ERYTHROMYCIN- erythromycin solution

Страна: САЩ

Език: английски

Източник: NLM (National Library of Medicine)

Активна съставка:

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

Предлага се от:

Teligent Pharma, Inc.

Начин на приложение:

TOPICAL

Вид предписание :

PRESCRIPTION DRUG

Терапевтични показания:

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

Каталог на резюме:

Erythromycin Topical Solution USP, 2% is a clear, colorless liquid, which is supplied as follows: 60 mL bottle with applicator NDC 52565-027-59 Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86° F) [See USP Controlled Room Temperature]. Manufactured by: Teligent Pharma, Inc. Buena, New Jersey 08310 Rev 07/16

Статус Оторизация:

Abbreviated New Drug Application

Данни за продукта

ERYTHROMYCIN - ERYTHROMYCIN SOLUTION
TELIGENT PHARMA, INC.
----------
ERYTHROMYCIN TOPICAL SOLUTION USP 2%
FOR TOPICAL USE ONLY.
NOT FOR USE IN EYES.
DESCRIPTION:
Erythromycin Topical Solution contains erythromycin 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:
(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.
It has the following
structural formula:
Erythromycin is a white or slightly yellow crystalline powder that is
very soluble in water, freely
soluble in alcohols, acetone, chloroform, acetonitrile, ethyl acetate,
and moderately soluble in ether,
ethylene dichloride and amyl acetate.
Each mL of Erythromycin Topical Solution USP 2% contains 20 mg of
erythromycin base in a vehicle
consisting of alcohol (71.5%), propylene glycol, and citric acid.
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 is indicated for the topical treatment
of acne vulgaris.
CONTRAINDICATIONS:
Erythromycin Topical Solution is contraindicated in those individuals
who have shown hypersensitivity
to any of its components.
WARNINGS:
PSEUDOMEMBRANOUS COLIT