ERYTHROCIN STEARATE- erythromycin stearate 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:

PD-Rx Pharmaceuticals, Inc.

INN (International Name):

ERYTHROMYCIN STEARATE

Composition:

ERYTHROMYCIN 250 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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

Product summary:

ERYTHROCIN ® STEARATE Film-coated Tablets (erythromycin stearate tablets, USP) are supplied in the following strengths and packages. ERYTHROCIN ® STEARATE Film-coated, 250 mg pink tablets imprinted with the Product Code designation ES: Bottles of 4 NDC 55289-112-04 Bottles of 10 NDC 55289-112-10 Bottles of 15 NDC 55289-112-15 Bottles of 20 NDC 55289-112-20 Bottles of 28 NDC 55289-112-28 Bottles of 40 NDC 55289-112-40 Bottles of 56 NDC 55289-112-56 Bottles of 100 NDC 55289-112-01 Bottles of 120 NDC 55289-112-98 Store below 86°F (30°C).

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ERYTHROCIN STEARATE- ERYTHROMYCIN STEARATE TABLET, FILM COATED
PD-RX PHARMACEUTICALS, INC.
----------
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
®
®
®
®
37
67
13
18
36
2
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 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-b