SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

Chloramphenicol Eye Ointment BP 1%w/w

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Chloramphenicol BP 1% w/w

3 PHARMACEUTICAL FORM

Sterile Eye Ointment

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

Chloramphenicol is a broad spectrum bacteriostatic antibiotic. It is active against a wide range of gram-negative and gram-positive organisms, including Salmonella typhi, Haemophilus influenzae, Neisseria meningitidis, Streptococcus pneumoniae and Bacteroides fragilis.

It has antirickettsial and antichlamydial activity. It is indicated for the topical treatment of superficial ocular infections caused by pathogens which are sensitive to it.

4.2 Posology and method of administration

Administration

For topical ocular use. A thin line of ointment to be placed along the inside of the lower eye lid.

Adults, including the elderly and children

The eye ointment is to be applied every 3 hours or more frequently, if required. Alternatively, the ointment may be applied at night with appropriate eye drops used during the day.

4.3 Contraindications

Hypersensitivity to chloramphenicol or to any other component of the preparation.

4.4 Special warnings and precautions for use

i)    In severe infections topical use of chloramphenicol should be supplemented with appropriate systemic treatment.

ii)    Aplastic anaemia has followed topical use of chloramphenicol eye drops and whilst this hazard is a rare one, it should be considered when the benefits of the use of chloramphenicol are assessed.

iii)    The association of chloramphenicol with childhood leukaemia’s and grey baby syndrome warrants careful consideration before using topical chloramphenicol in neonates and small children.

iv)    Prolonged use should be avoided as it may increase the likelihood of sensitisation and the emergence of resistant organisms.

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

vi)    Contact lenses should be removed during the period of use.

4.5 Interaction with other medicinal products and other forms of interaction

Chymotrysin will be inhibited if given simultaneously with chloramphenicol.

4.6 Fertility, pregnancy and lactation

Safety for use in pregnancy and lactation has not been established. A serious side effect of chloramphenicol is grey baby syndrome, known to occur if chloramphenicol is given to neonates.

Chloramphenicol has also been associated with childhood leukaemia’s and bone marrow depression. It is likely that systemic absorption of chloramphenicol occurs following ocular administration.

Chloramphenicol is known to penetrate well into foetal circulation and is found in breast milk at low concentrations. The reduced ability of the foetus and neonate to metabolise chloramphenicol may lead to the drug concentrating in the foetal or neonatal circulation.

Therefore topical ocular chloramphenicol must be used only if considered essential and not prophylactically or to treat minor infections.

4.7 Effects on ability to drive and use machines

The use of an eye ointment may cause some blurring of vision. Patients should not drive or operate hazardous machinery unless vision is clear.

4.8 Undesirable effects

Local effects

Sensitivity reactions such as transient irritation, burning, stinging, itching and dermatitis

Systemic effects

Several cases of major adverse haematological events (bone marrow depression, aplastic anaemia and death) have been reported following ocular use of chloramphenicol.

4.9 Overdose

Not applicable.

5    PHARMACOLOGICAL PROPERTIES

5.1    Pharmacodynamic properties

Chloramphenicol is an antibiotic with bacteriostatic action. It inhibits the growth of a wide range of Gram-negative and Gram-positive bacteria, rickettsiae, coxiella and chlamydia. However, serious side effects may be produced and thus the drug is restricted to the treatment of acute life threatening infections and for use topically to treat ear and eye infections.

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.

It 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.

5.3 Preclinical safety data

No additional data of relevance to the prescriber.

6.1 List of excipients

Liquid paraffin BP Wool fat BP Yellow soft paraffin. BP

6.2 Incompatibilities

None known

6.3 Shelf life

36 months Unopened 28 days once opened

6.4 Special precautions for storage

Do not store above 25°C.

6.5 Nature and contents of container

Collapsible Polyethylene/Aluminium foil laminated tube with tamper evident cap containing 4g of product. Pack size 1 tube.

6.6 Special precautions for disposal

No special requirements.

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