ERYTHROMYCIN gel

Pays: États-Unis

Langue: anglais

Source: NLM (National Library of Medicine)

Ingrédients actifs:

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

Disponible depuis:

Padagis Israel Pharmaceuticals Ltd

DCI (Dénomination commune internationale):

ERYTHROMYCIN

Composition:

ERYTHROMYCIN 20 mg in 1 g

Mode d'administration:

TOPICAL

Type d'ordonnance:

PRESCRIPTION DRUG

indications thérapeutiques:

Erythromycin Topical Gel USP, 2% is indicated for the topical treatment of acne vulgaris. Erythromycin Topical Gel USP, 2% is contraindicated in those individuals who have shown hypersensitivity to any of its components.

Descriptif du produit:

Erythromycin Topical Gel USP, 2% is available as follows: 30 g sealed metal tube (NDC 45802-966 -94) 60 g sealed metal tube (NDC 45802-966 -96)

Statut de autorisation:

Abbreviated New Drug Application

Résumé des caractéristiques du produit

ERYTHROMYCIN- ERYTHROMYCIN GEL
PADAGIS ISRAEL PHARMACEUTICALS LTD
----------
ERYTHROMYCIN TOPICAL GEL USP, 2%
FOR DERMATOLOGIC USE ONLY – NOT FOR OPHTHALMIC USE
RX ONLY
DESCRIPTION
Erythromycin Topical Gel USP, 2% contains erythromycin (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), for topical dermatological use. Erythromycin is a macrolide
antibiotic produced
from a strain of _Saccaropolyspora erythraea_ (formerly _Streptomyces
erythreus_). It is a
base and readily forms salts with acids.
Chemically, erythromycin is C
H
NO
. It has the following structural formula:
Erythromycin has a molecular weight of 733.94. It is a white or
slightly yellow, odorless
or practically odorless, bitter crystalline powder. Erythromycin is
very soluble in very
polar organic solvents such as alcohols, acetone, chloroform,
acetonitrile and ethyl
acetate. It is moderately soluble in less polar solvents such as
ether, dichloroethylene
and amyl acetate. It is slightly soluble in nonpolar solvents such as
hexane. It is very
37
67
13
poorly soluble in water.
Each gram of Erythromycin Topical Gel USP, 2% contains 20 mg of
erythromycin USP in
a vehicle consisting of dehydrated alcohol and hydroxypropyl
cellulose.
CLINICAL PHARMACOLOGY
The exact mechanism by which erythromycin reduces lesions of acne
vulgaris is not fully
known; however, the effect appears to be due in part to the
antibacterial activity of the
drug.
MICROBIOLOGY
Erythromycin acts by inhibition of protein synthesis in susceptible
organisms by
reversibly binding to 50S ribosomal subunits, thereby inhibiting
translocation of
aminoacyl transfer-RNA and inhibiting polypeptide synthesis.
Antagonism has been
demonstrated _in vitro _between erythromycin, lincomycin,
chloramphenicol, and
clindamycin.
INDICATIONS AND USAGE
Erythromycin Topic