CHLORSIG

What it is

CHLORSIG is chloramphenicol eye drops and eye ointment. 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 (under medical supervision only).

Dosing overview

For eye drops in adults and children 2 years and over, instil 1 or 2 drops in the affected eye(s) every two to six hours for two to three days. The interval between applications may then be increased, and treatment should be continued for at least 48 hours after the eye appears normal. Do not use for more than 5 days in total except on medical advice. For eye ointment in adults and children 2 years and over, apply 1.5 cm of ointment into the affected eye(s) every three hours. If ointment is used together with drops for day and night coverage, 1.5 cm should be applied before bedtime, while using the drops during the day. Treatment should be continued for at least 48 hours after the eye appears normal, and do not use for more than 5 days in total except on medical advice. CHLORSIG 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. The mechanism for the irreversible aplastic anaemia following ophthalmic use of chloramphenicol has not been established. The use of this antibiotic, as with other antibiotics, may result in the overgrowth of nonsusceptible organisms, including fungi, and if infections caused by nonsusceptible organisms appear during therapy, its use should be discontinued and appropriate measures should be taken. Patients who wear contact lenses should be advised to seek advice from their doctor or optometrist before using CHLORSIG, and contact lenses should not be worn during the course of CHLORSIG treatment.

Contraindications

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

PBS listing

CHLORSIG eye drops 5 mg per mL, 10 mL are listed on the PBS with restriction, with an ex-manufacturer price of A$3.70.

Regulatory history

CHLORSIG eye drops and eye ointment were both first registered on the ARTG on 14 October 1991.