Serious clinically significant upper GI bleeding has been observed in patients receiving Celecoxib Capsules in controlled and open-labeled trials [A randomized, double-blind study in 430 RA patients was conducted in which an endoscopic examination was performed at 6 months. 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 celecoxib 400 mg twice daily are described in Table 7. 5 (tartrazine) which may cause allergic-type reactions (including bronchial asthma) in certain susceptible persons. These changes resulted in a statistically significant and clinically meaningful difference of 3.9 mmHg (p=0.0009) between celecoxib and ibuprofen and a non-statistically significant difference of 1.8 (p=0.119) mmHg between celecoxib and naproxen.Cardiovascular safety was evaluated in two randomized, double-blind, placebo-controlled, three year studies involving patients with Sporadic Adenomatous Polyps treated with celecoxib: the APC trial (Adenoma Prevention with Celecoxib) and the PreSAP trial (Prevention of Spontaneous Adenomatous Polyps). There was no dose relationship for the incidence of gastroduodenal ulcers and the dose of celecoxib (50 mg to 400 mg twice daily). If no effect is observed after 6 weeks, a trial of 400 mg daily may be worthwhile. There was no placebo group in the CLASS trial, which limits the ability to determine whether the three drugs tested had no increased risk of CV events or if they all increased the risk to a similar degree. The entire capsule contents are carefully emptied onto a level teaspoon of cool or room temperature applesauce and ingested immediately with water. Patients on long-term treatment with Celecoxib Capsules should have their hemoglobin or hematocrit checked if they exhibit any signs or symptoms of anemia or blood loss.NSAIDs, including celecoxib, may increase the risk of bleeding events. Doses up to 2400 mg/day for up to 10 days in 12 patients did not result in serious toxicity. Among patients receiving placebo, 0.6% discontinued due to dyspepsia and 0.6% withdrew due to abdominal pain.In a 12-week, double-blind, active-controlled study, 242 JRA patients 2 years to 17 years of age were treated with celecoxib or naproxen; 77 JRA patients were treated with celecoxib 3 mg/kg twice daily, 82 patients were treated with celecoxib 6 mg/kg twice daily, and 83 patients were treated with naproxen 7.5 mg/kg twice daily. Therefore, there is a potential for an in vivo drug interaction with drugs that are metabolized by CYP2D6 (e.g.
Avoid use of NSAIDs, including Celecoxib Capsules, in pregnant women starting at 30 weeks of gestation (third trimester) [see Anemia has occurred in NSAID-treated patients. 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. For the management of the signs and symptoms of OA [For the management of the signs and symptoms of RA [For the management of the signs and symptoms of JRA in patients 2 years and older [For the management of the signs and symptoms of AS [Carefully consider the potential benefits and risks of Celecoxib Capsules and other treatment options before deciding to use Celecoxib Capsules. *A patient may have experienced more than one component; therefore, the sum of the components is larger than the number of patients who experienced the composite outcomeIn the ITT analysis population through 30 months, all-cause mortality was 1.6% in the celecoxib group, 1.8% in the ibuprofen group, and 2.0% in the naproxen group.In the PRECISION-ABPM substudy, among the total of 444 analyzable patients at Month 4, celecoxib dosed at 100 mg twice daily decreased mean 24-hour systolic blood pressure (SBP) by 0.3 mmHg, whereas ibuprofen and naproxen at the doses taken increased mean 24-hour SBP by 3.7 and 1.6 mmHg, respectively.
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