1. Name of the medicinal product
Chloramphenicol 0.5% w/v Eye Drops
Brolene Antibiotic 0.5% w/v Eye Drops
2. Qualitative and quantitative composition
Chloramphenicol 0.5% w/v
For excipients see 6.1
3. Pharmaceutical form
4. Clinical particulars
4.1 Therapeutic indications
Chloramphenicol is indicated in adults and children for the
treatment of acute bacterial conjunctivitis.
4.2 Posology and method of administration
For ocular use.
The recommended dosage for adults (including the elderly) and
children is one drop to be applied to the affected eye every two
hours for the first 48 hours and 4 hourly thereafter. To be used
during waking hours only.
Treatment should continue for 5 days, even if symptoms improve.
Dosage adjustment may be necessary in newborn infants because of
reduced systemic elimination due to immature metabolism and the
risk of dose-related adverse effects. The maximum duration of
treatment is 10-14 days.
Chloramphenicol eye drops should not be administered to patients
hypersensitive to chloramphenicol or any other ingredients in the
formulation, or given to those with a known personal or family
history of blood dyscrasias including aplastic anaemia.
4.4 Special warnings and precautions for use
Prolonged use of chloramphenicol eye drops should be avoided as it
may increase the likelihood of sensitisation and emergence of
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
• 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
If this product is used following advice from a contact lens
practitioner or doctor, contact lenses should not be worn during
the course of treatment. Soft contact lenses should not be replaced
for 24 hours after completing treatment.
The labels will state:
• If symptoms do not improve within 48 hours talk to your doctor.
• Seek further immediate medical advice at any time if symptoms
• Discard any remaining eye drops after the five day course of
• Do not use if you are allergic to chloramphenicol or any of the
4.5 Interaction with other medicinal products and other forms of
The concomitant administration of chloramphenicol with other drugs
liable to depress bone marrow function should be avoided.
4.6 Pregnancy and lactation
The safety of Chloramphenicol Eye Drops during 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
4.7 Effects on ability to drive and use machines
Chloramphenicol eye drops may cause transient blurring of vision
when applied to the eye. Patients should be warned not to drive or
operate hazardous machinery unless their vision is clear.
4.8 Undesirable effects
Chloramphenicol eye drops may cause transient stinging and
irritation when applied to the eye.
Bone marrow depression, including irreversible and fatal 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 the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard
5. Pharmacological properties
5.1 Pharmacodynamic properties
Chloramphenicol is a broad spectrum antibiotic with bacteriostatic
activity and is effective against a wide range of Gram-negative and
5.2 Pharmacokinetic properties
Not applicable to a topical (ophthalmic) preparation.
5.3 Preclinical safety data
Preclinical safety data does not add anything of further
6. Pharmaceutical particulars
6.1 List of excipients
Water for injections
6.3 Shelf life
24 months from the date of manufacture. The in-use shelf life is 28
days, however the patient should be advised to discard any
remaining contents after the 5-day course of treatment.
6.4 Special precautions for storage
Protect from light. Store between 2°C and 8°C.
6.5 Nature and contents of container
A flexible polypropylene bottle incorporating a polyethylene plug
and cap assembly. The bottles contain 10ml.
6.6 Special precautions for disposal and other handling