MOXICAM

What it is

Meloxicam is a non-steroidal anti-inflammatory drug (NSAID) of the enolic acid class, which has shown anti-inflammatory, analgesic and antipyretic properties in animals. MOXICAM is available as capsules containing 7.5 mg or 15 mg of meloxicam. The capsules contain lactose monohydrate as an excipient with known effect.

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 of meloxicam is 15 mg. In patients with end-stage renal failure on haemodialysis, the dose should not exceed 7.5 mg/day. No dose reduction is required in patients with mild or moderate renal impairment (creatinine clearance greater than 25 mL/min) nor in patients with mild to moderate hepatic impairment.

Key safety warnings

Gastrointestinal bleeding, ulceration or perforation, potentially fatal, can occur at any time during treatment with or without warning symptoms, with consequences generally more serious in the elderly. Upper gastrointestinal ulcers, gross bleeding or perforation caused by NSAIDs appear to occur in approximately 1% of patients treated for 3–6 months and in about 2–4% of patients treated for one year, with these trends increasing the likelihood of developing serious adverse gastrointestinal events, even during short-term therapy. In clinical trials, meloxicam has been shown to cause fewer gastrointestinal adverse events (including dyspepsia, abdominal pain, nausea and vomiting) than other NSAIDs with which it has been compared. All NSAIDs may cause an increased risk of serious cardiovascular thrombotic events including myocardial infarction and stroke, which may increase with dose and duration of use. To minimise the potential risk of an adverse cardiovascular event in patients taking meloxicam, especially those with cardiovascular risk factors, the lowest effective dose should be used for the shortest possible duration. Serious skin reactions, 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, with patients appearing to be at highest risk early in the course of therapy. Meloxicam should be discontinued at the first appearance of skin rash, mucosal lesions or any other sign of hypersensitivity. NSAIDs inhibit the synthesis of renal prostaglandins, which support renal perfusion, and in patients whose renal blood flow and blood volume are decreased, administration of an NSAID may precipitate overt renal decompensation, which typically recovers upon discontinuation.

Contraindications

Meloxicam is contraindicated in peri-operative treatment of pain in patients undergoing coronary artery bypass graft surgery, in patients with known hypersensitivity to meloxicam or excipients, in those with signs or symptoms of asthma, nasal polyps, angioedema or urticaria following aspirin or other NSAIDs, in 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, during breastfeeding, with concomitant administration of drugs known to inhibit CYP 2C9, in patients with rare hereditary galactose intolerance due to lactose content, and in patients with recent cerebrovascular bleeding or established systemic bleeding disorders.

PBS listing

No PBS listing information is provided in the available sources.

Regulatory history

MOXICAM meloxicam capsules were first listed on the Australian Register of Therapeutic Goods on 23 September 2015, with two strengths registered: 7.5 mg (ARTG 232584) and 15 mg (ARTG 232585).