BROCHLOR 0.5% W/W EYE DROPS
Active substance: CHLORAMPHENICOL
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SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Brochlor 0.5% w/v Eye Drops Brolene Antibiotic 0.5% w/v Eye Drops
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Chloramphenicol 0.5% w/v For excipients see 6.1
3.
PHARMACEUTICAL FORM Eye drops.
4 4.1.
CLINICAL PARTICULARS Therapeutic indications Treatment of acute bacterial conjunctivitis.
4.2.
Posology and method of administration The recommended dosage for adults (including the elderly) and children aged 2 years and over is one drop to be applied to the affected eye every two hours for the first 48 hours and 4 hourly thereafter. To be used during waking hours only. Treatment should continue for 5 days, even if symptoms improve.
4.3.
Contraindications Chloramphenicol eye drops should not be administered to patients hypersensitive to chloramphenicol or any other ingredients in the formulation, or given to those with a known personal or family history of blood dyscrasias including aplastic anaemia.
4.4.
Special warnings and precautions for use Prolonged use of chloramphenicol eye drops should be avoided as it may increase the likelihood of sensitisation and emergence of resistant organisms. Do not use for more than 5 days without consulting a doctor. Medical advice should be sought if there is no improvement in the condition after 2 days or if symptoms worsen at any time. Patients should be referred to their 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: 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 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 treatment. The labels 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. Discard any remaining eye drops after the five day course of treatment. Do not use if you are allergic to chloramphenicol or any of the other ingredients. Phenylmercuric nitrate is irritating to the skin. Topical application to eyes has been associated with mercurialentis and atypical band keratopathy.
4.5.
Interactions with other medicinal products and other forms of interaction The concomitant administration of chloramphenicol with other drugs liable to depress bone marrow function should be avoided.
4.6.
Pregnancy and lactation The safety of Chloramphenicol Eye Drops during pregnancy and lactation has not been established. Chloramphenicol may be absorbed systemically following the use of eye drops and may cross the placenta and appear in breast milk. Therefore this product is not recommended for use during pregnancy and lactation.
4.7.
Effects on ability to drive and use machines Chloramphenicol eye drops may cause transient blurring of vision when applied to the eye. Patients should be warned not to drive or operate hazardous machinery unless their vision is clear.
4.8.
Undesirable effects Chloramphenicol eye drops may cause transient stinging and irritation when applied to the eye. Bone marrow depression, including irreversible and fatal aplastic anaemia has been reported following topical use of chloramphenicol. Whilst the hazard is a rare one, it should be borne in mind when assessing the benefits expected from the use of this compound.
4.9.
Overdose Not applicable.
5 5.1.
PHARMACOLOGICAL PROPERTIES Pharmacodynamic properties
Chloramphenicol is a broad spectrum antibiotic with bacteriostatic activity and is effective against a wide range of Gram-negative and Gram-positive organisms.
5.2.
Pharmacokinetic properties Not applicable to topical (ophthalmic) preparation.
5.3.
Preclinical safety data Preclinical safety data does not add anything of further significance.
6 6.1.
PHARMACEUTICAL PARTICULARS List of excipients Borax, boric acid, phenylmercuric nitrate, purified water.
6.2.
Incompatibilities Not known.
6.3
Shelf life
24 months from the date of manufacture. The in-use shelf life is 28 days, however the patient should be advised to discard any remaining contents after the 5-day course of treatment.
6.4.
Special precautions for storage Protect from light. Store between 2 C and 8 C.
6.5.
Nature and contents of container A flexible polypropylene bottle incorporating a polyethylene plug and cap assembly. The bottles contain 10ml.
6.6.
Instruction for use and handling None.
7
MARKETING AUTHORISATION HOLDER
Aventis Pharma Limited One Onslow Street Guildford Surrey GU1 4YS UK Or trading as: Sanofi-aventis or Sanofi One Onslow Street Guildford Surrey GU1 4YS UK
8.
MARKETING AUTHORISATION NUMBER PL 04425/0366
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 12 August 2004
10
DATE OF REVISION OF THE TEXT
24/02/2012
1
NAME OF THE MEDICINAL PRODUCT
Brochlor 0.5% w/v Eye Drops Brolene Antibiotic 0.5% w/v Eye Drops
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Chloramphenicol 0.5% w/v For excipients see 6.1
3.
PHARMACEUTICAL FORM Eye drops.
4 4.1.
CLINICAL PARTICULARS Therapeutic indications Treatment of acute bacterial conjunctivitis.
4.2.
Posology and method of administration The recommended dosage for adults (including the elderly) and children aged 2 years and over is one drop to be applied to the affected eye every two hours for the first 48 hours and 4 hourly thereafter. To be used during waking hours only. Treatment should continue for 5 days, even if symptoms improve.
4.3.
Contraindications Chloramphenicol eye drops should not be administered to patients hypersensitive to chloramphenicol or any other ingredients in the formulation, or given to those with a known personal or family history of blood dyscrasias including aplastic anaemia.
4.4.
Special warnings and precautions for use Prolonged use of chloramphenicol eye drops should be avoided as it may increase the likelihood of sensitisation and emergence of resistant organisms. Do not use for more than 5 days without consulting a doctor. Medical advice should be sought if there is no improvement in the condition after 2 days or if symptoms worsen at any time. Patients should be referred to their 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: 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 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 treatment. The labels 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. Discard any remaining eye drops after the five day course of treatment. Do not use if you are allergic to chloramphenicol or any of the other ingredients. Phenylmercuric nitrate is irritating to the skin. Topical application to eyes has been associated with mercurialentis and atypical band keratopathy.
4.5.
Interactions with other medicinal products and other forms of interaction The concomitant administration of chloramphenicol with other drugs liable to depress bone marrow function should be avoided.
4.6.
Pregnancy and lactation The safety of Chloramphenicol Eye Drops during pregnancy and lactation has not been established. Chloramphenicol may be absorbed systemically following the use of eye drops and may cross the placenta and appear in breast milk. Therefore this product is not recommended for use during pregnancy and lactation.
4.7.
Effects on ability to drive and use machines Chloramphenicol eye drops may cause transient blurring of vision when applied to the eye. Patients should be warned not to drive or operate hazardous machinery unless their vision is clear.
4.8.
Undesirable effects Chloramphenicol eye drops may cause transient stinging and irritation when applied to the eye. Bone marrow depression, including irreversible and fatal aplastic anaemia has been reported following topical use of chloramphenicol. Whilst the hazard is a rare one, it should be borne in mind when assessing the benefits expected from the use of this compound.
4.9.
Overdose Not applicable.
5 5.1.
PHARMACOLOGICAL PROPERTIES Pharmacodynamic properties
Chloramphenicol is a broad spectrum antibiotic with bacteriostatic activity and is effective against a wide range of Gram-negative and Gram-positive organisms.
5.2.
Pharmacokinetic properties Not applicable to topical (ophthalmic) preparation.
5.3.
Preclinical safety data Preclinical safety data does not add anything of further significance.
6 6.1.
PHARMACEUTICAL PARTICULARS List of excipients Borax, boric acid, phenylmercuric nitrate, purified water.
6.2.
Incompatibilities Not known.
6.3
Shelf life
24 months from the date of manufacture. The in-use shelf life is 28 days, however the patient should be advised to discard any remaining contents after the 5-day course of treatment.
6.4.
Special precautions for storage Protect from light. Store between 2 C and 8 C.
6.5.
Nature and contents of container A flexible polypropylene bottle incorporating a polyethylene plug and cap assembly. The bottles contain 10ml.
6.6.
Instruction for use and handling None.
7
MARKETING AUTHORISATION HOLDER
Aventis Pharma Limited One Onslow Street Guildford Surrey GU1 4YS UK Or trading as: Sanofi-aventis or Sanofi One Onslow Street Guildford Surrey GU1 4YS UK
8.
MARKETING AUTHORISATION NUMBER PL 04425/0366
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 12 August 2004
10
DATE OF REVISION OF THE TEXT
24/02/2012
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.
