MELOXICAM-WGR

What it is

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

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, with a maximum recommended daily dose of 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. In patients with end-stage renal failure on haemodialysis, the dose should not exceed 7.5 mg/day.

Key safety warnings

Gastrointestinal bleeding, ulceration or perforation can occur at any time during treatment with meloxicam, with or without warning symptoms, and consequences are generally more serious in the elderly. Patients with prior history of ulcer disease and/or gastrointestinal bleeding who use NSAIDs have a greater than 10-fold higher risk of developing a gastrointestinal bleed than patients without these factors. In clinical trials, meloxicam has been shown to cause fewer gastrointestinal adverse events than other NSAIDs with which it has been compared. All NSAIDs may cause increased risk of serious cardiovascular thrombotic events including myocardial infarction and stroke, and this risk may increase with dose and duration of use. To minimise potential cardiovascular risk, the lowest effective dose should be used for the shortest possible duration, especially in patients with cardiovascular risk factors. Serious skin reactions, some fatal, including exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis and Drug Reaction with Eosinophilia with Systemic Symptoms (DRESS) have been reported very rarely, with patients at highest risk early in the course of therapy within the first month of treatment. NSAIDs inhibit renal prostaglandin synthesis; in patients whose renal blood flow and blood volume are decreased, meloxicam may precipitate overt renal decompensation, with greatest risk in elderly individuals, dehydrated patients, those with congestive heart failure, liver cirrhosis, nephrotic syndrome and overt renal disease, and those receiving diuretics or ACE inhibitors.

Contraindications

Meloxicam-WGR is contraindicated in peri-operative pain treatment during coronary artery bypass graft surgery, known hypersensitivity to meloxicam or excipients, aspirin triad symptoms following aspirin or NSAIDs, active gastrointestinal ulceration or perforation, active inflammatory bowel disease, severe hepatic insufficiency, non-dialysed severe renal insufficiency, severe uncontrolled heart failure, children and adolescents under 18 years, breastfeeding, concomitant use of CYP 2C9 inhibitors, rare hereditary galactose intolerance due to lactose content, and recent cerebrovascular bleeding or established systemic bleeding disorders.

PBS listing

Information regarding PBS listing status, item numbers, restriction types and ex-manufacturer pricing for Meloxicam-WGR is not available in the provided sources.

Regulatory history

Meloxicam-WGR 7.5 mg and 15 mg capsules were first listed on the Australian Register of Therapeutic Goods on 23 September 2015 (ARTG 232580 and 232581). Meloxicam-WGR 7.5 mg and 15 mg tablets were subsequently registered on 7 October 2022 (ARTG 389371 and 389372).