Chloramphenicol Eye Drops BP 0.5% W/V

Eye Drops

Treatment of bacterial conjunctivitis caused by the organisms Escherichia coli, Haemophilus influenzae, Staphylococcus aureus, Streptococcus haemolyticus, Morax-Axenfield and others

The recommended dosage for adults, children and infants of all age groups is two drops to be applied to the affected eye every three hours or more frequently if required. Treatment should be continued for at least 48 hours after eye appears normal.

• Hypersensitivity to chloramphenicol or to any other ingredient of the drops.

• Myelosuppression during previous exposure to chloramphenicol.

• Family history of dyscrasias.

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. The prolonged use of antibiotics may occasionally result in overgrowth of non susceptable organisms, including fungi. If any new infection appears during the 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.

Soft contact lenses should not be worn during treatment with chloramphenicol eye drops due to absorption of the preservative onto the lens which may cause damage to the lens. It is recommended that all types of contact lenses be avoided during ocular infections.

Chloramphenicol Eye Drops do not provide adequate coverage against Pseudomonas aeruginosa and Serratia marcescens.

Bone marrow suppressant drugs.

Safety for use in pregnancy and lactation has not been established. Therefore, use only when considered essential by the physician.

Transient blurring of vision may occur immediately after use and driving or using machinery should not occur until the vision is clear.

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.

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.

Accidental ingestion of the drops is unlikely to cause systemic toxicity due to the low content of the antibiotic in the product. If irritation, pain, swelling, lacrimation or photophobia occur after undesired eye contact, the exposed eye(s) should be irrigated for at least 15 minutes. If symptoms persist after this, an ophthalmological examination should be considered

Chloramphenicol is a broad spectrum antibiotic with bacteriostatic activity and is effective against a wide range of gram-negative and gram-positive organisms

Not applicable to topical (ophthalmic) preparations.

Nothing of relevance which is not included in other sections of the SPC

Borax

Boric Acid

Phenyl Mercuric Nitrate

Purified Water

None known

Protect from light.

Store between 2°C and 8°C

Low density polyethylene bottle with polystyrene spiked cap. Available in pack sizes of 5ml or 10ml

None

FDC International Ltd

Unit 6 Fulcrum 1

Solent Way

Whiteley

Fareham

Hants PO15 7FE

United Kingdom

PL 15872/0003

16 January 1998 / 07 March 2003

7 October 2010