CLINDAMYCIN PHOSPHATE solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

VersaPharm Incorporated

INN (International Name):

CLINDAMYCIN PHOSPHATE

Composition:

CLINDAMYCIN 10 mg in 1 mL

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Clindamycin Phosphate Topical Solution is indicated in the treatment of acne vulgaris. In view of the potential for diarrhea, bloody diarrhea and pseudomembranous colitis, the physician should consider whether other agents are more appropriate. (See CONTRAINDICATIONS , WARNINGS and ADVERSE REACTIONS .) Clindamycin Phosphate Topical Solution is contraindicated in individuals with a history of hypersensitivity to preparations containing clindamycin or lincomycin, a history of regional enteritis or ulcerative colitis, or a history of antibiotic-associated colitis.

Product summary:

Clindamycin Phosphate Pledgets contain Clindamycin Phosphate Topical Solution. The solution contains clindamycin phosphate equivalent to 10 mg clindamycin per milliliter. Clindamycin Phosphate Pledgets are available in a jar of 60 single-use pledget applicators. (NDC 61748-201-60)

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CLINDAMYCIN PHOSPHATE- CLINDAMYCIN PHOSPHATE SOLUTION
VERSAPHARM INCORPORATED
----------
CLINDAMYCIN PHOSPHATE TOPICAL
SOLUTION USP, 1% (PLEDGETS)
RX ONLY
FOR EXTERNAL USE
DESCRIPTION
Clindamycin Phosphate Topical Solution contains clindamycin phosphate,
USP, at a concentration
equivalent to 10 mg clindamycin per milliliter. Each Clindamycin
Phosphate Topical Solution pledget
applicator contains approximately 1 mL of topical solution.
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 50% v/v, propylene glycol,
sodium hydroxide (to adjust the pH
to between 4.0 – 7.0) 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
fatty acids on the skin surface ha