APO-MELOXICAM

What it is

APO-MELOXICAM is a non-steroidal anti-inflammatory drug (NSAID) of the enolic acid class, which has shown anti-inflammatory, analgesic and antipyretic properties. APO-MELOXICAM is available as 7.5 mg and 15 mg capsules. The medicine works by inhibiting the biosynthesis of prostaglandins, known mediators of inflammation, through inhibition of cyclooxygenase (COX).

Approved indications —

Symptomatic treatment of osteoarthritis — Symptomatic treatment of rheumatoid arthritis

Dosing overview

APO-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, such as a history of gastrointestinal disease or risk factors for cardiovascular disease, treatment should be started at 7.5 mg/day and increased to 15 mg/day only if clinically justified. The dose in patients with end-stage renal failure on haemodialysis should not exceed 7.5 mg/day.

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 GI events. The consequences of such events are generally more serious in the elderly. Patients with a 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 with neither of these factors. All NSAIDs may cause an increased risk of serious cardiovascular thrombotic events including myocardial infarction and stroke. This may increase with dose and duration of use. Patients with cardiovascular disease, history of atherosclerotic cardiovascular disease or risk factors for cardiovascular disease may be at greater risk. Serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis, and Drug Reaction with Eosinophilia with Systemic Symptoms (DRESS) have been reported very rarely in association with the use of NSAIDs. Patients appear to be at highest risk of these reactions early in the course of therapy, with onset occurring in the majority of cases within the first month of treatment. NSAIDs inhibit the synthesis of renal prostaglandins, which play a supportive role in maintaining renal perfusion. In patients whose renal blood flow and blood volume are decreased, administration of an NSAID may precipitate renal decompensation. Patients at greatest risk include 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. Borderline elevations of one or more liver tests may occur in up to 15% of patients taking NSAIDs. These laboratory values may progress, remain unchanged or be transient with continuing therapy. Notable elevations of ALT or AST have been reported in approximately 1% of patients in clinical trials.

Contraindications

APO-MELOXICAM is contraindicated in: peri-operative treatment of pain in patients undergoing coronary artery bypass graft surgery (CABG); known hypersensitivity to meloxicam or any excipients; signs/symptoms of asthma, nasal polyps, angioedema or urticaria following administration of aspirin or other 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 of age; breastfeeding; concomitant administration of drugs known to inhibit CYP 2C9; rare hereditary galactose intolerance due to lactose content; and recent cerebrovascular bleeding or established systemic bleeding disorders.

PBS listing

Information regarding PBS listing status for APO-MELOXICAM is not available in the provided source documents.

Regulatory history

APO-MELOXICAM 15 mg capsule was first listed on the ARTG on 18 October 2011, and APO-MELOXICAM 7.5 mg capsule was first listed on 20 October 2011.