Chloramphenicol 0.5% W/V (5mg/Ml) Antibiotic Eye Drops Solution
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Chloramphenicol 0.5% w/v (5 mg/ml) Antibiotic Eye Drops, solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Chloramphenicol 0.5% w/v (5 mg/ml)
Excipient(s): Also contains Phenylmercuric nitrate.
For full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Eye Drops, solution
Clear colourless to slightly yellow solution
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Treatment of acute bacterial conjunctivitis in both adults and children.
4.2 Posology and method of administration
Administration: For ocular use.
Adults (including the elderly) and children:
• Put one drop into the affected eye(s) every 2 hours for the first 48 hours and 4 hourly thereafter.
• To be used during waking hours only
• The course of treatment should be 5 days. If symptoms are worsening during treatment or not improving after 48 hours, consult a doctor. Courses longer than 5 days should only be used on the advice of a doctor. The maximum duration of treatment is 10-14 days.
Paediatric population
Dosage adjustment may be necessary in newborn infants because of reduced systemic elimination due to immature metabolism and the risk of dose-related adverse effects. The maximum duration of treatment is 10-14 days.
4.3 Contraindications
Hypersensitivity to chloramphenicol or to any other component of the preparation.
Family or personal history of blood dyscrasias including aplastic anaemia.
Patients who have experienced myelosuppression during previous exposure to chloramphenicol.
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 an overgrowth of nonsusceptible 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. For external use only.
Keep all medicines out of the sight and reach of children.
Prolonged use of chloramphenicol eye drops is not advisable. Chloramphenicol eye drops should not be used for more than 5 days at a time except on the advice of a doctor.
The label will state:
• Seek further immediate medical advice any time if symptoms worsen.
• Consult your doctor if your eye infection does not start to improve within 48 hours.
• Discard the medicine after a 5 day course of treatment.
• Do not use if you are allergic to chloramphenicol or any of the ingredients
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:
• Associated pain or swelling around the eye or face
• 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 users
If this product is used following advice from a contact lens practitioner or doctor, contact lenses should not be worn during the period of treatment. Contact lens users may use glasses during treatment with chloramphenicol eye drops. Hard contact lens users and disposable contact lens users can start using their lenses again after successfully completing a course of treatment. Soft contact lens wearers should wait 24 hours after completing a course of treatment before starting to use their lenses again.
Information relating specifically to excipients in this formulation
Phenylmercuric nitrate is irritant to the skin. Topical application to eyes has been associated with mercurialentis and atypical band keratopathy.
4.5 Interaction with other medicinal products and other forms of interaction
Chymotrypsin will be inhibited if given simultaneously with chloramphenicol.
The concomitant administration of chloramphenicol with other drugs liable to depress bone marrow function should be avoided.
4.6 Pregnancy and lactation
Chloramphenicol may be absorbed systemically following the use of the eye drops. Chloramphenicol does cross the placenta and enter breast milk. Therefore chloramphenicol eye drops should not be used during pregnancy and breastfeeding.
4.7
Effects on ability to drive and use machines
The use of the eye drops may cause transient blurring of vision. Patients should not drive or operate hazardous machinery unless vision is clear.
4.8 Undesirable effects
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.
Local Effects:
Sensitivity reactions such as transient irritation, burning, stinging, itching and dermatitis have been reported.
Sometimes the eye drops can be tasted or affect taste as they drain from the eye into the back of the mouth.
The prolonged use of eye drops containing a phenylmercuric preservative has been associated with skin irritation, primary atypical band keratopathy (changes to the cornea) and mercurialentis (pigmentation of the anterior capsule of the lens).
Systemic effects:
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 the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.
4.9 Overdose
Refer to a doctor in the event of accidental ingestion of the eye drops.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Chloramphenicol is a broad spectrum antibiotic which has activity against many types of Gram-positive and Gram-negative bacteria. Chloramphenicol is not effective against fungi, protozoa, and viruses.
Acute bacterial conjunctivitis is commonly caused by staphylococci or streptococci in adults, and Haemophilus influenzae and Moraxella catarrhalis (formerly known as Branhamella catarrhalis) particularly in children.
Chloramphenicol is effective against Gram-positive cocci including staphylococci such as Staph. epidermidis and some strains of Staph. aureus, and streptococci such as Str., pneumoniae, Str. pyogenes, and the viridans streptococci.
Gram-negative cocci such as Haemophilus influenzae are usually highly sensitive. Moraxella catarrhalis, a Gram-negative aerobic diplococcus frequently found as a commensal of the upper respiratory tract, is also highly sensitive.
5.2 Pharmacokinetic properties
Evidence suggests that chloramphenicol is absorbed systemically via topical ocular administration. Any chloramphenicol that is absorbed will be widely distributed in the body tissues and fluids. It is found in cerebrospinal fluid, is secreted in saliva, with the highest concentrations occurring in the kidneys and liver.
Chloramphenicol also diffuses across the placenta into the foetal circulation and into breast milk.
Chloramphenicol is excreted chiefly in the urine as the glucuronide with small amounts being excreted via the bile and faeces. It has a reported half life of 1.5 to 5 hours which is increased in patients with liver impairment and neonates to between 24 and 28 hours in the latter.
5.3 Preclinical safety data
No additional data of relevance to the prescriber.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Borax
Boric Acid
Phenylmercuric Nitrate Purified Water
6.2 Incompatibilities
None known
6.3 Shelf life
24 months Unopened
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 upright at 2 to 8°C in a dry place away from strong sunlight and do not freeze (for example keep in a fridge).
6.5 Nature and contents of container
Low density polyethylene bottle and dropper insert with high density polyethylene cap. There is a tamper evident seal, which is broken when the bottle is first opened.
Fill volume is 10ml. Each bottle is then packed into a carton with a patient information leaflet.
6.6 Special precautions for disposal
No special requirements
7. MARKETING AUTHORISATION HOLDER
Galpharm Healthcare Limited
Wrafton
Braunton
Devon
EX33 2DL
United Kingdom
8 MARKETING AUTHORISATION NUMBER(S)
PL 16028/0132
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
05/11/2009
10 DATE OF REVISION OF THE TEXT
28/10/2016