Gastrointestinal (GI) Effects
LIMBREL (flavocoxid) is expected to produce low toxicity in upper GI because of its mechanism of action, particularly its inhibition of 5-LOX and modest inhibition of COX-1. COX-1 inhibition causes the up-regulation of 5-LOX in the stomach, which converts AA to leukotrienes (particularly LTB4). LTB4 attracts WBCs to the stomach mucosa, which cause and expand ulcerations. Data from an interim analysis of a preliminary study showed that the number of upper GI adverse events of LIMBREL (flavocoxid) to be about the same as placebo and less than half that of naproxen. Clinical experience by physicians has shown LIMBREL (flavocoxid) to be well tolerated in patients with a history of mild ulceration.
Pediatric, Pregnancy and Lactation
There are no formal studies with LIMBREL (flavocoxid) in patients under the age of 18 years of age or pregnant or lactating patients. For this reason, LIMBREL (flavocoxid) is not recommended for pediatric, pregnant or lactating patients.This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 7/24/2008
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