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:

Bryant Ranch Prepack

INN (International Name):

ERYTHROMYCIN STEARATE

Composition:

ERYTHROMYCIN 500 mg

Prescription type:

PRESCRIPTION DRUG

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ERYTHROCIN STEARATE- ERYTHROMYCIN STEARATE TABLET, FILM COATED
BRYANT RANCH PREPACK
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ERYTHROCIN® STEARATE
(ERYTHROMYCIN STEARATE TABLETS, USP)
FILMTAB® TABLETS
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of ERYTHROCIN
STEARATE Filmtab tablets and other antibacterial drugs, ERYTHROCIN
STEARATE Filmtab tablets
should be used only to treat or prevent infections that are proven or
strongly suspected to be caused by
bacteria.
DESCRIPTION
ERYTHROCIN STEARATE Filmtab 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.
500 mg tablet
Cellulosic polymers, cornstarch, FD&C Red No. 3, magnesium hydroxide,
polacrilin potassium,
povidone, propylene glycol, sorbitan monooleate, titanium dioxide and
vanillin.
37
67
13
18
36
2
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