MELOXIBELL

What it is

MELOXIBELL is meloxicam, available as 7.5 mg and 15 mg capsules. Meloxicam is a non-steroidal anti-inflammatory drug (NSAID) of the enolic acid class, which has shown anti-inflammatory, analgesic and antipyretic properties. Meloxicam inhibits the biosynthesis of prostaglandins, known mediators of inflammation, by inhibition of cyclooxygenase (COX).

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 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, potentially fatal, 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. In clinical trials, meloxicam has been shown to cause fewer GI adverse events 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. This may increase 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 (DRESS) have been reported very rarely in association with NSAID use. Patients appear to be at highest risk early in the course of therapy, with onset occurring in the majority of cases within the first month of treatment.

Contraindications

Meloxicam is contraindicated in patients with peri-operative pain management in coronary artery bypass graft surgery, known hypersensitivity to meloxicam or its excipients, signs or symptoms of asthma or nasal polyps following aspirin or NSAID use, active gastrointestinal ulceration or perforation, active inflammatory bowel disease, severe hepatic insufficiency, non-dialysed severe renal insufficiency, severe uncontrolled heart failure, and in children and adolescents under 18 years of age. It is also contraindicated in breastfeeding, with concomitant CYP 2C9 inhibitors, in patients with rare hereditary galactose intolerance due to lactose content, and in patients with recent cerebrovascular bleeding or established systemic bleeding disorders.

Regulatory history

MELOXIBELL meloxicam 7.5 mg and 15 mg tablets were first listed on the Australian Register of Therapeutic Goods on 31 July 2007.