Because of its lack of platelet effects, Celebrex is not a substitute for aspirin for cardiovascular prophylaxis.
Doses of 200 mg twice daily provided no additional benefit above that seen with 100 mg twice daily. The most commonly occurring (≥5%) adverse experiences for naproxen-treated patients were headache, nausea, vomiting, fever, upper abdominal pain, diarrhea, cough, abdominal pain, and dizziness (Table 2).
Celecoxib 100 mg twice daily was non-inferior to naproxen 375 to 500 mg twice daily and ibuprofen 600 to 800 mg three times daily for the composite endpoint of the Antiplatelet Trialists' Collaboration (APTC), which consists of cardiovascular death (including hemorrhagic death), non-fatal myocardial infarction, and non-fatal stroke [Status Post Coronary Artery Bypass Graft (CABG) SurgeryRisk Factors for GI Bleeding, Ulceration, and PerforationPatients with a prior history of peptic ulcer disease and/or GI bleeding who used NSAIDs had a greater than 10-fold increased risk for developing a GI bleed compared to patients without these risk factors. There was no dose relationship for the incidence of gastroduodenal ulcers and the dose of Celebrex (50 mg to 400 mg twice daily). In addition, structural abnormalities (e.g., septal defects, ribs fused, sternebrae fused and sternebrae misshapen) were observed in rabbits given daily oral doses of celecoxib during the period of organogenesis at approximately 2 times the MRHD [The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. Since celecoxib is an inhibitor of prostaglandin synthesis, its mode of action may be due to a decrease of prostaglandins in peripheral tissues.In clinical trials using normal volunteers, Celebrex at single doses up to 800 mg and multiple doses of 600 mg twice daily for up to 7 days duration (higher than recommended therapeutic doses) had no effect on reduction of platelet aggregation or increase in bleeding time. In animal studies, NSAIDs, including celecoxib, inhibit prostaglandin synthesis, cause delayed parturition, and increase the incidence of stillbirth.The available data do not establish the presence or absence of developmental toxicity related to the use of Celebrex.Celecoxib at oral doses ≥150 mg/kg/day (approximately 2 times the human exposure at 200 mg twice daily as measured by AUCCelecoxib produced no evidence of delayed labor or parturition at oral doses up to 100 mg/kg in rats (approximately 7-fold human exposure as measured by the AUCLimited data from 3 published reports that included a total of 12 breastfeeding women showed low levels of Celebrex in breast milk. Celecoxib has not been studied in patients under the age of 2 years, in patients with body weight less than 10 kg (22 lbs), and in patients with active systemic features.
If these occur, instruct patients to stop Celebrex and seek immediate medical therapy [Advise patients to be alert for the symptoms of congestive heart failure including shortness of breath, unexplained weight gain, or edema and to contact their healthcare provider if such symptoms occur [Inform patients of the signs of an anaphylactic reaction (e.g., difficulty breathing, swelling of the face or throat). Celecoxib is contraindicated in the setting of coronary artery bypass graft (CABG) surgery. In some patients with systemic onset JRA, both celecoxib and naproxen were associated with mild prolongation of activated partial thromboplastin time (APTT) but not prothrombin time (PT).
In the 12-week study, there was no difference in the extent of improvement between the 200 mg and 400 mg Celebrex doses in a comparison of mean change from baseline, but there was a greater percentage of patients who responded to Celebrex 400 mg, 53%, than to Celebrex 200 mg, 44%, using the Assessment in Ankylosing Spondylitis response criteria (ASAS 20).
Alternative management should be considered in JRA patients identified to be CYP2C9 poor metabolizers [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.
Small studies in women treated with NSAIDs have also shown a reversible delay in ovulation. A report of two breastfed infants 17 and 22 months of age did not show any adverse events.
However, as with other NSAIDs, including those that selectively inhibit COX-2, there have been more spontaneous post-marketing reports of fatal GI events and acute renal failure in the elderly than in younger patients [The daily recommended dose of Celebrex capsules in patients with moderate hepatic impairment (Child-Pugh Class B) should be reduced by 50%.
The Kaplan-Meier rate for complicated ulcers at 9 months was 1.12% versus 0.32% for those on low-dose ASA and those not on ASA, respectively [The estimated cumulative rates at 9 months of complicated and symptomatic ulcers for patients treated with Celebrex 400 mg twice daily are described in Table 7.
"Increased risk of bleeding, ulcers, and tears (perforation) of the esophagus (tube leading from the mouth to the stomach), stomach and intestines:The risk of getting an ulcer or bleeding increases with:Before taking NSAIDS, tell your healthcare provider about all of your medical conditions, including if you:You should not take NSAIDs after 29 weeks of pregnancyTell your healthcare provider about all of the medicines you take, including prescription or over-the-counter medicines, vitamins or herbal supplements.Do not start taking any new medicine without talking to your healthcare provider first.Get emergency help right away if you get any of the following symptoms:Stop taking your NSAID and call your healthcare provider right away if you get any of the following symptoms:If you take too much of your NSAID, call your healthcare provider or get medical help right away.General information about the safe and effective use of NSAIDsWe comply with the HONcode standard for trustworthy health information -