11. CELEBREX (celecoxib) capsule is a nonsteroidal anti-inflammatory drug, available as capsules containing 50 mg, 100 mg, 200 mg and 400 mg celecoxib for oral administration. The chemical name is 4-[5-(4-methylphenyl)- 3-(trifluoromethyl)-1H-pyrazol-1-yl] benzenesulfonamide and is a diaryl-substituted pyrazole. The molecular weight is 381.38. Its molecular formula is C 17 H 14 F 3 N 3 O 2 S, and it has the following chemical structure: Celecoxib is a white to off-white powder with a pKa of 11.1 (su...

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1. CELEBREX is indicated CELEBREX is a nonsteroidal anti-inflammatory drug indicated for: • Osteoarthritis (OA) • Rheumatoid Arthritis (RA) • Juvenile Rheumatoid Arthritis (JRA) in patients 2 years and older • Ankylosing Spondylitis (AS) • Acute Pain (AP) • Primary Dysmenorrhea (PD) 1.1 Osteoarthritis (OA) For the management of the signs and symptoms of OA [ see Clinical Studies ]. 1.2 Rheumatoid Arthritis (RA) For the management of the signs and symptoms of RA [ see Clinical Studies ]. 1.3 Juvenil...

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3. CELEBREX (celecoxib) capsules: 50 mg white, with reverse printed white on red band of body and cap with markings of 7767 on the cap and 50 on the body. 100 mg white, with reverse printed white on blue band of body and cap with markings of 7767 on the cap and 100 on the body. 200 mg white, with reverse printed white on gold band with markings of 7767 on the cap and 200 on the body. 400 mg white, with reverse printed white on green band with markings of 7767 on the cap and 400 on the body. CELEBREX ...

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2. • Use the lowest effective dosage for shortest duration consistent with individual patient treatment goals. • OA: 200 mg once daily or 100 mg twice daily. ( 2.2 , 14.1 ) • RA: 100 mg to 200 mg twice daily. ( 2.3 , 14.2 ) • JRA: 50 mg twice daily in patients 10 kg to 25 kg. 100 mg twice daily in patients more than 25 kg. ( 2.4 , 14.3 ) • AS: 200 mg once daily single dose or 100 mg twice daily. If no effect is observed after 6 weeks, a trial of 400 mg (single or divided doses) may be of benefit. ( 2.5 ...

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4. CELEBREX is 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...

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10. Symptoms following acute NSAID overdosages have been typically limited to lethargy, drowsiness, nausea, vomiting, and epigastric pain, which have been generally reversible with supportive care. Gastrointestinal bleeding has occurred. Hypertension, acute renal failure, respiratory depression, and coma have occurred, but were rare [ see Warnings and Precautions (5.2 , 5.4 , 5.6) ]. No overdoses of CELEBREX were reported during clinical trials. Doses up to 2400 mg/day for up to 10 days in 12 patient...

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5. • 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. • 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 CELEBREX in patients with severe heart failure unless benefits are expected to outweigh risk o...

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7. See Table 3 for clinically significant drug interactions with celecoxib. Table 3: Clinically Significant Drug Interactions with Celecoxib Drugs That Interfere with Hemostasis Clinical Impact: • 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. • Serotonin release by platelets plays an important role in hemostasis. Case-control a...

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Use of NSAIDs, including CELEBREX, 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 CELEBREX use between about 20 and 30 weeks of gestation and avoid CELEBREX use at about 30 weeks of gestation and later in pregnancy ( see Error! Hyperlink reference not valid. , Error! Hyperlink reference not valid. ). Premature Closure of Fetal Ductus Art...

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