Betadine (Povidone-Iodine Ophthalmic) - Description and Clinical Pharmacology

DESCRIPTION

Povidone-Iodine is a broad-spectrum microbicide with the chemical formulas: 2-pyrrolidinone, 1- ethenyl-, homopolymer, compound with iodine; 1-vinyl-2-pyrrolidinone polymer, compound with iodine. The structural formula is as follows:

BETADINE® 5% Sterile Ophthalmic Prep Solution contains 5% povidone-iodine (0.5% available iodine) as a sterile dark brown solution stabilized by glycerin. Inactive Ingredients: citric acid, glycerin, nonoxynol-9, sodium chloride, sodium hydroxide, and dibasic sodium phosphate.

CLINICAL PHARMACOLOGY

A placebo-controlled study in 38 normal volunteers yielded data for 36 subjects who showed a mean log₁₀ reduction of 3.05 log₁₀ units in total aerobes at 10 minutes following prepping the skin with BETADINE 5% Sterile Ophthalmic Prep Solution compared with reduction of 1.58 log₁₀ units after prepping with vehicle free of the iodine complex. This placebo-controlled study indicates a mean log₁₀ reduction by the iodine complex compared with the control solution of 1.47 log₁₀ units at 10 minutes and 1.79 log₁₀ units at 45 minutes. The base-line mean aerobic bacterial count was 7,586 organisms per square cm.