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 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.
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.
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ACIPHEX is a registered trademark of Eisai Company, Ltd.
This site was last modified on: [Jan 04 2010 at 10:46:31 EST EDT]