ERYTHROMYCIN ETHYLSUCCINATE tablet

Kraj: Stany Zjednoczone

Język: angielski

Źródło: NLM (National Library of Medicine)

Składnik aktywny:

ERYTHROMYCIN ETHYLSUCCINATE (UNII: 1014KSJ86F) (ERYTHROMYCIN - UNII:63937KV33D)

Dostępny od:

Physicians Total Care, Inc.

INN (International Nazwa):

ERYTHROMYCIN ETHYLSUCCINATE

Skład:

ERYTHROMYCIN ETHYLSUCCINATE 400 mg

Droga podania:

ORAL

Typ recepty:

PRESCRIPTION DRUG

Wskazania:

To reduce the development of drug-resistant bacteria and maintain the effectiveness of erythromycin ethylsuccinate tablets and other antibacterial drugs, erythromycin ethylsuccinate tablets 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 tablets are 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. influenzae are not susce

Podsumowanie produktu:

Erythromycin ethylsuccinate Tablets, USP, 400 mg are supplied as mottled pink, oval tablets bearing the Code 74 ZE in: bottles of 15 (NDC 54868-0018-5) bottles of 20 (NDC 54868-0018-3) bottles of 30 (NDC 54868-0018-4) bottles of 40 (NDC 54868-0018-1) bottles of 100 (NDC 54868-0018-7) bottles of 120 (NDC 54868-0018-6). Protect tablets from exposure to light and moisture. Store below 86°F (30°C).

Status autoryzacji:

Abbreviated New Drug Application

Charakterystyka produktu

ERYTHROMYCIN ETHYLSUCCINATE - ERYTHROMYCIN ETHYLSUCCINATE TABLET
PHYSICIANS TOTAL CARE, INC.
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To reduce the development of drug-resistant bacteria and maintain the
effectiveness of erythromycin
ethylsuccinate tablets and other antibacterial drugs, erythromycin
ethylsuccinate tablets 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).
Erythromycin ethylsuccinate tablets for oral administration are
intended primarily for adults or older
children. Each tablet contains erythromycin ethylsuccinate equivalent
to 400 mg of erythromycin
activity. The molecular formula is C
H NO and the molecular weight is 862.06. The structural
formula is:
Inactive Ingredients
Confectioner's sugar (contains corn starch), corn starch, FD&C Red No.
40, magnesium stearate,
polacrilin potassium and sodium citrate.
CLINICAL PHARMACOLOGY
Orally administered erythromycin ethylsuccinate tablets are readily
and reliably absorbed under both
fasting and nonfasting conditions.
Erythromycin diffuses readily into most body fluids. Only low
concentrations are normally achieved in
the spinal fluid, but passage of the drug across the blood-brain
barrier increases in meningitis. In the
presence of normal hepatic function, erythromycin is concentrated in
the liver and excreted in the bile;
the effect of hepatic dysfunction on excretion of erythromycin by the
liver into the bile is not known.
Less than 5 percent of the orally administered dose of erythromycin is
excreted in active form in the
urine.
Erythromycin crosses the plac