This information is intended for use by health professionals

1. Name of the medicinal product

Chloramphenicol Eye Drops BP 0.5% w/v

2. Qualitative and quantitative composition

Chloramphenicol 0.5% w/v

For the full list of excipients, see section 6.1

3. Pharmaceutical form

Eye Drops

A bright, colourless to faint yellow aqueous solution.

4. Clinical particulars
4.1 Therapeutic indications

Chloramphenicol is a broad spectrum antibiotic indicated in both adults and children 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.

4.2 Posology and method of administration

Posology:

Adults and children (including the Elderly)

The recommended dosage for adults and children 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.

Paediatric population

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.

Administration: For ocular use only.

4.3 Contraindications

• 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.

4.4 Special warnings and precautions for use

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

• Photophobia

• 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

• Glaucoma

• 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.

4.5 Interaction with other medicinal products and other forms of interaction

The concomitant administration of Chloramphenicol with other drugs liable to depress bone marrow function should be avoided.

4.6 Fertility, pregnancy and lactation

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.

4.7 Effects on ability to drive and use machines

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

4.8 Undesirable effects

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.

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.

4.9 Overdose

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.

5. Pharmacological properties
5.1 Pharmacodynamic properties

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.

5.2 Pharmacokinetic properties

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.

5.3 Preclinical safety data

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

6. Pharmaceutical particulars
6.1 List of excipients

Borax

Boric Acid

Phenyl Mercuric Nitrate

Purified Water

6.2 Incompatibilities

None known

6.3 Shelf life

Unopened:

Opened:

24 months

28 days

6.4 Special precautions for storage

Protect from light.

Store in a refrigerator at a temperature between 2°C and 8°C.

Discard remaining contents 28 days after opening.

6.5 Nature and contents of container

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

6.6 Special precautions for disposal and other handling

None

7. Marketing authorisation holder

FDC International Ltd

Unit 6 Fulcrum 1

Solent Way

Whiteley

Fareham

Hants

PO15 7FE

United Kingdom

8. Marketing authorisation number(s)

PL 15872/0003

9. Date of first authorisation/renewal of the authorisation

16 January 1998 / 07 March 2003

10. Date of revision of the text

03 October 2016