ERYTHROMYCIN- erythromycin gel

Quốc gia: Hoa Kỳ

Ngôn ngữ: Tiếng Anh

Nguồn: NLM (National Library of Medicine)

Thành phần hoạt chất:

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

Sẵn có từ:

Renaissance Pharma, Inc.

INN (Tên quốc tế):

ERYTHROMYCIN

Thành phần:

ERYTHROMYCIN 20 mg in 1 g

Tuyến hành chính:

TOPICAL

Loại thuốc theo toa:

PRESCRIPTION DRUG

Chỉ dẫn điều trị:

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

Tóm tắt sản phẩm:

Erythromycin Topical Gel USP, 2% is available as follows:  30 g sealed metal tube (NDC 40085-315 -30) 60 g sealed metal tube (NDC 40085-315 -60)

Tình trạng ủy quyền:

New Drug Application Authorized Generic

Đặc tính sản phẩm

ERYTHROMYCIN- ERYTHROMYCIN GEL
RENAISSANCE PHARMA, INC.
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ERYTHROMYCIN TOPICAL GEL
Erythromycin Topical Gel USP, 2%
FOR DERMATOLOGIC USE ONLY – NOT FOR OPHTHALMIC USE
RX ONLY
DESCRIPTION
Erythromycin Topical Gel USP, 2% contains erythromycin (3R*, 4S*, 5S*,
6R*, 7R*, 9R*, 11R*,
12R*, 13S*,
14R*)-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
dermatological use. Erythromycin is
a macrolide antibiotic produced from a strain of
_Saccaropolysporaerythraea _(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 a molecular weight of 733.94. It is a white or
slightly yellow, odorless or
practically odorless, bitter crystalline powder. Erythromycin is very
soluble in very polar organic
solvents such as alcohols, acetone, chloroform, acetonitrile and ethyl
acetate. It is moderately soluble
in less polar solvents such as ether, dichloroethylene and amyl
acetate. It is slightly soluble in nonpolar
solvents such as hexane. It is very poorly soluble in water.
Each gram of Erythromycin Topical Gel USP, 2% contains 20 mg of
erythromycin USP in a
vehicle consisting of dehydrated alcohol and hydroxypropyl cellulose.
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
37
67
13
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
Eryth