CLINDAMYCIN PHOSPHATE solution

国家: 美国

语言: 英文

来源: NLM (National Library of Medicine)

有效成分:

Clindamycin phosphate (UNII: EH6D7113I8) (Clindamycin - UNII:3U02EL437C)

可用日期:

AvKARE, Inc.

INN（国际名称）:

Clindamycin phosphate

组成:

Clindamycin 10 mg in 1 mL

处方类型:

PRESCRIPTION DRUG

授权状态:

Abbreviated New Drug Application

产品特点

CLINDAMYCIN PHOSPHATE - CLINDAMYCIN PHOSPHATE SOLUTION
AVKARE, INC.
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CLINDAMYCIN PHOSPHATE
TOPICAL SOLUTION USP, 1%
RX ONLY
FOR EXTERNAL USE
DESCRIPTION
Clindamycin Phosphate Topical Solution contains clindamycin phosphate,
USP, at a concentration
equivalent to 10 mg clindamycin per milliliter.
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.
The solution contains isopropyl alcohol 39% w/v, propylene glycol, and
purified water. May contain
sodium hydroxide for pH balance.
The structural formula is represented below:
The chemical name for clindamycin phosphate is Methyl
7-chloro-6,7,8-trideoxy-6-(1-methyl-_trans_-4-
propyl-L-2-pyrrolidinecarboxamido)-1-thio-L-_threo_-α-D-_galacto_-octopyranoside
2-(dihydrogen
phosphate).
CLINICAL PHARMACOLOGY
Although clindamycin phosphate is inactive _in vitro_, rapid _in vivo_
hydrolysis converts this compound to
the antibacterially active clindamycin.
Cross resistance has been demonstrated between clindamycin and
lincomycin.
Antagonism has been demonstrated between clindamycin and erythromycin.
Following multiple topical applications of clindamycin phosphate at a
concentration equivalent to 10 mg
clindamycin per mL in an isopropyl alcohol and water solution, very
low levels of clindamycin are
present in the serum (0 to 3 ng/mL) and less than 0.2% of the dose is
recovered in urine as clindamycin.
Clindamycin activity has been demonstrated in comedones from acne
patients. The mean concentration of
antibiotic activity in extracted comedones after application of
Clindamycin Phosphate Topical Solution
for 4 weeks was 597 mcg/g of comedonal material (range 0 to 1490).
Clindamycin _in vitro_ inhibits all
_Propionibacterium acnes_ cultures tested (MICs 0.4 mcg/mL). Free
fatty acids on the skin surface have
been decreased from approximately 14% to 2% following application of
clindamycin.
INDICATIONS AND USAGE
Clindamycin Phosphate Topical Solu