POM: Prescription only medicine
This information is intended for use by health professionals
Chloramphenicol Eye Drops BP 0.5% w/v
Chloramphenicol Eye Drops BP 0.5% w/v contains 5mg/ml chloramphenicol.
Excipients with known effect
Phenylmercuric nitrate 0.002% w/v
Borax and Boric acid (one ml of solution contains 3.075 mg boron)
For the full list of excipients, see section 6.1
A bright, colourless to faint yellow aqueous solution.
Chloramphenicol is a broad spectrum antibiotic indicated in both adults and children aged 2 years and over for the treatment of bacterial conjunctivitis caused by chloramphenicol susceptible organisms including: Escherichia coli, Haemophilus influenzae, Staphylococcus aureus, Streptococcus haemolyticus, Morax-axenfeld, Klebsiella/Enterobacter species and others.
Adults (including the Elderly) and children over 2 years of age
The recommended dosage for adults and children over the age of 2 is two drops to be applied to the affected eye every three hours. To be used during waking hours only. Treatment should be continued for at least 48 hours after eye appears normal.
Method of Administration
For ocular use only.
• Hypersensitivity to the active substance, chloramphenicol or to any of the excipients listed in section 6.1
• Myelosuppression during previous exposure to chloramphenicol.
• Known personal or family history of blood dyscrasias including aplastic anaemia.
• Must not be given to a child less than 2 years old (see also section 4.4).
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
• 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
• 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
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.
The packaging will convey the following information:
• If symptoms do not improve within 48 hours talk to your doctor
• Seek further immediate medical advice at any time if symptoms worsen
• Do not use if you are allergic to chloramphenicol or any of the ingredients
Phenylmercuric nitrate is irritating to the skin. Topical application to eyes has been associated with mercurialentis and atypical band keratopathy.
This medicinal product must not be given to a child less than 2 years old as it contains boron and may impair fertility in the future (see also section 4.3).
The concomitant administration of Chloramphenicol with other drugs liable to depress bone marrow function should be avoided.
Pregnancy and Breast-feeding
The safety of topical use of chloramphenicol in pregnancy and lactation has not been established.
Chloramphenicol may be absorbed systemically following the use of eye drops and may cross the placenta and appear in breast milk. Therefore this product is not recommended for use during pregnancy and lactation.
No fertility data are available
Transient blurring of vision may occur immediately after use and driving or using machinery should not occur until the vision is clear.
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.
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 Yellow card scheme at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
Accidental ingestion of the eye 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.
Pharmacotherapeutic group: Antibiotics
ATC code: S01AA01
Chloramphenicol is a broad spectrum antibiotic with bacteriostatic activity and is effective against a wide range of gram-negative and gram-positive organisms including Haemophilus influenzae, Streptococcus pneumoniae, Staphylococcus aureus, Streptococcus viridans, Moraxella species and Enterobacteriaceae, the main pathogens responsible for acute bacterial conjunctivitis. Chloramphenicol exerts its antibacterial effect by reversibly binding to bacterial ribosomes thereby inhibiting bacterial protein synthesis.
Chloramphenicol is an extremely well established antibiotic and the successful use of the eye drops is well documented. Chloramphenicol is found in measurable amounts in the aqueous humour following local application to the eye.
Nothing of relevance which is not included in other sections of the SPC.
Phenyl Mercuric Nitrate
Water for injection
Unopened: 24 months
Opened: 28 days
Protect from light.
Store in a refrigerator at a temperature between 2°C and 8°C.
Discard remaining contents 28 days after opening.
Pack Type A
Low density polyethylene bottle with polystyrene spiked cap. Available in pack sizes of 5ml or 10ml
Pack Type B
Low density polyethylene (LDPE) vial with insert-cap assembly, comprising of white coloured, HDPE screw-cap over a LDPE nozzle with tamper-evident LDPE dust- cover sealing the vial cap.
Pack size: 10 ml
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
FDC International Ltd
Unit 6 Fulcrum 1
Date of first authorisation: 16 January 1998
Date of latest renewal: 07 March 2003