PROXEN

What it is

PROXEN is a non-steroidal anti-inflammatory drug (NSAID) with analgesic, anti-inflammatory and antipyretic properties. Naproxen sodium is a propionic acid derivative related to the arylacetic acid class of drugs.

Approved indications

PROXEN is indicated as an analgesic in acute migraine attacks, for the treatment of gout, rheumatoid arthritis, osteoarthritis, ankylosing spondylitis and for the relief of acute and/or chronic pain states in which there is an inflammatory component. — Acute migraine attacks — Gout — Rheumatoid arthritis — Osteoarthritis — Ankylosing spondylitis — Acute and/or chronic pain states with an inflammatory component

Dosing overview

The lowest effective dose for the shortest possible duration should be used after assessing the risk/benefit ratio in each individual patient.

Key safety warnings

Non-selective NSAIDs may be associated with an increased risk of serious cardiovascular events, including myocardial infarction and stroke, which may increase with dose or duration of use. Patients with cardiovascular disease, history of atherosclerotic cardiovascular disease or cardiovascular risk factors may be at greater risk. The lowest effective dose should be used for the shortest possible duration to minimise the potential risk of an adverse cardiovascular event in patients taking an NSAID, especially in those with cardiovascular risk factors. All NSAIDs can cause gastrointestinal discomfort and rarely serious, potentially fatal, gastrointestinal effects such as ulcers, irritation, bleeding and perforation, which may increase with dose or duration of use, but can occur at any time without warning symptoms. 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. These trends continue with longer duration of use. However, even short term therapy is not without risk. The elderly have an increased frequency of adverse effects to NSAIDs, especially gastrointestinal bleeding and perforation which may be fatal. NSAIDs may very rarely cause serious cutaneous adverse events such as exfoliative dermatitis, Stevens-Johnson Syndrome (SJS), Drug Reaction with Eosinophilia with Systemic Symptoms (DRESS) and toxic epidermal necrolysis (TEN), which can be fatal and occur without warning. These serious adverse events are idiosyncratic and are independent of dose or duration of use.

Contraindications

PROXEN is contraindicated in patients who are hypersensitive to naproxen or naproxen sodium or in whom acetylsalicylic acid (aspirin) or other non-steroidal anti-inflammatory/analgesic agents induce allergic manifestations, for example asthma, nasal polyps, rhinitis and urticaria. PROXEN is contraindicated in patients with either active, or a history of, peptic or gastrointestinal ulceration, chronic dyspepsia or active gastrointestinal bleeding or perforation, related to previous NSAIDs therapy. PROXEN is contraindicated in patients with active, or history of recurrent peptic ulcer/haemorrhage (two or more distinct episodes of proven ulceration or bleeding) unrelated to previous NSAIDs therapy. PROXEN is contraindicated in patients less than 2 years of age since safety in this age group has not been established. PROXEN is contraindicated in patients with severe heart failure. PROXEN is contraindicated in patients undergoing treatment of perioperative pain in setting of coronary artery surgery (CABG). PROXEN is contraindicated in patients with severe hepatic impairment. PROXEN is contraindicated in the 3rd trimester of pregnancy.

PBS listing

PROXEN 750 mg sustained release tablets are listed on the PBS as 3 items with restriction type, at an ex-manufacturer price of A$4.54. PROXEN 1 g sustained release tablets are listed on the PBS as 3 items with restriction type, at an ex-manufacturer price of A$6.10.

Regulatory history

PROXEN was first approved on 3 November 1998. PROXEN SR 750 mg and PROXEN SR 1000 mg sustained release tablets were first listed on the ARTG on 7 February 1994. PROXEN SR formulations in blister pack format were listed on 6 November 2015. PROXEN 500 mg and PROXEN 250 mg tablets were listed on 23 November 2016.