SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

Chloramphenicol Eye Drops BP 0.5%

Vistaphenicol Eye Drops.

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Chloramphenicol BP 0.5% w/v

3    PHARMACEUTICAL FORM

Eye Drops

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.

Adults (and the elderly) and children

One or two drops applied to each affected eye up to six times daily or more frequently if required. (Severe infections may require one to two drops every fifteen to twenty minutes initially, reducing the frequency of instillation gradually as the infection is controlled).

Contra-indications

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

4.4. Special Warnings and Precautions for Use

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

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.

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

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

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

Contact lenses should be removed during the period of use.

4.5. Interactions with other Medicaments and other forms of Interaction

Chymotrysin will be inhibited if given simultaneously with chloramphenicol.

4.6. 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 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

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.

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 BP Boric Acid BP Phenylmercuric Nitrate BP Purified Water BP

6.2.    Incompatibilities

None known

6.3.    Shelf-Life

24 months Unopened 28 days once opened

6.4.    Special Precautions for Storage

Store upright at 2 to 8°C in a dry place away from strong light. Do not freeze.

Nature and Content 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.

6.6. Instruction for Use, Handling and Disposal

No special requirements.

7. MARKETING AUTHORISATION HOLDER

Martindale Pharmaceuticals Limited Bampton Road Romford, RM3 8UG England

8 MARKETING AUTHORISATION NUMBER(S)

PL 00156/0048

9. DATE OF FIRST AUTHORISATION / RENEWAL OF THE AUTHORISATION

6 June 1997

10. DATE OF (PARTIAL) REVISION OF THE TEXT

August 2003