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Celecoxib is a non-steroidal anti-inflammatory drug indicated for: Osteoarthritis (OA) ( 1.1 ) Rheumatoid Arthritis (RA) ( 1.2 ) Juvenile Rheumatoid Arthritis (JRA) in patients 2 years and older ( 1.3 ) Ankylosing Spondylitis (AS) ( 1.4 ) Acute Pain (AP) ( 1.5 ) Primary Dysmenorrhea (PD) ( 1.6 ) Celecoxib capsules are indicated 1.1 Osteoarthritis (OA) For the management of the signs and symptoms of OA [ see Clinical Studies ( 14.1 ) ]. 1.2 Rheumatoid Arthritis (RA) For the management of the signs and symptoms of RA [ see Clinical Studies ( 14.2 ) ]. 1.3 Juvenile Rheumatoid Arthritis (JRA) For the management of the signs and symptoms of JRA in patients 2 years and older [ see Clinical Studies ( 14.3 ) ]. 1.4 Ankylosing Spondylitis (AS) For the management of the signs and symptoms of AS [ see Clinical Studies ( 14.4 ) ]. 1.5 Acute Pain For the management of acute pain in adults [ see Clinical Studies ( 14.5 ) ]. 1.6 Primary Dysmenorrhea For the management of primary dysmenorrhea [see Clinical Studies ( 14.5 ) ].

Known hypersensitivity to celecoxib, or any components of the drug product or sulfonamides. ( 4 ) History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs. ( 4 ) In the setting of CABG surgery. ( 4 ) Celecoxib capsules are contraindicated in the following patients: Known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to celecoxib, any components of the drug product [see Warnings and Precautions ( 5.7 , 5.9 ) ]. History of 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 [see Warnings and Precautions ( 5.7 , 5.8 )]. In the setting of CABG surgery [see Warnings and Precautions ( 5.1 )]. In patients who have demonstrated allergic-type reactions to sulfonamides. [ see Warnings and Precautions ( 5.7 ) ].

Hepatotoxicity : Inform patients of warning signs and symptoms of hepatotoxicity. Discontinue if abnormal liver tests persist or worsen or if clinical signs and symptoms of liver disease develop. ( 5.3 ) Hypertension : Patients taking some antihypertensive medications may have impaired response to these therapies when taking NSAIDs. Monitor blood pressure. ( 5.4 , 7 ) Heart Failure and Edema : Avoid use of celecoxib capsules in patients with severe heart failure unless benefits are expected to outweigh risk of worsening heart failure. ( 5.5 ) Renal Toxicity : Monitor renal function in patients with renal or hepatic impairment, heart failure, dehydration, or hypovolemia. Avoid use of celecoxib capsules in patients with advanced renal disease unless benefits are expected to outweigh risk of worsening renal function. ( 5.6 ) Anaphylactic Reactions : Seek emergency help if an anaphylactic reaction occurs. ( 5.7 ) Exacerbation of Asthma Related to Aspirin Sensitivity : Celecoxib capsules is contraindicated in patients with aspirin-sensitive asthma. Monitor patients with preexisting asthma (without aspirin sensitivity). ( 5.8 ) Serious Skin Reactions : Discontinue celecoxib capsules at first appearance of skin rash or other signs of hypersensitivity. ( 5.9 ) Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS): Discontinue and evaluate clinically. ( 5.10 ) Fetal Toxicity: Limit use of NSAIDs, including celecoxib, between about 20 to 30 weeks in pregnancy due to the risk …

8.1 Pregnancy Risk Summary Use of NSAIDs, including celecoxib capsules, can cause premature closure of the fetal ductus arteriosus and fetal renal dysfunction leading to oligohydramnios and, in some cases, neonatal renal impairment. Because of these risks, limit dose and duration of celecoxib use between about 20 and 30 weeks of gestation and avoid celecoxib use at about 30 weeks of gestation and later in pregnancy (see Clinical Considerations, Data ). Premature Closure of Fetal Ductus Arteriosus Use of NSAIDs, including celecoxib, at about 30 weeks gestation or later in pregnancy increases the risk of premature closure of the fetal ductus arteriosus. Oligohydramnios/Neonatal Renal …