Chloramphenicol Eye Ointment USP

CHLORAMPHENICOL EYE OINTMENT U.S.P. 1% 3.5G

It is a yellowish-white unctuous ointment, free of visible contamination. Odour faintly of paraffin and wool fat. It contains chloramphenicol 1.0% w/w in a sterile oculentum base. Contains no preservatives.

 

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Chloramphenicol is a broad spectrum antibiotic originally isolated from Streptomycesvenezuelae. It is primarily bacteriostatic and acts by inhibition of protein synthesis by interfering with the transfer of activated amino acids from soluble RNA toribosomes.

 

Indications

For the treatment of bacterial conjunctivitis and other superficial ocular infections caused by chloramphenicol-sensitive organisms.

 

Dosage and Administration

Apply 1.5 cm every three hours. If ointment is used together with drops for day and night coverage, 1.5 cm should be applied before retiring, while using the drops during the day.

Treatment should be continued for at least 48 hours after the eye appears normal.

 

Contraindications

Chloramphenicol is contraindicated in individuals with a history of hypersensitivity to any excipients and/or toxic reaction to the medicine.

 

Warnings and Precautions

Bone marrow hypoplasia, including aplastic anaemia and death, has been rarely reported following local application of chloramphenicol. Chloramphenicol should not be used when less potentially dangerous agents would be expected to provide effective treatment. Ophthalmic agents may retard corneal wound healing.

The use of this antibiotic, as with other antibiotics, may result in the overgrowth of non-susceptible organisms, including fungi. If infections caused by non-susceptible organism appear during therapy, its use should be discontinued and appropriate measures should be taken. In all serious infections, the topical use of chloramphenicol should be supplemented by appropriate systemic medication.

The mechanism for the irreversible aplastic anaemia following ophthalmic use of chloramphenicol has not been established.

 

Use in Pregnancy

Chloramphenicol enters the foetal circulation, and if given to the mother shortly before parturition, may cause the gray baby syndrome, with cyanosis and hypothermia, owing to the limited glucoronidating capacity of the new born infant’s liver. Chloramphenicol treatment should therefore be avoided during the last week before parturition and during breastfeeding.

 

Adverse Reactions

Bloody dyscrasisa have been reported in association with the use of chloramphenicol (see Warning and Precautions).

Chloramphenicol is absorbed systemically from the eye and toxicity has been reported following chronic exposure. Dose related toxicity following a single ocular exposure is unlikely. Local irritation with the ophthalmic form may include subjective symptoms of itching or burning. More serious side effects such as angioneurotic oedama, anaphylaxis, urticaria, fever, vesicular and maculopapular dermatitis have been reported in patients sensitive to chloramphenicol and are causes for discontinuing the medication. Similar sensitivity reactions to the materials in topical preparations also may occur.

 

Package

3.5 g /tube/Box.

 

Storage

Store below 25oC

 

Manufactured by

Zhejiang Shengji Pharmaceutical Co., Ltd.

Cagnan Industry Region Of Lingxi

Cagnan Country, Wenzhou, Zhejiang,

China.

 

Sole Agent

Embassy Pharmaceutical and Chemical Ltd.

Lagos – Nigeria.

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