ROFLO

What it is

ROFLO is ciprofloxacin available as 250 mg, 500 mg and 750 mg film-coated tablets for oral administration. Ciprofloxacin has in vitro activity against a wide range of Gram-negative and Gram-positive organisms, with bactericidal action that appears to result from interference with the enzyme DNA gyrase.

Approved indications

— 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

The dosage range for adults is 250–750 mg twice daily. Specific dosages by indication include: 250 mg single dose for acute uncomplicated gonorrhoeal urethritis; 250–500 mg twice daily for upper and lower urinary tract infections depending on severity; 500–750 mg twice daily for bronchial infections, skin and skin structure infections depending on severity; 750 mg twice daily for bone and joint infections; 500 mg twice daily for gastroenteritis; and 250–500 mg twice daily for chronic bacterial prostatitis. For inhalational anthrax post-exposure in adults, the recommended dose is 500 mg every 12 hours. For paediatric patients with inhalational anthrax, 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, including 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. 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. In general, 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. Ciprofloxacin may cause central nervous system (CNS) 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. 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 or self-injurious behaviour such as attempted or completed suicide; anxiety, agitation or nervousness; confusion, delirium, disorientation or disturbances in attention; insomnia or nightmares; 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. Therapy should be discontinued if photosensitisation occurs.

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 P. 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

ROFLO was first approved on 5 November 2004. ROFLO ciprofloxacin 250 mg, 500 mg and 750 mg tablets were registered on the Australian Register of Therapeutic Goods on 28 August 2006.