CLINDAMYCIN AND BENZOYL PEROXIDE- clindamycin and benzoyl peroxide

Kraj: Stany Zjednoczone

Język: angielski

Źródło: NLM (National Library of Medicine)

Składnik aktywny:

CLINDAMYCIN PHOSPHATE (UNII: EH6D7113I8) (CLINDAMYCIN - UNII:3U02EL437C)

Dostępny od:

Perrigo New York Inc

INN (International Nazwa):

CLINDAMYCIN PHOSPHATE

Skład:

CLINDAMYCIN PHOSPHATE 10 mg in 1 g

Typ recepty:

PRESCRIPTION DRUG

Wskazania:

Clindamycin and benzoyl peroxide topical gel, 1%/5% is indicated for the topical treatment of acne vulgaris. Clindamycin and benzoyl peroxide topical 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.

Podsumowanie produktu:

Size (Net Weight) NDC 45802 Benzoyl Peroxide Gel Active Clindamycin Powder (In plastic vial) Purified Water To Be Added to each vial 25 grams 507 -01 19.7g 0.3g 5 mL 35 grams (pump) 507 -03 27.6g 0.4g 7 mL 50 grams 507 -02 39.4g 0.6g 10 mL 50 grams (pump) 507 -04 39.4g 0.6g 10 mL Prior to dispensing, tap the vial until powder flows freely. Add indicated amount of purified water to the vial (to the mark) and immediately shake to completely dissolve clindamycin. If needed, add additional purified water to bring level up to the mark. Add the solution in the vial to the gel and stir until homogenous in appearance (1 to 1½ minutes). For the 35 and 50 gram pumps only, reassemble jar with pump dispenser. Clindamycin and benzoyl peroxide topical gel, 1%/5% (as reconstituted) can be stored at room temperature up to 25°C (77°F) for 3 months. Place a 3 month expiration date on the label immediately following mixing.

Status autoryzacji:

Abbreviated New Drug Application

Charakterystyka produktu

CLINDAMYCIN AND BENZOYL PEROXIDE- CLINDAMYCIN AND BENZOYL PEROXIDE
PERRIGO NEW YORK INC
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CLINDAMYCIN AND BENZOYL PEROXIDE TOPICAL GEL, 1%/5%
TOPICAL GEL: CLINDAMYCIN (1%) AS CLINDAMYCIN PHOSPHATE, BENZOYL
PEROXIDE (5%)
FOR DERMATOLOGICAL USE ONLY - NOT FOR OPHTHALMIC USE
*RECONSTITUTE BEFORE DISPENSING*
DESCRIPTION
CLINDAMYCIN AND BENZOYL PEROXIDE TOPICAL 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 a 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 TOPICAL 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 TOPICAL 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, sodium hydroxide, dioctyl sodium sulfosuccinate, and purified
water.
18
34
2
8
14
10
4
CLINICAL PHARMACOLOGY
An _in vitro _percutaneous penetration study comparing clindamycin and
benzoyl peroxide topical 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 topical 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 sys