INZA

What it is

INZA 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

INZA 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 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

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. 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. The elderly have an increased frequency of adverse effects to NSAIDs, especially gastrointestinal bleeding and perforation which may be fatal. 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. 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

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

Regulatory history

INZA 250 mg naproxen tablets were first listed on the Australian Register of Therapeutic Goods on 10 August 1992. INZA 500 mg naproxen tablets were first listed on the Australian Register of Therapeutic Goods on 10 August 1992.