Product Dossier

CILOQUIN

Product Dossier for CILOQUIN (ciprofloxacin, Novartis Pharmaceuticals). ARTG record, PBS listing, PBAC outcomes — compiled by arcimedes.

What it is

CILOQUIN contains ciprofloxacin hydrochloride and is available in tablet strengths of 250 mg, 500 mg or 750 mg. Ciprofloxacin hydrochloride is a synthetic carboxyquinolone derivative with broad spectrum antimicrobial activity.

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 to moderate severity.

Dosing overview

Ciprofloxacin should generally be continued for at least 2 days after the signs and symptoms of infection have disappeared, with a usual duration of 7 to 14 days, though more prolonged therapy may be required for severe and complicated infections.

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 adverse reactions involving the nervous system, musculoskeletal system and psychiatric effects. Tendonitis and tendon ruptures (predominately 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 or up to several months after discontinuation of ciprofloxacin. Patients who are elderly or have had prior systemic treatment with corticosteroids are thought to be at particular risk. Ciprofloxacin is associated with cases of QT prolongation, and 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 compared to men as they tend to have a longer baseline QTc interval. Fluoroquinolones, including ciprofloxacin, have been associated with an increased risk of psychiatric adverse reactions including toxic psychosis, psychotic reactions progressing to suicidal ideations or 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 and memory impairment. These reactions may occur following the first dose. 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.

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

CILOQUIN (ciprofloxacin hydrochloride tablets) was first approved on 22 April 2020.