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

  Each vial of Chloromycetin Ophthalmic contains 25 mg of Chloromycetin (chloramphenicol) with boric acid-sodium borate buffer. Sodium hydroxide may have been added for adjustment of pH. A 15 mL bottle of Sterile Distilled Water is included in each package for use as a diluent in the preparation of a solution of Chloromycetin suitable for ophthalmic use. By varying the quantity of diluent used, solutions ranging in strength from 0.16% to 0.5% may be prepared. Both the powder for solution and the diluent contain no preservatives. Sterile powder.

The chemical names for chloramphenicol are

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

(2) D- tbreo (--)-2,2-Dichloro- N -[(beta)-hydroxy-(alpha)-(hydroxymethyl)- p -nitrophenethyl] acetamide.

Chloramphenicol has the following empirical and structural formulas:

images/05/56504101.jpg

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 or 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.

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

The particular antiinfective drug in this product is active against the following common bacterial eye pathogens:

Staphylococcus aureus

Streptococci, including Streptococcus

pneumoniae

Escberichia coli

Haemophilus influenzae

Klebsiella/Enterobacter species

Moraxella lacunata

(Morax-Axenfeld bacillus)

Neisseria species

The product does not provide adequate coverage against:

Pseudomonas aeruginosa

Serratia marcescens

Contraindications:   This product is contraindicated in persons sensitive to any of its components.

:   See Boxed Warning

Precautions:   The prolonged use of antibiotics may occasionally result in overgrowth of nonsusceptible organisms, including fungi. If new infections appear during medication, the drug 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.

Adverse Reactions:   Blood dyscrasias have been reported in association with the use of chloramphenicol (see ).

Transient burning or stinging sensations may occur with use of Chloromycetin Ophthalmic Solution.

Dosage and Administration:   Two drops applied to the affected eye every three hours, or more frequently if deemed advisable by the prescribing physician. Administration should be continued day and night for the first 48 hours, after which the interval between applications may be increased. Treatment should be continued for at least 48 hours after the eye appears normal.

Directions for dispensing-- Prepare solution by adding sterile distilled water to the vial as follows:

Strength of Add sterile
solution desired distilled water

 0.5%  5 mL

0.25% 10 mL

0.16% 15 mL

Solutions remain stable at room temperature for ten days.

How Supplied:   NDC 61570-321-31 Chloromycetin Ophthalmic (Chloramphenicol for Ophthalmic Solution, USP) is supplied in a package containing dry ingredients in a 15 mL vial and also a vial containing 15 mL of Sterile Distilled Water for use as a diluent in preparing the solution for ophthalmic use. A sterilized dropper-cap assembly for use on the vial of solution is included in the package.

Store below 30°C (86°F).

Chloromycetin, brand of chloramphenicol. Reg US Pat Off

Rx only

Distributed by: Monarch Pharmaceuticals, Inc. Bristol, TN 37620