BEA-COXIB CAPSULE 200MG

BEACONS PHARMACEUTICALS PTE. LTD.

BEACONS PHARMACEUTICALS PTE. LTD.

Therapeutic

Prescription Only

CAPSULE

**4.2 Posology and method of administration** Posology Celecoxib capsules, at doses up to 200 mg twice per day, can be taken with or without food. 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. _Osteoarthritis_ The usual recommended daily dose is 200 mg taken once daily or as 100 mg twice per day. _Rheumatoid Arthritis_ The initial recommended daily dose is 100 mg twice per day. The dose may be increased to 200 mg twice per day if needed. _Ankylosing Spondylitis_ The recommended daily dose is 200 mg administered as a single dose or as 100 mg twice per day. The maximum recommended daily dose for the above indications is 400 mg for all indications. _Acute Pain in Adults_ The initial recommended dose is 400 mg followed by an additional 200mg dose if needed. On subsequent days, the recommended dose is 200mg twice daily as needed. _Chronic Low Back Pain in Adults_ The recommended dose of celecoxib is 200 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. _Primary Dysmenorrhea_ The recommended dose of celecoxib is 400 mg, followed by an additional 200 mg if needed. On subsequent days, the recommended dose is 200 mg twice daily, as needed. Special populations _Elderly (>65 years)_ No dosage adjustment is generally necessary. However, for elderly patients weighing less than 50 kg, it is advisable to initiate therapy at the lowest recommended dose. _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 established moderate liver impairment with a serum albumin of 25–35 g/l or Child-Pugh Class B. Patients with severe hepatic impairment (Child-Pugh Class C) have not been studied (see section 4.4 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). Use in patients with severe hepatic impairment (Child-Pugh Class C) is not recommended. _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 section 4.4 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). Use of celecoxib in patients with severe renal impairment is not recommended. _Co-administration with Fluconazole_ Celecoxib should be introduced at half the recommended dose in patients receiving fluconazole, a CYP2C9 inhibitor. Caution is advised if co-administration of celecoxib with other CYP2C9 inhibitors is required (see section 4.5 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). _CYP2C9 Poor Metabolisers_ Patients who are known, or suspected to be CYP2C9 poor metabolisers 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 starting treatment at half the lowest recommended dose (see section 5.2 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). _Paediatric population_ Celecoxib is not indicated for use in children. The safety and efficacy of Bea-coxib in children has not been established. No data are available. Method of administration Oral use. Bea-Coxib Capsule 200mg may be taken with or without food.