ERYTHROMYCIN AND BENZOYL PEROXIDE kit

Maa: Yhdysvallat

Kieli: englanti

Lähde: NLM (National Library of Medicine)

Aktiivinen ainesosa:

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

Saatavilla:

Oceanside Pharmaceuticals

Prescription tyyppi:

PRESCRIPTION DRUG

Käyttöaiheet:

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.

Tuoteyhteenveto:

How Supplied and Compounding Directions: 23.3 grams (as dispensed) 900-23 20 grams 0.8 grams 3 mL 46.6 grams (as dispensed) 901-46 40 grams 1.6 grams 6 mL 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° to 30°C (59° to 86°F). After reconstitution, store under refrigeration between 2° to 8°C (36° to 46°F). Do not freeze. Keep tightly closed. Keep out of reach of children.

Valtuutuksen tilan:

New Drug Application Authorized Generic

Valmisteyhteenveto

ERYTHROMYCIN AND BENZOYL PEROXIDE- ERYTHROMYCIN AND BENZOYL PEROXIDE
OCEANSIDE PHARMACEUTICALS
----------
ERYTHROMYCIN-BENZOYL PEROXIDE TOPICAL GEL
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-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
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
Homopolymer Type C, 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 absorbed by the skin where it is
converted to benzoic acid.
MICROBIOLOGY
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13
14
10
4
Eryth