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BOOTS PHARMACY ANTIBIOTIC EYE OINTMENT

Active substance(s): CHLORAMPHENICOL / CHLORAMPHENICOL

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Optrex Infected Eye Ointment
When sold by Boots The Chemist, the name will be Boots Pharmacy
Antibiotic Eye Ointment

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Chloramphenicol 1.0% w/w.
Each 1 gram of ointment contains 10mg chloramphenicol
For excipients, see 6.1.

3

PHARMACEUTICAL FORM
Eye ointment.

4

CLINICAL PARTICULARS

4.1

Therapeutic indications
Treatment of acute bacterial conjunctivitis.

4.2

Posology and method of administration
Topical administration to the eye only.
Adults, children aged 2 years and over and elderly
The recommended dose is a small amount of ointment (~ 1cm) to be applied to
the affected eye(s). The ointment should be applied either at night if eye drops
are used during the day, or 3 to 4 times a day if eye ointment is used alone
The pharmacist will advise on the most suitable treatment. Treatment should
continue for 5 days even if symptoms improve.

4.3

Contraindications
Chloramphenicol eye ointment must not be administered to:
• Patients who have a history of hypersensitivity to chloramphenicol or
to any other ingredient of the ointment.
• 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
Chloramphenicol is absorbed systemically from the eye and systemic toxicity
has been reported (see section 4.8).
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. Therefore, the patient
should be referred to seek medical advice.
The use of topical chloramphenicol may occasionally result in overgrowth of
non-susceptible organisms including fungi. If any new infection appears
during treatment, the patient should be referred to the doctor.
Prolonged or frequent intermittent topical application of chloramphenicol
should be avoided since it may increase the likelihood of sensitisation and
emergence of resistant organisms.
Do not use for more than 5 days without consulting your doctor.
The label will state:
• If symptoms do not improve within 48 hours talk to your doctor
• Seek further immediate medical advice at any time if symptoms worsen
• Do not use if you are allergic to chloramphenicol or any of the ingredients
• Discard any remaining eye ointment after the five day course of treatment
For external use only.
Keep all medicines out of the sight and reach of children.
Patients should be referred to a doctor if any of the following apply:

Disturbed vision

Any significant 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 optometrist, contact
lens practitioner 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.

4.5

Interaction with other medicinal products and other forms of interaction
Bone marrow depressant drugs

4.6

Pregnancy and lactation
The safety of chloramphenicol eye drops during pregnancy and lactation has
not been established. As this product is for sale without prescription it is not
recommended for use during pregnancy.
In view of the fact that chloramphenicol may appear in breast milk, use of the
product during lactation should be avoided.

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.

4.8

Undesirable effects
Transient burning or stinging sensations may occur with the use of
chloramphenicol eye ointment. 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 depression, including the idiosyncratic type of irreversible and
fatal aplastic anaemia that is recognised to occur with systemic therapy, has
been reported in association with topical administration of chloramphenicol.
4.9

Overdose
In view of the relatively small amount of chloramphenicol in chloramphenicol
eye ointment, overdosage with this product is unlikely to constitute a hazard.
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 opthalmological examination should be
considered.

5

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties
Chloramphenicol is a potent inhibitor of bacterial protein synthesis, and exerts
its effects by interfering with the transfer of activated amino acids from
soluble RNA to ribosomes.
Escherichia coli, Haemophilus influenzae, Staphyloccus aureus, Streptococcus
haemolyticus, Morax anenfeld, Klebsiella/Enterobacter species and others.
Entrobacteriaceae are variably resistant while Pseudomonas and Mycobacteria
are usually resistant.

5.2

Pharmacokinetic properties
Chloramphenicol enters the aqueous humour following topical application.
Chloramphenicol is widely distributed in body tissues and fluids: it enters the
CSF, giving concentrations of about 50% of those existing in the blood even in
the absence of inflamed meninges; it diffuses across the placenta into the fetal
circulation, into breast milk, and into the aqueous and vitreous humour of the
eye. Up to about 60% in the circulation is bound to plasma protein. The halflife of chloramphenicol has been reported to range from 1.5 to 4 hours; the
half-life is prolonged in patients with severe hepatic impairment and is also
much longer in neonates. Renal impairment has relatively little effect on the
half-life of the active drug, due to its extensive metabolism, but may lead to
accumulation of the inactive metabolites. Chloramphenicol is excreted mainly
in urine.
The absorption, metabolism, and excretion of chloramphenicol are subject to
considerable interindividual variation, especially in infants and children,

making monitoring of plasma concentrations necessary to determine
pharmacokinetic in a given patient.
5.3

Preclinical safety data
Preclinical safety data does not add anything of further significance to the
prescriber.

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients
Liquid Paraffin
Polyethylene in Mineral Oil (Plastibase 50W

6.2

Incompatibilities
Not applicable.

6.3

Shelf life
4 years

6.4

Special precautions for storage
Do not store above 25°C.
Although the shelf life once opened is 28 days, patients will be advised to
discard the medicine after a 5 day course of treatment.

6.5

Nature and contents of container
4 gm laminated tube fitted with an ophthalmic nozzle and screw cap

6.6

Special precautions for disposal
None

7

MARKETING AUTHORISATION HOLDER
Optrex Limited
1 Thane Road West
Nottingham
NG2 3AA

8

MARKETING AUTHORISATION NUMBER(S)
PL 00062/0052

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
30/07/2007
05/03/2012

10

DATE OF REVISION OF THE TEXT
23/07/2009

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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