APO-CIPROFLOXACIN

What it is

APO-CIPROFLOXACIN contains ciprofloxacin hydrochloride in strengths of 250 mg, 500 mg or 750 mg per tablet. The tablets are white to off-white film-coated formulations in round or caplet shapes. Ciprofloxacin hydrochloride is a synthetic carboxyquinolone derivative with broad spectrum antimicrobial activity.

Approved indications

APO-CIPROFLOXACIN 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 aerosolized *Bacillus anthracis*

Dosing overview

APO-CIPROFLOXACIN tablets are intended for oral administration. Dosing varies by indication and patient population.

The duration of treatment depends on the severity of infection, with usual duration of 7 to 14 days, although severe and complicated infections may require prolonged therapy. Bone and joint infections may require treatment for 4 to 6 weeks or longer. Gastrointestinal infections require treatment for only 5 days. Chronic bacterial prostatitis should be treated for 14 to 28 days. Inhalational anthrax (post-exposure) should be treated for 60 days.

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, including the nervous system, musculoskeletal system, and psychiatric effects. Patients of any age or without pre-existing risk factors have experienced these adverse reactions. Tendonitis and tendon ruptures (predominantly Achilles tendon) 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. The risk of tendinopathy may be increased in elderly patients, during strenuous physical activity, in patients treated concomitantly with corticosteroids, in patients with renal impairment and in patients with solid organ transplants. Ciprofloxacin is associated with cases of QT prolongation. Elderly patients may be more susceptible to drug-associated effects on the QT interval. Women may also be more sensitive to QT prolongation medicine compared to men as they tend to have a longer baseline QTc interval. Precaution should be taken when using ciprofloxacin with concomitant drugs that can result in prolongation of the QT interval (such as class IA or III antiarrhythmics, tricyclic antidepressants, macrolides, antipsychotics) or in patients with risk factors for QT prolongation or torsade de pointes (such as congenital long QT syndrome, uncorrected electrolyte imbalance, and cardiac disease). Ciprofloxacin may cause central nervous system stimulation which may lead to transient tremor, restlessness, light-headedness, confusion, and very rarely to hallucinations or convulsive seizures. Fluoroquinolones including ciprofloxacin have been associated with an increased risk of psychiatric adverse reactions including toxic psychosis, hallucinations, paranoia, depression, anxiety, insomnia, and memory impairment. Ciprofloxacin has been shown to be phototoxic in a number of *in vitro* and *in vivo* studies. Patients taking ciprofloxacin should avoid direct exposure to sunlight. Antibiotic-associated pseudomembranous colitis has been reported with ciprofloxacin. A toxin produced by *Clostridium difficile* appears to be the primary cause. The severity of the colitis may range from mild to life threatening. It is important to consider this diagnosis in patients who develop diarrhoea or colitis in association with antibiotic use. Epidemiologic studies report an increased risk of aortic aneurysm and dissection, particularly in elderly patients, and of aortic mitral valve regurgitation after intake of fluoroquinolones. Cases of aortic aneurysm and dissection, sometimes complicated by rupture (including fatal ones), and of regurgitation/incompetence of any of the heart valves have been reported in patients receiving fluoroquinolones.

Contraindications

A history of hypersensitivity to ciprofloxacin, any of the excipients, or other quinolones (including nalidixic acid) is a contraindication. Concurrent administration of ciprofloxacin and tizanidine is contraindicated.

Regulatory history

APO-CIPROFLOXACIN was first listed on the Australian Register of Therapeutic Goods on 7 August 2007, with three registered variants: 250 mg (ARTG 135650), 500 mg (ARTG 135651), and 750 mg (ARTG 135652) tablets in blister pack format.