinusitis / constipation / painful stomach cramps / viral gastroenteritis / intestinal obstruction / extrasystoles / thrombophlebitis / fungal reproductive infections / acne / Light sensitivity / resolved constipation / gastroenteritis / Patients With Irritable Bowel Syndrome / Crohn’s disease / severe constipation / reproductive infections / ischemic colitis / Hepatic Disorders LOTRONEX / ileus / pain / throat infections / urticaria / severe diarrheapredominant irritable bowel syndrome / cough / Tachyarrhythmias / / MedicalTreatment surgery / blood transfusions / herbal remedies / blood transfusion / antibiotics / / MusicGroup Nausea / / Organization DOSAGE AND ADMINISTRATION / FDA / Fluvoxamine Concomitant administration / Concomitant administration / U.S. Food and Drug Administration / / / Position investigator / counsel / pharmacist / Last Observation Carried Forward / / Product LUVOX / itraconazole / LOTRONEX / cimetidine / DOSAGE FORMS AND STRENGTHS Tablets / theophylline / PATIENT COUNSELING INFORMATION See Medication / This Medication / clarithromycin / isoniazid / Medication Guide MEDICATION / levonorgestrel / estradiol / Ketoconazole / 2C9 / intestinal circulation / thrombophlebitis / taking LOTRONEX / CYP1A2 / / ProvinceOrState California / / PublishedMedium the Medication Guide / / Technology Pharmacokinetics / DNA synthesis / Pharmacodynamics / / URL www.lotronexppl.com / www.fda.gov/medwatch / /
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LOTRONEX® (alosetron hydrochloride) Tablets HIGHLIGHTS OF PRESCRIBING INFORMATION