(5.4)The following adverse reactions occurred in 0.1 to 1.9% of patients treated with celecoxib (100 to 200 mg twice daily or 200 mg once daily):The following serious adverse events (causality not evaluated) occurred in <0.1% of patients (cases reported only in post-marketing experience are indicated in italics):System Organ Adverse Events from Ankylosing Spondylitis Studies:Adverse Events from Analgesia and Dysmenorrhea Studies:Because of its lack of platelet effects, celecoxib is not a substitute for aspirin for cardiovascular prophylaxis [see Table 3 Summary of Single Dose (200 mg) Disposition Kinetics of Celecoxib in Healthy Subjects[see Dosage and Administration (2.6) and Use in Specific Populations (8.5)]see Dosage and Administration (2.6) and Use in Specific Populations (8.6)]. These laboratory abnormalities may progress, may remain unchanged, or may be transient with continuing therapy. The sprinkled capsule contents on applesauce are stable for up to 6 hours under refrigerated conditions (2 to 8° C/ 35 to 45° F).For the management of the signs and symptoms of AS, the recommended dose of celecoxib is 200 mg daily in single (once per day) or divided (twice per day) doses. The cumulative rates in non-ASA users at nine months in each of the three treatment groups were less than 1%.
(Consider a dose reduction by 50% (or alternative management for JRA) in patients who are known or suspected to be CYP2C9 poor metabolizers, (2.6, 8.4, 8.8, 12.3). In these subjects, celecoxib did not alter the anticoagulant effect of warfarin as determined by prothrombin time. Doses up to 2400 mg/day for up to 10 days in 12 patients did not result in serious toxicity. In postmarketing experience, rare cases of anaphylactic reactions and angioedema have been reported in patients receiving celecoxib.
Celecoxib is a nonsteroidal anti-inflammatory drug indicated for: (Reduce daily dose by 50% in patients with moderate hepatic impairment (Child-Pugh Class B). 2004 Aug;51(2):57-62. doi: 10.1111/j.0105-1873.2004.00274.x.Senna G, Bilò MB, Antonicelli L, Schiappoli M, Crivellaro MA, Bonadonna P, Dama AR.Eur Ann Allergy Clin Immunol. These doses can be given without regard to timing of meals.For relief of the signs and symptoms of OA the recommended oral dose is 200 mg per day administered as a single dose or as 100 mg twice daily.For relief of the signs and symptoms of RA the recommended oral dose is 100 to 200 mg twice dailyFor 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. Patients should be informed about the signs and symptoms of serious skin manifestations and use of the drug should be discontinued at the first appearance of skin rash or any other sign of hypersensitivity.In late pregnancy, starting at 30 weeks gestation, celecoxib should be avoided because it may cause premature closure of the ductus arteriosus Celecoxib cannot be expected to substitute for corticosteroids or to treat corticosteroid insufficiency.
Safety and efficacy have not been studied beyond six months in children. Because of this structural component, celecoxib is contraindicated for use in patients who have demonstrated allergic reactions to sulfonamides. The long-term cardiovascular toxicity in children exposed to celecoxib has not been evaluated and it is unknown if the long-term risk may be similar to that seen in adults exposed to celecoxib or other COX-2 selective and non-selective NSAIDs [(see Boxed Warning, Warnings and Precautions (5.12)].Celecoxib was evaluated in AS patients in two placebo- and active-controlled clinical trials of 6 and 12 weeks duration.Celecoxib at doses of 100 mg twice daily, 200 mg once daily and 400 mg once daily was shown to be statistically superior to placebo in these studies for all three co-primary efficacy measures assessing global pain intensity (Visual Analogue Scale), global disease activity (Visual Analogue Scale) and functional impairment (Bath Ankylosing Spondylitis Functional Index). NSAIDs including celecoxib should be used only with caution in patients with systemic onset JRA, due to the risk of disseminated intravascular coagulation.