ERYTHROMYCIN AND BENZOYL PEROXIDE kit

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

Sandoz Inc.

INN (International Name):

ERYTHROMYCIN

Sammensetning:

ERYTHROMYCIN 30 mg in 1 g

Administreringsrute:

TOPICAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

Erythromycin and benzoyl peroxide topical gel USP, 3%;5% is indicated for the topical treatment of acne vulgaris. Erythromycin and benzoyl peroxide topical gel USP, 3%;5% is contraindicated in those individuals who have shown hypersensitivity to any of its components.

Produkt oppsummering:

TO THE PHARMACIST: IMPORTANT – 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 with supplied spatula until homogeneous in appearance (1 to 1 ½ minutes). Erythromycin and benzoyl peroxide topical gel USP, 3%;5% should then be stored under refrigeration. Do not freeze. Place a 3-month expiration date on the label. NOTE: Prior to reconstitution, store at 20° to 25°C (68° – 77°F). [See USP Controlled Room Temperature]. 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. Call your doctor for medical advice about side effects.  You may report side effects to FDA at 1-800-FDA-1088. Manufactured by TOLMAR Inc. Fort Collins, CO 80526 for Sandoz Inc. Princeton, NJ  08540 04275 Rev. 6 04/11

Autorisasjon status:

Abbreviated New Drug Application

Preparatomtale

ERYTHROMYCIN AND BENZOYL PEROXIDE- ERYTHROMYCIN AND BENZOYL PEROXIDE
SANDOZ INC.
----------
ERYTHROMYCIN AND BENZOYL PEROXIDE TOPICAL GEL, USP
TOPICAL GEL: ERYTHROMYCIN (3%), BENZOYL PEROXIDE (5%)
Rx only
PLEASE READ COMPLETE COMPOUNDING DIRECTIONS
NOTE: TAP VIAL UNTIL ALL POWDER FLOWS FREELY. ADD ROOM TEMPERATURE 70%
ETHYL ALCOHOL TO VIAL (TO THE MARK) AND IMMEDIATELY SHAKE/DISSOLVE
COMPLETELY.
FOR DERMATOLOGICAL USE ONLY – NOT FOR OPHTHALMIC USE
Reconstitute Before Dispensing
DESCRIPTION
Erythromycin and benzoyl peroxide topical gel USP, 3%;5% 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)-ß-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 and benzoyl peroxide topical gel USP, 3%;5% 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:
37
67
13
14
10
4
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, 3%;5%
contains, as dispensed, 30
mg (3%) of erythromycin, USP and 50 mg (5%) of benzoyl peroxide, USP
in a gel of purified water,
USP, alcohol 20%, carbomer homopolymer type C, NF, sodium hydroxide,
NF, docusate sodium and
fragrance.
CLINICAL PHARMA