ERYTHROMYCIN BASE tablet film coated

Država: Združene države Amerike

Jezik: angleščina

Source: NLM (National Library of Medicine)

Aktivna sestavina:

Erythromycin (UNII: 63937KV33D) (Erythromycin - UNII:63937KV33D)

Dostopno od:

Lake Erie Medical DBA Quality Care Products LLC

INN (mednarodno ime):

Erythromycin

Sestava:

Erythromycin 500 mg

Tip zastaranja:

PRESCRIPTION DRUG

Status dovoljenje:

Abbreviated New Drug Application

Lastnosti izdelka

ERYTHROMYCIN BASE- ERYTHROMYCIN TABLET, FILM COATED
LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC
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ERYTHROMYCIN
FILM-COATED TABLETS
ERYTHROMYCIN TABLETS, USP
Rx only
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of Erythromycin
Base Film- coated tablets and other antibacterial drugs, Erythromycin
Base Film-coated tablets would
be used only to treat or prevent infections that are proven or
strongly suspected to be caused by
bacteria.
DESCRIPTION
Erythromycin Base Film-coated (erythromycin tablets, USP) is an
antibacterial product containing
erythromycin, USP, in a unique, nonenteric film coating for oral
administration. Erythromycin Base
Film-coated tablets are available in two strengths containing either
250 mg or 500 mg of erythromycin
base.
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 is known chemically as (3R*, 4S*,
5S*, 6R*, 7R*, 9R*, 11R*,
12R*, 13S*, 14R*)-4-[(2,6-dideoxy-3-C-methyl-3-O
-methyl-α-L-ribo-hexopyranosyl)oxy]-14-ethyl-
7,12,13-trihydroxy-3,5,7,9,11,13-hexamethyl-6-[[3,4,6-trideoxy - 3 - (
dimethylamino)- β - D - xylo-
hexopyranosyl]oxy]oxacyclotetradecane-2,10-dione. The molecular
formula is C
H NO , and the
molecular weight is 733.94. The structural formula is:
INACTIVE INGREDIENTS
Colloidal silicon dioxide, croscarmellose sodium, crospovidone, D&C
Red No. 30 Aluminum Lake,
hydroxypropyl cellulose, hypromellose, hydroxypropyl methylcellulose
phthalate, magnesium stearate,
microcrystalline cellulose, povidone, polyethylene glycol, propylene
glycol, sodium citrate, sodium
hydroxide, sorbic acid, sorbitan monooleate, talc, and titanium
dioxide.
CLINICAL PHARMACOLOGY
37
67
13
Orally administered erythromycin base and its salts are readily
absorbed in the microbi