ERYTHROMYCIN GEL gel

Pays: États-Unis

Langue: anglais

Source: NLM (National Library of Medicine)

Ingrédients actifs:

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

Disponible depuis:

SOLA Pharmaceuticals

Mode d'administration:

TOPICAL

Type d'ordonnance:

PRESCRIPTION DRUG

indications thérapeutiques:

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: 60 g sealed metal tube (NDC 70512-035-60) Manufactured for: Sola Pharmaceuticals Baton Rouge, LA 70809 Rev. 10/2017

Statut de autorisation:

Abbreviated New Drug Application

Résumé des caractéristiques du produit

ERYTHROMYCIN GEL- ERYTHROMYCIN GEL GEL
SOLA PHARMACEUTICALS
----------
ERYTHROMYCIN TOPICAL GEL USP, 2%
FOR DERMATOLOGICA USE ONLY-NOT FOR OPTHALMIC USE
RX ONLY
DES CRIPTION
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 Saccharopolyspora
erythraea (formerly Streptomyces
erythreus). It is a base and readily forms salts with acids.
Chemically, erythromycin is C37H67NO13. . 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 poorly soluble in water.
Each gram of Erythromycin Topical Gel USP, 2% (clear, colorless, gel)
contains 20 mg of
erythromycin USP in a vehicle consisting of alcohol (92% v/v) 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.
INDICATION AND USAGE
Erythromycin Topical Ge