ERYTHROCIN STEARATE erythromycin tablet film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ERYTHROMYCIN STEARATE (UNII: LXW024X05M) (ERYTHROMYCIN - UNII:63937KV33D)

Available from:

KAISER FOUNDATION HOSPITALS

INN (International Name):

ERYTHROMYCIN STEARATE

Composition:

ERYTHROMYCIN 250 mg

Prescription type:

PRESCRIPTION DRUG

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ERYTHROCIN STEARATE- ERYTHROMYCIN STEARATE TABLET, FILM COATED
KAISER FOUNDATION HOSPITALS
----------
ERYTHROCIN STEARATE
ERYTHROMYCIN STEARATE
TABLETS, USP
FILM-COATED TABLETS
RX ONLY
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of ERYTHROCIN
STEARATE Film-coated tablets and other antibacterial drugs, ERYTHROCIN
STEARATE Film-
coated tablets should be used only to treat or prevent infections that
are proven or strongly suspected to
be caused by bacteria.
DESCRIPTION
ERYTHROCIN STEARATE Film-coated tablets (erythromycin stearate
tablets, USP) are an
antibacterial product containing the stearate salt of erythromycin in
a unique film coating.
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.
Erythromycin is a white to off-white powder, slightly soluble in
water, and soluble in alcohol,
chloroform, and ether. Erythromycin stearate is known chemically as
erythromycin octadecanoate. The
molecular formula of erythromycin stearate is C
H NO •C
H O , and the molecular weight is
1018.43. The structural formula is:
INACTIVE INGREDIENTS
250 mg tablet: Cellulosic polymers, corn starch, D&C Red No. 7,
polacrilin potassium, polyethylene
glycol, povidone, propylene glycol, sodium carboxymethylcellulose,
sodium citrate, sorbic acid,
sorbitan monooleate and titanium dioxide.
CLINICAL PHARMACOLOGY
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CLINICAL PHARMACOLOGY
Orally administered erythromycin base and its salts are readily
absorbed in the microbiologically active
form. Interindividual variations in the absorption of erythromycin
are, however, observed, and some
patients do not achieve optimal serum levels. Erythromycin is largely
bound to plasma proteins. After
absorption, erythromycin diffuses readily into most body fluids. In
the absence of meningeal
inflammation, low concentrations are normally achieved in the spinal
fluid but the passage of the drug
acros