Rx Item-Clindacin Etz 1% Kit 1 By Medimetriks Pharma

CLEOCIN T- clindamycin phosphate solution
CLEOCIN T- clindamycin phosphate lotion
CLEOCIN T- clindamycin phosphate gel
Pharmacia and Upjohn Company


For External Use

DESCRIPTION

CLEOCIN T Topical Solution and CLEOCIN T Topical Lotion contain clindamycin phosphate, USP, at a concentration equivalent to 10 mg clindamycin per milliliter. CLEOCIN T Topical Gel contains clindamycin phosphate, USP, at a concentration equivalent to 10 mg clindamycin per gram. Each CLEOCIN T 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, and water.

The gel contains allantoin, carbomer 934P, methylparaben, polyethylene glycol 400, propylene glycol, sodium hydroxide, and purified water.

The 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:

Chemical Structure
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 -?-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 CLEOCIN T 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.

Cleocin T Indications and Usage

CLEOCIN T Topical Solution, CLEOCIN T Topical Gel and CLEOCIN T Topical Lotion are 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.)

RX ITEM-Clindacin Etz 1% Kit 1 By Medime
NDC 43538-0173-60 UPC/GTIN No.3-43538-17360-1 Mfg.Part No.17360

Clindacin Etz 1% Kit 1 By Medimetriks Ph
BRAND: CLINDACIN NDC: 43538-0173-60,43538017360 UPC: 3-43538-17360-1,343538173601 Medimetriks Pharma, Inc.

CLINDAMYCIN PHOS/SKIN CLN
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