ERYTHROMYCIN ointment

Country: Ամերիկայի Միացյալ Նահանգներ

language: անգլերեն

source: NLM (National Library of Medicine)

active_ingredient:

ERYTHROMYCIN (UNII: 63937KV33D) (ERYTHROMYCIN - UNII:63937KV33D)

MAH:

Physicians Total Care, Inc.

INN:

ERYTHROMYCIN

composition:

ERYTHROMYCIN 5 mg in 1 g

administration_route:

OPHTHALMIC

prescription_type:

PRESCRIPTION DRUG

therapeutic_indication:

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.

leaflet_short:

Sterile Erythromycin Ophthalmic Ointment USP, 5 mg/g as follows: 3.5 g (1/8 oz) tamper-evident tubes NDC 54868-0644-1 Store at controlled room temperature 15°-30°C (59°-86°F). Avoid excessive heat. Protect from freezing.

authorization_status:

Abbreviated New Drug Application

SPC

ERYTHROMYCIN - ERYTHROMYCIN OINTMENT
PHYSICIANS TOTAL CARE, INC.
----------
ERYTHROMYCIN
OPHTHALMIC
OINTMENT USP
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-
-L-ribo-
hexopyranosyl)oxy]-14-ethyl-7,12,13-trihydroxy-3,5,7,9,11,13-hexamethyl-6-[[3,4,6-trideoxy-3-
(dimethylamino)-ß-D-xylo-hexopyranosyl]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:
_Streptococcus pyogenes _(group A ß-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)
37
67
13
_Haemophilus influenzae _(not all strains of this organism are
susceptible at the erythromycin
concentrations ordinarily achieved)
_Treponema pallidum_
_Corynebacterium diphtheriae_
_Neisseria gonorrhoeae_
_Chlamydia trachomatis_
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 oph