CELECOXIB

What it is

Celecoxib GH is a medicine containing celecoxib in 100 mg or 200 mg capsule strengths. Celecoxib is a cyclooxygenase-2 (COX-2) specific inhibitor that exhibits anti-inflammatory, analgesic, and antipyretic activities, and at therapeutic concentrations in humans does not inhibit cyclooxygenase-1 (COX-1). The mechanism of action is believed to be due to inhibition of prostaglandin synthesis, primarily by inhibition of COX-2.

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

The shortest duration possible and the lowest effective daily dose should be used, as the cardiovascular risks of celecoxib may increase with dose and duration of exposure.

Key safety warnings

**Cardiovascular thrombotic events.** COX-2 inhibitors, including celecoxib, have been associated with an increased risk of serious cardiovascular thrombotic adverse events, myocardial infarction, and stroke, which can be fatal. This risk may increase with dose and duration of use. To minimise the potential risk for an adverse cardiovascular event in patients treated with celecoxib, the lowest effective dose should be used for the shortest duration possible. **Gastrointestinal effects.** Infrequently, serious gastrointestinal toxicity such as bleeding, ulceration, and upper and lower gastrointestinal perforation has been observed in patients treated with celecoxib, though celecoxib exhibited a low incidence of gastroduodenal ulceration and serious clinically significant gastrointestinal events within clinical trials. 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, and Celecoxib GH should be prescribed with extreme caution in these patients. **Serious skin reactions.** 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, and celecoxib should be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity. **Hepatic effects.** Borderline elevations of liver tests may occur in up to 15% of patients taking NSAIDs, and rare cases of severe hepatic reactions, including jaundice, fatal fulminant hepatitis, liver necrosis and hepatic failure, have been reported with NSAIDs, including celecoxib. **Renal effects.** Long-term administration of NSAIDs has resulted in renal papillary necrosis and other renal injury, and in patients in whom renal prostaglandins have a compensatory role in the maintenance of renal perfusion, administration of an NSAID may cause a dose-dependent reduction in prostaglandin formation and, secondarily, in renal blood flow, which may precipitate overt renal decompensation.

Contraindications

Celecoxib is contraindicated in patients with known hypersensitivity to celecoxib or any of the excipients, or in those 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 NSAIDs, including other COX-2 specific inhibitors. Celecoxib should not be used with other NSAIDs 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 (CABG) surgery. Celecoxib is also contraindicated in patients with unstable ischaemic heart disease of thrombus aetiology or documented myocardial infarction or stroke within 3 months, active peptic ulceration or gastrointestinal bleeding, severe renal impairment (estimated creatinine clearance <30 mL/min), congestive heart failure (NYHA II-IV), or severe hepatic impairment (Child-Pugh score ≥ 10).

PBS listing

Information on the PBS listing for Celecoxib GH is not available in the provided documents.

Regulatory history

Celecoxib GH celecoxib 100 mg capsules and 200 mg capsules were first listed on the Australian Register of Therapeutic Goods on 13 June 2013.