CHLORAMPHENICOL 1.0% Eye ointment Ref.[6655] Active ingredients: Chloramphenicol

Chloramphenicol is absorbed systemically from the eye and toxicity has been reported following chronic exposure.

Bone marrow hypoplasia, including aplastic anaemia and death, has been reported following topical use of chloramphenicol. Whilst the hazard is a rare one, it should be borne in mind when assessing the benefits expected from the use of the compound. Where Chloramphenicol antibiotic eye ointment is used on a long-term or intermittent basis, it may be advisable to perform a routine blood profile before therapy and at appropriate intervals thereafter to detect haemopoietic abnormalities.

In severe infections the topical use of chloramphenicol should be supplemented by appropriate systemic treatment.

Prolonged use of chloramphenicol eye drops is not advisable, as it may increase the likelihood of sensitisation and emergence of resistant organisms. If any new infection appears during treatment, the antibiotic should be discontinued and appropriate measures taken. Chloramphenicol should be reserved for use only for infections for which it is specifically indicated.

Chloramphenicol does not provide adequate coverage against Pseudomonas aeruginosa and Serratia marcescens.

Chloramphenicol eye ointment should not be used for more than 5 days at a time except on the advice of a doctor.

Medical advice should be sought if there is no improvement in the condition after 2 days or if symptoms worsen at any time.

The label will state:

• Do not use this ointment if you are allergic to chloramphenicol or anything else in the ointment.
• If you do not get better within 48 hours talk to a doctor.
• If your eyes get worse see a doctor straight away.
• After 5 days, throw away any ointment left.

Chloramphenicol eye ointment should not be recommended under the following circumstances (in these circumstances patients should be referred to their doctor):

• Severe pain within the eye
• Disturbed vision
• Photophobia
• The pupil looks unusual
• The eye looks cloudy
• Associated pain or swelling around the eye or face
• The patient has had conjunctivitis previously in the recent past
• The patient has glaucoma
• The patient has dry eye syndrome
• The patient has an eye injury
• Suspected foreign body in the eye
• The patient is already using other eye ointments or eye drops
• The patient has had eye surgery or laser treatment in the last 6 months

If you wear contact lenses, seek advice either from your contact lens practitioner (optician, optometrist) or doctor before you use this product. You should not wear your contact lenses during the course of treatment. If you wear soft contact lenses do not start wearing them for at least 24 hours after you have finished the eye ointment.

The concomitant administration of chloramphenicol with other drugs liable to depress bone marrow function should be avoided.

The safety of topical chloramphenicol in pregnancy and lactation has not been established.

Chloramphenicol may be absorbed systemically following the use of the eye ointment. Chloramphenicol does cross the placenta and enter breast milk. Therefore chloramphenicol eye ointment should not be used during pregnancy and breastfeeding.

May cause transient blurring of vision on instillation of the ointment. User should not drive or operate hazardous machinery unless vision is clear.

Transient burning or stinging sensations may occur with the use of Chloramphenicol Antibiotic Eye Ointment. More serious side effects include bone marrow depression and rarely aplastic anaemia, angioneurotic oedema, anaphylaxis, urticaria, fever, vesicular and maculopapular dermatitis have been reported and are causes for discontinuation.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

Not Applicable.