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B.A. Schlech, S. Sutton, R.A. Rosenthal, R. Berry, S. Buck; Antimicrobial Preservative Effectiveness of VIGAMOX . Invest. Ophthalmol. Vis. Sci. 2004;45(13):4913.
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Purpose: VIGAMOX contains the 4th generation fluoroquinolone, moxifloxacin hydrochloride at 0.5%, as the active ingredient. It does not contain the typical antimicrobial preservative, benzalkonium chloride [BAK]. Nevertheless, VIGAMOX must meet all the FDA requirements for a sterile multidose ophthalmic product. This presentation reviews the microbiological challenge data supporting the adequacy of the antimicrobial preservative efficacy of this product. Methods: VIGAMOX was subjected to the Antimicrobial Preservative Efficacy Test currently required in the United States Pharmacopoeia [USP]. In addition, VIGAMOX was also challenged with additional organisms not required by the USP to measure the preservative effectiveness of the product. Results: The results of over 50 USP Preservative Efficacy Tests over a period of 3 years showed that VIGAMOX meets and exceeds the USP requirements. Staphylococcus aureus, Pseudomonas aeruginosa, Escherichia coli, Candida albicans, Aspergillus niger were all reduced to acceptable levels after gross contamination of the product. In addition, challenges with the protozoan, Acanthamoeba, and two other fungi, Nocardia and Fusarium, also show killing after inoculation. Conclusions: VIGAMOX proved to be adequately preserved and meets and exceeds all FDA requirements and USP standards without the need of BAK in the product. Special studies with additional challenge organisms indicate the breadth of antimicrobial preservative activity of this product.
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