Chloramphenicol 1%W/W Eye Ointment
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Chloramphenicol 1%w/w Eye Ointment
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1 gram of ointment contains 10mg Chloramphenicol.
For full list of excipients, see Section 6.1
3 PHARMACEUTICAL FORM
Eye ointment
A yellowish-white 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.
Consideration should be given to official guidance on the appropriate use of antibacterial agents. 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 48 hours after the eye appears normal.
Elderly: 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
The ointment must not be administered to:
• Patients who have a history of hypersensitivity to chloramphenicol or to any of the excipients listed in section 6.1.
• Patients who have experienced bone marrow suppression during previous exposure to chloramphenicol.
• Patients with a known personal or family 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).
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.
If the eye ointment is to be 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 any haemopoietic abnormalities.
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.
Chloramphenicol does not provide coverage against Pseudomonas spp. or serratia marcescens.
The use of topical chloramphenicol may occasionally result in overgrowth of nonsusceptible organisms including fungi. If any new infection appears during treatment, the antibiotic should be discontinued and appropriate treatment given.
It is recommended that all types of contact lenses be avoided during ocular infections.
Do not use for more than 5 days without consulting a doctor.
Medical advice should be sought if there is no improvement in the condition after 2 days or if symptoms worsen at any time.
Patients should be referred to their 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 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;
If you wear contact lenses, seek advice either from your contact lens practitioner (optician, optometrist) or doctor before you use this product. You should not wear your contact lenses during the course of treatment. If you wear soft contact lenses do not start wearing them for at least 24 hours after you have finished using the eye ointment.
The packaging will convey the following information:
• If symptoms do not improve within 48 hours talk to your doctor;
• Seek further immediate medical advice at any time if symptoms worsen.
4.5 Interaction with other medicinal products and other forms of interaction
None Known
If a concomitant topical treatment to the eye is required, the administration of the different products should be separated by an adequate period of time.
4.6 Fertility, pregnancy and lactation
The safety of topical chloramphenicol in pregnancy and lactation has not been established.
Chloramphenicol may be absorbed systemically following the use of eye ointment and may cross the placenta and appear in breast milk. Therefore this product is not recommended for use during pregnancy and lactation.
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 their vision is clear.
Undesirable effects
4.8
Transient burning or stinging sensations may occur with the use of ophthalmic chloramphenicol. Serious side effects include hypersensitivity reactions that may manifest as angioneurotic oedema, anaphylaxis, urticaria, fever, and vesicular and maculopapular dermatitis. Treatment must be discontinued immediately in such cases.
Bone marrow suppression, including the idiosyncratic type of irreversible and fatal aplastic anaemia that is recognized to occur with systemic therapy, has been reported in association with topical administration of chloramphenicol.
Reporting of suspected adverse reactions
Reporting suspected adverse reaction 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 the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.
4.9 Overdose
Accidental overdose or accidental ingestion of the ointment is unlikely to cause systemic toxicity due to low content of chloramphenicol 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
ATC Code: S01AA01 Pharmacotherapeutic group: Antibiotics Mechanism of Action:-
Chloramphenicol exerts its antibacterial effect by binding to bacterial ribosomes and inhibiting bacterial protein synthesis at an early stage.
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 as soon as 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.
Escherichia coli Staphylococcus aureus Streptococcus pyogenes Streptococcus pneumoniae
Other beta-haemolytic streptococci Haemophilius influenzae 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 nonfermenters such as Pseudomonas aeruginosa.
5.2 Pharmacokinetic properties
Chloramphenicol is found in measurable amounts in the aqueous humour following local application to the eye. Chloramphenicol may be absorbed systemically following the use of eye ointment.
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 White soft paraffin
6.2 Incompatibilities
Not Applicable
6.3 Shelf life
48 months unopened 28 days opened
6.4 Special precautions for storage
Do not store above 25°C. Protect from light.
6.5 Nature and contents of container
Aluminium tube with epoxy-phenolic-ureic resin internal coating.
Polyethylene screw cap and nozzle.
Pack size 4g tube
6.6 Special precautions for disposal
Dispose of any unused ointment 28 days after opening the pack. Do not use if the pack is open when supplied.
7 MARKETING AUTHORISATION HOLDER
Martindale Pharmaceuticals Ltd (Trading as Martindale Pharma)
Bampton Road, Romford RM3 8UG United Kingdom
8 MARKETING AUTHORISATION NUMBER(S)
PL 00156/0360
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 29 July 2010
10 DATE OF REVISION OF THE TEXT
20/05/2016