País: Estats Units
Idioma: anglès
Font: NLM (National Library of Medicine)
Erythromycin Ethylsuccinate (UNII: 1014KSJ86F) (Erythromycin - UNII:63937KV33D)
Wilshire Pharmaceuticals Inc.
Erythromycin Ethylsuccinate
Erythromycin 200 mg in 5 mL
ORAL
PRESCRIPTION DRUG
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
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.
New Drug Application
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. Llegiu el document complet
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 Llegiu el document complet