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Lidosite (Lidocaine Hydrochloride / Epinephrine Bitartrate Iontophoresis) - Indications and Dosage

 
 



INDICATIONS AND USAGE

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.

DOSAGE AND ADMINISTRATION

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).

LidoSite™ IONTOPHORETIC CONTROLLER FEATURES:

General description:

The LidoSite™ Topical System utilizes a solid-state electronic controller and a pre-filled patch to form an iontophoretic drug delivery system. The LidoSite™ Controller requires only an ON button actuation to start the treatment. Two light emitting diode (LED) indicators inform the user of the delivery status. 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).

Displays and Indicators: The LidoSite™ Controller is provided with both visual and auditory indicators to assist the user in monitoring the function of the device.

There are two LED indicators on the controller, one green and the other yellow. The green indicator is used to indicate normal operating conditions while the yellow indicator informs the user of an abnormal condition.

Table of LED Indicators, LCD and Beeper
CONDITION GREEN YELLOW LCD Beeper COMMENT
Controller without patch connected. ON pressed.Flashes rapidlyFlashes rapidlyDoses
Remain
Displayed
SingleSelf-check completed successfully. Green and yellow indicators alternate for 2 seconds.
Display shows doses remaining for 5 seconds.
Unit automatically shuts off. No current delivered.
Controller with patch detected, but not connected to skin. ON pressed.Flashes rapidlyFlashes rapidlyNo display3 beepsSelf-check completed successfully. Green and yellow indicators alternate for 2 seconds. If no skin detected after 2 minutes, flashing Yellow continues after 2 minutes for 30 minutes then turns OFF. Both indicators turn OFF.
No current is delivered.
If skin detected within 2 minutes, controller goes to delivery in progress.
If skin not detected within initial 2 minutes (i.e. during period of alternate blinking of green and yellow indicators), remove the patch from the controller and discard the patch.
Controller with patch connected & patch placed on the skin. ON pressed.Flashes rapidlyFlashes rapidlyNo display-Self-check completed successfully.
Green and yellow indicators alternate for 2 seconds.
Delivery in progress.Flashes slowlyOFFNo display-Green indicator continues flashing at a rate of once per second until delivery profile completed (10 minutes duration).
Delivery profile complete and target delivery achieved.Flashes rapidlyOFFNo display3 beepsFlashing of green indicator continues at a rate of four times per second for 30 minutes or until patch is disconnected.
After initial 3 beeps, beeper sounds every second for 3 seconds, which repeats every 30 seconds for 30 minutes or until patch is disconnected.
Delivery profile complete but target delivery not achieved.OFFFlashes rapidlyNo display3 beepsFlashing of yellow indicator continues at 4 times per second for 30 minutes or until patch is disconnected.
After initial 3 beeps, beeper sounds every second for 3 seconds, which repeats every 30 seconds for 30 minutes or until patch is disconnected.
Shutdown during delivery (over current or under current condition detected).OFFFlashes rapidlyNo display3 beepsFlashing of yellow indicator continues at 4 times per second for 30 minutes or until patch is disconnected.
After initial 3 beeps, beeper sounds every second for 3 seconds, which repeats every 30 seconds for 30 minutes or until patch is disconnected.
End of life (99 doses delivered) or low battery.OFFSteadyNo display-Remains ON after patch is removed.
Patch disconnected.OFFOFF--Remains OFF after patch is removed.

The LidoSite™ Controller has an internal beeper that sounds when the ON button is pressed, at the end of every delivery, and at the end of the self-check function.

When the ON button is pressed, the unit provides one beep. At the end of a delivery, there is a beep every second for three seconds which repeats every thirty seconds. The sequence continues for thirty minutes or until the patch is removed from the controller. It should be noted that this signal is present at the termination of a delivery, whether successful or not.

At the end of the self-check function, the unit provides one quick beep.

Delivery Profile: The LidoSite™ System has a fixed delivery profile that cannot be altered by the user. The entire delivery is accomplished in approximately 10 minutes. Delivery is initiated upon pressing the ON button and the subsequent detection of skin at the patch site. Once started, the profile proceeds through three stages.

Ramp-Up: When the controller detects the presence of skin, it begins the delivery. To minimize patient discomfort the current is slowly ramped up from zero to 1.77 milliamperes. This ramp up requires approximately 0.5 minutes to complete.

Main Delivery: When the controller has reached the 1.77 mA current, it holds this current constant for approximately the next 9 minutes.

Ramp-Down: Upon completion of the main delivery, the current is slowly ramped down to zero. This ramp-down takes about 0.5 minutes.

Delivery Monitor: The LidoSite™ Controller monitors the actual current delivered throughout the entire delivery profile. During this time, the controller checks for the following delivery conditions:

Over Current: If the controller detects a current in excess of the normal range (1.77 ± 0.09 mA) the current (and delivery) is stopped, the flashing YELLOW indicator is illuminated and the device beeps three times.

Under Current: If the controller detects a current below the normal range of current, the delivery is stopped, the flashing YELLOW indicator is illuminated, and the device beeps three times.

Under Delivery: If the controller detects that the total delivered charge was less than 90% at the end of the delivery profile, the flashing YELLOW indicator is illuminated and the device beeps three times.

If the YELLOW light flashes at 4 times per second, the medication may not have been fully delivered to the application site. This may be caused by a higher than normal skin resistance of the patient, improper patch application, poor patch adhesion or by a malfunction of the patch or controller. In this case drug delivery may or may not have been sufficient to produce the desired effect. A second application using a new LidoSite™ Patch may be applied after 30 minutes to a different skin site. LidoSite™ Patches should not be reapplied to a skin site that has previously been treated with a LidoSite™ Patch. Only one LidoSite™ Patch should be used at a time.

Automatic Shutoff: To maximize battery life, the controller operates with a number of automatic shutoffs.

No Patch: The controller goes through a Self-Check whenever the ON button is pushed. If the controller does not detect the presence of a patch, it will shut itself down. Both indicators turn OFF.

No Skin: After the controller detects the presence of the patch, it looks for the presence of skin. If it does not detect the presence of skin within 2 minutes of detecting the patch, the YELLOW LED continues to flash for 30 minutes then turns itself OFF. Both indicators turn OFF. If skin is not detected within the initial 2 minutes following controller activation (i.e. during alternating blinking of yellow and green LED indicators), remove the patch from the controller and discard the patch.

After Delivery: Upon completion of the delivery profile, the GREEN indicator continues to flash for 30 minutes or until the patch is removed.

Cleaning and Care: The LidoSite™ Controller is a sealed unit requiring no calibration and no maintenance service except for periodic cleaning. Cleaning should be performed with a cloth dampened with an isopropyl alcohol solution. LidoSite™ Controller should not be immersed in any liquid.

PATENTS:

The LidoSite™ Topical System is protected by U.S. patents: 5,246,418; 5,873,850; 6,377,847; 6,385,488; 6,402,732; 6,522,919; 6,629,968; 6,635,045. Additional patents pending.

HOW SUPPLIED:

LidoSite™ Patches are supplied as individually pouched, single-use, iontophoretic patches containing 10% Lidocaine and 0.1% Epinephrine, and are to be used only in conjunction with the LidoSite™ Controller. LidoSite™ Patches and LidoSite™ Controllers are available as follows:

LidoSite™ Topical System
Reorder Number Description NDC#
333901One (1) LidoSite™ ControllerN/A
333925Twenty five (25) LidoSite™ Patches0264-3001-25

Rx only. Store LidoSite™ Patches at controlled room temperature (20°C-25°C; 68°F-77°F). Excursions permitted between 15°-30° C (see USP Controlled Room Temperature).

Warning: Do not subject the patches to freezing temperatures.

© Vyteris, Inc. 2004

Manufactured by:
Vyteris, Inc. Fair Lawn, NJ 07410, USA

Part # 20082 Rev. 2
Printed in USA

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