ERYTHROMYCIN solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Padagis Israel Pharmaceuticals Ltd

INN (International Name):

ERYTHROMYCIN

Composition:

ERYTHROMYCIN 20 mg in 1 mL

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ERYTHROMYCIN- ERYTHROMYCIN SOLUTION
PADAGIS ISRAEL PHARMACEUTICALS LTD
----------
ERYTHROMYCIN TOPICAL SOLUTION USP, 2%
FOR DERMATOLOGIC USE ONLY
NOT FOR OPHTHALMIC USE
RX ONLY
DESCRIPTION
Erythromycin Topical Solution USP, 2% 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-_0_-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)-ß-D-_xylo_-
hexopyranosyl]oxy]oxacyclotetradecane-2,10-dione. It has the following
structural
formula:
Molecular Formula: C
H
NO
Molecular Weight: 733.94
Erythromycin is a white or slightly yellow crystalline powder that is
slightly 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 (66%), citric acid, and
propylene glycol.
37
67
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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 Topical Solution USP, 2% is indicated for the topical
treatment of acne
vulgaris.
CONTRAINDICATIONS
Erythromycin Topical Solution USP, 2% is contraindicated in