ERYTHROMYCIN AND BENZOYL PEROXIDE gel

Land: USA

Språk: engelska

Källa: NLM (National Library of Medicine)

Aktiva substanser:

ERYTHROMYCIN (UNII: 63937KV33D) (ERYTHROMYCIN - UNII:63937KV33D), BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM)

Tillgänglig från:

Rising Pharmaceuticals, Inc.

INN (International namn):

ERYTHROMYCIN

Sammansättning:

ERYTHROMYCIN 30 mg in 1 g

Administreringssätt:

TOPICAL

Receptbelagda typ:

PRESCRIPTION DRUG

Terapeutiska indikationer:

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

Bemyndigande status:

Abbreviated New Drug Application

Produktens egenskaper

ERYTHROMYCIN AND BENZOYL PEROXIDE - ERYTHROMYCIN AND BENZOYL
PEROXIDE GEL
RISING PHARMACEUTICALS, INC.
----------
ERYTHROMYCIN AND BENZOYL PEROXIDE TOPICAL GEL USP
TO THE PHARMACIST: IMPORTANT: PLEASE READ COMPLETE COMPOUNDING
DIRECTIONS
NOTE: TAP VIAL UNTIL ALL POWDER FLOWS FREELY. ADD INDICATED
AMOUNT OF ROOM TEMPERATURE 70% ETHYL ALCOHOL TO VIAL (TO THE
MARK) AND IMMEDIATELY SHAKE/DISSOLVE COMPLETELY.
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:
37
67
13
Erythromycin has the molecular weight of 733.94. It is a white
crystalline powder and
has a solubility 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
14
10
4
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 2