CIPROFLOXACIN-BL

What it is

CIPROFLOXACIN-BL is available as 250 mg, 500 mg and 750 mg film-coated tablets for oral administration, containing ciprofloxacin as the active ingredient. Ciprofloxacin has in vitro activity against a wide range of Gram-negative and Gram-positive organisms, with bactericidal action resulting from interference with the enzyme DNA gyrase.

Approved indications

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 or moderate severity — Inhalational anthrax (post-exposure): to reduce the incidence or progression of disease following exposure to aerosolised Bacillus anthracis

Dosing overview

For patients with creatinine clearance between 31–60 mL/min/1.73 m², the maximum daily dose should be 1000 mg/day; for creatinine clearance equal to or less than 30 mL/min/1.73 m², the maximum daily dose should be 500 mg/day.

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, which include serious effects involving the nervous system, musculoskeletal system, and psychiatric effects. Ciprofloxacin is associated with cases of QT prolongation. Elderly patients may be more susceptible to drug-associated effects on the QT interval, and women may be more sensitive to QT prolongation 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 QT prolongation (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, or cardiac disease). Tendonitis and tendon rupture (predominantly Achilles tendon), sometimes bilateral, and requiring surgical repair or resulting 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. Antibiotic-associated colitis has been rarely reported with ciprofloxacin. Antibiotic-associated pseudomembranous colitis has been reported with many antibiotics including ciprofloxacin, with a toxin produced by Clostridium difficile appearing to be the primary cause. The severity of the colitis may range from mild to life threatening. 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. In some instances, CNS reactions may occur even after the first administration of fluoroquinolones, including ciprofloxacin. Ciprofloxacin should be used with caution in patients with CNS disorders such as severe cerebral arteriosclerosis or epilepsy. Fluoroquinolones, including ciprofloxacin, have been associated with an increased risk of psychiatric adverse reactions including toxic psychosis, psychotic reactions progressing to suicidal ideations/thoughts, hallucinations or paranoia, depression, 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. 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.

Contraindications

A history of hypersensitivity to ciprofloxacin or other quinolones, including nalidixic acid, or any of the excipients is a contraindication to its use. Except in cases of exacerbations of cystic fibrosis associated with Pseudomonas aeruginosa (in patients aged 5–17 years) and inhalation anthrax, ciprofloxacin is contra-indicated in children and growing adolescents unless the benefits of treatment are considered to outweigh the risks.

Regulatory history

CIPROFLOXACIN-BL was first registered on the Australian Register of Therapeutic Goods on 5 November 2004, with three strengths listed: 250 mg, 500 mg and 750 mg tablets.