BENZACLIN- clindamycin phosphate and benzoyl peroxide gel
Country: United States
Language: English
Source: NLM (National Library of Medicine)
Summary of Product characteristics
(SPC)
16-02-2017
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Active ingredient:
CLINDAMYCIN PHOSPHATE (UNII: EH6D7113I8) (CLINDAMYCIN - UNII:3U02EL437C), BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM)
Available from:
Bausch Health US LLC
INN (International Name):
CLINDAMYCIN PHOSPHATE
Composition:
CLINDAMYCIN 10 mg in 1 g
Administration route:
TOPICAL
Prescription type:
PRESCRIPTION DRUG
Therapeutic indications:
BenzaClin Topical Gel is indicated for the topical treatment of acne vulgaris. BenzaClin 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 5190-25 19.7 g 0.3 g 5 mL 35 grams (pump) 5190-35 27.6 g 0.4 g 7 mL 50 grams (pump) 5190-50 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. BenzaClin 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 the reach of children. Rx only
Authorization status:
New Drug Application
Summary of Product characteristics
BENZACLIN- CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE GEL
BAUSCH HEALTH US LLC
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BENZACLIN 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
BenzaClin 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).
BenzaClin 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 BenzaClin 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
An _in vitro_ percutaneous penetration study comparing BenzaClin
Topical Gel and topical 1%
clindamycin gel alone demonstrated there was no statistical difference
in penetration between the two
®
®
18
34
2
8
14
10
4
clindamycin gel alone demonstrated there was no statistical difference
in penetration between the two
drugs. Mean systemic bioavailability of topical clindamycin in
BenzaClin 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 circulation as benzoic acid.
It is suggested that the lipophilic
nature
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