Each capsule contains: Celecoxib BP 200 mg.
Excipients q.s.
Approved colour used in EHG capsule shell.
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. Celecoxib is distributed into breast milk. The pharmacokinetics of celecoxib may vary in different ethnic groups; it has been stated that the area under the curve is elevated in patients of Afro-Caribbean origin, although any clinical significance is unclear.
Used in the treatment of rheumatoid arthritis including juvenile idiopathic arthritis, osteoarthritis, and ankylosing spondylitis, and in the adjunctive treatment of adenomatous colorectal polyps. Celecoxib is also used in the management of acute pain and dysmenorrhoea.
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 elderly patients treatment should be begun at the lowest recommended dose.
For doses in children with juvenile idiopathic arthritis (aged 2 years and over), the recommended oral doses based on body weight are: 10 kg to 25 kg: 50 mg twice daily; Over 25 kg: 100 mg twice daily.
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.
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. Reduced doses are recommended in patients with hepatic impairment.
Not to be given to those patients who have history of: Stroke cerebrovascular accident (CVA); Heart attack: MI, coronary artery bypass graft (CABG); Uncontrolled hypertension; Congestive Heart Failure (CHF) NYHA II to IV.
COX-2 inhibitors are not to be given to 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.
If not yet instituted, warning statement should include potential gastrointestinal (gastric and liver) and renal toxicities.
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, hyperlipidemia, and diabetes mellitus.
Therapy is contraindicated in patients with moderate to severe heart failure (NYHA class II to IV), inflammatory bowel disease, and renal impairment associated with a creatinine clearance of less than 30 mL/minute.
Celecoxib should also not be used in patients with severe hepatic impairment (Child-Pugh category C). Caution is recommended when using celecoxib in dehydrated patients; rehydration may be advisable before giving celecoxib. Celecoxib treatment may need to be stopped if signs or symptoms of organ toxicity develop.
Serious skin reactions such as exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis have been reported with celecoxib. Other hypersensitivity reactions, including anaphylaxis and angioedema, have also occurred. Celecoxib should be stopped at the first signs of hypersensitivity. Some of these reactions have been seen in patients with a history of allergic reactions to sulfonamides and the use of celecoxib is contraindicated in such patients.
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.
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.
Shelf life: 36 months.
M01AH01 - celecoxib ; Belongs to the class of non-steroidal antiinflammatory and antirheumatic products, coxibs.
Icox cap 200 mg
100's (P2,625/box, P26.25/cap)
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