ERYTHROMYCIN ointment

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

Bausch & Lomb Incorporated

INN (International Name):

ERYTHROMYCIN

Sammensetning:

ERYTHROMYCIN 5 mg in 1 g

Administreringsrute:

OPHTHALMIC

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

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.

Produkt oppsummering:

Erythromycin ophthalmic ointment USP, 0.5% is available in the following sizes: 3.5 g (1/8 oz) in a tamper-resistant tube – NDC 24208-910-55 Storage: Store between 15°C to 25°C (59°F to 77°F). Keep out of reach of children. Distributed by: Bausch & Lomb Americas Inc. Bridgewater, NJ 08807 USA Manufactured by : Bausch & Lomb Incorporated Tampa, FL 33637 USA © 2023 Bausch & Lomb Incorporated or its affiliates Revised: May 2023 9795000 (Folded) 9795100 (Flat)

Autorisasjon status:

Abbreviated New Drug Application

Preparatomtale

ERYTHROMYCIN- ERYTHROMYCIN OINTMENT
BAUSCH & LOMB INCORPORATED
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ERYTHROMYCIN
OPHTHALMIC
OINTMENT
USP
0.5%
(STERILE)
RX ONLY
DESCRIPTION
Erythromycin ophthalmic ointment, USP belongs to the macrolide group
of antibiotics.
The sterile ophthalmic ointment flows freely over the conjunctiva.
Erythromycin base, as
crystals or powder, is slightly soluble in water, moderately soluble
in ether, and readily
soluble in alcohol or chloroform. Erythromycin is an antibiotic
produced from a strain of
_Streptomyces erythraeus_. It is basic and readily forms a salt when
combined with an
acid. It has the following structural formula:
Molecular Formula: C
H
NO
Mol. Wt. 733.94
Chemical Name: ((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-(dimethylamino)-_β_-D-_xylo_-
hexopyranosyl]oxy]oxacyclotetradecane-2,10-dione)
Each gram contains: Active: erythromycin USP, 5 mg (0.5%); Inactives:
mineral oil and
white petrolatum.
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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