chloromycetin- chloramphenicol ointment

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

chloramphenicol (UNII: 66974FR9Q1) (chloramphenicol - UNII:66974FR9Q1)

Available from:

PARKE-DAVIS

INN (International Name):

chloramphenicol

Pharmaceutical form:

OINTMENT

Administration route:

OPHTHALMIC

Prescription type:

PRESCRIPTION DRUG

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

Product summary:

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 March 1997 ©1997, Warner-Lambert Co. PARKE-DAVIS Div of Warner-Lambert Co/Morris Plains, NJ 07950 USA

Summary of Product characteristics

CHLOROMYCETIN- CHLORAMPHENICOL OINTMENT
PARKE-DAVIS
----------
CHLOROMYCETIN OPHTHALMIC OINTMENT, 1%
(CHLORAMPHENICOL OPHTHALMIC OINTMENT, USP)
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.
DES CRIPTION
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 antiinfective drug in this product is activ