ERYTHROMYCIN ETHYLSUCCINATE granule, for suspension

Pays: États-Unis

Langue: anglais

Source: NLM (National Library of Medicine)

Ingrédients actifs:

Erythromycin Ethylsuccinate (UNII: 1014KSJ86F) (Erythromycin - UNII:63937KV33D)

Disponible depuis:

Wilshire Pharmaceuticals Inc.

DCI (Dénomination commune internationale):

Erythromycin Ethylsuccinate

Composition:

Erythromycin 200 mg in 5 mL

Mode d'administration:

ORAL

Type d'ordonnance:

PRESCRIPTION DRUG

indications thérapeutiques:

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Erythromycin Ethylsuccinate and other antibacterial drugs, Erythromycin Ethylsuccinate should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Erythromycin Ethylsuccinate is indicated in the treatment of infections caused by susceptible strains of the designated organisms in the diseases listed below: Upper respiratory tract infections of mild to moderate degree caused by Streptococcus pyogenes , Streptococcus pneumoniae , or Haemophilus influenzae (when used concomitantly with adequate doses of sulfonamides, since many strains of H. influenza e are not susceptible to the erythromycin concentrati

Descriptif du produit:

Erythromycin Ethylsuccinate Granules 200 mg per 5 mL (erythromycin ethylsuccinate for oral suspension, USP) are pink granules with a cherry aroma and are supplied in 100-mL (NDC 52536-134-13) and 200-mL (NDC 52536-136-13) size bottles. Following reconstitution Erythromycin Ethylsuccinate Granules become a pink opaque suspension with a cherry aroma. Store granules, prior to mixing, at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. After mixing, refrigerate and use within 10 days.

Statut de autorisation:

New Drug Application

Notice patient

Wilshire Pharmaceuticals Inc.
----------
Revised: January 2019
Wilshire Pharmaceuticals, Inc.
Atlanta, GA 30328
EES-AGPI-03
(No. 6369)
Revised: 1/2019
Document Id: 98a85646-cc9b-429f-9b46-4a3ce1b5c129
34391-3
Set id: f4a3fffd-ce02-450f-bbcc-d425374e3e32
Version: 3
Effective Time: 20190129
Wilshire Pharmaceuticals Inc.

Résumé des caractéristiques du produit

ERYTHROMYCIN ETHYLSUCCINATE- ERYTHROMYCIN ETHYLSUCCINATE GRANULE, FOR
SUSPENSION
WILSHIRE PHARMACEUTICALS INC.
----------
ERYTHROMYCIN ETHYLSUCCINATE
R ONLY
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of Erythromycin
Ethylsuccinate and other antibacterial drugs, Erythromycin
Ethylsuccinate should be used only to treat
or prevent infections that are proven or strongly suspected to be
caused by bacteria.
DESCRIPTION
Erythromycin is produced by a strain of _Saccharopolyspora erythraea_
(formerly _Streptomyces erythraeus_)
and belongs to the macrolide group of antibiotics. It is basic and
readily forms salts with acids. The
base, the stearate salt, and the esters are poorly soluble in water.
Erythromycin ethylsuccinate is an ester
of erythromycin suitable for oral administration. Erythromycin
ethylsuccinate is known chemically as
erythromycin 2'-(ethylsuccinate). The molecular formula is C
H NO and the molecular weight is
862.06. The structural formula is:
Erythromycin Ethylsuccinate Granules are intended for reconstitution
with water. Each 5-mL
teaspoonful of reconstituted cherry-flavored suspension contains
erythromycin ethylsuccinate
equivalent to 200 mg of erythromycin.
The pleasant tasting, fruit-flavored liquids are supplied ready for
oral administration.
Erythromycin Ethylsuccinate 200 Liquid: Each 5-mL teaspoonful of
fruit-flavored suspension contains
erythromycin ethylsuccinate equivalent to 200 mg of erythromycin.
Erythromycin Ethylsuccinate 400 Liquid: Each 5-mL teaspoonful of
orange-flavored suspension
contains erythromycin ethylsuccinate equivalent to 400 mg of
erythromycin.
Granules and ready-made suspensions are intended primarily for
pediatric use but can also be used in
adults.
INACTIVE INGREDIENTS
Erythromycin Ethylsuccinate Granules: Citric acid, FD&C Red No. 3,
magnesium aluminum silicate,
sodium carboxymethylcellulose, sodium citrate, sucrose and artificial
flavor.
CLINICAL PHARMACOLOGY
X
43
75
16
Orally administered erythromycin ethylsuccinate suspensions