1. Name Of The Medicinal Product
Chloromycetin Ophthalmic Ointment
2. Qualitative And Quantitative Composition
Each 1 gram of ointment contains 10mg of chloramphenicol Ph Eur.
3. Pharmaceutical Form
Eye ointment.
4. Clinical Particulars
4.1 Therapeutic Indications
Chloramphenicol is a broad spectrum antibiotic 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
Topical administration to the eye only.
Adults, children and infants:
The recommended dosage for adults, children and infants of all age groups is a small amount of the ointment to be applied to the affected eye every 3 hours or more frequently if required. Treatment should be continued for at least 48 hours after the eye appears normal.
Elderly (over 65 years):
As for adults. Chloramphenicol has been used successfully at normal dosages in elderly patients. The pattern and incidence of adverse effects does not appear to differ from younger adults.
4.3 Contraindications
Chloromycetin Ophthalmic Ointment should not be administered to patients hypersensitive to chloramphemcol or any other component of the preparation.
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 Chloromycetin Ophthalmic ointment is 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 can cause sensitisation and occasionally result in overgrowth of non-susceptible organisms, including fungi. If any new infection appears during 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.
Chloramphenicol does not provide adequate coverage against Pseudomonas aeruginosa and Serratia marcescens.
It is reconunended that all types of contact lenses are avoided during ocular infections. Chloromycetin Ophthalmic ointment may smear over the surface of contact lenses
4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction
None known.
4.6 Pregnancy And Lactation
The safety of topical chioramphenicol in pregnancy and lactation has not bee established. It should therefore only be used when considered essential by the physician.
4.7 Effects On Ability To Drive And Use Machines
Blurring of vision can occur with the ointment and patients should be warned not to drive or operate machinery unless vision is clear.
4.8 Undesirable Effects
Transient burning or stinging sensations may occur with the use of Chloromycetin Ophthalmic Ointment. More serious side effects include bone marrow depression and rarely aplastic anaemia, angioneurotic oedema, anaphylaxis, urticaria, fever, vesicular and maculopapular dermatitis have been reported and are causes for discontinuation.
4.9 Overdose
Accidental ingestion of Chloromycetin Ophthalmic Ointment is unlikely to cause systemic toxicity due to the low content of the antibiotic. 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 potent inhibitor of bacterial protein synthesis, and exerts its affects by interfering with the transfer of activated amino acids from soluble RNA to ribosomes.
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
Pre-clinical safety data does not add anything of further significance to the prescriber.
6. Pharmaceutical Particulars
6.1 List Of Excipients
Liquid paraffin
Polyethylene in paraffin liquid
6.2 Incompatibilities
None known.
6.3 Shelf Life
Four years.
6.4 Special Precautions For Storage
Do not store above 25°C.
Discarded after 28 days.
6.5 Nature And Contents Of Container
Supplied in a 4g laminate tube fitted with an ophthalmic nozzle.
6.6 Special Precautions For Disposal And Other Handling
None.
7. Marketing Authorisation Holder
Goldshield Pharmaceuticals,
NLA Tower,
12-16 Addiscombe Road
Croydon CR0 OXT
UK
8. Marketing Authorisation Number(S)
PL 12762/0205
9. Date Of First Authorisation/Renewal Of The Authorisation
13th February 2001
10. Date Of Revision Of The Text
23/02/2010
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