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DEXILANT is a proton pump inhibitor (PPI) indicated for:
• Healing of all grades of erosive esophagitis (EE). (1.1) • Maintaining healing of EE and relief of heartburn. (1.2)
• Treating heartburn associated with symptomatic non-erosive gastroesophageal reflux disease
- Most commonly reported adverse reactions (≥2%): diarrhea, abdominal pain, nausea, upper respiratory tract infection, vomiting, and flatulence. (6.1)
Atazanavir: Do not co-administer with DEXILANT because atazanavir systemic concentrations may be substantially decreased. (7.1)
• Drugs with pH-dependent absorption (e.g., Ampicillin esters, Digoxin, iron salts, ketoconazole): DEXILANT may interfere with absorption of drugs for which gastric pH is important for bioavailability. (7.1)
• Warfarin: Patients taking concomitant warfarin may require monitoring for increases in international normalized ratio (INR) and prothrombin time. (7.2)
• Tacrolimus: Concomitant tacrolimus use may increase tacrolimus whole blood concentrations. (7.3)
• Methotrexate: DEXILANT may increase serum levels of methotrexate (7.5)
Gastric Malignancy: Symptomatic response with DEXILANT does not preclude the presence of gastric malignancy. (5.1)
• Clostridium difficile associated diarrhea: PPI therapy may be associated with increased risk of Clostridium difficile associated diarrhea. (5.2)
• Bone Fracture: Long-term and multiple daily dose PPI therapy may be associated with an increased risk for osteoporosis-related fractures of the hip, wrist or spine. (5.3)
• Hypomagnesemia: Hypomagnesemia has been reported rarely with prolonged treatment with PPIs. (5.4)
