APO-PIROXICAM

What it is

Piroxicam is the active ingredient in APO-PIROXICAM. Piroxicam is a non-steroidal anti-inflammatory drug (NSAID) which also possesses analgesic and antipyretic properties. APO-PIROXICAM is available as 10 mg and 20 mg capsules.

Approved indications

— Symptomatic treatment of rheumatoid arthritis — Symptomatic treatment of osteoarthritis — Symptomatic treatment of ankylosing spondylitis

Dosing overview

The optimal response generally has been achieved at a daily dose of 20 mg, given as a single dose. The recommended starting dose is 10 mg and administration of doses higher than 20 mg daily carries an increased risk of adverse effects and is not recommended. After assessing the risk versus benefit for each patient, use the minimum effective dose for the shortest duration possible. The duration of treatment should preferably be limited to 14 days. If continued treatment is considered necessary, this should be accompanied by evaluation at 14 days and subsequent frequent review with regards to efficacy, risk factors and ongoing need for treatment.

Key safety warnings

Evidence from observational studies suggests that piroxicam may be associated with a high risk of serious gastrointestinal toxicity, relative to other NSAIDs. Piroxicam should only be commenced after careful weighing of the risks and benefits in each individual patient. NSAIDs, including piroxicam, can cause serious, potentially fatal gastrointestinal (GI) toxicity, including inflammation, bleeding, ulceration, and perforation of the stomach, small intestine, or large intestine. GI toxicity can occur at any time, with or without warning symptoms, in patients treated chronically with NSAID therapy. The frequency of such events may increase with dose or duration of use. In patients observed in clinical trials of several months to two years duration, symptomatic upper GI ulcers, gross bleeding or perforation appear to occur in approximately 1% of patients treated for 3–6 months, and in about 2–4% of patients treated for one year. NSAIDs may cause an increased risk of serious cardiovascular (CV) thrombotic events, myocardial infarction and stroke, which can be fatal. This risk may increase with dose or duration of use. NSAIDs, including piroxicam, may lead to the onset of new hypertension or worsening of pre-existing hypertension. Evidence from observational studies suggests that piroxicam may be associated with a higher risk of severe cutaneous adverse reactions than other non-oxicam NSAIDs. Patients appear to be at highest risk of these reactions early in the course of therapy, the onset of the reaction occurring in the majority of cases within the first month of treatment. Piroxicam should be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity.

Contraindications

Piroxicam should not be administered to patients with active peptic ulcerations, active gastrointestinal ulceration, bleeding or perforation, active inflammatory disease of the gastrointestinal tract or with a history of these conditions. Piroxicam should not be used in those patients who have previously shown a hypersensitivity to the drug or in whom a hypersensitive reaction(s) (e.g. asthma, nasal polyps, angioedema or urticaria) has been precipitated by aspirin or other non-steroidal anti-inflammatory drugs (NSAIDs) since cross-sensitivity exists. Piroxicam should not be administered to patients with a history of previous severe allergic drug reaction of any type, especially cutaneous reactions such as erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, or those who have exhibited a previous skin reaction (regardless of severity) to piroxicam. Piroxicam is contraindicated in patients in their third trimester of pregnancy or are breastfeeding. Piroxicam is contraindicated in the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery. Piroxicam is contraindicated in patients with severe renal failure. Piroxicam is contraindicated in patients with severe hepatic impairment. Piroxicam is contraindicated in patients with severe heart failure. Piroxicam should not be administered concomitantly with other NSAIDs, including cyclooxygenase-2 (COX-2) selective NSAIDs and aspirin at analgesic doses.

PBS listing

APO-PIROXICAM 20 mg capsules are listed on the PBS with 2 items at restricted access, with an ex-manufacturer price of A$2.96. APO-PIROXICAM 10 mg capsules are listed on the PBS with 2 items at restricted access, with an ex-manufacturer price of A$4.15.

Regulatory history

APO-PIROXICAM 10 mg and 20 mg capsules were first listed on the Australian Register of Therapeutic Goods on 30 August 2000.