ANAPROX

What it is

ANAPROX 550 is a film-coated tablet containing 550 mg of naproxen sodium. The tablet is oblong and dark blue, engraved "NPS 550" on one side, with a break-line on both faces. Naproxen sodium is a non-steroidal anti-inflammatory drug (NSAID) with analgesic, anti-inflammatory and antipyretic properties.

Approved indications

— Acute migraine attacks. — Treatment of gout. — Treatment of rheumatoid arthritis. — Treatment of osteoarthritis. — Treatment of ankylosing spondylitis. — Relief of acute and/or chronic pain states in which there is 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

Observational studies have indicated that 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 also be at greater risk. To minimise the potential risk of an adverse cardiovascular event in patients taking an NSAID, especially in those with cardiovascular risk factors, the lowest effective dose should be used for the shortest possible duration. 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 to 6 months and in about 2 to 4% of patients treated for one year. These trends continue with longer duration of use, increasing the likelihood of developing a serious gastrointestinal event at some time during the course of therapy. However, even short term therapy is not without risk. 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. Patients should be advised of the signs and symptoms of serious skin reactions and to consult their physician at the first appearance of a skin rash or other sign of hypersensitivity. NSAIDs may lead to onset of new hypertension or worsening of pre-existing hypertension and patients taking anti-hypertensives with NSAIDs may have an impaired anti-hypertensive response. Caution is advised when prescribing NSAIDs to patients with hypertension. Blood pressure should be monitored closely during initiation of NSAID treatment and at regular intervals thereafter.

Contraindications

ANAPROX 550 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. ANAPROX 550 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. It 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. ANAPROX 550 is contraindicated in children less than 2 years of age since safety in this age group has not been established. It is contraindicated in patients with severe heart failure. ANAPROX 550 is contraindicated in patients undergoing treatment of perioperative pain in the setting of coronary artery surgery (CABG). It is contraindicated in patients with severe hepatic impairment. ANAPROX 550 is contraindicated in the 3rd trimester of pregnancy.

PBS listing

ANAPROX 550 (tablet containing naproxen sodium 550 mg) is listed on the PBS with 3 items at an ex-manufacturer price of A$7.82 and is subject to restriction.

Regulatory history

ANAPROX 550 was first listed on the Australian Register of Therapeutic Goods on 3 November 1998.