APO-NORFLOXACIN

What it is

APO-NORFLOXACIN contains 400 mg of norfloxacin, a fluoroquinolone synthetic antibacterial agent for oral administration.

Approved indications

— Treatment of adults with complicated and uncomplicated urinary tract infections caused by susceptible strains of microorganisms. — Treatment of adults with gastrointestinal infections, in particular shigellosis and traveller's diarrhoea.

Dosing overview

In patients with a creatinine clearance rate of 30 mL/min/1.73 m² or less, the recommended dosage is one 400 mg tablet once daily. Norfloxacin tablets should be taken 1 hour before or 2 hours after a meal with a glass of water.

Key safety warnings

Fluoroquinolones, including norfloxacin, have been associated with disabling and potentially irreversible serious adverse reactions involving the nervous system, musculoskeletal system and psychiatric effects. Patients of any age or without pre-existing risk factors have experienced these adverse reactions. Fluoroquinolones should be reserved for proven or suspected infections where alternative agents are ineffective or contraindicated. Tendon inflammation and rupture have been reported with fluoroquinolone therapy including norfloxacin, with increased risk in elderly patients, patients with renal impairment, patients with solid organ transplants and those treated concurrently with corticosteroids. Tendon rupture can occur during or after completion of therapy; cases occurring up to several months after completion have been reported. Convulsions have been reported rarely in patients receiving norfloxacin, and norfloxacin should be used with caution in individuals with a history of convulsions or known factors that predispose to seizures. Quinolones, including norfloxacin, may exacerbate the signs of myasthenia gravis and lead to life-threatening weakness of the respiratory muscles. Cases of sensory or sensorimotor polyneuropathy resulting in paraesthesias, hypoesthesias, dysethesias, or weakness have been reported, and norfloxacin should be discontinued in patients experiencing symptoms of neuropathy in order to prevent the development of an irreversible condition. Fluoroquinolones have been associated with an increased risk of psychiatric adverse reactions including toxic psychosis, hallucinations, paranoia, depression, self-injurious behaviour, anxiety, agitation, confusion, insomnia and memory impairment, which may occur following the first dose. Cholestatic hepatitis is commonly reported with norfloxacin. Antibiotic-associated pseudomembranous colitis has been reported with norfloxacin. Epidemiologic studies report an increased risk of aortic aneurysm and dissection after intake of fluoroquinolones, particularly in the older population, and fluoroquinolones should only be used after careful benefit-risk assessment in patients with positive family history of aneurysm disease or pre-existing aortic aneurysm and/or dissection.

Contraindications

APO-NORFLOXACIN is contraindicated in patients with hypersensitivity to any component of this product or any chemically related quinolone antibacterials. Norfloxacin should not be used in children (paediatric patients, adolescents under the age of 18 years) or pregnant women.

PBS listing

The 400 mg tablet is listed on the PBS with authority required restriction at an ex-manufacturer price of A$3.50.

Regulatory history

APO-NORFLOXACIN norfloxacin 400 mg tablet was first listed on the ARTG on 19 November 2008.