Posology: As the cardiovascular risks of celecoxib may increase with dose and duration of exposure, the shortest duration possible and the lowest effective daily dose should be used. The patient's need for symptomatic relief and response to therapy should be re-evaluated periodically, especially in patients with osteoarthritis (see Contraindications, Precautions, Adverse Reactions and Pharmacology: Pharmacodynamics under Actions).
Osteoarthritis: The usual recommended daily dose is 200 mg taken once daily. In some patients, with insufficient relief from symptoms, an increased dose of 200 mg twice daily may increase efficacy.
Rheumatoid arthritis: The initial recommended daily dose is 200 mg taken once daily. The dose may, if needed, later be increased to 200 mg twice daily.
Ankylosing Spondylitis: The recommended daily dose is 200 mg taken once daily. In a few patients, with insufficient relief from symptoms, an increased dose of 400 mg once daily or in two divided
doses may increase efficacy.
The maximum recommended daily dose is 400 mg for all indications.
Elderly patients: (>65 years) 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).
Patients with hepatic impairment: No dosage adjustment is necessary in patients with mild hepatic impairment (Child-Pugh Class A). Treatment should be initiated at half the recommended dose in
patients with moderate liver impairment (with serum albumin 25-35 g/L or Child-Pugh Class B.
Patients with severe hepatic impairment (Child-Pugh Class C) have not been studied (see Precautions). The use of celecoxib in this patient population is not recommended.
Patients with renal impairment: No dosage adjustment is necessary in patients with mild or moderate renal impairment. There is no clinical experience in patients with severe renal impairment (see Precautions). The use of celecoxib in this patient population is not recommended.
Paediatric population: Celecoxib is not indicated for use in children under 18 years of age.
CYP2C9 Poor Metabolizers: Patients who are known, or suspected to be CYP2C9 poor metabolizers based on genotyping or previous history/experience with other CYP2C9 substrates should be
administered celecoxib with caution as the risk of dose-dependent adverse effects is increased. Consider reducing the dose to half the lowest recommended dose (see Pharmacology: Pharmacokinetics under Actions).
Method of administration: Oral use.
Capsules should be swallowed whole with a drink of water.
Aclexa may be taken with or without food.