INDICATIONS AND USAGE:
MAXPRO® IV is a proton pump inhibitor indicated for the treatment of Gastroesophageal Reflux Disease (GERD) with erosive esophagitis (EE) in adults and pediatric patients greater than one month of age, when oral therapy is not possible or appropriate.
MAXPRO® is contraindicated in patients with known hypersensitivity to any component of the formulation or to substituted benzimidazoles.
• MAXPRO® IV inhibits gastric acid secretion and may interfere with the absorption of drugs where gastric pH is an important determinant of bioavailability.
• Patients treated with proton pump inhibitors and warfarin concomitantly may need to be monitored for increases in INR and prothrombin time.
• MAXPRO® IV may reduce the plasma levels of atazanavir, nelfinavir, and saquinavir.
• Concomitant treatment with a combined inhibitor of CYP2C19 and CYP3A4, such as voriconazole, may result in more than doubling of the esomeprazole exposure.
USE IN SPECIFIC POPULATIONS:
• Pregnancy: FDA pregnancy category B
• Nursing Mothers: Caution should be exercised when administered to a nursing woman.
• Hepatic Insufficiency: For patients with severe liver impairment (Child Pugh Class C), a dose of 20 mg of MAXPRO® should not be exceeded.