药物信息为LidoSite™ Topical Systemcomprised of theLidoSite™ Patch (Lidocaine HCl / Epinephrine topical iontophoretic patch) 10%/0.1%and theLidoSite™ Controller (B. Braun Medical, Inc.): DESCRIPTION

The LidoSite™ Topical System (LidoSite™ System) consists of a LidoSite™ Patch and a LidoSite™ Controller, a portable microprocessor-controlled battery-powered DC current source. The LidoSite™ System delivers lidocaine and epinephrine simultaneously by topical iontophoresis to achieve dermal analgesia on intact skin.

Iontophoresis is based on the principle that a soluble salt or drug can be transported across the skin barrier as a part of an electric current induced in the skin. The quantity and distribution of delivered drug(s) is dependent on the ion charge, molecular weight, intensity of the electric current, concentration of the drug(s), contact surface area of the delivery electrode, and duration of current. In most iontophoretic systems, iontophoresis is measured as total charge delivered in milliampere-minutes (mA-min) units. At the patch electrode pH (4.5), lidocaine HCl and epinephrine are both positively charged.

The LidoSite™ Controller is designed with a non-replaceable battery that provides up to 99 drug applications at 1.77 mA for 10 minutes (17.7 mA-min). Refer to the “LidoSite™ Topical System Instructions” for proper system operation.

The LidoSite™ Patch is for single use only and is disposable. The patch contains a 5-cm² circular drug reservoir that delivers lidocaine and epinephrine to the skin and an elongated return reservoir containing electrolytes to complete the electrical circuit.

The drug reservoir contains 100-mg lidocaine HCl, 1.05 mg of epinephrine (equivalent to 1.91 mg of epinephrine bitartrate) and excipients consisting of sodium chloride, glycerin, preservatives (2-phenoxyethanol, methyl-, ethyl-, propyl-, butyl-, and isobutyl-p-hydroxybenzoate), citric acid as a buffer and chelator, edetate disodium as a chelator, and sodium metabisulfite as an antioxidant, in a non-sterile hydrogel. The elongated return reservoir contains glycerin, sodium chloride, preservatives (2-phenoxyethanol, methyl-, ethyl-, propyl-, butyl-, and isobutyl-p-hydroxybenzoate), and monobasic sodium phosphate as an acidulating agent. The drug and return reservoirs are made from a polyvinylpyrrolidone (PVP) hydrogel.

Lidocaine is a local anesthetic of the amide type. Lidocaine hydrochloride is chemically designated as:

• 2-(Diethylamino)-2′, 6′-acetoxylidide mono-hydrochloride, monohydrate, is a white crystalline powder freely soluble in water, with a molecular weight of 288.81. Its molecular formula is C₁₄H₂₂N₂O•HCl and its structural formula is:

Epinephrine is a sympathomimetic (adrenergic) agent. Epinephrine bitartrate is designated chemically as:

• 1,2 Benzenediol, 4-[1-hydroxy-2-(methylamino) ethyl]-,(R)-, [R-(R*,R*)]-2,3-dihydroxybutanedioate (1:1) (salt) is a white, crystalline powder with a molecular weight of 333.29. Its molecular formula is C₉H₁₃NO₃•C₄H₆O₆ and its structural formula is: