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Data Presented at DDW About Rebound Symptoms in Healed Erosive Esophagitis Patients After Completion of Treatment with DEXILANT(TM) (dexlansoprazole)
Date:5/5/2010

eating heartburn associated with symptomatic non-erosive gastroesophageal reflux disease (GERD) for four weeks.

Important Safety Information

DEXILANT is contraindicated in patients with known hypersensitivity to any component of the formulation. Hypersensitivity and anaphylaxis have been reported with DEXILANT use. Symptomatic response with DEXILANT does not preclude the presence of gastric malignancy.

The most commonly reported treatment-emergent adverse reactions include diarrhea (4.8%), abdominal pain (4.0%), nausea (2.9%), upper respiratory tract infection (1.9%), vomiting (1.6%), and flatulence (1.6%). DEXILANT must not be co-administered with atazanavir because atazanavir systemic concentrations may be substantially decreased.

DEXILANT may interfere with the absorption of drugs for which gastric pH is important for bioavailability (e.g., ampicillin esters, digoxin, iron salts, ketoconazole). Patients taking concomitant warfarin may require monitoring for increases in international normalized ratio (INR) and prothrombin time. Increases in INR and prothrombin time may lead to abnormal bleeding and even death. Concomitant tacrolimus use may increase tacrolimus whole blood concentrations.

Please click here for full prescribing information and visit the DEXILANT Web site at w
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SOURCE Takeda Pharmaceuticals North America, Inc.
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