Each capsule contains: Celecoxib 200 mg.
Pharmacology: Pharmacokinetics: Celecoxib is absorbed from the gastrointestinal tract, peak plasma concentrations being achieved after about 3 hours. Protein binding is about 97%. Celecoxib is metabolised in the liver mainly by the cytochrome P450 isoenzyme CYP2C9; the three identified metabolites are inactive as inhibitors of COX-1 or COX-2 enzymes. It is eliminated mainly as metabolites in the faeces and urine; less than 3% is recovered as unchanged drug. The effective terminal half-life is about 11 hours.
Used for the relief of the signs and symptoms of osteoarthritis and rheumatoid arthritis in adults. It is also used as an adjunct for reduction of number of adenomatous colorectal polyps in familial polyposis, also used in the management of acute pain and dysmenorrhea.
For osteoarthritis the recommended oral dose is 200 mg daily given as a single dose or in 2 divided doses. If necessary a dose of 200 mg twice daily may be used.
For rheumatoid arthritis the dose is 100 to 200 mg given twice daily. Celecoxib is also used for ankylosing spondylitis in an initial dose of 200 mg daily, as a single dose or in 2 divided doses.
In the treatment of pain and dysmenorrhoea, an initial dose of 400 mg followed by an additional dose of 200 mg, if necessary, is recommended on the first day; thereafter the dose is 200 mg twice daily. Or as prescribed by the physician.
Not to be given to those patients who have history of: Stroke: Cerebrovascular accident (CVA).
Heart attack: Myocardial infarction (MI).
Coronary artery bypass graft (CABG).
Congestive heart failure (CHF) NYHA II-IV.
Celecoxib should not be used after coronary artery bypass surgery as there may be an increased risk of adverse effects such as myocardial infarction and stroke. It should be used with caution, if at all, in patients with a history of ischaemic heart disease, peripheral arterial disease, or cerebrovascular disease; it should also be used with caution in patients with significant risk factors for cardiovascular disease such as hypertension, hyperlipidaemia, and diabetes mellitus.
The metabolism of celecoxib is mediated mainly by the cytochrome P450 isoenzyme CYP2C9. Use with other drugs that inhibit or induce or are metabolised by this isoenzyme may result in changes in plasma concentration of celecoxib; fluconazole has increased plasma concentrations of celecoxib and licensed product information recommends that the dose of celecoxib should be halved when given with fluconazole. Celecoxib is an inhibitor of the isoenzyme CYP2D6 and the potential therefore exists for an effect on drugs metabolised by this enzyme.
Store at temperatures not exceeding 30°C.
M01AH01 - celecoxib ; Belongs to the class of non-steroidal antiinflammatory and antirheumatic products, coxibs.