CELEBREX

What it is

CELEBREX contains celecoxib. It is available as 100 mg and 200 mg capsules.

Approved indications

— Symptomatic treatment of osteoarthritis, rheumatoid arthritis and ankylosing spondylitis. — Treatment of primary dysmenorrhoea in adults. — Short-term treatment of acute pain in adults following surgery or musculoskeletal and/or soft tissue injury.

Dosing overview

As the cardiovascular risks of celecoxib may increase with dose and duration of exposure, the shortest duration possible and the lowest effective daily dose should be used. Doses can be given without regard to timing of meals.

Key safety warnings

COX-2 inhibitors have been associated with an increased risk of serious cardiovascular and thrombotic adverse events, myocardial infarction, and stroke, which can be fatal. This risk may increase with duration of use, and patients with cardiovascular disease or cardiovascular risk factors may be at greater risk in terms of absolute incidence. Celecoxib should be used with caution in patients with significant established ischaemic heart disease, peripheral arterial disease and/or cerebrovascular disease as well as patients at high risk of cardiovascular disease including those with significant and multiple risk factors such as diabetes, hypertension, hypercholesterolaemia, cardiac failure and smokers. Infrequently, serious gastrointestinal toxicity such as bleeding, ulceration, and upper and lower gastrointestinal perforation has been observed in patients treated with celecoxib. Patients most at risk of developing gastrointestinal complications with NSAIDs are elderly patients; patients with cardiovascular disease; patients using concomitant antiplatelet drugs such as aspirin or corticosteroids; patients who consume alcohol; or patients with a prior history of gastrointestinal disease. Celecoxib should be prescribed with extreme caution in these patients. Serious skin reactions, some of them fatal, including drug reaction with eosinophilia and systemic symptoms (DRESS syndrome), exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis, have been reported very rarely in association with the use of celecoxib. Patients appear to be at highest risk for these events early in the course of therapy, with the onset occurring in the majority of cases within the first month of treatment. Celecoxib should be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity. Celecoxib can lead to the onset of new hypertension or worsening of pre-existing hypertension, either of which may contribute to the increased incidence of cardiovascular events. NSAIDs, including celecoxib, should be used with caution in patients with hypertension.

Contraindications

Celecoxib is contraindicated in patients with known hypersensitivity to celecoxib or any of the excipients contained in the capsules. It is contraindicated in patients with demonstrated allergic-type reactions to sulfonamides. Celecoxib should not be given to patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other non-steroidal anti-inflammatory drugs, including other COX-2 specific inhibitors, as severe, rarely fatal, anaphylactoid reactions have been reported in such patients. Celecoxib should not be used with other non-steroidal anti-inflammatory drugs because of the absence of any evidence demonstrating synergistic benefits and the potential for additive adverse reactions. Celecoxib is contraindicated for the peri-operative treatment of pain in patients undergoing coronary artery bypass graft surgery. Celecoxib is contraindicated in patients with unstable ischaemic heart disease of thrombus aetiology or documented myocardial infarction or stroke within 3 months. It is contraindicated in patients with active peptic ulceration or gastrointestinal bleeding. Celecoxib is contraindicated in patients with estimated creatinine clearance less than 30 mL/min. It is contraindicated in patients with congestive heart failure (NYHA II–IV). Celecoxib is contraindicated in patients with severe hepatic impairment (Child-Pugh score ≥10).

PBS listing

CELEBREX 100 mg capsule is listed on the PBS with one item and a restriction type of restricted, at an ex-manufacturer price of A$4.00. CELEBREX 200 mg capsule is listed on the PBS with one item and a restriction type of restricted, at an ex-manufacturer price of A$4.00.

Regulatory history

CELEBREX 100 mg capsule was first listed on the ARTG on 25 August 1999. CELEBREX 200 mg capsule was first listed on the ARTG on 25 August 1999.