- For Print
- January 30, 2007
Eisai Co., Ltd. (Headquarters: Tokyo, President & CEO: Haruo Naito) announced today that the company's proton pump inhibitor Pariet® Tablets 10mg (generic name: rabeprazole sodium), in combination with the antibiotics amoxicillin and clarithromycin, received an approval in Japan for a new indication to eradicate Helicobacter pylori (H. pylori) infection related to gastric/duodenal ulcers.
H. pylori is a type of bacterium in the human stomach and is commonly associated with peptic ulcers. Pariet® , in combination with certain antibiotics, has been shown to eradicate H. pylori, thereby reducing the risk for ulcer recurrence. The drug, in combination with certain antibiotics, is also indicated for H. pylori eradication in the U.S. and Europe.
In clinical trials involving gastric/duodenal ulcer and gastroesophageal reflux disease, Pariet® was proven efficacious for fast and reliable inhibition of gastric acid secretion. Eisai originally introduced the drug in Japan in 1997, followed by the launch in Europe in 1998 and in the United States in 1999 (with its U.S. brand name, AcipHex®). Today, the drug is marketed in 79 countries around the world.
Eisai hopes that this new approved indication will increase the clinical value of Pariet®, thereby further improving patients' quality of life, as well as enhancing the treatment of acid-related disease.
[Please see the following notes for information on Pariet® and the antibiotics used as combination treatment.]
< Note to Editors >
About the New Approval
- Product Name: Pariet® Tablets 10mg (generic name: rabeprazole sodium)
- New Approved Indication, Dosage & Administration:
- Indication:
Adjuvant therapy for H. pylori eradication related to gastric/duodenal ulcer - Dosage & Administration:
Adjuvant therapy for H. pylori eradication related to gastric/duodenal ulcer
Adult patients should take the following three-drug regime twice a day, for seven days: rabeprazole sodium (10mg per dose, titer), amoxicillin (750mg per dose, titer), and clarithromycin (200mg per dose, titer).
When necessary, the dosage of clarithromycin can be increased up to twice a day and 400mg per dose (titer).
- Indication:
About the antibiotics which can be used as combination treatment with Pariet® in H. pylori eradication
- Amoxicillin
- PASETOCIN® Capsules, PASETOCIN® Fine granules, PASETOCIN® Tablets 250
(Imported and distributed by: Kyowa Hakko Kogyo Co., Ltd.) - AMOPENIXIN CAPSULES 250
(Manufactured and marketed by: Nipro Pharma Corporation) - Sawacillin® Capsules, Sawacillin® Fine Granules, Sawacillin® Tablets 250mg
(Manufactured and marketed by: Astellas Pharma Inc.)
- PASETOCIN® Capsules, PASETOCIN® Fine granules, PASETOCIN® Tablets 250
- Clarithromycin
- Clarith® Tab. 200
(Manufactured and marketed by: Taisho Pharmaceutical Co., Ltd., distributed by: Taisho Toyama Pharmaceutical Co., Ltd.) - Klaricid® Tablets 200mg
(Manufactured and marketed by: Abbott Japan Co., Ltd.)
- Clarith® Tab. 200
Approval in the United States
The seven-day treatment for H. pylori eradication described above was approved in the United States in 2002 (the U.S. brand name for Pariet® is AcipHex®).