CHOLFEN EYE

What it is

CHOLFEN EYE is available as eye drops (5 mg/mL) and eye ointment (10 mg/g) formulations. The eye drops contain 0.5% w/v chloramphenicol. The eye ointment contains 1.0% w/w chloramphenicol. Chloramphenicol is a broad spectrum antibiotic that is primarily bacteriostatic and acts by inhibition of protein synthesis by interfering with the transfer of activated amino acids from soluble RNA to ribosomes.

Approved indications

— Treatment of bacterial conjunctivitis. — Treatment of other superficial ocular infections caused by chloramphenicol-sensitive organisms, for use under medical supervision only.

Dosing overview

For eye drops: adults and children 2 years and over should instil 1 or 2 drops in the affected eye(s) every two to six hours for two to three days, with the interval between applications then increased; treatment should be continued for at least 48 hours after the eye appears normal and should not exceed 5 days total except on medical advice. For eye ointment: adults and children 2 years and over should apply 1.5 cm of ointment into the affected eye(s) every three hours; if used together with drops for day and night coverage, 1.5 cm should be applied before bedtime while using drops during the day; treatment should be continued for at least 48 hours after the eye appears normal and should not exceed 5 days total except on medical advice. CHOLFEN EYE is not recommended for children under 2 years except on medical advice.

Key safety warnings

Bone marrow hypoplasia, including aplastic anaemia and death, has been rarely reported following local application of chloramphenicol. Chloramphenicol should not be used when less potentially dangerous agents would be expected to provide effective treatment. Ophthalmic agents may retard corneal wound healing. The use of this antibiotic, as with other antibiotics, may result in the overgrowth of nonsusceptible organisms, including fungi; if infections caused by nonsusceptible organisms appear during therapy, its use should be discontinued and appropriate measures should be taken. In all serious infections, the topical use of chloramphenicol should be supplemented by appropriate systemic medication. If symptoms worsen at any time or if the eye infection does not improve within 48 hours, patients should seek prompt medical advice.

Contraindications

Chloramphenicol is contraindicated in individuals with a history of hypersensitivity to any excipients and/or toxic reaction to the drug.

Regulatory history

CHOLFEN EYE DROPS was first listed on the Australian Register of Therapeutic Goods on 23 November 2020. CHOLFEN EYE OINTMENT was first listed on 6 December 2021.