Chloramphenicol 1% W/W Antibiotic Eye Ointment
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Chloramphenicol 1% w/w Antibiotic Eye Ointment
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Chloramphenicol 1% w/w
Excipient(s): Also contains wool fat.
For full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Eye Ointment Smooth yellow ointment.
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 topical ocular use.
The ointment is applied into the space between the lower eyelid and the eye.
Adults (including elderly people) and children aged 2 years and over:
If using just the eye ointment, apply about 1 cm of ointment to the affected eye(s) 3 to 4 times a day.
If using chloramphenicol eye drops during the day and the eye ointment at night - apply the ointment at night, before going to bed.
The course of treatment is 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 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.
For external use only.
Keep all medicines out of the sight and reach of children.
The eye ointment should not be used in children under the age of 2, since there have been very rare reports of leukemia and grey baby syndrome.
Prolonged use of chloramphenicol ointment is not advisable.
Chloramphenicol eye ointment should not be used for more than 5 days at a time except on the advice of a doctor.
The label will state:
• Consult your doctor immediately if :
♦ symptoms worsen at any time
♦ no improvement within 48 hours.
• Discard after a 5 day course of treatment.
• Do not use if allergic to:
♦ chloramphenicol
♦ the other 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 ointments or eye drops
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 the eye ointment.
The product contains wool fat (lanolin) which may cause local skin reactions (e.g. contact dermatitis).
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 ointment. Chloramphenicol does cross the placenta and enter breast milk. Therefore chloramphenicol eye ointment should not be used during pregnancy and breastfeeding.
4.7 Effects on ability to drive and use machines
May cause transient blurring of vision on instillation of the ointment. User 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.
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 ointment.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Pharmacotherapeutic group (AITC code): S01 AA01, antibiotics for topical use.
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
Liquid paraffin, wool fat, yellow soft paraffin.
6.2 Incompatibilities
None known
Shelf life
6.3
36 months unopened
28 days once opened
6.4 Special precautions for storage
Do not store above 25°C.
6.5 Nature and contents of container
Pre-printed collapsible polyethylene / aluminium foil laminated tube with integral nozzle and a tamper evident polyethylene cap. Each tube is packed into a carton.
Contents: 4g of product.
6.6 Special precautions for disposal
Sterile until opened.
Although the shelf life once opened is 28 days, patients should be advised to discard the medicine after a 5 day course of treatment.
7. MARKETING AUTHORISATION HOLDER
Galpharm Healthcare Limited
Wrafton
Braunton
Devon
EX33 2DL
United Kingdom
8 MARKETING AUTHORISATION NUMBER(S)
PL 16028/0133
9
10
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
05/11/2009
DATE OF REVISION OF THE TEXT
23/08/2016