Chloramphenicol 1% w/w Eye Ointment
Each gram of ointment contains Chloramphenicol 1.0% w/w
Chloramphenicol is a broad spectrum antibiotic for the treatment of bacterial conjunctivitis caused by chloramphenicol susceptible organisms.
Consideration should be given to official guidance on the appropriate use of antibacterial agents.
Chloramphenicol is indicated in adults and children.
The recommended dosage for adults is a small amount of the ointment to be applied to the affected eye every 3 hours or more frequently if required. Treatment should be continued for 48 hours after the eye appears normal.
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.
As for adults. Chloramphenicol has been used successfully at normal dosages in elderly patients. The pattern and incidence of adverse effects does not appear to differ from younger adults.
Topical administration to the eye only.
• Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
• Chloramphenicol ointment must not be administered to patients who have experienced bone marrow suppression during previous exposure to chloramphenicol.
Special warnings and precautions for use
Chloramphenicol is absorbed systemically from the eye and systemic toxicity has been reported (see section 4.8).
Bone marrow hypoplasia, including aplastic anaemia and death, 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 the compound.
If chloramphenicol eye ointment is to be used on a long-term or intermittent basis, it may be advisable to perform a routine blood profile before therapy and at appropriate intervals thereafter to detect any haemopoietic abnormalities.
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.
Chloramphenicol does not provide coverage against Pseudomonas spp. or Serratia marcescens.
The use of topical chloramphenicol may occasionally result in overgrowth of non-susceptible organisms including fungi. If any new infection appears during treatment, the antibiotic should be discontinued and appropriate treatment given.
It is recommended that all types of contact lenses be avoided during ocular infections.
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