The Cathay Drug Co., Inc.
Each hard gelatin capsule contains:
Celecoxib …………………………………200 mg
Celecoxib is absorbed from the gastrointestinal tract, peak plasma concentrations being achieved after about 3 hours. Protein binding is about 97%. Celecoxib is metabolized 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 metabolite in feces and urine; less than 3% is recovered as unchanged drug. The effective terminal half-life is about 11 hours.
It is used in the treatment of rheumatoid 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 dysmenorrhea.
DOSAGE AND ADMINISTRATION
For 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 a day after 6 weeks, although if no response is seen at this dose after a further 6 weeks, alternative treatments should be considered.
For rheumatoid arthritis, the dose is 100 to 200 mg twice daily. In elderly patients treatment should begin at the lowest recommended dose.
For osteoarthritis, the recommended dose is 200 mg a day given by mouth as a single dose or 2 divided doses. If necessary, dose of 200 mg twice daily may be used.
In the 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 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.
Known hypersensitivity to celecoxib, sulfonamides, or any ingredient in the formulation.
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/min/
Celecoxib should also not be used in patients with severe hepatic impairment (Child-Pugh category C).
Celecoxib treatment may need to be stopped if signs or symptoms of organ toxicity develop.
As for NSAIDs 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.
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.
Celecoxib is contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery.
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 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 asthma
- 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
Celecoxib should be used in caution in patients with a history of ischemic 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.
Absorption of Celecoxib is decreased by antacids or histamines H2 receptor antagonists. Probenecid reduces the renal excretion of Celecoxib.
Alu-Pvc Blister Pack of 10’s (Box of 30’s)
Store at temperatures not exceeding 30°C. Protect from light.
KEEP OUT OF REACH OR CHILDREN.
Endurance Healthcare Ltd.
823, Devpath, B/h. Lal Bunglow,
Ellisbridge, Ahmedabad-6, India
The Cathay Drug Co., Inc.
2/F Vernida I Condominium
120 Amorsolo St. Legaspi Village, Makati City
Date of revision: January 2014