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CLOROGEN EYE DROPS 0.5% W/V

Active substance(s): CHLORAMPHENICOL / CHLORAMPHENICOL / CHLORAMPHENICOL

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Clorogen Eye Drops 0.5% w/v

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Chloramphenicol
0.5 % w/v
Excipients with known effect
Phenylmercuric Nitrate
0.002 % w/v
For the full list of excipients, see Section 6.1

3

PHARMACEUTICAL FORM
Eye Drops, solution.
A bright, colourless to faint yellow aqueous solution

4.1

Therapeutic indications
Chloramphenicol is broad spectrum antibiotic indicated in both adults and children
aged 2 years and over for the treatment of acute bacterial conjunctivitis.

4.2

Posology and method of administration
Posology:
Adults, children aged 2 years and over and the elderly
One drop to be instilled into the infected eye every 2 hours for the first 48 hours and 4
hourly thereafter. To be used during waking hours only. The course of treatment is 5
days.
Treatment should continue for 5 days even if symptoms improve.
Administration:
For ocular use only.

4.3

Contraindications
Chloramphenicol eye drops must not be administered to patients who have:


Hypersensitivity to chloramphenicol or to any other ingredient of the drops
listed in section 6.1.



Myelosuppression during previous exposure to chloramphenicol.



4.4

Family history of blood dyscrasias.

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 drops after the five day course of treatment
For external use only.
Keep all medicines out of the sight and reach of children.
Phenylmercuric nitrate is irritant to the skin. Topical application to eyes has
been associated with mercurialentis and atypical band keratopathy.
Patients should be referred to a 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
• Contact lens use
If this product is used following advice from a contact lens practitioner or
doctor contact lenses should not be worn during the course of treatment. Soft
contact lenses should not be replaced for 24 hours after completing the
treatment.

4.5

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

4.6

Fertility, 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
Transient blurring of vision may occur immediately after use and driving or using
machinery should not occur until the vision is clear.

4.8

Undesirable effects
Eye disorders:
Transient irritation, burning, stinging and sensitivity reactions such as
itching and dermatitis.
Immune System Disorders
Hypersensitivity reactions including angioedema, anaphylaxis, urticaria,
fever, vesicular and maculopapular dermatitis. Treatment must be
discontinued immediately in such cases.
Blood and lymphatic system disorders:
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.
Reporting of suspected adverse reactions:
Reporting suspected adverse reactions 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 Yellow card scheme at
www.mhra.gov.uk/yellowcard.

4.9

Overdose
In view of the relatively small amount of chloramphenicol in Chloramphenicol
Eye Drops, overdosage with this product is unlikely to constitute a hazard. No
specific treatment would be required.

5

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties
ATC Code: S01AA01 Ophthalmological antibiotics.
Chloramphenicol is a broad spectrum antibiotic with bacteriostatic activity and is
effective against a wide range of gram-negative and gram-positive organisms.

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 if 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.
Staphylococcus aureus
Streptococcus pyogenes
Streptococcus pneumoniae
Other beta-haemolytic streptococci
Haemophilius influenze
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
non-fermenters such as Pseudomonas aeruginosa.

5.2

Pharmacokinetic properties
Following topical application to the eye, chloramphenicol may be absorbed
into the aqueous humour. Sufficient chloramphenicol may be absorbed from
the eye to appear in the systemic circulation.
Specific data on systemic absorption from this dosage presentation is not
available.
Chloramphenicol is readily absorbed when given by mouth. Blood
concentrations of 10µg per ml or more may be reached about 1 or 2 hours after
a single dose of 1g by mouth, and blood concentrations of about 18.5µg per ml
have been reported after multiple 1g doses. Choramphenicol palmitate is
hydrolysed to chloramphenicol in the gastrointestinal tract prior to absorption,
and the sodium succinate, which is given parenterally is probably hydrolysed
to free drug mainly in the liver, lungs, and kidneys; such hydrolysis may be

incomplete in infants and neonates, contributing to the variable
pharmacokinetics in this age group. Chloramphenicol sodium succinate is,
even in adults, only partially and variably hydrolysed, so that blood
concentrations of chloramphenicol obtained after parenteral administration of
the sodium succinate are often lower than those obtained after administration
of chloramphenicol by mouth, with up to 30% of a dose excreted unchanged in
the urine before hydrolysis can take place.
Chloramphenicol is widely distributed in body tissues and fluids; it enters the
cerebrospinal fluid, 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 foetal circulation, into breast milk, and into the aqueous and
vitreous humours of the eye. Up to about 60% in the circulation is bound to
plasma protein. The half-life 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 the urine but only 5 to 10% of an oral
dose appears unchanged; the remainder is inactivated in the liver, mostly by
conjugation with glucorinic acid. About 3% is excreted in the bile. However,
most is reabsorbed and only about 1%, mainly in the inactive form, is excreted
in the faeces.
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
pharmacokinetics in a given patient.
5.3

Preclinical safety data
Nothing of relevance which is not included in other sections of the SPC

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients
Borax
Boric Acid
Phenylmercuric Nitrate
Purified Water

6.2

Incompatibilities
Not Applicable

6.3

Shelf life
Unopened:

24 months

Although the shelf life once opened is 28 days, patients should be advised to
discard the medicine after a 5 day course of treatment.

6.4

Special precautions for storage
Store at 2ºC to 8ºC

Store in the original carton to protect from light.
6.5

Nature and contents of container
Pack Type A
10 ml Low density polyethylene bottle with polystyrene spiked cap.
Pack Type B
Low density polyethylene (LDPE )vial with insert-cap assembly, comprising of white
coloured, HDPE screw-cap over a LDPE nozzle with tamper- evident LDPE dustcover sealing the vial cap.
Pack size: 10 ml

6.6

Special precautions for disposal
None stated

7

MARKETING AUTHORISATION HOLDER
FDC International Ltd
Unit 6 Fulcrum 1, Solent Way, Whiteley, Fareham, Hampshire PO15 7FE

8

MARKETING AUTHORISATION NUMBER(S)
PL 15872/0015

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
27/09/2010

10

DATE OF REVISION OF THE TEXT
04/10/2016

Expand Transcript

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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