WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS
Cardiovascular Risk
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NSAIDs 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 and Precautions
].
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NSAIDs, including DUEXIS, are contraindicated for treatment of perioperative pain in the setting of coronary artery bypass graft (CABG) surgery [see Warnings and Precautions
].
Gastrointestinal Risk
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NSAIDs cause an increased risk of serious gastrointestinal adverse reactions including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These reactions can occur at any time during use and without warning symptoms. Elderly patients are at greater risk for serious gastrointestinal events [see Warnings and Precautions
].
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DUEXIS SUMMARY
DUEXIS (ibuprofen and famotidine) is supplied as a tablet for oral administration which combines the nonsteroidal anti-inflammatory agent, ibuprofen, and the histamine H2-receptor antagonist, famotidine.
Carefully consider the potential benefits and risks of DUEXIS and other treatment options before deciding to use DUEXIS. Use the shortest duration consistent with individual patient treatment goals [ see Warnings and Precautions (5), Drug Interactions (7) and Use in Specific Populations (8) ].
DUEXIS, a combination of the NSAID ibuprofen and the histamine H2-receptor antagonist famotidine, is indicated for the relief of signs and symptoms of rheumatoid arthritis and osteoarthritis and to decrease the risk of developing upper gastrointestinal ulcers, which in the clinical trials was defined as a gastric and/or duodenal ulcer, in patients who are taking ibuprofen for those indications. The clinical trials primarily enrolled patients less than 65 years of age without a prior history of gastrointestinal ulcer. Controlled trials do not extend beyond 6 months. [see Clinical Studies and Use in Specific Populations]
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NEWS HIGHLIGHTS
Clinical Trials Related to Duexis (Ibuprofen / Famotidine)
Open-label Safety and Pharmacokinetic Study of DUEXIS� (Ibuprofen and Famotidine) Tablets in Juvenile Idiopathic Arthritis [Completed]
The primary objective of this Phase 4, multi-center, open-label study is to evaluate the
safety and tolerability of DUEXIS in Juvenile Idiopathic Arthritis (JIA) patients aged 10
years to 16 years, 11 months, treated up to 24 weeks.
The secondary objectives are to evaluate the PK characteristics of DUEXIS in JIA patients
and to evaluate the signs and symptoms of JIA in patients aged 10 years to 16 years, 11
months receiving DUEXIS for up to 24 weeks.
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Page last updated: 2014-08-13
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