Indicated for:

Osteoarthritis (OA):

• The management of the signs and symptoms of OA.

Rheumatoid Arthritis (RA):

• The management of the signs and symptoms of RA.

Juvenile Rheumatoid Arthritis (JRA):

• The management of the signs and symptoms of JRA in patients 2 years and older.

Ankylosing Spondylitis (AS):

• The management of the signs and symptoms of AS.

Acute Pain (AP):

• The management of acute pain in adults.

Primary Dysmenorrhea (PD):

• The management of primary dysmenorrhea.

Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction, and stroke, which can be fatal. This risk may occur early in the treatment and may increase with duration of use.

CELEBREX is contraindicated for the treatment of perioperative pain in the setting of coronary artery bypass graft (CABG) surgery.

Avoid the use of CELEBREX in patients with a recent MI unless the benefits are expected to outweigh the risk of recurrent CV thrombotic events. If CELEBREX is used in patients with a recent MI, monitor patients for signs of cardiac ischemia.

In a Danish National Registry study of patients with heart failure, NSAID use increased the risk of MI, hospitalization for heart failure, and death. Additionally, fluid retention and edema have been observed in some patients treated with NSAIDs. Use of celecoxib may blunt the CV effects of several therapeutic agents used to treat these medical conditions (e.g., diuretics, ACE inhibitors, or angiotensin receptor blockers [ARBs].

NSAIDs cause an increased risk of serious gastrointestinal (GI) 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 and patients with a prior history of peptic ulcer disease and/or GI bleeding are at greater risk for serious GI events.

CELEBREX is contraindicated in patients with asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs. Severe, sometimes fatal, anaphylactic reactions to NSAIDs, have been reported in such patients.

CELEBREX is contraindicated in patients who have demonstrated allergic-type reactions to sulfonamides.

The use of CELEBREX in patients with severe hepatic impairment is not recommended.

In patients with moderate hepatic impairment (Child-Pugh Class B), reduce the dose by 50%.

Long-term administration of NSAIDs has resulted in renal papillary necrosis and other renal injury. The renal effects of CELEBREX may hasten the progression of renal dysfunction in patients with preexisting renal disease.

Increases in serum potassium concentration, including hyperkalemia, have been reported with use of NSAIDs, even in some patients without renal impairment.

NSAIDs, including CELEBREX can lead to new onset of hypertension or worsening of preexisting hypertension, either of which may contribute to the increased incidence of CV events.

Serious skin reactions have occurred following treatment with CELEBREX, including erythema multiforme, exfoliative dermatitis, Stevens-Johnson Syndrome (SJS), toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP). These serious events may occur without warning and can be fatal.

NSAIDs, including CELEBREX, may increase the risk of bleeding events. Comorbid conditions such as coagulation disorders or concomitant use of warfarin, other anticoagulants, antiplatelet agents (e.g., aspirin), serotonin reuptake inhibitors (SSRIs) and serotonin norepinephrine reuptake inhibitors (SNRIs) may increase this risk.

Anemia has occurred in NSAID-treated patients. This may be due to occult or gross blood loss, fluid retention, or an incompletely described effect on erythropoiesis.

Because of the risk of disseminated intravascular coagulation with use of CELEBREX in pediatric patients with systemic onset JRA, monitor patients for signs and symptoms of abnormal clotting or bleeding, and inform patients and their caregivers to report symptoms as soon as possible.

In patients with JRA who are known or suspected to be poor CYP2C9 metabolizers, consider using alternative treatments.

In adult patients who are known or suspected to be poor CYP2C9 metabolizers based on genotype or previous history/experience with other CYP2C9 substrates (such as warfarin, phenytoin), initiate treatment with half of the lowest recommended dose.

Co-administration of celecoxib with drugs that are known to inhibit CYP2C9 (e.g. fluconazole) may enhance the exposure and toxicity of celecoxib whereas co administration with CYP2C9 inducers (e.g. rifampin) may lead to compromised efficacy of celecoxib.

Celecoxib and anticoagulants such as warfarin have a synergistic effect on bleeding. The concomitant use of Celecoxib and anticoagulants have an increased risk of serious bleeding compared to the use of either drug alone.

Concomitant use of CELEBREX and analgesic doses of aspirin is not generally recommended because of the increased risk of bleeding.

NSAIDs may diminish the antihypertensive effect of angiotensin converting enzyme (ACE) inhibitors, angiotensin receptor blockers (ARBs), or beta-blockers (including propranolol).

NSAIDs reduced the natriuretic effect of loop diuretics (e.g., furosemide) and thiazide diuretics in some patients.

The concomitant use of Celecoxib with digoxin has been reported to increase the serum concentration and prolong the half-life of digoxin.

Concomitant use of NSAIDs and methotrexate may increase the risk for methotrexate toxicity (e.g., neutropenia, thrombocytopenia, renal dysfunction).

Concomitant use of CELEBREX and cyclosporine may increase cyclosporine nephrotoxicity.

Concomitant use of CELEBREX and pemetrexed may increase the risk of pemetrexed-associated myelosuppression, renal, and GI toxicity.

Concomitant use of corticosteroids with CELEBREX may increase the risk of GI ulceration or bleeding.

Avoid use of NSAIDs, including CELEBREX, in pregnant women at about 30 weeks gestation and later. NSAIDs, including CELEBREX, increase the risk of premature closure of the fetal ductus arteriosus at approximately this gestational age.

Limited data from 3 published reports that included a total of 12 breastfeeding women showed low levels of CELEBREX in breast milk.

GoToSource

• Use in patients under the age of 2. GoToSource

• Inflammatory (type IIIA) chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS-IIIA type). GoToSource

• Age-related macular degeneration and diabetic retinopathy. GoToSource

• Alzheimer’s disease. GoToSource

• Barrett’s esophagus. GoToSource

• Adjunctive therapy for breast cancer metastasis. GoToSource

• Adjunctive therapy for advanced head and neck carcinoma. GoToSource

• Schizophrenia and major depression. GoToSource

• Improve endothelial dysfunction in patients with coronary artery disease. GoToSource

• Amyotrophic lateral sclerosis. GoToSource

• Use with antibiotic prophylaxis for chronic tourette syndrome. GoToSource

• Adjunctive therapy for bipolar disorder. GoToSource

• Adjunctive therapy for disseminated malignant mesothelioma of the peritoneum. GoToSource

• Prevention of heterotopic ossification. GoToSource

• Prophylaxis for cystoid macular edema. GoToSource

• Decrease urinary retention associated with prostate brachytherapy. GoToSource

• Hydronephrosis. GoToSource

• Adjunctive therapy to reduce progressive attachment loss in patients with chronic periodontitis. GoToSource

• Adjunctive therapy for renal cell carcinoma. GoToSource

• Adjunctive therapy for advanced cancer of the cervix. GoToSource

• Nasopharyngeal carcinoma. GoToSource

• Refractory solid tumors in pediatric patients. GoToSource

• Severe cervical dysplasia. GoToSource

• Adjunctive therapy for treatment of malignant pleural effusion and ascites associated with advanced-stage cancers. GoToSource

• Adjunctive therapy for recurrent malignant glioma. GoToSource

• Non-small cell lung cancer. GoToSource

• Adjunctive treatment for pancreatic cancer. GoToSource

Myocardial infarction, stroke and heart failure. GoToSource

Gastrointestinal adverse events including bleeding, ulceration and perforation of the stomach or intestines. GoToSource

Hypertension (high blood pressure), angioedema (swelling in deep layers of skin) and allergic reactions. GoToSource

Edema (excess fluid within tissues), hyponatremia (low sodium level in blood) and hyperkalemia (high potassium levels in blood). GoToSource

Liver injury. GoToSource

Stevens-johnson syndrome and toxic epidermal necrolysis (severe skin reaction). GoToSource

Kidney failure. GoToSource

Lawsuits filed for deaths, gastrointestinal hemorrhages, kidney and liver damage, ulcers, strokes and heart attacks.