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ACIPHEX is a proton-pump inhibitor (PPI) indicated in adults for:
• Healing of Erosive or Ulcerative Gastroesophageal Reflux Disease (GERD) (1.1)
• Maintenance of Healing of Erosive or Ulcerative GERD (1.2) •
Treatment of Symptomatic GERD (1.3) • Healing of Duodenal Ulcers (1.4)
• Helicobacter pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence (1.5)
• Treatment of Pathological Hypersecretory Conditions, Including Zollinger-Ellison Syndrome (1.6)
In adolescent patients 12 years of age and older for: • Short-term treatment of Symptomatic GERD (1.7)
In pediatric patients 1 to 11 years of age for: • Treatment of GERD (1.8)
In the adult studies (4 to 8 weeks), adverse reactions that occurred at a rate greater than 2% and greater than placebo included pain, pharyngitis, flatulence, infection, and constipation (6.1).
• In studies of pediatric and adolescent patients (ages 1 to 16 years, and up to 36 weeks exposure) adverse reactions that occurred at a rate of ≥5% of patients included abdominal pain, diarrhea, and headache (6.1).
Increased INR and prothrombin times have been reported with concomitant use with warfarin. Patients need to be monitored (7.2).
• Rabeprazole has been shown to inhibit cyclosporine metabolism in vitro (7.3).
• ACIPHEX inhibits gastric acid secretion and may interfere with the absorption of drugs where gastric pH is an important determinant of bioavailability (e.g., ketoconazole, iron salts, digoxin, and mycophenolate mofetil) (7.4).
• ACIPHEX may reduce the plasma levels of atazanavir (7.4).
• Methotrexate: ACIPHEX may increase serum level of methotrexate (7.7).
• Symptomatic response to therapy with rabeprazole does not preclude the presence of gastric malignancy (5.1).
• Use with warfarin: Monitor for increases in INR and prothombin time (5.2).
• Acute interstitial nephritis has been observed in patients taking PPIs (5.3).
• Cyanocobalamin (vitamin B-12) Deficiency: Daily long-term use (e.g., longer than 3 years) may lead to malabsorption or a deficiency of cyanocobalamin (5.4).
• PPI therapy may be associated with increased risk of Clostridium difficile associated diarrhea (5.5).
• 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 (5.6).
• Hypomagnesemia has been reported rarely with prolonged treatment with PPIs (5.7).
