IPC-CIPROFLOXACIN

What it is

IPC-CIPROFLOXACIN is available as 250 mg, 500 mg and 750 mg film-coated tablets for oral administration. Ciprofloxacin is a synthetic carboxyquinolone derivative with broad spectrum antimicrobial activity. The bactericidal action of ciprofloxacin appears to result 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

The dosage range for adults is 250–750 mg twice daily. Specific dosages vary by indication, ranging from 250 mg as a single dose for acute uncomplicated gonorrhoeal urethritis to 750 mg twice daily for bone and joint infections. For paediatric patients with inhalational anthrax post-exposure, the recommended dose is 15 mg/kg per dose (not to exceed 500 mg per dose), every 12 hours. For patients with impaired renal function, dosage adjustments are necessary: for 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, 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, and women may also be more sensitive to QT prolongation compared to men. Precaution should be taken when using ciprofloxacin with concomitant drugs that can result in prolongation of the QT interval or in patients with risk factors for QT prolongation or torsade de pointes. As with other quinolones, 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. 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. Cases of sensory or sensorimotor polyneuropathy resulting in paraesthesias, hypoaesthesias, dysaesthesias, or weakness have been reported in patients receiving fluoroquinolones including ciprofloxacin. Ciprofloxacin should be discontinued in patients experiencing symptoms of neuropathy, including pain, burning, tingling, numbness, and/or weakness in order to prevent the development of an irreversible condition.

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

IPC-CIPROFLOXACIN was first approved on 05 November 2004. The three strength variants (250 mg, 500 mg and 750 mg tablets) were first listed on the Australian Register of Therapeutic Goods on 20 May 2009.