CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE gel

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

CLINDAMYCIN PHOSPHATE (UNII: EH6D7113I8) (CLINDAMYCIN - UNII:3U02EL437C), BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM)

Available from:

Oceanside Pharmaceuticals

INN (International Name):

CLINDAMYCIN PHOSPHATE

Composition:

CLINDAMYCIN 10 mg in 1 g

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Clindamycin and Benzoyl Peroxide Topical Gel is indicated for the topical treatment of acne vulgaris. Clindamycin and Benzoyl Peroxide Topical Gel 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:

25 grams 190-25 19.7 g 0.3 g 5 mL 35 grams (pump) 190-35 27.6 g 0.4 g 7 mL 50 grams (pump) 190-50 39.4 g 0.6 g 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 homogeneous 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 (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. Store at room temperature up to 25°C (77°F) [See USP]. Do not freeze. Keep tightly closed. Keep out of reach of children. Rx only

Authorization status:

New Drug Application

Summary of Product characteristics

CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE- CLINDAMYCIN PHOSPHATE AND
BENZOYL PEROXIDE GEL
OCEANSIDE PHARMACEUTICALS
----------
CLINDAMYCIN AND BENZOYL PEROXIDE TOPICAL GEL
(CLINDAMYCIN - BENZOYL PEROXIDE GEL)
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 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 CIN 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 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 contains, as
dispensed, 10 mg (1%)
clindamycin as phosphate and 50 mg (5%) benzoyl peroxide in a base of
carbomer, sodium hydroxide,
dioctyl sodium sulfosuccinate, and purified water.
CLINICAL PHARMACOLOGY
®
18
34
2
8
14
10
4
An _in vitro_ percutaneous penetration study comparing Clindamycin and
Benzoyl Peroxide Topical Gel
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 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