INDICATIONS

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 or 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.

IMPORTANT SAFETY INFORMATION

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

As with all PPIs, patients treated concomitantly with warfarin may need to be monitored for increases in INR and prothrombin time, which may lead to abnormal bleeding and even death.

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.

Symptomatic response to therapy does not preclude the presence of gastric malignancy.

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 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.

Click here to view Full Prescribing Information for ACIPHEX.

References: 1. Data on file, Eisai Inc. 2. ACIPHEX Full Prescribing Information.

©2010 Eisai Inc. and Ortho-McNeil Janssen Pharmaceuticals, Inc. This site originates in the United States.

This information is intended for use by healthcare professionals in the United States only. Eisai Inc. and PriCara^®, Division of Ortho-McNeil Janssen Pharmaceuticals, Inc., recognize that the Internet is a global communications medium; however, laws, regulatory requirements and medical practices for pharmaceutical products vary from country to country. The Prescribing Information included here is not appropriate for use outside the United States.

This site contains information about products that may have different product labeling in different countries. This site is intended for adults 18 years and older.

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ACIPHEX is a registered trademark of Eisai Company, Ltd.

This site was last modified on: [Jan 04 2010 at 10:29:42 EST EDT]