CIPROL

What it is

Ciprol tablets contain 250 mg, 500 mg or 750 mg of ciprofloxacin (as the hydrochloride). Ciprofloxacin hydrochloride 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 conditions listed below: — 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.

Dosing overview

The usual duration is 7 to 14 days, however for severe and complicated infections more prolonged therapy may be required. Bone and joint infections may require treatment for 4 to 6 weeks or longer. Gastrointestinal infections (infectious diarrhoea) need treatment for only 5 days. Chronic bacterial prostatitis should be treated for 14 to 28 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. 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 ruptures (predominately Achilles tendon), sometime 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. 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 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. 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. Antibiotic-associated colitis has been rarely reported with ciprofloxacin. Antibiotic associated pseudomembranous colitis has been reported with many antibiotics including ciprofloxacin. 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 (this may occur up to several weeks after cessation of antibiotic therapy).

Contraindications

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

Regulatory history

Ciprol received initial approval on 9 April 2002. ARTG registration records show CIPROL 250, 500 and 750 mg tablets in blister pack and bottle formats first listed on 2002-04-19.