Recommended Dose: Celecoxib capsules, at doses up to 200 mg twice per day, can be taken with or without food.
As the cardiovascular (CV) risks of celecoxib may increase with dose and duration of exposure, the shortest duration possible and the lowest effective daily dose should be used.
Symptomatic Treatment of Osteoarthritis (OA): The usual recommended dose of celecoxib is 200 mg administered as a single dose. In some patients, with insufficient relief from symptoms, an increased dose of 200 mg twice daily may increase efficacy. In the absence of an increase in therapeutic benefit after 2 weeks, other therapeutic options should be considered.
Symptomatic treatment of Rheumatoid Arthritis (RA): The recommended dose of celecoxib is 200 mg twice per day.
Ankylosing Spondylitis (AS): The recommended dose of celecoxib is 200 mg administered as a single dose. Some patients may benefit from a total daily dose of 400 mg.
Management of Acute Pain: The recommended dose of celecoxib 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 or 400 mg once daily as needed.
Treatment of Primary Dysmenorrhea: The recommended dose of celecoxib 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 or 400 mg once daily as needed.
Low Back Pain (LBP): The recommended dose of celecoxib is 200 mg or 400 mg daily, administered as a 200 mg single dose, or as 100 or 200 mg twice per day. Some patients may benefit from a total daily dose of 400 mg.
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 Interactions and Pharmacology: Pharmacokinetics under Actions).
Pediatric Patients: Celecoxib has not been studied in subjects under 18 years of age.
Elderly: 200 mg: As in younger adults, 200 mg per day should be used initially. The dose may, if needed, later be increased to 200 mg twice daily. Particular caution should be exercised in elderly with a body weight less than 50 kg (see Precautions and Pharmacology: Pharmacokinetics under Actions).
400 mg: No dosage adjustment is generally necessary. However, for elderly patients weighing lower than 50 kg, it is advisable to initiate therapy at the lowest recommended dose.
Hepatic Impairment: 200 mg: Treatment should be initiated at half the recommended dose in patients with established moderate liver impairment with a serum albumin of 25-35 g/l. Experience in such patients is limited to cirrhotic patients (see Contraindications, Precautions and Pharmacology: Pharmacokinetics under Actions).
400 mg: No dosage adjustment is necessary in patients with mild hepatic impairment (Child-Pugh Class A). Introduce celecoxib at half the recommended dose in arthritis or pain patients with moderate hepatic impairment (Child-Pugh Class B).
Patients with severe hepatic impairment (Child-Pugh Class C) have not been studied.
Renal Impairment: 200 mg: Experience with celecoxib in patients with mild or moderate renal impairment is limited, therefore such patients should be treated with caution (see Contraindications, Precautions and Pharmacology: Pharmacokinetics under Actions).
400 mg: No dosage adjustment is necessary in patients with mild or moderate renal impairment. There is no clinical experience in patients with severe renal impairment.
Co-administration with Fluconazole: 400 mg: Celecoxib should be introduced at half the recommended dose in patients receiving fluconazole, a CYP2C9 inhibitor. Caution is advised when co-administering celecoxib with other CYP2C9 inhibitors.
Mode of Administration: Oral.
Celecoxib may be taken with or without food. 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 240 ml of water. The sprinkled capsule contents on applesauce, rice gruel or yogurt are stable for up to 6 hours under refrigerated conditions (2-8°C). The sprinkled capsule contents on mashed banana should not be stored under refrigerated conditions and should be ingested immediately.
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