ERYTHROMYCIN-BENZOYL PEROXIDE gel

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Physicians Total Care, Inc.

INN (International Name):

ERYTHROMYCIN

Composition:

ERYTHROMYCIN 30 mg in 1 g

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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

Product summary:

Prior to dispensing, tap vial until all powder flows freely. Add indicated amount of room temperature 70% ethyl alcohol to vial (to the mark) and immediately shake to completely dissolve erythromycin . Add this solution to gel and stir until homogeneous in appearance (1 to 1½ minutes). Erythromycin-Benzoyl Peroxide Topical Gel should then be stored under refrigeration. Do not freeze. Place a 3-month expiration date on the label. NOTE: Prior to reconstitution, store at room temperature between 15° and 30°C (59° – 86°F). After reconstitution, store under refrigeration between 2° and 8°C (36° – 46°F). Do not freeze. Keep tightly closed. Keep out of the reach of children. Prescribing Information as of March 2006. Manufactured by: sanofi-aventis Canada Inc., Laval, Quebec, Canada H7L 4A8 Distributed by: Perrigo® Allegan, MI 49010 Country of Origin: Canada Relabeling of "Additional Barcode Label" by: Physicians Total Care, Inc. Tulsa, OK     74146 Erythromycin-Benzoyl Peroxide Topical Gel

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ERYTHROMYCIN-BENZOYL PEROXIDE - ERYTHROMYCIN-BENZOYL PEROXIDE GEL
PHYSICIANS TOTAL CARE, INC.
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TOPICAL GEL: ERYTHROMYCIN (3%), BENZOYL PEROXIDE (5%)
FOR DERMATOLOGICAL USE ONLY – NOT FOR OPHTHALMIC USE
RECONSTITUTE BEFORE DISPENSING
DESCRIPTION
Erythromycin-Benzoyl Peroxide Topical Gel 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-hexa-methyl-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
of approximately 1 mg/mL in water and is soluble in alcohol at 25°C.
Erythromycin-Benzoyl Peroxide Topical Gel 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-Benzoyl Peroxide Topical Gel contains, as
dispensed, 30 mg (3%) of
erythromycin and 50 mg (5%) of benzoyl peroxide in a base of purified
water USP, carbomer, 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 desquamative effect which may
also contribute to its efficacy.
Benzoyl peroxide has been shown to be abso