CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE- clindamycin and benzoyl peroxide gel kit

Land: Verenigde Staten

Taal: Engels

Bron: NLM (National Library of Medicine)

Werkstoffen:

Clindamycin (UNII: 3U02EL437C) (Clindamycin - UNII:3U02EL437C)

Beschikbaar vanaf:

Taro Pharmaceuticals U.S.A., Inc.

Prescription-type:

PRESCRIPTION DRUG

therapeutische indicaties:

Clindamycin and Benzoyl Peroxide Gel, 1%/5% is indicated for the topical treatment of acne vulgaris. Clindamycin and Benzoyl Peroxide Gel, 1%/5% is contraindicated in those individuals who have shown hypersensitivity to any of its components or to lincomycin. It is also contraindicated in those having a history of regional enteritis, ulcerative colitis, or antibiotic-associated colitis.

Product samenvatting:

Prior to dispensing, add the solution in the bottle to the gel and stir until homogenous in appearance (1 to 1½ minutes). Clindamycin and Benzoyl Peroxide Gel, 1%/5% (as reconstituted) can be stored at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature] for 3 months. Place a 3 month expiration date on the label immediately following mixing. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Do not freeze. Keep tightly closed. Keep out of the reach of children.

Autorisatie-status:

Abbreviated New Drug Application

Productkenmerken

CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE- CLINDAMYCIN AND BENZOYL
PEROXIDE GEL
TARO PHARMACEUTICALS U.S.A., INC.
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CLINDAMYCIN AND BENZOYL PEROXIDE GEL, 1%/5%
TOPICAL GEL: CLINDAMYCIN (1%) AS CLINDAMYCIN PHOSPHATE, BENZOYL
PEROXIDE (5%)
FOR DERMATOLOGICAL USE ONLY - NOT FOR OPHTHALMIC USE
*MIX BEFORE DISPENSING
DESCRIPTION
Clindamycin and Benzoyl Peroxide Gel, 1%/5% contains clindamycin
phosphate, (7(S)-chloro-7-
deoxylincomycin-2-phosphate). Clindamycin phosphate is a water soluble
ester of the semi-synthetic
antibiotic produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl
group of the parent antibiotic
lincomycin.
Chemically, clindamycin phosphate is (C
H ClN O PS). The structural formula for clindamycin is
represented below:
Clindamycin phosphate has molecular weight of 504.97 and its chemical
name is Methyl 7-chloro-
6,7,8-trideoxy-6-(1-methyl-trans-4-propyl-L-2-pyrrolidinecarboxamido)-1-thio-L-threo-alpha-D-
galacto-octopyranoside 2-(dihydrogen phosphate).
Clindamycin and Benzoyl Peroxide Gel, 1%/5% also contains benzoyl
peroxide, for topical use.
Chemically, benzoyl peroxide is (C
H O ). It has the following structural formula:
Benzoyl peroxide has a molecular weight of 242.23.
Each gram of Clindamycin and Benzoyl Peroxide Gel, 1%/5% contains, as
dispensed, 10 mg (1%)
clindamycin as phosphate and 50 mg (5%) benzoyl peroxide in a base of
carbomer homopolymer type C,
potassium hydroxide, propylene glycol, and purified water.
18
34
2
8
14
10
4
CLINICAL PHARMACOLOGY
An _in vitro_ percutaneous penetration study comparing Clindamycin and
Benzoyl Peroxide Gel, 1%/5%
and topical 1% clindamycin gel alone, demonstrated there was no
statistical difference in penetration
between the two drugs. Mean systemic bioavailability of topical
clindamycin in Clindamycin and
Benzoyl Peroxide Gel, 1%/5% is suggested to be less than 1%.
Benzoyl peroxide has been shown to be absorbed by the skin where it is
converted to benzoic acid.
Less than 2% of the dose enters systemic circulation as benzoic acid.
It is suggest