C-FLOX

What it is

C-FLOX is a film-coated tablet containing ciprofloxacin hydrochloride as the active ingredient, available in strengths of 250 mg, 500 mg or 750 mg.

Approved indications

C-FLOX is indicated for the treatment of infections caused by susceptible organisms in the following conditions: — Urinary tract infections — Gonorrhoeal urethritis and cervicitis — Gastroenteritis — Bronchial infections — Skin and skin structure infections — Bone and joint infections — Chronic bacterial prostatitis of mild to moderate severity — Inhalational anthrax (post-exposure): to reduce the incidence or progression of disease following exposure to aerosolised *Bacillus anthracis*.

Dosing overview

Dosing varies according to the indication. For urinary tract infections, the usual adult dosage is 250 mg every 12 hours, although for patients with complicated infections caused by organisms not highly susceptible, such as *Enterococcus faecalis*, 500 mg may be administered every 12 hours. For bronchial infections and skin and skin structure infections, the usual dose is 500 mg every 12 hours, with a dosage of 750 mg given every 12 hours for more severe or complicated infections. For bone and joint infections, the dose is 750 mg every 12 hours. For gastroenteritis, the dose is 500 mg every 12 hours. For acute, uncomplicated gonorrhoeal urethritis, the dose is 250 mg as a single dose. For chronic bacterial prostatitis, the dose is 250 to 500 mg every 12 hours. For inhalational anthrax post-exposure in adults, the recommended dose is 500 mg every 12 hours; for paediatric patients, the recommended dose is 15 mg/kg per dose (not to exceed 500 mg per dose), every 12 hours.

Key safety warnings

Fluoroquinolones, including ciprofloxacin, have been associated with disabling and potentially irreversible serious adverse reactions involving different body systems that have occurred together in the same patient. Patients of any age or without pre-existing risk factors have experienced these adverse reactions. These include serious adverse reactions involving the nervous system, musculoskeletal system, and psychiatric effects. Tendonitis and tendon rupture (predominantly Achilles tendon), sometimes bilateral, that required surgical repair or resulted in prolonged disability have been reported with ciprofloxacin and other quinolones. This may occur even within the first 48 hours of treatment, and cases occurring up to several months after completion of therapy have been reported. Fluoroquinolones, including ciprofloxacin, have been associated with an increased risk of psychiatric adverse reactions including toxic psychosis, psychotic reactions progressing to suicidal ideations or thoughts, hallucinations or paranoia, depression or self-injurious behaviour such as attempted or completed suicide, anxiety, agitation or nervousness, confusion, delirium, disorientation or disturbances in attention, insomnia or nightmares, and memory impairment. These reactions may occur following the first dose. Epidemiologic studies report an increased risk of aortic aneurysm and dissection after intake of fluoroquinolones, particularly in the older population. Therefore, fluoroquinolones should only be used after careful benefit-risk assessment and after consideration of other therapeutic options in patients with positive family history of aneurysm disease, or in patients diagnosed with pre-existing aortic aneurysm or dissection, or in the presence of other risk factors or conditions predisposing for aortic aneurysm and dissection, such as Marfan syndrome, vascular Ehlers-Danlos syndrome, Takayasu arteritis, giant cell arteritis, Behcet's disease, hypertension, or known atherosclerosis.

Contraindications

C-FLOX is contraindicated in patients with a history of hypersensitivity to ciprofloxacin, other quinolones, including nalidixic acid, or any of the excipients. Concurrent administration of ciprofloxacin and tizanidine is contraindicated.

PBS listing

C-FLOX 250 mg tablets, 500 mg tablets and 750 mg tablets are each listed on the PBS with authority required restriction. The ex-manufacturer prices are A$3.48 for the 250 mg strength, A$4.00 for the 500 mg strength, and A$4.98 for the 750 mg strength.

Regulatory history

C-FLOX 250 mg, 500 mg and 750 mg tablets were first listed on the ARTG on 19 April 2012 under licence category RE.