- CELEBREX may cause an increased risk of serious cardiovascular (CV) thrombotic events, myocardial infarction, and stroke, which can be fatal. All nonsteroidal anti-inflammatory drugs (NSAIDs) may have a similar risk. This risk may increase with duration of use. Patients with CV disease or risk factors for CV disease may be at greater risk.
- CELEBREX is contraindicated for the treatment of perioperative pain in coronary artery bypass graft (CABG) surgery.
- NSAIDs, including CELEBREX, 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.
CELEBREX is contraindicated in patients with active gastrointestinal bleeding; in patients who have demonstrated allergic-type reactions to sulfonamides; or in patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs.
Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals.
As with all NSAIDs, CELEBREX can lead to the onset of new hypertension or worsening of pre-existing hypertension, either of which may contribute to the increased incidence of CV events. Blood pressure should be monitored closely with all NSAIDs.
Fluid retention and edema have been observed in some patients taking NSAIDs, including CELEBREX. NSAIDs should be used with caution in patients with fluid retention or heart failure.
NSAIDs, including CELEBREX, may diminish the antihypertensive effect of angiotensin converting enzyme (ACE) inhibitors and angiotensin II antagonists, and in some patients can reduce the natriuretic effect of furosemide and thiazides.
In patients who are elderly, volume-depleted (including those on diuretic therapy), or with compromised renal function, co-administration of NSAIDs, including selective COX-2 inhibitors, with ACE inhibitors, may result in deterioration of renal function, including possible acute renal failure. Discontinuation of NSAID therapy is usually followed by recovery to the pretreatment state.
CELEBREX can be used with low-dose aspirin. There is no consistent evidence that concurrent use of aspirin mitigates the increased risk of serious CV thrombotic events associated with NSAID use.
Concomitant administration of aspirin with CELEBREX increases the rate of GI ulceration or other complications, compared with use of CELEBREX alone.
Treatment with NSAIDs, including CELEBREX, is not recommended in those patients with advanced renal disease. In addition, NSAIDs may cause renal toxicity.
Serious skin reactions such as exfoliative dermatitis, Stevens Johnson syndrome, and toxic epidermal necrolysis have been reported in patients receiving CELEBREX. These reactions can be fatal. They can occur without warning and in patients without prior known sulfa allergy. CELEBREX should be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity.
Rare cases of anaphylactic reactions and angioedema have been reported in patients receiving CELEBREX. Patients should seek immediate emergency assistance if they have swelling of the face or throat or have difficulty breathing.
CELEBREX should be avoided in late pregnancy.
NSAIDs, including CELEBREX, should be used with caution in pediatric patients with systemic onset JRA, due to the risk of disseminated intravascular coagulation.
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CELEBREX is indicated for the relief of the signs and symptoms of osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis, and for the management of acute pain in adults; the treatment of primary dysmenorrhea; and for relief of the signs and symptoms of juvenile rheumatoid arthritis in patients 2 years and older.
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