CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE- clindamycin phosphate and benzoyl peroxide

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Mylan Pharmaceuticals Inc.

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Clindamycin Phosphate and Benzoyl Peroxide Gel, 1%/5% is indicated for the topical treatment of acne vulgaris. Clindamycin Phosphate 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 summary:

Size (Net Weight) NDC # Benzoyl Peroxide Gel Clindamycin Phosphate Solution (in plastic bottle) 25 grams 0378-8688-35 20 grams 5 grams 35 grams (pump) 0378-8688-52 28 grams 7 grams 50 grams 0378-8688-54 40 grams 10 grams 50 grams (pump) 0378-8688-50 40 grams 10 grams Prior to dispensing, add the solution in the bottle 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 Phosphate and Benzoyl Peroxide Gel, 1%/5% 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. Store at room temperature up to 25°C (77°F) [see USP]. Do not freeze. Keep tightly closed. Keep out of the reach of children. Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. Manufactured by: Mylan Institutional Inc. Sugar Land, TX 77478 U.S.A. 1188.9 Revised: 9/2018 MI:CLBZPX:R9

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE- CLINDAMYCIN PHOSPHATE AND
BENZOYL PEROXIDE
MYLAN PHARMACEUTICALS INC.
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CLINDAMYCIN PHOSPHATE 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 Phosphate 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 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 Phosphate 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 Phosphate 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, propylene
glycol, potassium hydroxide, and purified water.
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2
8
14
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CLINICAL PHARMACOLOGY
An _in vitro_ percutaneous penetration study comparing Clindamycin
Phosphate 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
Phosphate 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 s