Celecoxib Dosage

Usual Adult Dose for Pain

Acute pain: 400 mg initially, followed by 200 mg if needed on the first day. Then, 200 mg twice daily as needed.

Usual Adult Dose for Dysmenorrhea

400 mg initially, followed by 200 mg if needed on the first day. Then, 200 mg twice daily as needed.

Usual Adult Dose for Osteoarthritis

200 mg orally once daily or 100 mg orally twice daily.

Usual Adult Dose for Rheumatoid Arthritis

100 to 200 mg orally twice daily.

Usual Adult Dose for Familial Adenomatous Polyposis

400 mg orally twice daily with food.

Usual Adult Dose for Ankylosing Spondylitis

200 mg orally once daily or 100 mg orally twice daily. If after 6 weeks of therapy no results are observed, a trial dose of 400 mg orally daily may be worthwhile. If no response is seen after 6 weeks, consideration should be given to alternate treatment options.

Usual Pediatric Dose for Juvenile Rheumatoid Arthritis

2 years or older:

10 to less than or equal to 25 kg: 50 mg orally twice daily

Greater than 25 kg: 100 mg orally twice daily

Renal Dose Adjustments

Celecoxib has not been studied in patients with severe renal impairment.

Liver Dose Adjustments

Celecoxib has not been studied in patients with severe hepatic impairment. Its use is not recommended in these patients.

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

Dose Adjustments

In patients with less than 50 kg in body weight, start therapy at the lowest recommended dose.

Precautions

Celecoxib metabolism is predominantly mediated via cytochrome P450 (CYP450) 2C9 in the liver. Co-administration of celecoxib with drugs that are known to inhibit CYP450 2C9 should be done with caution. Significant interactions may occur when celecoxib is administered together with drugs that inhibit CYP450 2C9.

Patients who are known or suspected to be poor CYP450 2C9 metabolizers based on previous history/experience with other CYP450 2C9 substrates (such as warfarin, phenytoin) should be administered celecoxib with caution. Treatment should be started at the lowest recommended dose. Alternative management should be considered in JRA patients identified to be poor CYP450 2C9 metabolizers.

Celecoxib is approved for relief of the signs and symptoms of juvenile rheumatoid arthritis (JRA) in patients 2 years and older. Efficacy and safety have not been studied beyond six months in children. The long-term cardiovascular toxicity in children exposed to celecoxib has not been studied and it is unknown if long-term risks may be similar to that seen in adults exposed to celecoxib or other COX-2 selective and nonselective NSAIDs. The use of celecoxib in patients 2 to 17 years of age with pauciarticular, polyarticular course JRA or in patients with systemic onset JRA was studied in a 12-week, double-blind, active controlled, pharmacokinetic, safety and efficacy study, with a 12-week open-label extension. Celecoxib has not been studied in patients under 2 years of age, in patients with body weight less than 10 kg (22 lbs), and in patients with active systemic features. Patients with systemic onset JRA (without active systemic features) appear to be at risk for the development of abnormal coagulation tests. In some patients with systemic onset JRA, both naproxen and celecoxib were associated with mild prolongation of activated partial thromboplastin time (APTT) but not prothrombin time (PT). Due to the risk of disseminated intravascular coagulation, NSAIDs including celecoxib should be used only with caution in patients with systemic onset JRA. Patients with systemic onset JRA should be monitored for the development of abnormal coagulation laboratory tests.

Dialysis

Data not available

Other Comments

Celecoxib doses for the treatment of osteoarthritis and rheumatoid arthritis can be given without regard to timing of meals. If higher doses (400 mg twice daily) are needed, give with food.

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