作者
SeJeong Yoon, Stephanie L Gianturco, Laura L Pavlech, Kathena D Storm, Melissa V Yuen, Ashlee N Mattingly
发表日期
2020
简介
Cyclopentolate HCl was nominated for use in ophthalmic surgeries and procedures as a 0.25-1% topical ophthalmic solution and gel, cycloplegia and mydriasis induction as a 0.2-2% ophthalmic solution, and cylcoplegia for pain control in chronic uveitis as well as confirmation of toric lens placement confirmation as a 0.5-1% topical drop, spray and 0.1% intracameral injection. Reasons provided for nomination to the 503B Bulks List include:• The dilution of multiple FDA-approved products reduces the effectiveness of the drug during the procedure. The reduction to using one (1) combination product instead of multiple separate ingredients reduces the chance of the wrong medication being used and increases productivity in pre-op staging.
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SJ Yoon, SL Gianturco, LL Pavlech, KD Storm… - 2020