APX-MELOXICAM

What it is

APX-MELOXICAM is available as capsules containing either 7.5 mg or 15 mg of meloxicam. Meloxicam is a non-steroidal anti-inflammatory drug of the enolic acid class, which has shown anti-inflammatory, analgesic and antipyretic properties.

Approved indications —

Symptomatic treatment of osteoarthritis — Symptomatic treatment of rheumatoid arthritis

Dosing overview

Meloxicam should be used at the lowest dose and for the shortest duration consistent with effective treatment. The maximum recommended daily dose is 15 mg. In patients with increased risks of adverse reactions, treatment should be started at 7.5 mg/day and increased to 15 mg/day only if clinically justified.

Key safety warnings

Gastrointestinal bleeding, ulceration or perforation can occur at any time during treatment, with or without warning symptoms or a previous history of serious gastrointestinal events. The consequences of such events are generally more serious in the elderly. In clinical trials, meloxicam has been shown to cause fewer gastrointestinal adverse events than other NSAIDs with which it has been compared. Long-term therapy with some cyclooxygenase-2 selective NSAIDs has been shown to increase the risk of serious cardiovascular thrombotic events. Meloxicam is a COX-2 selective NSAID. All NSAIDs may cause an increased risk of serious cardiovascular thrombotic events including myocardial infarction and stroke, with risk increasing with dose and duration of use. To minimise the potential risk of an adverse cardiovascular event, the lowest effective dose should be used for the shortest possible duration. Serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis, and Drug Reaction with Eosinophilia with Systemic Symptoms have been reported very rarely. Patients appear to be at highest risk early in the course of therapy, with the onset occurring in the majority of cases within the first month of treatment. NSAIDs inhibit the synthesis of renal prostaglandins. In patients whose renal blood flow and blood volume are decreased, an NSAID may precipitate overt renal decompensation. Patients at greatest risk are elderly individuals, dehydrated patients, those with congestive heart failure, liver cirrhosis, nephrotic syndrome and overt renal disease, and those receiving concomitant treatment with a diuretic, ACE inhibitor or angiotensin II receptor antagonist.

Contraindications

Peri-operative treatment of pain in patients undergoing coronary artery bypass graft surgery, known hypersensitivity to meloxicam or any excipients, and signs or symptoms of asthma, nasal polyps, angioedema or urticaria following the administration of aspirin or other NSAIDs are contraindications. Active gastrointestinal ulceration or perforation, active inflammatory bowel disease, severe hepatic insufficiency, non-dialysed severe renal insufficiency, severe uncontrolled heart failure, and children and adolescents under 18 years of age are contraindications. Breastfeeding and concomitant administration of drugs known to inhibit CYP 2C9 are contraindications. Meloxicam is contraindicated in patients with rare hereditary galactose intolerance, due to the lactose content. Meloxicam is contraindicated in patients with recent cerebrovascular bleeding or established systemic bleeding disorders.

Regulatory history

APX-MELOXICAM 7.5 mg and 15 mg tablet blister packs were first listed on the Australian Register of Therapeutic Goods on 18 October 2017.