Chloramphenicol ocular
- Drugs List
- Therapeutic Indications
- Dosage
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Ocular ointment and solution containing chloramphenicol (preservative containing and preservative free)
Drugs List
Therapeutic Indications
Uses
Bacterial ocular infection: topical treatment
Dosage
Adults
Eye Drops
Instil one or two drop(s) into the affected eye(s) every 2 hours for 48 hours, then every 4 hours thereafter.
Severe infections may require more frequent treatment initially.
Treatment should continue for 5 days even if symptoms improve.
Eye Ointment
Apply inside the lower eyelid of the affected eye(s) 3 to 4 times a day. More frequent application may be used if required. Alternatively use at night with appropriate drops during the day.
Treatment should be continued for 5 days even if symptoms improve.
Children
Eye Drops
Not all available brands are licensed for children under 2 years.
Instil one or two drop(s) into the affected eye(s) every 2 hours for 48 hours, then every 4 hours thereafter.
Severe infections may require more frequent treatment initially.
Treatment should continue for 5 days even if symptoms improve. Maximum duration is 10-14 days.
Eye Ointment
On the advice of a physician, apply inside the lower eyelid of the affected eye(s) 3 to 4 times a day. More frequent application may be used if required. Alternatively use at night with appropriate drops during the day.
Treatment should continue for 5 days even if symptoms improve. Maximum duration is 10-14 days.
Contraindications
Family history of haematological disorder
Wearing of contact lenses
Breastfeeding
Haematological disorder
History of haematological disorder
Pregnancy
Precautions and Warnings
Advise patient blurred vision may affect ability to drive/operate machinery
Consult national/regional policy on the use of anti-infectives
Not all available brands are licensed for all age groups
Some formulations may contain traces of silver - risk of hypersensitivity
Discard any remaining solution 28 days after opening
In combined therapy, administer eye products at least five minutes apart
To reduce systemic absorption compress lacrimal sac during administration
Haematological monitoring required in long term use
Prolonged use may result in superinfection with non-susceptible organisms
Advise patient to avoid touching the eye/other surfaces with container tip
Advise patient to seek medical advice if symptoms persist for > 5 days
Contact lenses should not be worn during treatment
Pregnancy and Lactation
Pregnancy
Chloramphenicol is contraindicated during pregnancy.
The manufacturer advises that this medication is not recommended for use during pregnancy, given the lack of data and concerns over safety. Alternative antimicrobials should always be considered.
Following administration of chloramphenicol topically to the eye, a small degree of systemic absorption may occur. When administered systemically to the mother, chloramphenicol crosses the placenta and levels in the foetus can reach levels equal to those in the mother's serum. There is no evidence that chloramphenicol increases the incidence of congenital malformations. At term, grey baby syndrome has been reported in babies whose mothers were treated with chloramphenicol systemically during the final stages of pregnancy (due to inadequate metabolism in the neonate). When use is considered essential, after careful evaluation of the risks, compression of the nasolacrimal sac following ocular administration may help minimise maternal absorption and foetal exposure.
Lactation
Chloramphenicol is contraindicated during breastfeeding.
The manufacturer advises that this medication is not recommended for use during breastfeeding. Alternative antimicrobials should always be considered.
Following administration of chloramphenicol topically to the eye, a small degree of systemic absorption may occur. There is no clear evidence as to the safety of ocular chloramphenicol use during breastfeeding. Following systemic administration chloramphenicol is excreted into breast milk. The safety of maternal chloramphenicol use and breast-feeding is unknown. Adverse reactions such as vomiting, excessive intestinal gas and falling asleep at the breast have been reported in breastfed infants whose mothers were taking oral chloramphenicol. Milk concentrations are not considered sufficient to induce grey baby syndrome. Chloramphenicol-induced aplastic anaemia is not dose related and this could occur, but has not been reported in an infant following breastfeeding. Chloramphenicol exposure must always be avoided in premature infants and in those with a family history of blood dyscrasias. If chloramphenicol use is considered unavoidable, monitor the infant's gastrointestinal function (for possible effects on bowel flora), the infant's response to feeding and the infant's full blood count should also be monitored closely. When use is essential, compression of the nasolacrimal sac following ocular administration may help minimise maternal absorption and infant exposure.
Side Effects
Anaphylaxis
Angioedema
Angioneurotic oedema
Aplastic anaemia
Blurred vision (transient)
Bone marrow depression
Fever
Keratopathy
Maculopapular dermatitis
Mercurialentis
Ocular irritation
Ocular itching
Photophobia
Stinging (transient)
Transient burning
Urticaria
Vesicular dermatitis
Overdosage
It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.
The following number will direct the caller to the relevant local centre (0844) 892 0111
Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Further Information
Last Full Review Date: January 2018
Reference Sources
Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 3nd edition (2015) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.
Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 10th edition (2015) ed. Briggs, G., Freeman, R. and Yaffe, S. Lippincott Williams & Wilkins, Philadelphia.
Medications and Mothers' Milk, Sixteenth Edition (2014) Hale, T and Rowe, H, Hale Publishing, Plano, Texas.
Summary of Product Characteristics: Brolene Antibiotic 0.5% Eye Drops. Sanofi. Revised October 2019.
Summary of Product Characteristics: Clorogen Eye Drops 0.5%. FDC International Ltd. Revised November 2020.
Summary of Product Characteristics: Minims Chloramphenicol 0.5% Eye Drops. Bausch & Lomb U.K. Limited. Revised July 2019.
Summary of Product Characteristics: Mollifeye 5mg/ml Eye Drops solution. Aspire Pharma Ltd. Revised April 2022.
Summary of Product Characteristics: Optrex Infected Eyes Eye Drops. Reckitt Benckiser Healthcare (UK) Ltd. Revised October 2020.
Summary of Product Characteristics: Brochlor 1% Eye Ointment. Sanofi. Revised October 2016.
Summary of Product Characteristics: Golden Eye Antibiotic 1% Chloramphenicol Eye Ointment. Cambridge Healthcare Supplies. Revised May 2016.
Summary of Product Characteristics: Optrex Bacterial Conjunctivitis 1% Eye Ointment. Reckitt Benckiser Healthcare (UK) Ltd. Revised February 2016.
NICE Evidence Services Available at: www.nice.org.uk Last accessed: 10 January 2018
MHRA Drug Safety Update July 2021
Available at: https://www.gov.uk/drug-safety-update/chloramphenicol-eye-drops-containing-borax-or-boric-acid-buffers-use-in-children-younger-than-2-years
Last accessed: 12 July 2021
UK Drugs in Lactation Advisory Service.
Available at: https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1
Last accessed: 12 October 2015
Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content
FDB Disclaimer : FDB Multilex is intended for the use of healthcare professionals and is provided on the basis that the healthcare professionals will retain FULL and SOLE responsibility for deciding what treatment to prescribe or dispense for any particular patient or circumstance.