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Chloromycetin Ophthalmic Ointment
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  • FDA PI

Chloromycetin Ophthalmic Ointment

Generic name:chloramphenicol
Dosage form: ophthalmic ointment
Drug class:Ophthalmic anti-infectives

Medically reviewed by Drugs.com. Last updated on Sep 21, 2021.

WARNING

Bone marrow hypoplasia including aplastic anemia and death has been reported following topical application of chloramphenicol. Chloramphenicol should not be used when less potentially dangerous agents would be expected to provide effective treatment.

Description

Each gram of Chloromycetin Ophthalmic Ointment, 1% contains 10 mg of chloramphenicol in a special base of liquid petrolatum and polyethylene. It contains no preservatives. Sterile ointment.

The chemical names for chloramphenicol are:

(1) Acetamide, 2,2-dichloro-N-[2-hydroxy-1-(hydroxymethyl)-2-(4-nitrophenyl) ethyl]-, and

(2) D-threo-(—)-2,2-Dichloro-N-[β-hydroxy-α-(hydroxymethyl)-p-nitrophenethyl] acetamide.

Chloramphenicol has the following empirical and structural formulas:

Clinical Pharmacology

Chloramphenicol is a broad-spectrum antibiotic originally isolated from Streptomyces venezuelae. It is primarily bacteriostatic and acts by inhibition of protein synthesis by interfering with the transfer of activated amino acids from soluble RNA to ribosomes. It has been noted that chloramphenicol is found in measurable amounts in the aqueous humor following local application to the eye. Development of resistance to chloramphenicol can be regarded as minimal for staphylococci and many other species of bacteria.

Indications and Usage

Chloramphenicol should be used only in those serious infections for which less potentially dangerous drugs are ineffective or contraindicated. Bacteriological studies should be performed to determine the causative organisms and their sensitivity to chloramphenicol (see Boxed Warning).

Chloromycetin Ophthalmic Ointment, 1% (Chloramphenicol Ophthalmic Ointment, USP) is indicated for the treatment of surface ocular infections involving the conjunctiva and/or cornea caused by chloramphenicol-susceptible organisms.

The particular antiinf...