BOOTS PHARMACY ANTIBIOTIC EYE OINTMENT
Active substance: CHLORAMPHENICOL
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SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Optrex Infected Eye Ointment When sold by Boots The Chemist, the name will be Boots Pharmacy Antibiotic Eye Ointment
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Chloramphenicol 1.0% w/w. Each 1 gram of ointment contains 10mg chloramphenicol For excipients, see 6.1.
3
PHARMACEUTICAL FORM
Eye ointment.
4
4.1
CLINICAL PARTICULARS
Therapeutic indications Treatment of acute bacterial conjunctivitis.
4.2
Posology and method of administration Topical administration to the eye only. Adults, children aged 2 years and over and elderly The recommended dose is a small amount of ointment (~ 1cm) to be applied to the affected eye(s). The ointment should be applied either at night if eye drops are used during the day, or 3 to 4 times a day if eye ointment is used alone The pharmacist will advise on the most suitable treatment. Treatment should continue for 5 days even if symptoms improve.
4.3
Contraindications Chloramphenicol eye ointment must not be administered to: Patients who have a history of hypersensitivity to chloramphenicol or to any other ingredient of the ointment. 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 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 ointment 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 Any significant 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 If you wear contact lenses, seek advice either from your optometrist, contact lens practitioner 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 using the eye ointment.
4.5
Interaction with other medicinal products and other forms of interaction Bone marrow depressant drugs
4.6
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 Blurring of vision can occur with the ointment 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 ointment. 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 recognised to occur with systemic therapy, has been reported in association with topical administration of chloramphenicol. 4.9 Overdose In view of the relatively small amount of chloramphenicol in chloramphenicol eye ointment, overdosage with this product is unlikely to constitute a hazard. If irritation, pain, swelling, lacrimation or photophobia occur after undesired eye contact, the exposed eye(s) should be irrigated for at least 15 minutes. If symptoms persist after this, an opthalmological examination should be considered.
5
5.1
PHARMACOLOGICAL PROPERTIES
Pharmacodynamic properties Chloramphenicol is a potent inhibitor of bacterial protein synthesis, and exerts its effects by interfering with the transfer of activated amino acids from soluble RNA to ribosomes. Escherichia coli, Haemophilus influenzae, Staphyloccus aureus, Streptococcus haemolyticus, Morax anenfeld, Klebsiella/Enterobacter species and others. Entrobacteriaceae are variably resistant while Pseudomonas and Mycobacteria are usually resistant.
5.2
Pharmacokinetic properties Chloramphenicol enters the aqueous humour following topical application. Chloramphenicol is widely distributed in body tissues and fluids: it enters the CSF, 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 fetal circulation, into breast milk, and into the aqueous and vitreous humour of the eye. Up to about 60% in the circulation is bound to plasma protein. The halflife 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 urine. 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 pharmacokinetic in a given patient. 5.3 Preclinical safety data Preclinical safety data does not add anything of further significance to the prescriber.
6
6.1
PHARMACEUTICAL PARTICULARS
List of excipients Liquid Paraffin Polyethylene in Mineral Oil (Plastibase 50W
6.2
Incompatibilities Not applicable.
6.3
Shelf life 4 years
6.4
Special precautions for storage Do not store above 25C. Although the shelf life once opened is 28 days, patients will be advised to discard the medicine after a 5 day course of treatment.
6.5
Nature and contents of container 4 gm laminated tube fitted with an ophthalmic nozzle and screw cap
6.6
Special precautions for disposal None
7
MARKETING AUTHORISATION HOLDER
Optrex Limited 1 Thane Road West Nottingham NG2 3AA
8
MARKETING AUTHORISATION NUMBER(S)
PL 00062/0052
9
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
30/07/2007 05/03/2012
10
DATE OF REVISION OF THE TEXT
23/07/2009
1
NAME OF THE MEDICINAL PRODUCT
Optrex Infected Eye Ointment When sold by Boots The Chemist, the name will be Boots Pharmacy Antibiotic Eye Ointment
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Chloramphenicol 1.0% w/w. Each 1 gram of ointment contains 10mg chloramphenicol For excipients, see 6.1.
3
PHARMACEUTICAL FORM
Eye ointment.
4
4.1
CLINICAL PARTICULARS
Therapeutic indications Treatment of acute bacterial conjunctivitis.
4.2
Posology and method of administration Topical administration to the eye only. Adults, children aged 2 years and over and elderly The recommended dose is a small amount of ointment (~ 1cm) to be applied to the affected eye(s). The ointment should be applied either at night if eye drops are used during the day, or 3 to 4 times a day if eye ointment is used alone The pharmacist will advise on the most suitable treatment. Treatment should continue for 5 days even if symptoms improve.
4.3
Contraindications Chloramphenicol eye ointment must not be administered to: Patients who have a history of hypersensitivity to chloramphenicol or to any other ingredient of the ointment. 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 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 ointment 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 Any significant 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 If you wear contact lenses, seek advice either from your optometrist, contact lens practitioner 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 using the eye ointment.
4.5
Interaction with other medicinal products and other forms of interaction Bone marrow depressant drugs
4.6
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 Blurring of vision can occur with the ointment 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 ointment. 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 recognised to occur with systemic therapy, has been reported in association with topical administration of chloramphenicol. 4.9 Overdose In view of the relatively small amount of chloramphenicol in chloramphenicol eye ointment, overdosage with this product is unlikely to constitute a hazard. If irritation, pain, swelling, lacrimation or photophobia occur after undesired eye contact, the exposed eye(s) should be irrigated for at least 15 minutes. If symptoms persist after this, an opthalmological examination should be considered.
5
5.1
PHARMACOLOGICAL PROPERTIES
Pharmacodynamic properties Chloramphenicol is a potent inhibitor of bacterial protein synthesis, and exerts its effects by interfering with the transfer of activated amino acids from soluble RNA to ribosomes. Escherichia coli, Haemophilus influenzae, Staphyloccus aureus, Streptococcus haemolyticus, Morax anenfeld, Klebsiella/Enterobacter species and others. Entrobacteriaceae are variably resistant while Pseudomonas and Mycobacteria are usually resistant.
5.2
Pharmacokinetic properties Chloramphenicol enters the aqueous humour following topical application. Chloramphenicol is widely distributed in body tissues and fluids: it enters the CSF, 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 fetal circulation, into breast milk, and into the aqueous and vitreous humour of the eye. Up to about 60% in the circulation is bound to plasma protein. The halflife 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 urine. 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 pharmacokinetic in a given patient. 5.3 Preclinical safety data Preclinical safety data does not add anything of further significance to the prescriber.
6
6.1
PHARMACEUTICAL PARTICULARS
List of excipients Liquid Paraffin Polyethylene in Mineral Oil (Plastibase 50W
6.2
Incompatibilities Not applicable.
6.3
Shelf life 4 years
6.4
Special precautions for storage Do not store above 25C. Although the shelf life once opened is 28 days, patients will be advised to discard the medicine after a 5 day course of treatment.
6.5
Nature and contents of container 4 gm laminated tube fitted with an ophthalmic nozzle and screw cap
6.6
Special precautions for disposal None
7
MARKETING AUTHORISATION HOLDER
Optrex Limited 1 Thane Road West Nottingham NG2 3AA
8
MARKETING AUTHORISATION NUMBER(S)
PL 00062/0052
9
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
30/07/2007 05/03/2012
10
DATE OF REVISION OF THE TEXT
23/07/2009
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 drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
