ERYTHROMYCIN capsule, delayed release

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

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

Διαθέσιμο από:

Arbor Pharmaceuticals, Inc.

INN (Διεθνής Όνομα):

Erythromycin

Σύνθεση:

Erythromycin 250 mg

Οδός χορήγησης:

ORAL

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Θεραπευτικές ενδείξεις:

Erythromycin is indicated in the treatment of infections caused by susceptible strains of the designated organisms 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 erythromycin concentrations ordinarily achieved). (see appropriate sulfonamide labeling for prescribing information). Lower respiratory tract infections of mild to moderate severity caused by Streptococcus pneumoniae or Streptococcus pyogenes . Listeriosis caused by Listeria monocytogenes . Pertussis (whooping cough) caused by Bordetella pertussis . Erythromycin is effective in eliminating the organism from the nasopharynx of infected individuals rendering them noninfectious. Some clinical studies suggest that erythromycin may be helpful in the prophylaxis of pertussis in exposed susceptible ind

Περίληψη προϊόντος:

Erythromycin Delayed-release Capsules, USP, are clear and opaque maroon capsules bearing the Product Code ER with pink and yellow particles containing 250 mg of erythromycin supplied in: Bottles of 100 (NDC 24338-120-13) Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature] Protect from moisture and excessive heat.

Καθεστώς αδειοδότησης:

Abbreviated New Drug Application

Αρχείο Π.Χ.Π.

ERYTHROMYCIN- ERYTHROMYCIN CAPSULE, DELAYED RELEASE
ARBOR PHARMACEUTICALS, INC.
----------
ERYTHROMYCIN
DELAYED-RELEASE
CAPSULES, USP
RX ONLY
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of Erythromycin
Delayed-release Capsules, USP and other antibacterial drugs,
Erythromycin Delayed-release Capsules,
USP 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, USP contain enteric-coated
pellets of erythromycin base for
oral administration.
Each Erythromycin Delayed-release Capsule, USP contains 250 mg of
erythromycin base.
INACTIVE INGREDIENTS
Cellulosic polymers, citrate ester, D&C Red No. 30, D&C Yellow No. 10,
magnesium stearate and
povidone. The capsule shell contains FD&C Blue No. 1, FD&C Red No. 3,
gelatin, and titanium
dioxide.
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 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.
ERYTHROMYCIN
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 percent
of the total erythromycin absorbed. After absorption, erythromycin
diffuses readily into most body
fluids. In the absence of