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ACIPHEX®
rabeprazole sodium tablets
http://www.aciphex.com
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Aciphex®, discovered and developed by Eisai, is a proton pump inhibitor that suppresses acid production in the cells of the stomach lining. Aciphex® was approved by the FDA in 1999 for the healing of erosive gastroesophageal reflux disease (GERD), maintenance of healed erosive GERD, healing of duodenal ulcers and treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome. It also is approved for treatment of daytime and nighttime heartburn and other symptoms associated with GERD. According to the American College of Gastroenterology, approximately 19 million Americans may have GERD.
In November 2002, Aciphex®, in combination with appropriate antibiotics, was approved by the FDA for eradication of H. pylori infections. H. pylori is a type of bacteria that is believed to be responsible for the majority of peptic ulcers. Aciphex®- known as Pariet® outside the United States - was first approved in Japan in 1997 and subsequently has been launched by Eisai, various alliance partners or through collaborations in more than 70 countries. In the United States, Eisai Inc. and PriCara, Unit of Ortho-McNeil, Inc. copromote the product, which is distributed by Eisai. Aciphex® is used for the treatment of persistent, frequent (two or more days a week) heartburn and other symptoms associated with acid reflux disease.
Aciphex® has a well-established safety profile. The most common side effect possibly related to Aciphex® is headache. Symptom relief does not rule out other serious stomach conditions. Patients on warfarin (such as Coumadin®) may need to be monitored more closely by their doctor.
In studies with Aciphex® plus amoxicillin and clarithromycin, no side effects unique to this drug combination were observed. The most frequently reported drug-related side effects for patients who received this combination therapy for seven days were diarrhea (eight percent) and taste disturbance (six percent).
If you are taking the medication cisapride or pimozide or if you are allergic to clarithromycin or any macrolide antibiotic, you should not take clarithromycin. Clarithromycin may increase blood levels of digoxin (a heart medication). Clarithromycin should not be used if you are pregnant except where no other therapy is appropriate (see warnings in prescribing information for clarithromycin).
If you are allergic to any penicillin, you should not take amoxicillin.
Speak to your physician about any other medications you are taking. For more information on side effects with amoxicillin or clarithromycin, please refer to their full prescribing information and talk to your doctor.
For more information about Aciphex®, including full prescribing information, visit www.aciphex.com or call 1-888-422-4743. If you are a US Healthcare Professional you may also search for more information at www.eisaimedicalinformation.com.
Coumadin® is a registered trademark of Bristol-Myers Squibb Pharma Company
Package Insert: FINAL ACIPHEX PLR 06-30-08 - SPL Version.pdf
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