Document
DailyMed Label: chloramphenicol
Title
DailyMed Label: chloramphenicol
Date
2006
Document type
DailyMed Prescription
Name
chloramphenicol
Generic name
chloramphenicol
Manufacturer
PARKE-DAVIS
Product information
NDC: 0071-3070
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:
Indications
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
Dosage
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.
Contraindications
This product is contraindicated in persons sensitive to
any of its components.
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
How supplied
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
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.
1 organization
1 product
Product
chloramphenicolOrganization
Parke-Davis Div of Pfizer Inc