CELOX-R Capsule

1. For the relief of pain and inflammation of osteoarthritis.

2. For the relief of pain and inflammation of rheumatoid arthritis

3. To reduce the number of adenomatous colorectal polyps in familial adenomatous polyposis (FAP); as an adjunct to usual care (e.g. endoscopic surveillance, surgery).

Dosage and administration

Osteoarthritis: 200mg/day as a single dose or 100mg twice daily.

Rheumatoid arthritis: 100-200mg twice daily.

Familial adenomatous polyposis: To reduce the umber of adenomatous colorectal polyps in patients with FAP, the recommended oral dose is 400mg (2200mg capsules) twice daily to be taken with food.

In patients with known hypersensitivity to celecoxib.

To patients who have demonstrated allergic-type reactions to sulfonamides.

To patients who have demonstrated asthma, urticaria or allergic-type reaction after taking aspirin or other NSAIDs.

Gastrointestinal side effects include abdominal discomfort, diarrhea, dyspepsia, flatulence and nausea.

Central nervous system side effects include dizziness, headache and insomnia.

Other side effects include upper respiratory tract infections, skin rash, back pain and peripheral oedema.

See the package insert about the details below:

- fluconazole

- lithium

- furosemide

- ACE inhibitors

- aspirin

- warfarin

See the package insert about the details below:

Pregnancy

Celecoxib should be used during pregnancy only if the potential benefit justifies the potential risk of the fetus.

In late pregnancy (third trimester), celecoxib should be avoided because it may cause premature closure of the ductus arteriosus.

Lactation

It is not known whether celecoxib is excreted in human milk.

A decision should be made whether to discontinue the drug, taking into account the importance of the drug to the mother.

PRECAUTION IN DRUG ADMINISTRATION

Celox-R, at doses up to 200mg bid, can be administered without regard to timing of meal. Higher doses (400mg bid) should be administered with food.

Co-administration of Celox-R with an aluminum and magnesium containing antacid should be avoided because they may reduce absorption of celecoxib.

PRECAUTION IN PATIENTS WITH CV DISEASES

COX-2 selective inhibitors to be avoided in patients having ischaemic disease or cardiovascular disease.

PRECAUTION IN PATIENTS WITH CORTICOSTEROID THERAPY

Celox-R cannot be expected to substitute for corticosteroids or to treat corticosteroid insufficiency. Patients on prolonged corticosteroid therapy should have their therapy tapered slowly if a decision is made to discontinue corticosteroids.

USE IN SPECIAL POPULATION (see the package insert about the details.)

Paediatric and Children: Aspirin or other NSAIDs cannot be given in patients with any type of viral infections, especially in children.

Celecoxib is a selective cyclooxygenase-2 (COX-2) inhibitor, nonsteroidal anti-inflammatory drug (NSAID). It exhibits anti-inflammatory, analgesic and antipyretic activities. The mechanism of action is believed to be due to the inhibition of COX-2 enzyme. At therapeutic concentration, celecoxib does not inhibit COX-1 isoenzyme.