ERYTHROMYCIN capsule, delayed release

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv bestanddel:

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

Tilgængelig fra:

Stat Rx USA

INN (International Name):

ERYTHROMYCIN

Sammensætning:

ERYTHROMYCIN 250 mg

Indgivelsesvej:

ORAL

Recept type:

PRESCRIPTION DRUG

Terapeutiske indikationer:

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Erythromycin Delayed-release Capsules and other antibacterial drugs, Erythromycin Delayed-release Capsules 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. Erythromycin is 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 , or Haemophilus influenzae (when used concomitantly with adequate doses of sulfonamides, since many strains of H. influenzae are not susceptible to the er

Produkt oversigt:

Erythromycin Delayed-release Capsules, USP, are clear and opaque maroon capsules bearing the corporate Abbott“A” logo and Abbo-Code ER with pink and yellow particles containing 250 mg of erythromycin supplied in bottles of 100 (NDC 0074-6301-13) and 500 (NDC 0074-6301-53). Store below 86°F (30°C). Protect from moisture and excessive heat.

Autorisation status:

Abbreviated New Drug Application

Produktets egenskaber

ERYTHROMYCIN - ERYTHROMYCIN CAPSULE, DELAYED RELEASE
STAT RX USA
----------
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of Erythromycin
Delayed-release Capsules and other antibacterial drugs, Erythromycin
Delayed-release Capsules
should be used only to treat or prevent infections that are proven or
strongly suspected to be caused by
bacteria.
DESCRIPTION
Erythromycin Delayed-release Capsules contain enteric-coated pellets
of erythromycin base for oral
administration. Each Erythromycin Delayed-release Capsule contains 250
milligrams of erythromycin
base.
INACTIVE INGREDIENTS
Cellulosic polymers, citrate ester, D and C Red No. 30, D and C Yellow
No. 10, magnesium stearate
and povidone. The capsule shell contains FD and C Blue No. 1, FD and C
Red No. 3, gelatin, and
titanium dioxide.
Erythromycin is produced by a strain of _Saccharopolyspora erythaea_
(formerly _Streptomyces erythraeus_)
and belongs to the macrolide group of antibiotics. It is basic and
readily forms salts with acids but it is
the base which is microbiologically active. Erythromycin base is (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.
C
H NO MW 734
37
67
13
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 acceptable serum levels. Erythromycin is
largely bound to plasma proteins, and
the freely dissociating bound fraction after administration of
erythromycin base represents 90% of the
total erythromycin absorbed. After absorption, erythromycin diffuses
readily into most body fluids. In
the absence of meningeal inflammation, low concentrations are normally
achieved in the spinal fluid,