VIMOVO 萘普生 埃索美拉唑复方制剂 处方.pdfVIP

HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use VIMOVO safely and effectively. See full prescribing information for VIMOVO. VIMOVO? (naproxen and esomeprazole magnesium) delayed release tablets, for oral use Initial US Approval: 2010 WARNING: CARDIOVASCULAR AND GASTROINTESTINAL RISKS See full prescribing information for complete boxed warning Cardiovascular Risk ? Naproxen, a component of VIMOVO, 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. (5.1) ? VIMOVO is contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery. (4, 5.1) Gastrointestinal Risk ? NSAIDs, including naproxen, a component of VIMOVO, 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 (GI) events. (5.4) RECENT MAJOR CHANGES Warnings and Precautions, Renal Effects (5.6) 03/2014 Warnings and Precautions, Acute Interstitial Nephritis (5.16) 12/2014 Warnings and Precautions, Cyanocobalamin (vitamin B-12) Deficiency (5.17) 12/2014 INDICATIONS AND USAGE Relief of signs and symptoms of osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis and to decrease the risk of developing gastric ulcers in patients at risk of developing NSAID associated gastric ulcers (1) DOSAGE AND ADMINISTRATION One tablet twice daily. Use the lowest effective dose. Should