CHLORAMPHENICOL

Adults, Children and the Elderly Apply 3 - 4 drops into the affected ear 2 - 3 times daily for up to 1 week. Following administration of ear drops patients should be advised to lie down with the affected ear uppermost for a minimum of 10 minutes.

After this time cotton wool may be inserted into the ear and normal activities resumed. Infants Only use if considered essential by the physician. Method of administration For topical use

Immune System Disorders:

Hypersensitivity reactions including angioedema, anaphylaxis, urticaria, fever, vesicular and maculopapular dermatitis.

Blood and lymphatic system disorders:

Bone marrow depression and rarely aplastic anaemia 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 this compound.

Chloramphenicol may ocassionally cause blood dyscrasia. 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.

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Avoid use for more than 1 week as this may result in sensitivity to chloramphenicol or the emergence of resistant organisms. Where chloramphenicol ear 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.

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.

In severe infections topical use of chloramphenicol should be supplemented with appropriate systemic treatment. Prolonged use should be avoided as it may increase the likelihood of sensitisation and the 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. 9g of propylene glycol in 1ml which is equivalent to 90% w/v

1 • If the ear drum is perforated. • Myelosuppression during previous exposure to chloramphenicol. • Known personal or family history of blood dyscrasias including aplastic anaemia