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BOXED WARNING
Cardiovascular Risk
- NSAIDs1 may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. This risk may increase with duration of use. Patients with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk (see WARNINGS).
- Flurbiprofen tablets are contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery (see WARNINGS).
Gastrointestinal Risk
- NSAIDs cause an increased risk of serious gastrointestinal adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients are at greater risk for serious gastrointestinal events (see WARNINGS).
1 Throughout this package insert, the term NSAID refers to a non-aspirin non-steroidal anti-inflammatory drug. | | |
FLURBIPROFEN SUMMARY
FLURBIPROFEN TABLETS USP, 100 mg
Flurbiprofen is a nonsteroidal anti-inflammatory agent.
Flurbiprofen tablets are indicated for the acute or long-term treatment of the signs and symptoms of rheumatoid arthritis and osteoarthritis.
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FLURBIPROFEN NEWS HIGHLIGHTS
Published Studies Related to Flurbiprofen
Safety, tolerability, pharmacokinetics, and Abeta levels after short-term administration of R-flurbiprofen in healthy elderly individuals. [2007.10]
Validation of incorporating flurbiprofen into the Pittsburgh cocktail. [2006.09]
Influence of age on flurbiprofen axetil requirements for preventing pain on injection of propofol in Japanese adult surgical patients: a prospective, randomized, double-blind, vehicle-controlled, parallel-group, dose-ranging study. [2006.08]
Ginkgo biloba Does Not Alter Clearance of Flurbiprofen, a Cytochrome P450-2C9 Substrate. [2006.02]
Interaction of flurbiprofen with cranberry juice, grape juice, tea, and fluconazole: in vitro and clinical studies. [2006.01]
Clinical Trials Related to Flurbiprofen
Local Flurbiprofen to Treat Pain Following Wisdom Tooth Extraction [Completed]
The Efficacy and Safety of PerioChip Plus (Flurbiprofen/Chlorhexidine) Formulation in the Therapy of Adult Periodontitis [Not yet recruiting]
R-Flurbiprofen in Treating Patients With Localized Prostate Cancer at Risk of Recurrence [Active, not recruiting]
A Placebo-Controlled Study to Investigate the Safety, and Pharmacokinetics of Oral GSK626616AC in Healthy Subjects [Completed]
Comparison of Pain Therapeutic Effects After Benign Mastectomy [Completed]
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Page last updated: 2008-03-26
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