This information is intended for use by health professionals
Clorogen Eye Drops 0.5% w/v
Clorogen Eye Drops 0.5% w/v contains 5mg/ml Chloramphenicol
Excipients with known effect
Phenylmercuric Nitrate 0.002 % w/v
Borax and Boric acid (one ml of solution contains 3.075 mg boron)
For the full list of excipients, see Section 6.1
Eye Drops, solution.
A bright, colourless to faint yellow aqueous solution
Chloramphenicol is broad spectrum antibiotic indicated in both adults and children aged 2 years and over for the treatment of acute bacterial conjunctivitis.
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.
Method of Administration
For ocular use only.
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.
• Family history of blood dyscrasias.
• Must not be given to a child less than 2 years old (see also section 4.4).
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.
Patients should be referred to a doctor if any of the following apply:
• Disturbed vision
• Severe pain within the eye
• 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
• 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.
Phenylmercuric nitrate is irritant to the skin. Topical application to eyes has been associated with mercurialentis and atypical band keratopathy.
This medicinal product must not be given to a child less than 2 years old as it contains boron and may impair fertility in the future (see also section 4.3).
Bone marrow suppressant drugs.
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.
No fertility data are available.
Transient blurring of vision may occur immediately after use and driving or using machinery should not occur until the vision is clear.
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 or search for MHRA Yellow Card in the Google Play or Apple App Store.
In view of the relatively small amount of chloramphenicol in Clorogen Eye Drops, overdosage with this product is unlikely to constitute a hazard. No specific treatment would be required.
Pharmacotherapeutic group: Ophthalmological antibiotics
ATC Code: S01AA01
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.
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.
Other beta-haemolytic streptococci
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.
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.
Nothing of relevance which is not included in other sections of the SPC
BoraxBoric AcidPhenylmercuric Nitrate
Water for injection
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.
Store at 2°C to 8°C
Store in the original carton to protect from light.
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 dust- cover sealing the vial cap.
Pack size: 10 ml
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
FDC International Ltd
Unit 6 Fulcrum 1
27 September 2010
10 November 2020