MELOBIC

What it is

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

Approved indications

Melobic is indicated for the symptomatic treatment of: — Osteoarthritis — Rheumatoid arthritis

Dosing overview

Meloxicam should be used at the lowest dose and for the shortest duration consistent with effective treatment, with a maximum daily dose of 15 mg. In patients with increased risks of adverse reactions, such as a history of gastrointestinal disease or cardiovascular disease risk factors, treatment should be started at 7.5 mg daily and increased to 15 mg daily only if clinically justified. In patients with end-stage renal failure on haemodialysis, the dose should not exceed 7.5 mg daily.

Key safety warnings

Gastrointestinal bleeding, ulceration or perforation can occur at any time during treatment with Melobic, with or without warning symptoms, and the consequences of such events are generally more serious in the elderly. Patients with a prior history of ulcer disease and those who use NSAIDs have a greater than 10-fold higher risk of developing gastrointestinal bleeding 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 an increased risk of serious cardiovascular thrombotic events including myocardial infarction and stroke, which may increase with dose and duration of use, particularly in patients with cardiovascular disease or cardiovascular risk factors. 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, including exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis, and Drug Reaction with Eosinophilia with Systemic Symptoms have been reported rarely in association with NSAIDs, with patients at highest risk early in the course of therapy, typically within the first month of treatment. Melobic should be discontinued at the first appearance of skin rash, mucosal lesions or any other sign of hypersensitivity. NSAIDs inhibit renal prostaglandin synthesis, and in patients with decreased renal blood flow, administration may precipitate overt renal decompensation, with the highest risk in elderly individuals, dehydrated patients, those with congestive heart failure, liver cirrhosis, nephrotic syndrome and renal disease, and those receiving diuretics or ACE inhibitors. Borderline elevations of liver tests may occur in up to 15% of patients taking meloxicam, and notable elevations of liver enzymes have been reported in approximately 1% of patients in clinical trials. Rare cases of severe hepatic reactions, including jaundice and fatal fulminant hepatitis, liver necrosis and hepatic failure, have been reported with NSAIDs.

Contraindications

Melobic is contraindicated in patients with known hypersensitivity to meloxicam or any excipients, those with signs or symptoms of asthma, nasal polyps, angioedema or urticaria following 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, patients who are breastfeeding, and those receiving concomitant drugs known to inhibit CYP 2C9. Melobic is contraindicated in patients with rare hereditary galactose intolerance due to the lactose content. As with all NSAIDs, meloxicam is contraindicated in patients with recent cerebrovascular bleeding or established systemic bleeding disorders. Melobic is also contraindicated for peri-operative treatment of pain in patients undergoing coronary artery bypass graft surgery.

PBS listing

Information regarding PBS listing, including strength, item count, restriction type and ex-manufacturer price, is not provided in the available source documents.

Regulatory history

MELOBIC 7.5 mg tablets (ARTG 188882) and MELOBIC 15 mg tablets (ARTG 188883) were first listed on the ARTG on 28 August 2012. MELOBIC 7.5 mg capsules (ARTG 232582) and MELOBIC 15 mg capsules (ARTG 232583) were first listed on the ARTG on 23 September 2015.