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Drug Catalog - Product Detail

CLINDAMYCIN PHOSPHATE TOP SOL

NDC Mfr Size Str Form
45802-0562-01 PADAGIS 30 1% SOLUTION
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Generic Name
CLINDAMYCIN PHOSPHATE
Substance Name
CLINDAMYCIN PHOSPHATE
Product Type
HUMAN PRESCRIPTION DRUG
Route
TOPICAL
Application Number
ANDA064050
Description
DESCRIPTION Clindamycin Phosphate Topical Solution 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 solution contains isopropyl alcohol 50% v/v, propylene glycol, purified water, and sodium hydroxide (to adjust the pH to between 4.0 - 7.0). 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). Chemical Structure
How Supplied
HOW SUPPLIED Clindamycin Phosphate Topical Solution USP, 1% is available as follows: 30 mL applicator bottle (NDC 45802- 562 -01) 60 mL applicator bottle (NDC 45802- 562 -02)
Indications & Usage
INDICATIONS AND USAGE Clindamycin Phosphate Topical Solution USP, 1% 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 ).
Dosage and Administration
DOSAGE AND ADMINISTRATION Apply a thin film of Clindamycin Phosphate Topical Solution USP, 1% twice daily to affected area. Keep container tightly closed.