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Celebrex is indicated for relief of the signs and symptoms of Juvenile Rheumatoid Arthritis (JRA) in patients 2 years and older. Juvenile rheumatoid arthritis causes prolonged joint inflammation in children younger than 16. Recommended dosage For the relief of the signs and symptoms of JRA the recommended oral dose for pediatric patients (age 2 years and older) is based on weight. For patients = 10 kg to = 25 kg the recommended dose is 50 mg twice daily. For patients > 25 kg the recommended dose is 100 mg twice daily. Use lowest effective dose for the shortest duration consistent with treatment goals for the individual patient. For patients who have difficulty swallowing capsules, the contents of a Celebrex capsule can be added to applesauce. The entire capsule contents are carefully emptied onto a level teaspoon of cool or room temperature applesauce and ingested immediately with water. The sprinkled capsule contents on applesauce are stable for up to 6 hours under refrigerated conditions (2-8° C/ 35-45° F). Clinical studies In a 12-week, randomized, double-blind active-controlled, parallel-group, multicenter, non-inferiority study, patients from 2 years to 17 years of age with pauciarticular, polyarticular course JRA or systemic onset JRA (with currently inactive systemic features), received one of the following treatments: celecoxib 3 mg/kg (to a maximum of 150 mg) twice daily; celecoxib 6 mg/kg (to a maximum of 300 mg) twice daily; or naproxen 7.5 mg/kg (to a maximum of 500 mg) twice daily. The response rates were based upon the JRA Definition of Improvement greater than or equal to 30% (JRA DOI 30) criterion, which is a composite of clinical, laboratory, and functional measures of JRA. The JRA DOI 30 response rates at week 12 were 69%, 80% and 67% in the celecoxib 3 mg/kg BID, celecoxib 6 mg/kg BID, and naproxen 7.5 mg/kg BID treatment groups, respectively. The efficacy and safety of Celebrex for JRA have not been studied beyond six months. The long-term cardiovascular toxicity in children exposed to Celebrex has not been evaluated and it is unknown if the long-term risk may be similar to that seen in adults exposed to Celebrex or other COX-2 selective and non-selective NSAIDs. |
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