Carefully consider the potential benefits and risks of CELEBREX and other treatment options before deciding to use CELEBREX. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).
For osteoarthritis and rheumatoid arthritis, the lowest dose of CELEBREX should be sought for each patient. These doses can be given without regard to timing of meals.
Osteoarthritis: For relief of the signs and symptoms of osteoarthritis the recommended oral dose is 200 mg per day administered as a single dose or as 100 mg twice per day.
Rheumatoid Arthritis: For relief of the signs and symptoms of rheumatoid arthritis the recommended oral dose is 100 to 200 mg twice per day.
Ankylosing Spondylitis (AS): The recommended dose of celecoxib is 200 mg administered as a single dose or as 100 mg twice per day. Some patients may benefit from a total daily dose of 400 mg.
Management of Acute Pain: The recommended dose 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 maximum 7 days.
Method of Administration: For patients who have difficulty swallowing capsules, the contents of a celecoxib capsule can be added to applesauce, rice gruel, yogurt or mashed banana. To do so, the entire capsule contents must be carefully emptied onto a level teaspoon of cool or room temperature applesauce, rice gruel, yogurt or mashed banana and should be ingested immediately with water. The sprinkled capsule contents on applesauce, rice gruel or yogurt are stable for up to 6 hours under refrigerated conditions (2°C-8°C/35°F-45°F). The sprinkled capsule contents on mashed banana should not be stored under refrigerated conditions and should be ingested immediately.
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 approximately 50%. The use of CELEBREX in patients with severe hepatic impairment is not recommended (see Pharmacology: Special Populations under Actions).
CYP2C9 Poor Metabolizers: Patients who are known, or suspected to be CYP2C9 poor metabolizers based on previous history/experience with other CYP2C9 substrates should be administered celecoxib with caution. Consider starting treatment at half the lowest recommended dose (see Pharmacology: Pharmacokinetics: Metabolism under Actions and Interactions).
Renal Impairment: There is no clinical experience in patients with severe renal impairment (see WARNINGS).