INDICATIONS & IMPORTANT SAFETY INFORMATION

• In adults (≥18 years of age), ACIPHEX^® 20 mg is indicated for: treatment of daytime and nighttime heartburn and other
  symptoms associated with GERD; short-term, up to 4 weeks, treatment in the healing and symptomatic relief of duodenal
  ulcers; short-term, 4 to 8 weeks, treatment in the healing and symptomatic relief of erosive GERD; and maintenance of
  healing and reduction in relapse rates of heartburn symptoms in erosive GERD (controlled maintenance studies do not
  extend beyond 12 months)
• In adults, ACIPHEX^® 20 mg bid, in combination with amoxicillin 1000 mg bid and clarithromycin 500 mg bid, for 7 days
  is indicated for H. pylori eradication to reduce the risk of duodenal ulcer recurrence
• In adolescent patients 12 years of age and above, ACIPHEX^® 20 mg is indicated for: short-term, up to 8 weeks,
  treatment of daytime and nighttime heartburn and other symptoms associated with GERD

• 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

• In H. pylori clinical trials using combination therapy with rabeprazole sodium plus amoxicillin and clarithromycin (RAC),
  no adverse events unique to this drug combination were observed. In the US multicenter study, the most frequently
  reported drug-related adverse events for patients who received RAC therapy for 7 days were diarrhea (8%)
  and taste perversion (6%)
• No clinically significant laboratory abnormalities particular to the drug combinations were observed
• Clarithromycin is contraindicated in patients taking cisapride or pimozide; or in patients with a known hypersensitivity
  to clarithromycin or any macrolide antibiotic. Clarithromycin may elevate digoxin serum concentrations. Serum digoxin
  levels should be carefully monitored while digoxin and clarithromycin are taken concomitantly. Clarithromycin should
  not be used in pregnant women except in circumstances where no alternative therapy is appropriate. (See WARNINGS
  and Drug Interactions in Prescribing Information for clarithromycin.) Amoxicillin is contraindicated in patients who
  are allergic to any penicillin
• For more information on adverse events or laboratory changes with amoxicillin or clarithromycin, refer to their
  respective full Prescribing Information

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

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