ARTHREXIN

What it is

ARTHREXIN (indometacin) is a highly effective non-steroidal anti-inflammatory drug with marked analgesic and antipyretic properties. ARTHREXIN is available as a 25 mg capsule, white powder in an opaque ivory capsule.

Approved indications ARTHREXIN is indicated in active stages of:

— Rheumatoid arthritis — Osteoarthritis — Degenerative joint disease of the hip — Ankylosing spondylitis — Gout ARTHREXIN is also indicated for acute musculoskeletal disorders, such as bursitis, tendonitis, synovitis, tenosynovitis, capsulitis of the shoulder, sprains and strains. — Low back pain (commonly referred to as lumbago). — Inflammation, pain and oedema following orthopaedic surgical procedures and nonsurgical procedures associated with reduction and immobilisation of fractures or dislocations. — Pain and associated symptoms of primary dysmenorrhoea.

Dosing overview

The recommended dosage of ARTHREXIN is 50 mg to 200 mg daily in divided doses and should be individually adjusted to the patient's response and tolerance. In the treatment of acute gouty arthritis, the recommended daily dosage is 150 mg to 200 mg until all symptoms and signs subside. In primary dysmenorrhoea, the recommended dosage is 25 mg three times a day starting with onset of cramps or bleeding and continuing for as long as the symptoms usually last. To minimise the possibility of gastrointestinal disturbances, it is recommended that oral ARTHREXIN be taken with food, milk, or an antacid.

Key safety warnings

Non-selective nonsteroidal anti-inflammatory drugs (NSAIDs) may be associated with an increased risk of serious cardiovascular thrombotic events, including myocardial infarction, stroke, and heart failure, which may increase with dose and duration of use and patients with cardiovascular disease, history of atherosclerotic cardiovascular disease or risk factors for cardiovascular disease may be at greater risk. To minimize the potential risk for an adverse cardiovascular event, especially in patients with cardiovascular risk factors, the lowest effective dose should be used for the shortest possible duration. All NSAIDs can cause gastrointestinal discomfort and serious, potentially fatal gastrointestinal effects such as ulcers, bleeding and perforation, which may increase with dose or duration of use, but can occur at any time without warning. Upper gastrointestinal ulcers, gross bleeding or perforation caused by NSAIDs occur in approximately 1% of patients treated for 3–6 months and in about 2–4% of patients treated for one year. NSAIDs, including ARTHREXIN, can cause serious skin adverse events such as exfoliative dermatitis, Stevens-Johnson Syndrome (SJS), toxic epidermal necrolysis (TEN), and Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) syndrome which can be fatal and may occur without warning. NSAIDs can lead to onset of new hypertension or worsening of pre-existing hypertension, either of which may contribute to the increased incidence of cardiovascular events. Patients taking antihypertensives along with NSAIDs may have impaired anti-hypertensive response and hence NSAIDs should be administered with caution in patients with hypertension. Furthermore, when given to patients with hypertension, blood pressure should be monitored closely during the initiation of NSAID treatment and at regular intervals thereafter.

Contraindications

ARTHREXIN should not be used in patients who are hypersensitive to any component of this product; patients in whom acute asthmatic attacks, urticaria, or rhinitis are precipitated by acetylsalicylic acid or other non-steroidal anti-inflammatory agents; patients with severe heart failure; patients with severe hepatic impairment; or patients with active peptic ulcer or with a recurrent history of gastrointestinal ulceration. ARTHREXIN is contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery.

PBS listing

ARTHREXIN 25 mg capsule is listed on the PBS with restriction, and an ex-manufacturer price of A$3.10.

Regulatory history

ARTHREXIN indometacin 25 mg capsule was first listed on the ARTG on 1 June 2021.