Omeclamox®-Pak is indicated for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or one-year history of duodenal ulcer) to eradicate H. pylori. Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence. The most frequently reported adverse events with Omeclamox-Pak were diarrhea, headache, and taste perversion. No adverse events unique to triple therapy were observed. Adverse reactions were limited to those previously reported with omeprazole, clarithromycin or amoxicillin alone.

1. Omeclamox-Pak Complete Prescribing Information.
* Three U.S., randomized, double-blind clinical studies in patients with H. pylori infection and duodenal ulcer disease (n = 558) compared omeprazole plus clarithromycin plus amoxicillin with clarithromycin plus amoxicillin. Two studies (1 and 2) were conducted in patients with an active duodenal ulcer, and the other study (3) was conducted in patients with a history of a duodenal ulcer in the past 5 years but without an ulcer present at the time of enrollment. The combination of omeprazole plus clarithromycin plus amoxicillin, was effective in eradicating H. pylori.

 

 

© 2014 Cumberland Pharmaceuticals, Inc.   All rights reserved   This information is intended only for residents of the United States.
WWW01OP0914