Juvenile Rheumatoid Arthritis Study
In a 12-week, double-blind, active-controlled study, 242 JRA patients 2 years to 17 years of age were treated with Cexb or naproxen; 77 JRA patients were treated with Cexb 3 mg/kg twice daily, 82 patients were treated with Cexb 6 mg/kg twice daily, and 83 patients were treated with naproxen 7.5 mg/kg twice daily. The most commonly occurring (≥5%) adverse events in Cexb treated patients were headache, fever (pyrexia), upper abdominal pain, cough, nasopharyngitis, abdominal pain, nausea, arthralgia, diarrhea and vomiting. 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). Compared with naproxen, Cexb at doses of 3 and 6 mg/kg twice daily had no observable deleterious effect on growth and development during the course of the 12-week double-blind study. There was no substantial difference in the number of clinical exacerbations of uveitis or systemic features of JRA among treatment groups.
In a 12-week, open-label extension of the double-blind study described above, 202 JRA patients were treated with Cexb 6 mg/kg twice daily. The incidence of adverse events was similar to that observed during the double-blind study; no unexpected adverse events of clinical importance emerged.
Table 2: Adverse Events Occurring in ≥5% of JRA Patients in Any Treatment Group, by System Organ Class (% of patients with events)
If you take Cexb with digoxin, the levels of digoxin in your body may be increased. If you take these drugs together, your doctor may monitor your digoxin levels.
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What should I discuss with my healthcare provider before taking Cexb?
Cexb can increase your risk of fatal heart attack or stroke, especially if you use it long term or take high doses, or if you have heart disease. Even people without heart disease or risk factors could have a stroke or heart attack while taking this medicine.
Do not use this medicine just before or after heart bypass surgery (coronary artery bypass graft, or CABG).
Cexb may also cause stomach or intestinal bleeding, which can be fatal. These conditions can occur without warning while you are using Cexb, especially in older adults.
You should not use Cexb if you are allergic to it, or if you have:
- bleeding in your stomach or intestines;
- an allergy to sulfa drugs; or
- a history of asthma attack or severe allergic reaction after taking aspirin or an NSAID.
To make sure Cexb is safe for you, tell your doctor if you have:
- heart disease, high blood pressure, high cholesterol, diabetes, or if you smoke;
- a history of heart attack, stroke, or blood clot;
- a history of stomach ulcers or bleeding;
- liver or k >
Taking Cexb during the last 3 months of pregnancy may harm the unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using Cexb.
Cexb can pass into breast milk and may harm a nursing baby. Tell your doctor if you are breast-feeding a baby.
Cexb is not approved for use by anyone younger than 2 years old.
Cardiovascular safety was evaluated in two randomized, double-blind, placebo-controlled, three year studies involving patients with Sporadic Adenomatous Polyps treated with CELEBREX: the APC trial (Adenoma Prevention with Cexb) and the PreSAP trial (Prevention of Spontaneous Adenomatous Polyps). In the APC trial, there was a dose-related increase in the composite endpoint (adjudicated) of cardiovascular death, myocardial infarction, or stroke with Cexb compared to placebo over 3 years of treatment. The PreSAP trial did not demonstrate a statistically significant increased risk for the same composite endpoint (adjudicated):
- In the APC trial, the hazard ratios compared to placebo for a composite endpoint (adjudicated) of cardiovascular death, myocardial infarction, or stroke were 3.4 (95% CI 1.4 -8.5) with Cexb 400 mg twice daily and 2.8 (95% CI 1.1 -7.2) with Cexb 200 mg twice daily. Cumulative rates for this composite endpoint over 3 years were 3.0% (20/671 subjects) and 2.5% (17/685 subjects), respectively, compared to 0.9% (6/679 subjects) with placebo treatment. The increases in both Cexb dose groups versus placebo-treated patients were mainly due to an increased incidence of myocardial infarction.
- In the PreSAP trial, the hazard ratio for this same composite endpoint (adjudicated) was 1.2 (95% CI 0.6 -2.4) with Cexb 400 mg once daily compared to placebo. Cumulative rates for this composite endpoint over 3 years were 2.3% (21/933 subjects) and 1.9% (12/628 subjects), respectively.
Clinical trials of other COX-2 selective and non-selective NSAIDs of up to three-years duration have shown an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. As a result, all NSAIDs are considered potentially associated with this risk.
Arthralgia, arthrosis, bone disorder, accidental fracture, myalgia, neck stiffness, synovitis, and tendinitis were reported in 0.1% to 1.9% of patients taking Cexb 100 to 200 mg twice a day or 200 mg once a day. In the long-term polyp prevention studies in which exposure to Cexb was 400 to 800 mg per day for up to 3 years, epicondylitis or tendon rupture were reported in at least 0.1% of patients to less than 1% of patients.
Uncommon (0.1% to 1%): Epicondylitis, tendon rupture
Frequency not reported: Arthralgia, arthrosis, bone disorder, accidental fracture, myalgia, neck stiffness, synovitis, tendinitis
Q: How often should you take Celebrex?
A: How often you should take Celebrex (Cexb) depends upon the reason for treatment. Celebrex is approved for the relief of symptoms caused by pain or inflammation associated with several medical conditions, including osteoarthritis, rheumatoid arthritis, juvenile rheumatoid arthritis in children ages two and older, ankylosing spondylitis, primary dysmenorrhea, acute pain or familial adenomatous polyposis as an adjunct treatment to usual care. When prescribed for the symptomatic relief in patients with osteoarthritis, Celebrex is usually taken once or twice daily. As a treatment option for relief of signs and symptoms of rheumatoid arthritis in the adult population, Celebrex is typically taken twice daily. For the treatment of symptoms of juvenile rheumatoid arthritis in the pediatric population, the usual administration schedule for Celebrex is twice daily. For the relief of signs and symptoms associated with ankylosing spondylitis, Celebrex is typically administered once or twice daily. In adult patients being treated with Celebrex for the management of acute pain or the treatment of primary dysmenorrhea, the usual dose is initially a higher dose, followed by a lower dose if needed on the first day and typically administered twice daily as needed on subsequent days of treatment when required. Lastly, when Celebrex is used as an adjunct to usual care in patients with familial adenomatous polyposis, the dose is usually taken twice daily with food. When deciding upon Celebrex as a treatment option, health care providers are urged to carefully consider the risk versus benefit of treatment with Celebrex and use the lowest effective dose for the shortest duration of treatment possible to achieve positive therapeutic outcomes.
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Cite this Entry
“Cexb.” The Merriam-Webster.com Medical Dictionary, Merriam-Webster Inc., https://www.merriam-webster.com/medical/Cexb. Accessed 27 December 2019.
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Otitis media, deafness, ear abnormality, earache, and tinnitus were reported in 0.1% to 1.9% of patients taking Cexb 100 to 200 mg twice a day or 200 mg once a day. In the long-term polyp prevention studies in which exposure to Cexb was 400 to 800 mg per day for up to 3 years, labyrinthitis was reported in at least 0.1% of patients to less than 1% of patients.
Uncommon (0.1% to 1%): Labyrinthitis
Very rare (less than 0.01%): Hearing decreased
Frequency not reported: Otitis media, deafness, ear abnormality, earache, tinnitus