ERYTHROMYCIN- erythromycin solution

Land: USA

Språk: engelska

Källa: NLM (National Library of Medicine)

Aktiva substanser:

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

Tillgänglig från:

E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.

INN (International namn):

ERYTHROMYCIN

Sammansättning:

ERYTHROMYCIN 20 mg in 1 mL

Administreringssätt:

TOPICAL

Receptbelagda typ:

PRESCRIPTION DRUG

Terapeutiska indikationer:

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.

Produktsammanfattning:

Erythromycin Topical Solution USP, 2% is supplied as follows: 60 mL bottle with applicator NDC 0168-0215-60 Store in a dry place at temperatures between 15° - 25°C (59° - 77°F)[See USP Controlled Room Temperature]. E. FOUGERA & CO. A division of Fougera PHARMACEUTICALS INC. Melville, New York 11747 I2215F/IF2215H R12/11 #85

Bemyndigande status:

Abbreviated New Drug Application

Produktens egenskaper

ERYTHROMYCIN- ERYTHROMYCIN SOLUTION
E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.
----------
ERYTHROMYCIN TOPICAL SOLUTION USP 2%
FOR TOPICAL USE ONLY.
NOT FOR USE IN EYES.
RX ONLY
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%), and propylene glycol. It may contain
citric acid to adjust pH.
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 hy