SUMMARY OF PRODUCT CHARACTERISTICS

1    NAME OF THE MEDICINAL PRODUCT

Chloramphenicol Eye Drops 0.5% w/v BP

2    QUALITATIVE AND QUANTITATIVE COMPOSITION

Chloramphenicol Ph.Eur. 0.5% w/v

For the full list of excipients, see section 6.1.

3    PHARMACEUTICAL FORM

Eye Drops

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

Chloramphenicol Eye Drops BP are for use in the treatment of bacterial infections of the eye caused by organisms shown to be susceptible to chloramphenicol.

4.2 Posology and method of administration

Posology

Adults, children aged 2 years and over and elderly

1 or 2 drops are instilled into the eye initially every two hours. This frequency should be reduced as the infection is controlled. Treatment to be continued for at least 48 hours after the 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.

Route of administration: For ocular use.

4.3 Contraindications

Chloramphenicol eye drops should not be administered to:

•    Patients hypersensitive to chloramphenicol or to any of the excipients listed in section 6.1 or to those with a dry eye syndrome.

•    Patients who have experienced myelosuppression during previous exposure to chloramphenicol.

•    Patients with a family history of blood dyscrasias.

4.4 Special warnings and precautions for use

Severe infection may require the use of an additional systemic antibiotic. Avoid prolonged use of chloramphenicol eye drops since bacterial resistance may occur. Discard the drops 4 weeks after first opening or if they become cloudy or discoloured.

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 haemopoietic abnormalities.

In severe infections the topical use of chloramphenicol should be supplemented by appropriate systemic treatment. The prolonged use of antibiotics may occasionally result in overgrowth of non susceptable organisms, including fungi. If any new infection appears during the treatment, the antibiotic should be discontinued and appropriate measures taken. Chloramphenicol should be reserved for use only for infections for which it is specifically indicated.

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.

Chloramphenicol Eye Drops do not provide adequate coverage against Pseudomonas aeruginosa and Serratia marcescens.

Prolonged usage of products containing phenylmercuric nitrate is to be avoided.

4.5 Interaction with other medicinal products and other forms of interaction

Chymotrypsin will be inhibited if given simultaneously with chloramphenicol. Chloramphenicol may interact with bone marrow suppressant drugs such as azathioprine.

4.6    Fertility, pregnancy and lactation

No information available to ensure safety during pregnancy and lactation.

4.7    Effects on ability to drive and use machines

May cause transient blurring of vision. Patients should be advised not to drive or operate heavy machinery unless their vision is clear.

4.8 Undesirable effects

List of adverse reactions

The frequencies of adverse events are ranked according to the following: very common (> 1/10), common (> 1/100 to < 1/10), uncommon (> 1/1,000 to < 1/100), rare (> 1/10,000 to < 1/1,000), very rare (< 1/10,000), not known (cannot be estimated from the available data).

For eye drops

Blood and lymphatic system disorders:

Aplastic anaemia (incidence 1 in 4000 to 1 in 100,000) and dose related reversible depression of the bone marrow can occur following ocular administration 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.

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.

Incidences of peripheral and optic neuritis, myeloblastic leukaemia have also been reported.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinalproduct 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

4.9    Overdose

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.

5    PHARMACOLOGICAL PROPERTIES

5.1    Pharmacodynamic properties

Chloramphenicol is a broad spectrum bacteriostatic antibiotic. It interferes with bacterial protein synthesis and is effective against a wide range of gramnegative and gram-positive organisms.

5.2    Pharmacokinetic properties

Although used topically, systemic absorption may occur via the conjunctiva or nasal mucosa. Chloramphenicol is widely distributed in body tissues including the aqueous and vitreous humours of the eye. The half life of chloramphenicol is estimated to be between 1.5 and 5 hours. Only a small percentage of a dose is excreted unchanged in the urine. The chief route for inactivation is via hepatic metabolism and conjugation.

Preclinical safety data

None available.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Borax Ph.Eur.

Boric Acid PH. Eur. Phenylmercuric Nitrate B.P. Purified Water B.P.

6.2 Incompatibilities

Contact lenses should not be worn during the treatment period.

6.3 Shelf life

Unopened - 2 years.

Discard the drops 4 weeks after first opening or if they become cloudy or discoloured.

6.4 Special precautions for storage

Store between 2°C - 8°C.

Protect from light.

6.5 Nature and contents of container

Eye dropper bottle containing 10ml with dropper insert both composed of natural low density polyethylene. The closure is tamper proof and composed of white high density polyethylene.

6.6 Special precautions for disposal

None

7 MARKETING AUTHORISATION HOLDER

Teva UK Limited Brampton Road