Lidosite
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Questions & Answers
Side Effects & Adverse Reactions
Rx Only
DANGER-EXPLOSIVE HAZARD: This product could serve as an ignition source and should not be used in the presence of flammable anesthetics.
Accidental Exposure in Children: Even a used LidoSite™ Patch contains a large amount of lidocaine (up to 100 mg). The potential exists for a small child to suffer serious adverse effects from chewing or ingesting a new or used LidoSite™ Patch. Children should be closely observed when treated with the LidoSite™ System, and LidoSite™ Patches should be stored and disposed of in the proper manner.
Skin Reactions: Iontophoresis can cause skin irritation, burning sensation and/or burns. Patients should be warned of the possibilities and alerted to early signs such as itching or warmth. Patients should be instructed to notify appropriate personnel as soon as symptoms are detected. Longer than recommended durations of application, repeat applications or continued application after the occurrence of symptoms may increase the risk of local skin irritation or injury.
Iontophoresis with the LidoSite™ Patch may cause transient, local blanching or erythema in the dermis under the patch. The redness under the elongated reservoir is normally uniform in color, while under the circular reservoir the color may be mottled.
Sulfite Allergy: LidoSite™ Patch contains sodium metabisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms, and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown. Sulfite sensitivity is seen more frequently in asthmatic than in non-asthmatic people.
Vasoconstriction Related to Epinephrine: Since the LidoSite™ Patch contains a vasoconstrictor, it should not be used on areas of the body supplied by end arteries or having otherwise compromised blood supply. Repeated applications should not be made to the same site. Patients with peripheral vascular disease and those with hypertensive vascular disease may exhibit an exaggerated vasoconstrictor response. LidoSite™ System should be used with caution in patients with severe coronary artery disease, hypertension or cardiac disrhythmias or in patients who are currently taking monoamine oxidase (MAO) inhibitors or tricyclic antidepressants.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
LidoSite™ System is a topical local anesthetic delivery system indicated for use on normal intact skin to provide local analgesia for superficial dermatological procedures such as venipuncture, intravenous cannulation, and laser ablation of superficial skin lesions.
LidoSite™ System is indicated for use on patients 5 years of age and older.
History
There is currently no drug history available for this drug.
Other Information
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 C
14H
22N
2O•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 C
9H
13NO
3•C
4H
6O
6 and its structural formula is:
Sources
Lidosite Manufacturers
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B. Braun Medical, Inc.
![Lidosite (Lidocaine Hydrochloride And Epinephrine Bitartrate) Patch [B. Braun Medical, Inc.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Lidosite | B. Braun Medical, Inc.
LidoSite™ Controller can only be used with the LidoSite™ Patch as the complete LidoSite™ System, and LidoSite™ Patches should only be used with a LidoSite™ Controller.
LidoSite™ System should be applied only by a health care practitioner in a health care setting.
One LidoSite™ Patch is to be used with one LidoSite™ Controller. Do not use a damaged or altered patch. To administer, see the “LidoSite™ Topical System Instructions” contained in this package insert. Following iontophoresis and patch removal, the treatment site should be cleansed according to standard practice prior to the medical procedure. Disinfecting agents containing heavy metal ions (mercury, zinc, copper, etc.) should not be used for skin disinfection prior to iontophoresis as they have been associated with swelling and edema.
LidoSite™ Controller should not be subjected to any sterilization procedure.
LidoSite™ Controller should be disposed of in a trash receptacle.
Recommended Dose: Each iontophoretic treatment delivers lidocaine and epinephrine at the 5-cm2 site below the circular reservoir. Only one LidoSite™ Patch should be used at a time. Application: See “LidoSite™ Topical System Instructions” Apply patch immediately after opening pouch. The LidoSite™ Patch reservoirs must remain in complete contact with the skin during treatment to ensure maximal safety and efficacy. A new patch may be applied to a different skin site after
30 minutes. The LidoSite™ Patch is for single use only. Treatment Duration: Current delivery lasts for 10 minutes following actuation of the LidoSite™ Controller. In clinical studies the medical procedure was initiated within 10 minutes of patch removal. Patch Disposal: LidoSite™ Patch should be disposed of as medical waste. Storage Conditions: Store LidoSite™ Patches at controlled room temperature (20°C-25°C; 68°F-77°F).
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