- Approval Id
- c25453d134cfb292
- Drug Approval Emc Name
- Optrex Infected Eye Drops
- Drug Name
- Optrex Infected Eye Drops
- Company Address
- RB Consumer Relations, PO Box 4644, SLOUGH, SL1 0NS, UK
- Company Website
- http://www.reckittbenckiser.com
- Company Telephone
- 0333 2005 345
- Company Medical Info Direct Line
- 0333 2005 345
- Company Customer Care Direct Line
- 0333 2005 345
- Atc Code
- S01AA01
- Legal Category
- Pharmacy
- Authorisation Holder
- Optrex Limited
103-105 Bath Road
Slough
SL1 3UH
UK
- Authorisation Number
- PL 00062/0051
- Authorisation Date
- 10 March 2004
- Instruction Authorisation Holder
- Optrex Limited
103-105 Bath Road
Slough
SL1 3UH
UK
- Instruction Authorisation Number
- PL 00062/0051
- Instruction Authorisation Date
- 10 March 2004
- Instruction Composition
- Chloramphenicol 0.5% w/v.
Excipients with known effect: Phenylmercuric nitrate, Boric Acid (and Borates) (0.115 mg boron/drop)
For full list of excipients, see Section 6.1.
- Instruction Dosage Form
- Eye drops, solution.A clear, slightly yellow solution.
- Instruction Clinical Particulars
- 4.1 Therapeutic indications
Treatment of acute bacterial conjunctivitis.4.2 Posology and method of administration
\*\*Posology\*\*
\*\*Adults:\*\*
One drop instilled into the infected eye every 2 hours for the first 48 hours and 4 hourly thereafter. To be used during waking hours only. The course of treatment is 5 days. Treatment should continue for 5 days even if symptoms improve.
If symptoms persist or worsen after 48 hours, or have not resolved within 5 days, consult a healthcare professional.
\*\*Paediatric Population:\*\*
Children aged 2 years and over: As above for adults.
Children under 2 years: this product is not recommended for children under 2 years of age.
\*\*Elderly\*\*:
No dosage adjustments are required for elderly
\*\*Method of administration:\*\*
For ocular use.4.3 Contraindications
Chloramphenicol eye drops must not be administered to:
• Patients who have a history of hypersensitivity to chloramphenicol or to any other ingredient of the drops.
• Patients with pre-existing bone-marrow depression or 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.
Toxic epidermal necrolysis have been reported very rarely in association with the use of chloramphenicol (see section 4.8).
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 drops after the five day course of treatment
For external use only.
Keep all medicines out of the sight and reach of children.
Phenylmercuric nitrate may cause allergic reactions. Topical application to eyes has been associated with mercurialentis and atypical band keratopathy.
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:
• 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 the treatment.4.5 Interaction with other medicinal products and other forms of interaction
Bone marrow depressant drugs4.6 Fertility, pregnancy and lactation
Pregnancy
The safety of chloramphenicol eye drops during pregnancy has not been established. As this product is for sale without prescription it is not recommended for use during pregnancy.
Breast-feeding
In view of the fact that chloramphenicol/metabolites are excreted in human milk and effects have been shown in breastfed newborns/ infants of treated women, the product should not be used during lactation.
Fertility
No data on human fertility are available.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
Adverse events which have been associated with topical chloramphenicol are given below, tabulated by system organ class and frequency. Frequencies are defined as: Very common (≥1/10); Common (≥1/100 and <1/10); Uncommon (≥1/1000 and <1/100); Rare (≥1/10,000 and <1/1000); Very rare (< 1/10,000); Not known (cannot be estimated from the available data). Within each frequency grouping, adverse events are presented in order of decreasing seriousness.
| | | |
| --- | --- | --- |
| System Organ Class | Frequency | Adverse Events |
| Blood and Lymphatic System Disorders | Not known | Bone marrow failure1, aplastic anaemia1,2 |
| Immune System Disorders | Not known | Hypersensitivity3 |
| Eye Disorders | Not known | Vision blurred, eye pain, eye swelling, eye irritation |
| Skin and Subcutaneous Tissue Disorders | Not known | Rash vesicular, rash maculo-papular |
Description of Selected Adverse Reactions:
1 Bone marrow failure, 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.
2 This can include neutropenia and thrombocytopenia.
3 This can include rashes, fever, angioedema, urticaria and anaphylaxis. Treatment must be discontinued immediately in such cases.
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/yellowcard4.9 Overdose
\*\*Symptoms\*\*
In view of the relatively small amount of chloramphenicol in chloramphenicol eye drops, overdosage with this product is unlikely to constitute a hazard. Localised symptoms such as eye irritation, pain or swelling, lacrimation or photophobia may occur.
\*\*Management\*\*
If excess product is applied to the eye the eye should be washed out with water and symptomatic treatment given.
- Instruction Pharmacology
- 5.1 Pharmacodynamic properties
\*\*Pharmacotherapeutic group:\*\* Sensory organs; Ophthalmologicals; Antiinfectives; Antibiotics; Chloramphenicol;
\*\*ATC Code:\*\* S01AA01
Chloramphenicol is a broad spectrum bacteriostatic antibiotic active against a wide variety of gram-negative and gram-positive organisms.
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 if 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
\*Haemophilius influenze\*
\*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
Following topical application to the eye, chloramphenicol may be absorbed into the aqueous humour. Sufficient chloramphenicol may be absorbed from the eye to appear in the systemic circulation.
Specific data on systemic absorption from this dosage presentation is not available.
Chloramphenicol is readily absorbed when given by mouth. Blood concentrations of 10µg per ml or more may be reached about 1 or 2 hours after a single dose of 1g by mouth, and blood concentrations of about 18.5µg per ml have been reported after multiple 1g doses. Choramphenicol palmitate is hydrolysed to chloramphenicol in the gastrointestinal tract prior to absorption, and the sodium succinate, which is given parenterally is probably hydrolysed to free drug mainly in the liver, lungs, and kidneys; such hydrolysis may be incomplete in infants and neonates, contributing to the variable pharmacokinetics in this age group. Chloramphenicol sodium succinate is, even in adults, only partially and variably hydrolysed, so that blood concentrations of chloramphenicol obtained after parenteral administration of the sodium succinate are often lower than those obtained after administration of chloramphenicol by mouth, with up to 30% of a dose excreted unchanged in the urine before hydrolysis can take place.
Chloramphenicol is widely distributed in body tissues and fluids; it enters the cerebrospinal fluid, 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 foetal circulation, into breast milk, and into the aqueous and vitreous humours of the eye. Up to about 60% in the circulation is bound to plasma protein. The half-life 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 the urine but only 5 to 10% of an oral dose appears unchanged; the remainder is inactivated in the liver, mostly by conjugation with glucorinic acid. About 3% is excreted in the bile. However, most is reabsorbed and only about 1%, mainly in the inactive form, is excreted in the faeces.
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 pharmacokinetics in a given patient.5.3 Preclinical safety data
There are no preclinical data of relevance to the prescriber which are additional to that already included.
- Instruction Pharmaceutical Particulars
- 6.1 List of excipients
Borax powder
Boric acid powder
Phenylmercuric nitrate
Purified Water6.2 Incompatibilities
Not applicable.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 at 2° to 8°C.
Protect from light.6.5 Nature and contents of container
The product will be packed in a capped bottle consisting of an opaque white Low Density Polyethylene (LDPE) bottle and dropper nozzle insert, with an opaque, screw on Polypropylene (PP), dropper cap with tamper evident band.
Pack size: 10 ml.6.6 Special precautions for disposal and other handling
None
- Instruction Content
- ## Composition
Chloramphenicol 0.5% w/v.
Excipients with known effect: Phenylmercuric nitrate, Boric Acid (and Borates) (0.115 mg boron/drop)
For full list of excipients, see Section 6.1.
## Pharmaceutical Form
Eye drops, solution.A clear, slightly yellow solution.
## Clinical Particulars
4.1 Therapeutic indications
Treatment of acute bacterial conjunctivitis.4.2 Posology and method of administration
\*\*Posology\*\*
\*\*Adults:\*\*
One drop instilled into the infected eye every 2 hours for the first 48 hours and 4 hourly thereafter. To be used during waking hours only. The course of treatment is 5 days. Treatment should continue for 5 days even if symptoms improve.
If symptoms persist or worsen after 48 hours, or have not resolved within 5 days, consult a healthcare professional.
\*\*Paediatric Population:\*\*
Children aged 2 years and over: As above for adults.
Children under 2 years: this product is not recommended for children under 2 years of age.
\*\*Elderly\*\*:
No dosage adjustments are required for elderly
\*\*Method of administration:\*\*
For ocular use.4.3 Contraindications
Chloramphenicol eye drops must not be administered to:
• Patients who have a history of hypersensitivity to chloramphenicol or to any other ingredient of the drops.
• Patients with pre-existing bone-marrow depression or 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.
Toxic epidermal necrolysis have been reported very rarely in association with the use of chloramphenicol (see section 4.8).
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 drops after the five day course of treatment
For external use only.
Keep all medicines out of the sight and reach of children.
Phenylmercuric nitrate may cause allergic reactions. Topical application to eyes has been associated with mercurialentis and atypical band keratopathy.
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:
• 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 the treatment.4.5 Interaction with other medicinal products and other forms of interaction
Bone marrow depressant drugs4.6 Fertility, pregnancy and lactation
Pregnancy
The safety of chloramphenicol eye drops during pregnancy has not been established. As this product is for sale without prescription it is not recommended for use during pregnancy.
Breast-feeding
In view of the fact that chloramphenicol/metabolites are excreted in human milk and effects have been shown in breastfed newborns/ infants of treated women, the product should not be used during lactation.
Fertility
No data on human fertility are available.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
Adverse events which have been associated with topical chloramphenicol are given below, tabulated by system organ class and frequency. Frequencies are defined as: Very common (≥1/10); Common (≥1/100 and <1/10); Uncommon (≥1/1000 and <1/100); Rare (≥1/10,000 and <1/1000); Very rare (< 1/10,000); Not known (cannot be estimated from the available data). Within each frequency grouping, adverse events are presented in order of decreasing seriousness.
| | | |
| --- | --- | --- |
| System Organ Class | Frequency | Adverse Events |
| Blood and Lymphatic System Disorders | Not known | Bone marrow failure1, aplastic anaemia1,2 |
| Immune System Disorders | Not known | Hypersensitivity3 |
| Eye Disorders | Not known | Vision blurred, eye pain, eye swelling, eye irritation |
| Skin and Subcutaneous Tissue Disorders | Not known | Rash vesicular, rash maculo-papular |
Description of Selected Adverse Reactions:
1 Bone marrow failure, 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.
2 This can include neutropenia and thrombocytopenia.
3 This can include rashes, fever, angioedema, urticaria and anaphylaxis. Treatment must be discontinued immediately in such cases.
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/yellowcard4.9 Overdose
\*\*Symptoms\*\*
In view of the relatively small amount of chloramphenicol in chloramphenicol eye drops, overdosage with this product is unlikely to constitute a hazard. Localised symptoms such as eye irritation, pain or swelling, lacrimation or photophobia may occur.
\*\*Management\*\*
If excess product is applied to the eye the eye should be washed out with water and symptomatic treatment given.
## Pharmacological Properties
5.1 Pharmacodynamic properties
\*\*Pharmacotherapeutic group:\*\* Sensory organs; Ophthalmologicals; Antiinfectives; Antibiotics; Chloramphenicol;
\*\*ATC Code:\*\* S01AA01
Chloramphenicol is a broad spectrum bacteriostatic antibiotic active against a wide variety of gram-negative and gram-positive organisms.
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 if 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
\*Haemophilius influenze\*
\*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
Following topical application to the eye, chloramphenicol may be absorbed into the aqueous humour. Sufficient chloramphenicol may be absorbed from the eye to appear in the systemic circulation.
Specific data on systemic absorption from this dosage presentation is not available.
Chloramphenicol is readily absorbed when given by mouth. Blood concentrations of 10µg per ml or more may be reached about 1 or 2 hours after a single dose of 1g by mouth, and blood concentrations of about 18.5µg per ml have been reported after multiple 1g doses. Choramphenicol palmitate is hydrolysed to chloramphenicol in the gastrointestinal tract prior to absorption, and the sodium succinate, which is given parenterally is probably hydrolysed to free drug mainly in the liver, lungs, and kidneys; such hydrolysis may be incomplete in infants and neonates, contributing to the variable pharmacokinetics in this age group. Chloramphenicol sodium succinate is, even in adults, only partially and variably hydrolysed, so that blood concentrations of chloramphenicol obtained after parenteral administration of the sodium succinate are often lower than those obtained after administration of chloramphenicol by mouth, with up to 30% of a dose excreted unchanged in the urine before hydrolysis can take place.
Chloramphenicol is widely distributed in body tissues and fluids; it enters the cerebrospinal fluid, 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 foetal circulation, into breast milk, and into the aqueous and vitreous humours of the eye. Up to about 60% in the circulation is bound to plasma protein. The half-life 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 the urine but only 5 to 10% of an oral dose appears unchanged; the remainder is inactivated in the liver, mostly by conjugation with glucorinic acid. About 3% is excreted in the bile. However, most is reabsorbed and only about 1%, mainly in the inactive form, is excreted in the faeces.
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 pharmacokinetics in a given patient.5.3 Preclinical safety data
There are no preclinical data of relevance to the prescriber which are additional to that already included.
## Pharmaceutical Particulars
6.1 List of excipients
Borax powder
Boric acid powder
Phenylmercuric nitrate
Purified Water6.2 Incompatibilities
Not applicable.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 at 2° to 8°C.
Protect from light.6.5 Nature and contents of container
The product will be packed in a capped bottle consisting of an opaque white Low Density Polyethylene (LDPE) bottle and dropper nozzle insert, with an opaque, screw on Polypropylene (PP), dropper cap with tamper evident band.
Pack size: 10 ml.6.6 Special precautions for disposal and other handling
None
- Company Detail Path
- /organization/reckitt-benckiser-healthcare-uk-ltd
