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.
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 ...
A small amount of ointment placed in the lower conjunctival sac every three hours, or more frequently if deemed advisable by the prescribing physician. Administration should be continued day and night 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.
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.
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:
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.
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 antiinfective drug in this product is active against the following common bacterial eye pathogens:
Staphylococcus aureus
Streptococcus, including Streptococcus pneumoniae
Escherichia coli
Haemophilus influenzae
Klebsiella/Enterobacter species
Moraxella lucunata
(Morax-Axenfeld bacillus)
Neisseria species
This product does not provide adequate coverage against:
Pseudomonas aeruginosa
Serratia marcescens
This product is contraindicated in persons sensitive to any of its components.
SEE BOXED WARNING
Ophthalmic ointments may retard corneal wound healing.
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.
Blood dyscrasias have been reported in association with the use of chloramphenicol (see WARNINGS).
Allergic or inflammatory reactions due to individual hypersensitivity and occasional burning or stinging may occur with the use of Chloromycetin Ophthalmic Ointment.
A small amount of ointment placed in the lower conjunctival sac every three hours, or more frequently if deemed advisable by the prescribing physician. Administration should be continued day and night 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.
N 0071–3070–07
Chloromycetin Ophthalmic Ointment, 1% (Chloramphenicol Ophthalmic Ointment, USP) is supplied, sterile, in ophthalmic ointment tubes of 3.5 grams.
Chloromycetin, brand of chloramphenicol. Reg US Pat Off
Caution—Federal law prohibits dispensing without prescription.March 1997
©1997, Warner-Lambert Co.
PARKE-DAVIS
Div of Warner-Lambert Co/Morris Plains, NJ 07950 USA
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 309172 | chloramphenicol 1 % Ophthalmic Ointment | PSN | 1 |
| 1293338 | Chloromycetin 1 % Ophthalmic Ointment | PSN | 1 |
| 1293338 | chloramphenicol 0.01 MG/MG Ophthalmic Ointment [Chloromycetin] | SBD | 1 |
| 309172 | chloramphenicol 0.01 MG/MG Ophthalmic Ointment | SCD | 1 |
| 309172 | chloramphenicol 1 % Ophthalmic Ointment | SY | 1 |
| 1293338 | Chloromycetin 0.01 MG/MG Ophthalmic Ointment | SY | 1 |
| 1293338 | Chloromycetin 1 % Ophthalmic Ointment | SY | 1 |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0071-3070-07 | Chloromycetin | 3.5 g in 1 TUBE | OINTMENT | 3.5 | 1 |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| chloramphenicol | ACTIVE INGREDIENT | 66974FR9Q1 | 1 | |
| chloramphenicol | ACTIVE MOIETY | 66974FR9Q1 | 1 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 0071-3070 | 0071-3070-07 |
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 698AAA0A-9FD3-40C2-EC93-0DC2170A75BA | 698AAA0A-9FD3-40C2-EC93-0DC2170A75BA | 2006-10-08 | Boxed warning, Warnings, Adverse reactions | 698AAA0A-9FD3-40C2-EC93-0DC2170A75BA 698AAA0A-9FD3-40C2-EC93-0DC2170A75BA |
Adverse event summaries are temporarily unavailable. Other product information remains available.