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Consider withdrawal of NSAIDs, including CELEBREX, in women who have difficulties conceiving or who are undergoing investigation of infertility. The concurrent use of aspirin and an NSAID, such as celecoxib, increases the risk of serious Two large, controlled clinical trials of a COX-2 selective NSAID for the treatment of pain in the first 10-14 days following surgery found an increased incidence of myocardial infarction and stroke. The pharmacokinetic parameters of celecoxib in a group of healthy subjects are shown in Table 4.

Under fasting conditions, at doses above 200 mg, there is less than a proportional increase in Cmax and AUC, which is thought to be due to the low solubility of the drug in aqueous media. Use of celecoxib may blunt the CV effects of several therapeutic agents used to treat these medical conditions (e. Cumulative rates for this composite endpoint over 3 years were 3. Patients taking converting enzyme (ACE) inhibitors, thiazide diuretics or loop diuretics may have impaired response to these therapies when taking NSAIDs [see The rates of hypertension from the CLASS trial in the CELEBREX, ibuprofen and diclofenac-treated patients were 2. This risk may occur early in the treatment and may increase with duration of use.



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Avoid the use of CELEBREX in patients with advanced renal disease unless the benefits are expected to outweigh the risk of worsening renal function. It appears that the low solubility of the drug prolongs the absorption process making terminal half-life (t½) determinations more variable. Peak plasma levels of celecoxib occur approximately 3 hrs after an oral dose.

The Coxib and traditional NSAID Trialists' Collaboration meta-analysis of randomized controlled trials demonstrated an approximately twofold increase in hospitalizations for in COX-2 selective-treated patients and nonselective NSAID-treated patients compared to placebo-treated patients. This includes any possible side effects not listed in this leaflet. Table 2: Adverse Events Occurring in ≥ 5% of JRA Patients in Any Treatment Group, by System Organ Class (% of patients with events) * Abnormal laboratory tests, which include: Prolonged activated partial thromboplastin time, Bacteriuria NOS present, Blood creatine phosphokinase increased, Blood culture positive, Blood glucose increased, Blood pressure increased, Blood uric acid increased, Hematocrit decreased, Hematuria present, Hemoglobin decreased, Liver function tests NOS abnormal, Proteinuria present, Transaminase NOS increased, Urine analysis abnormal NOS A total of 378 patients were treated with CELEBREX in placebo- and active-controlled AS studies. In placebo- or active-controlled clinical trials, the discontinuation rate due to adverse events was 7. Avoid taking NSAIDs after a recent heart attack, unless your healthcare provider tells you to.


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