ERYTHROMYCIN solution

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

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

Διαθέσιμο από:

VersaPharm Incorporated

INN (Διεθνής Όνομα):

ERYTHROMYCIN

Σύνθεση:

ERYTHROMYCIN 20 mg in 1 mL

Οδός χορήγησης:

TOPICAL

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Θεραπευτικές ενδείξεις:

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

Περίληψη προϊόντος:

Erythromycin Pledgets USP, 2% are available in a plastic jar containing 60 pledgets - NDC 61748-202-60. Each pledget is filled to contain 0.8 mL of erythromycin topical solution, 2%. Keep jar tightly closed.

Καθεστώς αδειοδότησης:

Abbreviated New Drug Application

Αρχείο Π.Χ.Π.

ERYTHROMYCIN- ERYTHROMYCIN SOLUTION
VERSAPHARM INCORPORATED
----------
ERYTHROMYCIN PLEDGETS USP, 2%
RX ONLY
FOR DERMATOLOGIC USE ONLY
NOT FOR OPHTHALMIC USE
DESCRIPTION
Erythromycin Pledgets USP, 2% contain erythromycin, USP 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 C
H NO . It
has the following structural formula:
Molecular weight of 733.94
The chemical name for erythromycin is
(3R*,4S*,5S*,6R*_,_7_R*_,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.
Erythromycin is a white or slightly yellow, crystalline powder,
slightly soluble in water, soluble in
alcohol, in chloroform, and in ether. It is odorless or practically
odorless. It has a pH range between
8.0 and 10.5 in a methanol and water solution prepared by diluting 1
volume of a methanol solution,
containing 40 mg per mL, with 19 volumes of water.
Each mL of expressible liquid contains 20 mg erythromycin in a base of
alcohol (68.5%) (denatured
with _tert_-butyl alcohol and denatonium benzoate), propylene glycol
and citric acid to adjust pH. Each
pledget is filled to contain 0.8 mL of erythromycin topical solution.
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, and
37
67
13
lincomycin, chloramphenicol, and cli