CLINDAMAX LOTION clindamycin phosphate suspension

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

PharmaDerm, A division of Nycomed US Inc.

INN (International Name):

clindamycin phosphate

Composition:

clindamycin phosphate 10 mg in 1 mL

Prescription type:

PRESCRIPTION DRUG

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CLINDAMAX LOTION- CLINDAMYCIN PHOSPHATE SUSPENSION
PHARMADERM, A DIVISION OF NYCOMED US INC.
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CLINDAMAX LOTION
(CLINDAMYCIN PHOSPHATE TOPICAL SUSPENSION USP 1%)
RX ONLY
FOR EXTERNAL USE ONLY
DESCRIPTION
ClindaMax
Lotion (clindamycin phosphate topical suspension USP 1%) 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 topical lotion contains cetostearyl alcohol (2.5%), glycerin,
glyceryl stearate SE (with potassium
monostearate), isostearyl alcohol (2.5%), methylparaben (0.3%), sodium
lauroyl sarcosinate, stearic
acid and purified water.
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 (0-3 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 0-1490).
Clindamycin _in vitro_ inhibits all
_Propionibacterium acnes_ cultures tested (MICs 0.4 mcg/mL). Free