Celebrex Indications and Dosage
- ankylosing spondylitis
- bone pain
- dental pain
- dysmenorrhea
- familial adenomatous polyposis
- headache
- moderate pain
- osteoarthritis
- rheumatoid arthritis
- severe pain
Celebrex Indications...Dosage
For the relief of the signs and symptoms of osteoarthritis:
Oral dosage:
Adults: 200 mg PO once daily or 100 mg PO twice daily (both regimens were equally effective). Doses of 200 mg twice daily provided no further benefit in phase III osteoarthritis trials. The lowest effective dose of celecoxib should be sought for each patient.
Elderly: Initiate therapy at the lowest recommended dose.
Adolescents and children: Safety and efficacy has not been established.
For the relief of the signs and symptoms of rheumatoid arthritis:
Oral dosage:
Adults: 100 or 200 mg PO twice daily. These doses were similarly effective in pre-marketing rheumatoid arthritis trials. The lowest effective dose of celecoxib should be sought for each patient. For patients weighing < 50 kg, initiate therapy at the lowest recommended dose.
Elderly: Initiate therapy at the lowest recommended dose.
Adolescents and children: Safety and efficacy has not been established.
For the treatment of acute moderate pain (e.g., bone pain, dental pain, headache, and orthopedic surgical pain) and dysmenorrhea:
Oral dosage:
Adults: 400 mg PO initially, then followed by an additional 200 mg PO on the first day, if needed. On subsequent days, 200 mg PO twice daily, as needed.
Adolescents and children: Safety and efficacy has not been established.
for moderate-to-severe pain associated with orthopedic surgery:
Oral dosage:
Adults: In one study, celecoxib 400 mg/day PO (up to 200 mg PO three times daily allowed) for 2—5 days after outpatient orthopedic surgery was shown to be as effective as hydrocodone 10 mg/acetaminophen 1000 mg PO twice daily (allowable 3 times daily). Most patients were well-controlled with 200 mg PO twice daily. In addition, during the first 8 hours following surgery, a single 200 mg PO dose of celecoxib was as effective as a single dose of the hydrocodone/acetaminophen combination.
For the relief of the signs and symptoms of ankylosing spondylitis:
Oral dosage:
Adults: 200 mg PO once daily or 100 mg PO twice daily. If no effect after 6 weeks, consider a 6-week trial of 400 mg PO daily. If no effect after 6 weeks, a response in unlikely; consider alternate treatment. The lowest effective dose of celecoxib should be sought for each patient.
For adjuvant treatment of patients with familial adenomatous polyposis (FAP) to reduce the number of adenomatous colorectal polyps:
NOTE: The use of celecoxib for treatment of FAP has not been shown to reduce the risk of gastrointestinal malignancies or the need for prophylactic colectomy or other FAP-related surgeries. Therefore, the usual care of FAP patients should not be altered because of the concurrent administration of celecoxib. In particular, the frequency of routine endoscopic surveillance should not be decreased and prophylactic colectomy or other FAP-related surgeries should not be delayed.
Oral dosage:
Adults: 400 mg PO twice daily with food. The safety and efficacy of celecoxib treatment in patients with FAP beyond 6 months has not been studied. Also, whether or not a clinical benefit is obtained from a reduction in the number of colorectal polyps or if the reduction is maintained after celecoxib discontinuation are unknown. Patients who were treated with celecoxib had a 28% reduction in the number of adenomatous polyps. In addition, celecoxib treatment resulted in a 30% reduction in polyp burden.
Maximum Dosage Limits:
- Adults: 800 mg/day PO.
- Elderly: 400 mg/day PO.
- Adolescents: Safe and effective use has not been established.
- Children: Safe and effective use has not been established.
Patients with hepatic impairment:
The recommended daily dose of celecoxib should be reduced by approximately 50% in patients with moderate hepatic impairment (Child-Pugh Class B). Celecoxib is not recommended in patients with severe hepatic impairment (Child-Pugh Class C).
Patients with renal impairment:
No dosage adjustment needed; however, celecoxib has not been studied in patients with severe renal insufficiency. The use of celecoxib is not recommended in patients with advanced renal disease.
[ Last revised: 8/3/2005 5:45:00 PM ]
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