CLOROGEN

Posology Adults, children aged 2 years and over and the elderly One drop to be instilled into the infected eye every 2 hours for the first 48 hours and 4 hourly thereafter. To be used during waking hours only. The course of treatment is 5 days.

Treatment should continue for 5 days even if symptoms improve. Method of Administration For ocular use only.

Eye disorders Transient irritation, burning, stinging and sensitivity reactions such as itching and dermatitis. Immune system disorders Hypersensitivity reactions including angioedema, anaphylaxis, urticaria, fever, vesicular and maculopapular dermatitis.

Treatment must be discontinued immediately in such cases. Blood and lymphatic system disorders Bone marrow depression, including the idiosyncratic type of irreversible and fatal aplastic anaemia that is recognised to occur with systemic therapy, has been reported in association with topical administration of chloramphenicol.

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. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

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 eye drops are 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 any haemopoietic abnormalities.

In severe infections the topical use of chloramphenicol should be supplemented by appropriate systemic treatment. Prolonged use of chloramphenicol eye drops should be avoided as it may increase the likelihood of sensitisation and emergence of resistant organisms.

If any new infection appears during the treatment, the antibiotic should be discontinued and appropriate measures taken. Chloramphenicol should be reserved for use only in infections for which it is specifically indicated. Chloramphenicol Eye Drops does not provide adequate coverage against Pseudomonas aeruginosa and Serratia marcescens.

Do not use for more than 5 days without consulting 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. Patients should be referred to their doctor if any of the following apply: • Disturbed vision • Severe pain within the eye • Photophobia • Eye inflammation associated with a rash on the scalp or face • The eye looks cloudy • The pupil looks unusual • Suspected foreign body in the eye Patients should also be referred to their doctor if any of the following in his/her medical history apply: • Previous conjunctivitis in the recent past • Glaucoma • Dry eye syndrome • Eye surgery or laser treatment in the last 6 months • Eye injury • Current use of other eye drops or eye ointment • Contact lens use Contact lenses should not be worn in an infected eye.

1. • Myelosuppression during previous exposure to chloramphenicol. • Family history of blood dyscrasias.