ERYTHROMYCIN ointment

Šalis: Jungtinės Valstijos

kalba: anglų

Šaltinis: NLM (National Library of Medicine)

Veiklioji medžiaga:

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

Prieinama:

Proficient Rx LP

INN (Tarptautinis Pavadinimas):

ERYTHROMYCIN

Sudėtis:

ERYTHROMYCIN 5 mg in 1 g

Vartojimo būdas:

OPHTHALMIC

Recepto tipas:

PRESCRIPTION DRUG

Terapinės indikacijos:

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.

Produkto santrauka:

Sterile Erythromycin Ophthalmic Ointment USP, 0.5% is available as follows: 3.5 g (1/8 oz) sterile tamper-resistant tube (NDC 63187-267-35) STORAGE: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Avoid excessive heat. Protect from freezing. Akorn Manufactured by: Akorn Inc Lake Forest, IL 60045 ERT00N Rev. 05/10 Relabeled by: Proficient Rx LP Thousand Oaks, CA 91320

Autorizacija statusas:

Abbreviated New Drug Application

Prekės savybės

ERYTHROMYCIN- ERYTHROMYCIN OINTMENT
PROFICIENT RX LP
----------
ERYTHROMYCIN OPHTHALMIC OINTMENT USP, 0.5%
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-_O_-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_-hexopyranosyl]oxy]oxacyclotetradecane-2,10-dione)) is an
antibiotic produced
from a strain of _Streptomyces erythraeus._
It has the following structural formula:
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 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)
_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 ophthalmia
caused by
penicillinase-producing _N.gonorrhoeae_ is