ERYTHROCIN STEARATE- erythromycin stearate tablet, film coated

Država: Združene države Amerike

Jezik: angleščina

Source: NLM (National Library of Medicine)

Aktivna sestavina:

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

Dostopno od:

A-S Medication Solutions

INN (mednarodno ime):

ERYTHROMYCIN STEARATE

Sestava:

ERYTHROMYCIN 250 mg

Pot uporabe:

ORAL

Tip zastaranja:

PRESCRIPTION DRUG

Terapevtske indikacije:

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 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. ERYTHROCIN® STEARATE tablets are indicated in the treatment of infections caused by susceptible strains of the designated microorganisms in the diseases listed below: Upper respiratory tract infections of mild to moderate degree caused by Streptococcus pyogenes ; Streptococcus pneumoniae ; Haemophilus influenzae (when used concomitantly with adequate doses of sulfonamides, since many strains of H. influenzae are not susceptibl

Povzetek izdelek:

Product: 50090-0025 NDC: 50090-0025-3 40 TABLET, FILM COATED in a BOTTLE

Status dovoljenje:

Abbreviated New Drug Application

Lastnosti izdelka

ERYTHROCIN STEARATE- ERYTHROMYCIN STEARATE TABLET, FILM COATED
A-S MEDICATION SOLUTIONS
----------
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
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
®
®
®
®
37
67
13
18
36
2
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
across the blood-brain