IMPORTANT SAFETY INFORMATION ABOUT SPRIX® (ketorolac tromethamine) Nasal Spray
WARNING: LIMITATIONS OF USE, GASTROINTESTINAL, BLEEDING, CARDIOVASCULAR, and RENAL RISK
Limitations of Use – The total duration of use of SPRIX® and other ketorolac formulations should not exceed 5 days
Gastrointestinal (GI) Risk – Ketorolac can cause peptic ulcers, GI bleeding, and/or perforation of the stomach or intestines, which can be fatal. SPRIX® is CONTRAINDICATED in patients with peptic ulcer disease or history of GI bleeding
Bleeding Risk – SPRIX® inhibits platelet function and is CONTRAINDICATED in patients with suspected or confirmed cerebrovascular bleeding, hemorrhagic diathesis, incomplete hemostasis, or high risk of bleeding
Cardiovascular (CV) Risk – NSAIDs may cause an increased risk of serious CV thrombotic events, myocardial infarction, and stroke, which can be fatal. This risk may increase with duration of use. Patients with CV disease or risk factors for CV disease may be at greater risk. SPRIX® is CONTRAINDICATED for treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery
Renal Risk – SPRIX® is CONTRAINDICATED in patients with advanced renal impairment and in patients at risk for renal failure due to volume depletion
Fluid retention and edema have been observed in patients taking NSAIDs. SPRIX® should be used with caution in patients with cardiac decomposition or similar conditions.
The most common adverse reactions (incidence > 2%) in patients treated with SPRIX® and occurring at a rate at least twice that of placebo are nasal discomfort, rhinalgia, increased lacrimation, throat irritation, oliguria, rash, bradycardia, decreased urine output, increased ALT and/or AST, hypertension, and rhinitis.
Treat patients for the shortest duration possible, and do not exceed 5 days of therapy with SPRIX®.
SPRIX® is also contraindicated in patients with known hypersensitivity or history of asthma, urticaria, or other al ergic-type reactions to aspirin, ketorolac, other NSAIDs or EDTA. However, anaphylactoid reactions may occur in patients with or without a history of al ergic reactions to aspirin or NSAIDs. SPRIX® is contraindicated in patients as a prophylactic analgesic prior to major surgery; or in labor or delivery.
SPRIX® should not be used concomitantly with IM/IV or oral ketorolac, aspirin, or other NSAIDs, or with probenecid or pentoxifyl ine.
Ketorolac can cause serious GI adverse events including bleeding, ulceration, and perforation. Elderly patients are at increased risk for serious GI events. Ketorolac can cause renal injury in patients with advanced renal disease and should be used with caution in patients taking diuretics or ACE inhibitors. NSAIDs can cause serious dermatologic adverse reactions such as exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis, which can be fatal. SPRIX® should be discontinued immediately in patients with skin reactions. During pregnancy, use of SPRIX® beyond 30 weeks gestation can cause premature closure of the ductus arteriosus, resulting in fetal harm. Do not use SPRIX® in patients for whom hemostasis is critical.
A R R E T E N°2010-09858 Accordant la médaille d'honneur régionale, départementale A l'occasion de la promotion du 1er janvier 2011; VU le décret n° 87-594 du 22 juillet 1987, portant création de la Médaille d'Honneur Régionale, Départementale et Communale, VU le décret n°88-309 du 28 mars 1988, VU le décret n°2005-48 du 25 janvier 2005. Article 1. - La médaille d’ho
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