ERYTHROMYCIN solution

Pays: États-Unis

Langue: anglais

Source: NLM (National Library of Medicine)

Ingrédients actifs:

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

Disponible depuis:

Morton Grove Pharmaceuticals, Inc.

Mode d'administration:

TOPICAL

Type d'ordonnance:

PRESCRIPTION DRUG

indications thérapeutiques:

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

Descriptif du produit:

Erythromycin Topical Solution, USP 2% is supplied as follows: 60 mL bottle with applicator NDC 60432-671-60 Store in a dry place at temperatures between 15 °–25 °C (59 °–77 °F) [See USP Controlled Room Temperature]. KEEP TIGHTLY CLOSED

Statut de autorisation:

Abbreviated New Drug Application

Résumé des caractéristiques du produit

ERYTHROMYCIN- ERYTHROMYCIN SOLUTION
MORTON GROVE PHARMACEUTICALS, INC.
----------
ERYTHROMYCIN TOPICAL SOLUTION,
USP 2%
FOR TOPICAL USE ONLY
NOT FOR USE IN EYES
RX ONLY
DESCRIPTION
Erythromycin Topical Solution, USP 2% contains erythromycin
((3_R_*,4_S_*,5_S_*,6_R_*,7_R_*, 9_R_*,11_R_*,
12_R_*,13_S_*,14_R_*)-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
dermatologic 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 the molecular weight of 733.94. It is a white or
slightly yellow, crystalline powder
and it is slightly soluble in water; soluble in alcohol, in chloroform
and in ether.
Each mL of Erythromycin Topical Solution, USP 2% contains 20
milligrams of erythromycin in a base
of alcohol, USP (66.0%) and propylene glycol, USP.
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
50 S 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 Topical Solution, USP 2% is indicated for the topical
treatment of acne vulgaris.
CONTRAINDICATIONS
37
67
13
Erythromycin Topical Solution, USP 2% is contraindicated in those
individuals who have shown
hypersensitivity to any of its components.
WARNINGS
PSEUDOMEMBRANOUS COLITIS HAS BEEN