ERYTHROMYCIN AND BENZOYL PEROXIDE gel

Država: Združene države Amerike

Jezik: angleščina

Source: NLM (National Library of Medicine)

Aktivna sestavina:

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

Dostopno od:

Lyne Laboratories, Inc.

INN (mednarodno ime):

ERYTHROMYCIN

Sestava:

ERYTHROMYCIN 30 mg in 1 g

Tip zastaranja:

PRESCRIPTION DRUG

Status dovoljenje:

Abbreviated New Drug Application

Lastnosti izdelka

ERYTHROMYCIN AND BENZOYL PEROXIDE- ERYTHROMYCIN AND BENZOYL PEROXIDE
GEL
LYNE LABORATORIES, INC.
----------
ERYTHROMYCIN AND BENZOYL PEROXIDE TOPICAL GEL USP
Topical Gel: erythromycin (3%),
benzoyl peroxide (5%)
For Dermatological Use Only –
Not for Ophthalmic Use
Reconstitute Before Dispensing
DESCRIPTION
Erythromycin and Benzoyl Peroxide Topical Gel USP contains
erythromycin [(3R*, 4S*, 5S*, 6R*,
7R*, 9R*, 11R*, 12R*, 13S*, 14R*)-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)-β-D-
_xylo_-hexopyranosyl]oxy]oxacyclotetradecane-2,10-dione]. 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
crystalline powder and has a solubility
37
67
13
of approximately 1 mg/mL in water and is soluble in alcohol at 25˚C.
Erythromycin and Benzoyl Peroxide Topical Gel USP also contains
benzoyl peroxide for topical use.
Benzoyl peroxide is an antibacterial and keratolytic agent.
Chemically, benzoyl peroxide is (C
H
O
). It has the following structural formula:
Benzoyl peroxide has the molecular weight of 242.23. It is a white
granular powder and is sparingly
soluble in water and alcohol and soluble in acetone, chloroform and
ether.
Each gram of Erythromycin and Benzoyl Peroxide Topical Gel USP
contains, as dispensed, 30 mg (3%)
of erythromycin and 50 mg (5%) of benzoyl peroxide in a base of
purified water USP, carbomer 940
NF, ethyl alcohol 20%, sodium hydroxide NF, docusate sodium and
fragrance.
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.
Benzoyl peroxide has a keratolytic and de