ADOLESCENTS

• ACIPHEX^® is contraindicated in patients with known hypersensitivity to rabeprazole, substituted benzimidazoles, or to any component of the formulation

• Symptomatic response to therapy does not preclude the presence of gastric malignancy
• As with all PPIs, patients treated concomitantly with warfarin may need to be monitored for increases in INR and prothrombin time. Increases in INR and prothrombin time may lead to abnormal bleeding and even death
• 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
• Hypomagnesemia has been reported rarely with prolonged treatment with PPIs. Serious adverse events include tetany, arrhythmias, and seizures. Consider monitoring magnesium levels in patients on prolonged PPI therapy or concomitant medications such as digoxin or medications that may cause hypomagnesemia (eg, diuretics)

• In adolescents, the related reported adverse reactions that occurred in ≥2% of patients were headache and nausea. The adverse reactions reported without regard to relationship to ACIPHEX^® that occurred in ≥2% of patients were headache, diarrhea, nausea, vomiting and abdominal pain
• In adults, clinical trials revealed the following adverse reactions appearing in ≥2% of ACIPHEX^® patients and with a frequency greater than placebo: pain, pharyngitis, flatulence, infection, and constipation

• ACIPHEX^® inhibits gastric acid secretion and may interfere with the absorption of drugs where gastric pH is an important determinant of bioavailability (eg, ketoconazole, iron salts and digoxin)
• ACIPHEX^® may reduce the plasma levels of atazanavir
• Rabeprazole has been shown to inhibit cyclosporine metabolism in vitro

For more information about ACIPHEX^®, see full Prescribing Information.

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