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Therapeutic Category
- OPHTHALMOLOGICAL DRUGS
- ANTI-INFECTIVE AGENTS
- Pharmaceutical Form : Eye Drops
- Composition : Chloramphenicol 5 mg / 1 ml
- Active Substance : Chloramphenicol
Mechanism of action:
Chloramphenicol is a broad spectrum antibiotic with bacteriostatic activity and is effective against a wide range of Gram-negative and Gram-positive organisms, including Haemophilus influenza, Streptococcus pneumoniae, Staphylococcus aureus, Streptococcus pyogenes, Moraxella species and Neisseria gonorrhoeae. Chloramphenicol exerts its antibacterial effect by reversibly binding to bacterial ribosomes thereby inhibiting bacterial protein synthesis.
Pharmacokinetic:
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.
Indications:
For the treatment of acute bacterial conjunctivitis.
Contraindications:
- Patients hypersensitive to chloramphenicol or to any other component of the drops.
- Patients who have experienced myelosuppression during previous exposure to chloramphenicol.
- Patients with a known personal or family history of blood dyscrasias including aplastic anaemia.
Warning:
Chloramphenicol is absorbed systemically from the eye and toxicity has been reported.
In severe infection and where it is not confined to the conjunctivae, the patient should be referred to the doctor in case the topical use of chloramphenicol should be supplemented by appropriate systemic treatment.
The use of topical chloramphenicol may occasionally result in overgrowth of nonsusceptible
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.
If any new infection appears during treatment or symptoms worsen, the patient should consult a doctor immediately.
This product must not be used for more than 5 days.
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
Contact lens Users should consult the Doctor before using ophthalmic solution of chloramphenicol.
Soft contact lenses should not be replaced for 24 hours after completing the treatment .
Drug interaction:
The concomitant administration of chloramphenicol with other drugs liable to depress bone marrow function should be avoided.
Pregnancy and lactation:
The safety of topical chloramphenicol 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.
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 the vision is clear.
Undesirable effect:
Bone marrow hypoplasia, including aplastic anaemia and death, has been reported following topical use of chloramphenicol. Whilst the hazard is rare, it should be borne in mind when assessing the benefits expected from the use of the compound.
Transient irritation, burning, stinging and sensitivity reactions such as itching and dermatitis.
Hypersensitivity reactions including angioedema, anaphylaxis, urticaria, fever, vesicular and maculopapular dermatitis. Treatment must be discontinued immediately in such cases.
Dosage and administration:
Adults, children aged 2 years and over and the elderly:
One drop to be 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.For ocular use.
Overdosage:
In view of the relatively small amount of chloramphenicol in Chloramphenicol Eye Drops, overdosage with this product is unlikely to constitute a hazard. No specific treatment would be required.
Storage conditions:
Store between 2° and 8° C, protect from light.
Packaging:
10 mL in plastic bottle.