This information is intended for use by health professionals

1. Name of the medicinal product

Chloramphenicol 0.5% w/v Antibiotic Eye Drops

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, solution

Clear, colourless to slightly yellow solution

4. Clinical particulars
4.1 Therapeutic indications

Chloramphenicol is broad spectrum antibiotic indicated in both adults and children aged 2 years and over for the treatment of acute bacterial conjunctivitis.

4.2 Posology and method of administration

Posology

Adults (including the elderly) and children aged 2 years and over:

• Put one drop into the affected eye(s) every 2 hours for the first 48 hours and 4 hourly thereafter.

• To be used during waking hours only

• The course of treatment should be 5 days.

Method of administration

For ocular use.

4.3 Contraindications

• Hypersensitivity to the active substance or to any of the excipients listed in section 6.1

• Myelosuppression during previous exposure to chloramphenicol.

• Family or personal history of blood dyscrasias including aplastic anaemia.

4.4 Special warnings and precautions for use

Chloramphenicol is absorbed systemically from the eye and systemic toxicity has been reported (see section 4.8).

In severe bacterial conjunctivitis and in cases where infection is not confined to the conjunctivae, the topical use of chloramphenicol should be supplemented by appropriate systemic treatment. Therefore, the patient should be referred to seek medical advice.

Prolonged use of chloramphenicol eye drops is not advisable. Prolonged or frequent intermittent topical application of chloramphenicol should be avoided since it may increase the likelihood of sensitisation and emergence of resistant organisms.

Do not use for more than 5 days without consulting your doctor.

The use of topical chloramphenicol may occasionally result in overgrowth of non-susceptible organisms including fungi. If any new infection appears during treatment, the patient should be referred to the doctor.

The label will state:

• Seek further immediate medical advice any time if symptoms worsen.

• Consult your doctor if your eye infection does not start to improve within 48 hours.

• Discard the medicine after a 5 day course of treatment.

• Do not use if you are allergic to chloramphenicol or any of the ingredients

• For external use/use in the eye only

• Keep all medicines out of the sight and reach of children.

Phenylmercuric nitrate is irritant to the skin. Topical application to eyes has been associated with mercurialentis and atypical band keratopathy.

Patients should be referred to a 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 patient has glaucoma

• 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

If this product is used following advice from a contact lens practitioner or doctor, contact lenses should not be worn during the period of treatment. Contact lens users may use glasses during treatment with chloramphenicol eye drops. Hard contact lens users and disposable contact lens users can start using their lenses again after successfully completing a course of treatment.

Soft contact lens wearers should wait 24 hours after completing a course of treatment before starting to use their lenses again.

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 chloramphenicol eye drops during pregnancy and lactation has not been established.

Preganancy

As this product is for sale without prescription it is not recommended for use during pregnancy.

Breast – feeding

In view of the fact that chloramphenicol may appear in breast milk, use of the product during lactation should be avoided.

4.7 Effects on ability to drive and use machines

The use of the eye drops may cause transient blurring of vision. Patients should not drive or operate hazardous machinery unless 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. Treatment must be discontinued immediately in such cases.

Blood and lymphatic system disorders:

Bone marrow depression, including the idiosyncratic type of irreversible and fatal aplastic anaemia that is recognised to occur with systemic therapy, has been reported in association with topical administration of chloramphenicol.

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.

In view of the relatively small amount of chloramphenicol in Chloramphenicol Eye Drops, overdosage with this product is unlikely to constitute a hazard.

No specific treatment would be required. 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

Mechanism of action

Chloramphenicol is a broad spectrum antibiotic with bacteriostatic activity which has activity against many types of Gram-positive and Gram-negative bacteria. Chloramphenicol is not effective against fungi, protozoa, and viruses.

Susceptibility

The following bacterial species are recognised conjunctival pathogens and may be susceptible to chloramphenicol. However due to the prevalence of acquired resistance to chloramphenicol in these species, the results of susceptibility testing should be taken into account if these are available. If no susceptibility test result is available, the choice of antibacterial agent should be influenced by local information on the likely prevalence of resistance to chloramphenicol in species that are commonly pathogenic in the eye.

Staphylococcus aureus

Streptococcus pyogenes

Streptococcus pneumoniae

Other beta-haemolytic streptococci

Haemophilius influenze

Moraxella catarrhalis

Neisseria gonorrhoeae

Resistance

Acquired resistance to chloramphenicol has been described in all the above species. Most commonly this is mediated by bacterial production of a chloramphenicol acetyl transferase that inactivates the drug. Chloramphenicol is not generally active against the enterobacteriaceae and is not active against non-fermenters such as Pseudomonas aeruginosa.

5.2 Pharmacokinetic properties

Evidence suggests that chloramphenicol is absorbed systemically via topical ocular administration. Any chloramphenicol that is absorbed will be widely distributed in the body tissues and fluids. It is found in cerebrospinal fluid, is secreted in saliva, with the highest concentrations occurring in the kidneys and liver.

Chloramphenicol also diffuses across the placenta into the foetal circulation and into breast milk.

Chloramphenicol is excreted chiefly in the urine as the glucuronide with small amounts being excreted via the bile and faeces. It has a reported half life of 1.5 to 5 hours which is increased in patients with liver impairment and neonates to between 24 and 28 hours in the latter.

5.3 Preclinical safety data

No additional data of relevance to the prescriber.

6. Pharmaceutical particulars
6.1 List of excipients

Borax

Boric Acid

Phenylmercuric Nitrate

Purified Water

6.2 Incompatibilities

None known

6.3 Shelf life

24 months Unopened

Although the shelf life once opened is 28 days, patients should be advised to discard the medicine after a 5 day course of treatment.

6.4 Special precautions for storage

Store upright at 2 to 8°C in a dry place away from strong sunlight and do not freeze (for example keep in a fridge).

6.5 Nature and contents of container

Low density polyethylene bottle and dropper insert with high density polyethylene cap. There is a tamper evident seal, which is broken when the bottle is first opened.

Fill volume is 10ml. Each bottle is then packed into a carton with a patient information leaflet.

6.6 Special precautions for disposal and other handling

No special requirements

7. Marketing authorisation holder

Martindale Pharmaceuticals Ltd

Bampton Road

Romford

Essex

RM3 8UG

8. Marketing authorisation number(s)

PL 00156/0109

9. Date of first authorisation/renewal of the authorisation

Date of first authorisation: 20/11/2009

10. Date of revision of the text

28/12/2017