ERYTHROMYCIN ointment

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Erythromycin (UNII: 63937KV33D) (Erythromycin - UNII:63937KV33D)

Available from:

MWI

INN (International Name):

Erythromycin

Composition:

Erythromycin 5 mg in 1 g

Administration route:

OPHTHALMIC

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

For the treatment of superficial ocular infections involving the conjunctiva and/or cornea caused by organisms susceptible to erythromycin. For prophylaxis of ophthalmia neonatorum due to N. gonorrhoeae or C. trachomatis. The effectiveness of erythromycin in the prevention of ophthalmia caused by penicillinase-producing N.gonorrhoeae is not established. For infants born to mothers with clinically apparent gonorrhea, intravenous or intramuscular injections of aqueous crystalline penicillin G should be given; a single dose of 50,000 units for term infants or 20,000 units for infants of low birth weight. Topical prophylaxis alone is inadequate for these infants. This drug is contraindicated in patients with a history of hypersensitivity to erythromycin.

Product summary:

Sterile Erythromycin Ophthalmic Ointment USP, 0.5% is available as follows: 3.5 g (1/8 oz) sterile tamper-resistant tube (NDC 13985-605-03)

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ERYTHROMYCIN- ERYTHROMYCIN OINTMENT
MWI
----------
APEXA™
ERYTHROMYCIN
OPHTHALMIC OINTMENT USP, 0.5%
STERILE
RX ONLY
DESCRIPTION:
Erythromycin Ophthalmic Ointment belongs to the macrolide group of
antibiotics. It is
basic and readily forms a salt when combined with an acid. The base,
as crystals or
powder, is slightly soluble in water, moderately soluble in ether, and
readily soluble in
alcohol or chloroform. Erythromycin ((3R*, 4S*, 5S*, 6R*, 7R*, 9R*,
11R*, 12R*, 13S*,
14R*)-4-[(2,6-dideoxy-3-C-methyl-3-_0_-methyl-α-L-ribo-hexopyranosyl)-oxy]-14-ethyl-
7,12,13-trihydroxy-3,5,7,9,11,13-hexamethyl-6-[[3,4,6-trideoxy-3-(dimethyl-amino)-β-D-
xylo-hexo-pyranosyl]oxy]oxacyclotetradecane-2,10-dione)) is an
antibiotic produced
from a strain of _Streptomyces erythraeus._
It has the following structural formula:
Molecular Formula: C
H
NO
Molecular Weight: 733.94
Each gram contains Erythromycin USP 5 mg in a sterile ophthalmic base
of mineral oil
and white petrolatum.
CLINICAL PHARMACOLOGY:
_MICROBIOLOGY:_ Erythromycin inhibits protein synthesis without
affecting nucleic acid
synthesis. Erythromycin is usually active against the following
organisms _in vitro_ and in
clinical infections:
37
67
13
_Streptococcus pyogenes_ (group A β-hemolytic)
Alpha-hemolytic streptococci (viridans group)
_Staphylococcus aureus,_ including penicillinase-producing strains
(methicillin-
resistant staphylococci are uniformly resistant to erythromycin)
_Streptococcus pneumoniae_
_Mycoplasma pneumoniae_ (Eaton Agent, PPLO)
INDICATIONS AND USAGE:
For the treatment of superficial ocular infections involving the
conjunctiva and/or cornea
caused by organisms susceptible to erythromycin.
For prophylaxis of ophthalmia neonatorum due to _N. gonorrhoeae_ or
_C. trachomatis._
The effectiveness of erythromycin in the prevention of ophthalmia
caused by
penicillinase-producing _N.gonorrhoeae_ is not established.
For infants born to mothers with clinically apparent gonorrhea,
intravenous or
intramuscular injections of aqueous crystalline penicillin G sh