CILOXAN

What it is

CILOXAN Ear Drops contain ciprofloxacin hydrochloride (equivalent to 3 mg/mL ciprofloxacin base). CILOXAN Ear Drops is a sterile, multiple-dose product, for topical otic use.

Approved indications

— Treatment of chronic suppurative otitis media (CSOM) when caused by organisms susceptible to ciprofloxacin in adults and children 1 month or older.

Dosing overview

For chronic suppurative otitis media in adults and children 1 month or older, the recommended dosage is five drops into the affected ear canal(s) twice daily for 9 days. If the solution is cold, it should be warmed by holding the bottle in the hand for one or two minutes before instillation, to avoid dizziness which may be associated with instillation of a cold solution into the ear.

Key safety warnings

CILOXAN Ear Drops should be discontinued at the first appearance of a skin rash or any other sign of hypersensitivity. Serious and occasionally fatal hypersensitivity (anaphylactic) reactions, some following the first dose, have been reported in patients receiving systemic quinolones. Some reactions were accompanied by cardiovascular collapse, loss of consciousness, tingling, pharyngeal or facial oedema, dyspnoea, urticaria, and itching. Serious anaphylactic reactions require immediate emergency treatment with adrenaline and other resuscitation measures, including oxygen, intravenous fluids, intravenous antihistamines, corticosteroids, pressor amines and airway management, as clinically required. Moderate to severe phototoxicity manifested by an exaggerated sunburn reaction has been observed in some patients who were exposed to direct sunlight while receiving some members of the quinolone class of drugs, including oral ciprofloxacin. Excessive sunlight should be avoided. As with other antibacterial preparations, prolonged use of ciprofloxacin may result in overgrowth of nonsusceptible organisms, including yeast and fungi. If the infection has not improved after 9 days of treatment, cultures should be obtained to guide further treatment. CILOXAN 0.3% Ear Drops contain benzalkonium chloride which may be an irritant and cause skin reactions.

Contraindications

A history of hypersensitivity to ciprofloxacin or any other component of the medication is a contraindication. A history of hypersensitivity to other quinolones, including nalidixic acid, may also contraindicate the topical use of ciprofloxacin.

PBS listing

CILOXAN Ear Drops 3 mg (as hydrochloride) per mL, 5 mL is listed on the PBS with 1 item. The restriction type is authority required, with an ex-manufacturer price of A$24.58.

Regulatory history

CILOXAN ciprofloxacin ear drops (ARTG 121897) was first listed on 17 May 2006.