NAPROSYN

What it is

NAPROSYN contains naproxen 250 mg or 500 mg as the active ingredient. Naproxen is a non-steroidal anti-inflammatory drug (NSAID) with analgesic, anti-inflammatory and antipyretic properties, and is a propionic acid derivative related to the arylacetic acid class of drugs.

Approved indications

— Treatment of rheumatoid arthritis — Treatment of osteoarthritis — Treatment of juvenile rheumatoid arthritis — Treatment of ankylosing spondylitis — Symptomatic treatment of primary dysmenorrhoea — Relief of acute and/or chronic pain states in which there is an inflammatory component — Analgesic use in acute migraine attack

Dosing overview

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 or cardiovascular risk factors may be at greater risk. To minimise potential cardiovascular risk, the lowest effective dose should be used for the shortest possible duration. NSAIDs can cause serious, potentially fatal gastrointestinal effects such as ulcers, irritation, bleeding and perforation. Upper gastrointestinal ulcers, gross bleeding or perforation occur in approximately 1% of patients treated for 3–6 months and in about 2–4% of patients treated for one year. 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, Drug Reaction with Eosinophilia with Systemic Symptoms (DRESS) and toxic epidermal necrolysis, which can be fatal and occur without warning. These serious adverse events are idiosyncratic and independent of dose or duration of use. NSAIDs may lead to the onset of new hypertension or worsening of pre-existing hypertension. Caution is advised when prescribing NSAIDs to patients with hypertension, and blood pressure should be monitored closely during initiation and at regular intervals thereafter. Naproxen decreases platelet aggregation and prolongs bleeding time. Patients who have coagulation disorders or are receiving drug therapy that interferes with haemostasis should be carefully observed.

Contraindications

NAPROSYN 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 such as asthma, nasal polyps, rhinitis and urticaria. NAPROSYN is contraindicated in patients with active or a history of peptic or gastrointestinal ulceration, chronic dyspepsia, or active gastrointestinal bleeding or perforation related to previous NSAID therapy, and 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. NAPROSYN is contraindicated in children under 2 years of age since safety in this age group has not been established. NAPROSYN is contraindicated in patients with severe heart failure and in those undergoing treatment of perioperative pain in the setting of coronary artery surgery (CABG). NAPROSYN is contraindicated in patients with severe hepatic impairment and in the 3rd trimester of pregnancy.

PBS listing

NAPROSYN 250 mg tablets are listed on the PBS with a restriction and an ex-manufacturer price of A$4.39.

Regulatory history

NAPROSYN sustained release 750 mg and 1000 mg tablets were first registered on the ARTG on 19 July 1991. NAPROSYN 250 mg and 500 mg tablets were first registered on the ARTG on 24 September 1998.