Full Prescribing Info
Each hard gelatin 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 faeces and urine; less than 3% is recovered as unchanged drug. The effective terminal half-life is about 11 hours.
Used in the treatment of rheumatoid arthritis, osteoarthritis, and ankylosing spondylitis, and in the adjunctive treatment of adenomatous colorectal polyps. Also used in the management of acute pain and dysmenorrhea.
Dosage/Direction for Use
For osteoarthritis the recommended dose is 200 mg daily given by mouth as a single dose or in two divided doses. If necessary, dose of 200 mg twice daily may be used. For rheumatoid arthritis, the dose is 100 to 200 mg given twice daily. In elderly patients treatment should begin at the lowest recommended dose. Ankylosing spondylitis the initial dose is 200 mg daily as a single dose or in 2 divided doses. If necessary, the dose may be increased to 400 mg daily after 6 weeks, although if no response is seen at this dose after a further 6 weeks, alternative treatments should be considered. In treatment of pain and dysmenorrhea, 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. Celecoxib is also used as an adjunct to standard therapy to reduce the number of adenomatous colorectal polyps in patients with familial adenomatous polyposis. For this purpose, it may be given in doses of 400 mg twice daily with food. Or as prescribed by the physician.
Celecoxib is contraindicated in patients with known hypersensitivity to Celecoxib.
Cardiovascular Risk: Celecoxib may cause an increased risk of serious cardiovascular thrombotic event, myocardial infarction and stroke which can be fatal. This may increase with duration of use. Patients with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk. (See Precautions.)
Celecoxib is contraindicated for the treatment of perioperative pain in the setting of coronary artery bypass graft (CABG) surgery.
Gastrointestinal Risk: Celecoxib causes an increased risk of serious gastrointestinal adverse events including bleeding, ulceration and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients are at greater risk for serious gastrointestinal events.
COX-2 inhibitors are not given in patients with allergy to NSAIDs and those with asthma.
Exercise caution when prescribing Selective COX-2 inhibitors in patients with ischemic heart disease and those with risk factors for heart disease, hypertension, hyperlipidemia, diabetes, smoking and patients with peripheral arterial disease.
Considering association between cardiovascular risk and exposure to COX-2 inhibitors, doctors are advised to use the lowest effective dose for the shortest duration of treatment.
Intake of COX-2 inhibitors should be stopped with appearance of skin rash and signs of hypersensitivity.
Special Precautions
Celecoxib should be used with caution in patients with a history of ischaemic heart disease or cerebrovascular disease. It should be used with caution in patients with significant risk factors for cardiovascular disease or peripheral arterial disease. Caution is recommended when using Celecoxib in dehydrated patients.
Adverse Reactions
As for NSAID's in general, serious skin reactions such as exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis have been frequently reported with Celecoxib. Other hypersensitivity reactions including anaphylaxis and angioedema, have also occurred.
The most frequently reported adverse effects of Celecoxib are gastrointestinal disturbances, especially diarrhea.
Drug Interactions
Absorption of Celecoxib is decreased by antacids or histamines H2-receptor antagonists. Probenecid reduces the renal excretion of Celecoxib.
Store at temperatures not exceeding 30°C.
MIMS Class
Nonsteroidal Anti-Inflammatory Drugs (NSAIDs)
ATC Classification
M01AH01 - celecoxib ; Belongs to the class of non-steroidal antiinflammatory and antirheumatic products, coxibs.
Cap 200 mg x 100's.
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