ERYTHROMYCIN solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Physicians Total Care, Inc.

INN (International Name):

ERYTHROMYCIN

Composition:

ERYTHROMYCIN 20 mg

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Erythromycin pledgets, USP are indicated for the topical treatment of acne vulgaris. Erythromycin pledgets, USP are contraindicated in those individuals who have shown hypersensitivity to any of its components.

Product summary:

Each pledget is filled to contain 1 mL of Erythromycin Topical Solution USP 2%. Each mL of Erythromycin Topical Solution USP 2% contains 20 mg of erythromycin. Each pledget is supplied in an individual foil packet in boxes of 60. NDC 54868-0946-0. Store at 20°- 25°C (68°- 77°F)[See USP Controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ERYTHROMYCIN - ERYTHROMYCIN SOLUTION
PHYSICIANS TOTAL CARE, INC.
----------
FOR DERMATOLOGIC USE ONLY
NOT FOR OPHTHALMIC USE
Rx only
DESCRIPTION
Erythromycin Pledgets, USP 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_-_
-_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 _Saccharopolyspora
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 powder, is freely soluble in alcohols, acetone,
chloroform, acetonitrile, ethyl acetate, and
moderately soluble in ether, ethylene dichloride and amyl acetate.
Erythromycin pledgets, USP are
absorbent pads impregnated with Erythromycin Topical Solution 2%. Each
pledget contains 1 mL of
Erythromycin Topical Solution 2% and each 1 mL of Erythromycin Topical
Solution 2% contains 20 mg
of erythromycin base in a vehicle consisting of alcohol (71.5% v/v)
and propylene glycol. May contain
anhydrous citric acid and/or alcohol 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 pledgets, USP are indicated for the topical treatment of
acne vulgaris.