Tubilux Infected Eyes Eye Drops
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Tubilux Infected Eyes Eye Drops
Golden Eye Antibiotic 0.5% w/v Chloramphenicol Eye Drops
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of solution contains Chloramphenicol 0.5% w/v.
For full list of excipients, see Section 6.1
3 PHARMACEUTICAL FORM
Eye drops, Solution.
A clear, colourless solution.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Topical treatment of acute bacterial conjunctivitis.
Consideration should be given to official guidance on the appropriate use of antibacterial agents.
Chloramphenicol is indicated in adults and children.
4.2 Posology and method of administration
Posology
Adults
One drop into the affected eye(s) every 2 hours for the first 48 hours and 4 hourly thereafter. The course of treatment is 5 days.
Paediatric population
As for adults. However, 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.
Method of administration
Topical treatment to the eye only.
Drops to be used during waking hours only.
4.3 Contraindications
• Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Chloramphenicol eye drops must not be administered to:
• 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
The label will convey the following information:
• 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 out of reach and sight of children
The product should not be used for more than 5 days without consulting a doctor.
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 and the patient should be referred to the doctor.
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.
Soft contact lenses should not be worn during treatment and for 24 hours after finishing treatment with chloramphenicol eye drops due to absorption of the preservative onto the lens, which may cause damage to the lens. It is recommended that all types of lenses be avoided during treatment.
The product contains phenylmercuric nitrate as preservative which may cause allergic reactions.
Patients should be referred to the doctor if they:-
• are contact lens wearers
• have had eye surgery, or laser treatment, within the last 6 months.
• are already using other eye drops or eye ointments
• have an eye injury
• are pregnant or breast feeding
• have glaucoma
• have dry eye syndrome
• have had conjunctivitis in the recent past
• have disturbed vision
• have photophobia
• have severe pain in the eye
• have cloudy eye,
• have eye inflammation accompanied by a rash on the scalp or face
• have a suspected foreign body in the eye
4.5 Interaction with other medicinal products and other forms of interaction
None Known. Do not use with other eye drops or eye ointments without first consulting a doctor
4.6 Fertility, pregnancy and lactation
The product should not be used during pregnancy and lactation.
4.7 Effects on ability to drive and use machines
Blurring of vision can occur with the drops 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 drops. 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 recognized to occur with systemic therapy, has been reported in association with topical administration of chloramphenicol.
The adverse reactions reported are tabulated below, classified by system organ class and ordered by descending order of severity.
The frequency of possible side effects listed below is defined using the following convention:
Rare (> 1/10 000 to < 1/1000)
Not known (frequency cannot be estimated from the available data).
|
Rare |
Not known |
|
Immune system disorders | |
|
Anaphylaxis | |
|
Angioneurotic oedema | |
|
Hypersensitivity reaction | |
|
Blood and lymphatic system disorders | |
|
Bone marrow depression | |
|
Aplastic anaemia | |
|
Skin and subcutaneous tissue disorders | |
|
Urticaria | |
|
Maculopapular rash | |
|
Vesicular rash | |
|
Dermatitis | |
|
General disorders and administration site conditions | |
|
Fever | |
|
Application site stinging | |
|
Application site burning | |
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:
United Kingdom
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard
4.9 Overdose
Accidental overdose or accidental ingestion of chloramphenicol eye drops is unlikely to cause systemic toxicity due to low content of chloramphenicol in the product.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: ophtalmologicals, antibiotics ATC Code: S01AA01
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 as soon as 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
Haemophilus influenzae 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
Absorption
Chloramphenicol is found in measurable amounts in the aqueous humour following local application to the eye.
Systemic exposure to chloramphenicol occurs at a very low level after topical ophthalmic use.
5.3 Preclinical safety data
All relevant information is included in the sections above.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Phenyl mercuric nitrate
Boric acid
Borax
Purified Water
6.2 Incompatibilities
Not Applicable.
6.3 Shelf life
Chloramphenicol 0.5% eye drops has a shelf-life of 2 years when unopened. When opened the shelf life is 28 days but any drops remaining after the 5-day course of treatment should be discarded.
6.4 Special precautions for storage
Store at 2-8° C. Keep container in outer carton.
6.5
Nature and contents of container
Bottle and tip are made of polypropylene and low density Polyethylene respectively with white coloring.
Pack size 10.0 ml.
6.6 Special precautions for disposal
Do not use if the pack is open when supplied.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
7 MARKETING AUTHORISATION HOLDER
Bausch & Lomb (UK) Ltd
Bausch &Lomb House 106 London Road Kingston-Upon-Thames Surrey KT2 6TN
UK
8 MARKETING AUTHORISATION NUMBER(S)
PL 03468/0025
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
9 September 2003
10 DATE OF REVISION OF THE TEXT
19/05/2016