Clindamax Topical Suspension

Rx Only

FOR EXTERNAL USE ONLY

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).

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 have been decreased from approximately 14% to 2% following application of clindamycin.

Topically applied ClindaMax® Lotion (clindamycin phosphate topical suspension USP 1%) can be absorbed in sufficient amounts to produce systemic effects. (See WARNINGS.)

Apply a thin film of ClindaMax® Lotion (clindamycin phosphate topical suspension USP 1%) twice daily to affected area.

Shake well immediately before using.

Keep in container and keep tightly closed.

ClindaMax® Lotion (clindamycin phosphate topical suspension USP 1%) containing clindamycin phosphate equivalent to 10 mg clindamycin per mL, is supplied as follows:

Store at 20°-25°C (68°-77°F). [See USP Controlled Room Temperature].

PharmaDerm®
A division of Nycomed US Inc., Melville, NY 11747
www.pharmaderm.com

I8391C/IF8391C
#43
R10/08