CLINDAMYCIN AND BENZOYL PEROXIDE kit

Land: USA

Språk: engelska

Källa: NLM (National Library of Medicine)

Aktiva substanser:

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

Tillgänglig från:

Sandoz Inc.

INN (International namn):

CLINDAMYCIN PHOSPHATE

Sammansättning:

CLINDAMYCIN 10 mg in 1 g

Receptbelagda typ:

PRESCRIPTION DRUG

Terapeutiska indikationer:

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.

Produktsammanfattning:

Size (Net Weight) NDC 0781- Benzoyl Peroxide Gel Clindamycin Phosphate Solution (In plastic bottle) 25 grams 7263-68 20 grams 5 grams 35 grams (pump) 7275-43 28 grams 7 grams 50 grams 7287-50 40 grams 10 grams 50 grams (pump) 7291-46 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 and Benzoyl Peroxide 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. 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. Call your doctor for medical advice about side effects.  You may report side effects to FDA at 1-800-FDA-1088. Prescribing Information as of July 2017. Rx Only Manufactured by TOLMAR Inc. Fort Collins, CO 80526 for Sandoz Inc. Princeton, NJ 08540 44849 Rev. 3 07/17

Bemyndigande status:

Abbreviated New Drug Application

Produktens egenskaper

CLINDAMYCIN AND BENZOYL PEROXIDE- CLINDAMYCIN AND BENZOYL PEROXIDE
SANDOZ INC.
----------
CLINDAMYCIN AND BENZOYL PEROXIDE GEL, 1%/5%
DESCRIPTION
FOR DERMATOLOGICAL USE ONLY - NOT FOR OPHTHALMIC USE
*RECONSTITUTE BEFORE DISPENSING*
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
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
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
carbopol 980, d-limonene,
docusate sodium solution, phosphoric acid, propylene glycol, purified
water and sodium hydroxide.
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.
18
34
2
8
14
10
4
Less than 2% of the dose enters systemic circulation as benzoic acid.
It is suggested that the lipophilic
natu