H. pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence

The components in PREVPAC (lansoprazole, amoxicillin and clarithromycin) (PREVACID, amoxicillin, and clarithromycin) are indicated for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or one-year history of a duodenal ulcer) to eradicate H. pylori . Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence (see Clinical Studies and DOSAGE AND ADMINISTRATION).

To reduce the development of drug-resistant bacteria and maintain the effectiveness of PREVPAC (lansoprazole, amoxicillin and clarithromycin) and other antibacterial drugs, PREVPAC (lansoprazole, amoxicillin and clarithromycin) should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

H. pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence

The recommended adult oral dose is 30 mg PREVACID, 1 g amoxicillin, and 500 mg clarithromycin administered together twice daily (morning and evening) for 10 or 14 days (see INDICATIONS AND USAGE).

PREVPAC (lansoprazole, amoxicillin and clarithromycin) is not recommended in patients with creatinine clearance less than 30 mL per min.

PREVPAC (lansoprazole, amoxicillin and clarithromycin) is supplied as an individual daily administration card, each containing:

PREVACID:

• Two opaque, hard gelatin, black and pink PREVACID 30-mg capsules, with “TAP” and “PREVACID 30” imprinted on the capsules.

Amoxicillin Capsules, USP:

• Four yellow, opaque, hard gelatin amoxicillin 500-mg capsules, USP, imprinted AMOX 500 on one side and GG 849 on the other side.

BIAXIN Filmtab:

Two yellow oval film-coated clarithromycin 500-mg tablets, USP, debossed with the Abbott logo on one side and “KL” on the other side of the tablets.

NDC 64764-702-01 Carton containing 14 daily administration cards

NDC 64764-702-11 Daily administration card

Store at a controlled room temperature between 20°C and 25°C (68°F and 77°F). Protect from light and moisture.

PREVPAC (lansoprazole, amoxicillin and clarithromycin) is distributed by Takeda Pharmaceuticals America, Inc. Delayed-Release Capsules, Distributed by Takeda Pharmaceuticals America, Inc., Deerfield, IL 60015, U.S.A. Amoxicillin Capsules, USP, Manufactured in Austria by Sandoz GmbH for Sandoz Inc., Princeton, NJ 08540, U.S.A. BIAXIN® Filmtab® (clarithromycin tablets, USP), Manufactured by Abbott Pharmaceuticals PR, Ltd., Barceloneta, PR 00617. Rev March 2009

Last reviewed on RxList: 1/22/2010
This monograph has been modified to include the generic and brand name in many instances.