Use lowest effective dose for the shortest duration consistent with treatment
goals for the individual patient.
These doses can be given without regard to timing of meals.
Osteoarthritis
For relief of the signs and symptoms of OA the recommended oral dose is
200 mg per day administered as a single dose or as 100 mg twice daily.
Rheumatoid arthritis
For relief of the signs and symptoms of RA the recommended oral dose is
100 to 200 mg twice daily.
Juvenile Rheumatoid Arthritis
For the relief of the signs and symptoms of JRA the recommended oral dose
for pediatric patients (age 2 years and older) is based on weight. For patients
≥10 kg to ≤25 kg the recommended dose is 50 mg twice daily. For patients
>25 kg the recommended dose is 100 mg twice daily.
For patients who have difficulty swallowing capsules, the contents of
a CELEBREX capsule can be added to applesauce. The entire capsule contents
are carefully emptied onto a level teaspoon of cool or room temperature
applesauce and ingested immediately with water. The sprinkled capsule contents
on applesauce are stable for up to 6 hours under refrigerated conditions
(2-8° C/ 35-45° F).
Ankylosing Spondylitis
For the management of the signs and symptoms of AS, the recommended dose
of CELEBREX is 200 mg daily in single (once per day) or divided (twice per
day) doses. If no effect is observed after 6 weeks, a trial of 400 mg daily
may be worthwhile. If no effect is observed after 6 weeks on 400 mg daily,
a response is not likely and consideration should be given to alternate
treatment options.
Management of Acute Pain and Treatment of Primary Dysmenorrhea
The recommended dose of CELEBREX is 400 mg initially, followed by an additional
200 mg dose if needed on the first day. On subsequent days, the recommended
dose is 200 mg twice daily as needed.
Familial Adenomatous Polyposis
Usual medical care for FAP patients should be continued while on CELEBREX.
To reduce the number of adenomatous colorectal polyps in patients with FAP,
the recommended oral dose is 400 mg twice per day to be taken with food.
Special Populations
Hepatic insufficiency: The daily recommended dose of CELEBREX
capsules in patients with moderate hepatic impairment (Child-Pugh Class
B) should be reduced by 50%. The use of CELEBREX in patients with severe
hepatic impairment is not recommended (see Warnings and Precautions,
Use in Specific Populations and Clinical Pharmacology).
Poor Metabolizers of CYP2C9 Substrates: Patients who are
known or suspected to be poor CYP2C9 metabolizers based on previous history/experience
with other CYP2C9 substrates (such as warfarin, phenytoin) should be administered
celecoxib with caution. Consider starting treatment at half the lowest recommended
dose in poor metabolizers. Consider using alternative management in JRA
patients who are poor metabolizers. (see Use in Specific populations,
and Clinical Pharmacology).