INDOCID

What it is

INDOCID (indometacin) is a highly effective non-steroidal anti-inflammatory drug with marked analgesic and antipyretic properties. Indometacin is a potent inhibitor of prostaglandin synthesis in vitro, with concentrations reached during therapy that have been demonstrated to have an effect in vivo. INDOCID is available as 25 mg capsules and as 100 mg suppositories.

Approved indications

INDOCID is indicated in active stages of rheumatoid arthritis, osteoarthritis, degenerative joint disease of the hip, ankylosing spondylitis, and gout. — Rheumatoid arthritis — Osteoarthritis — Degenerative joint disease of the hip — Ankylosing spondylitis — Gout — 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 INDOCID is 50 mg to 200 mg daily in divided doses and should be individually adjusted to the patient's response and tolerance. The lowest effective dose should be used for the shortest duration consistent with individual patient treatment goals. 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.

Key safety warnings

**Cardiovascular thrombotic events.** 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 minimise 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. **Hypertension.** 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. When given to patients with hypertension, blood pressure should be monitored closely during the initiation of NSAID treatment and at regular intervals thereafter. **Gastrointestinal effects.** 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. **Serious skin reactions.** NSAIDs, including INDOCID, 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. <cite index index="1-59">Patients should be informed about the signs and symptoms of serious skin reactions and to consult their doctor at the first appearance of skin rash or any other sign of hypersensitivity.</cite>

**Platelet aggregation and anticoagulants.** Concurrent use of NSAIDs and warfarin has been associated with severe, sometimes fatal, haemorrhage, especially in the elderly. INDOCID should be used in combination with warfarin only if absolutely necessary, and patients taking this combination should be closely monitored.

Contraindications

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

PBS listing

INDOCID suppository 100 mg is listed on the PBS as an unrestricted item with an ex-manufacturer price of A$6.50.

Regulatory history

INDOCID suppository 100 mg (ARTG 10480) was first listed on 22 July 1991. INDOCID capsule 25 mg (ARTG 76021) was first listed on 11 September 2000.