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Questions & Answers
Side Effects & Adverse Reactions
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Legal Issues
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FDA Safety Alerts
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Manufacturer Warnings
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FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
Zingo™ is indicated for use on intact skin to provide topical local analgesia prior to venipuncture or peripheral intravenous cannulation, in children 3-18 years of age.
History
There is currently no drug history available for this drug.
Other Information
Zingo™ (lidocaine hydrochloride monohydrate) powder intradermal injection system contains 0.5 mg of sterile lidocaine hydrochloride monohydrate.
The chemical name is 2-diethylamino-2',6'-acetoxylidide, monohydrochloride, monohydrate. The molecular formula is C14H22N2O · HCl · H2O with a molecular weight of 288.8 Da. Lidocaine hydrochloride monohydrate, a local anesthetic of the amide class, has the following structural formula:
Lidocaine hydrochloride monohydrate is freely soluble in water, soluble in alcohol and chloroform, insoluble in ether, and melts at around 74–79°C.
Zingo™ is a ready-to-use, sterile, single-use, disposable, needle-free delivery system. Zingo™ consists of the following components: a drug reservoir cassette filled with 0.5 mg lidocaine hydrochloride monohydrate as a powder with a nominal particle size of 40 µm, a pressurized helium gas cylinder, and a safety interlock. The safety interlock prevents inadvertent actuation of the device. Once Zingo™ is pressed against the skin, the interlock is released, allowing the button to be depressed to actuate the device. A sound similar to that of a popping balloon is emitted at the time Zingo™ is actuated.
Sources
Zingo Manufacturers
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Anesiva, Inc.
Zingo | Anesiva, Inc.
Apply one Zingo™ (0.5 mg lidocaine hydrochloride monohydrate) to the site planned for venipuncture or intravenous cannulation, one to three minutes prior to needle insertion.
Perform the procedure within 10 minutes after Zingo™ administration.
Use Zingo™ only on intact skin.
Application of one additional Zingo™ at a new location is acceptable after a failed attempt at venous access. Multiple administrations of Zingo™ at the same location are not recommended.
When Zingo™ is used concomitantly with other products containing local anesthetic agents, the amount absorbed from all sources should be considered, as local anesthetics are thought to have at least additive toxicities.
2.1 Instructions for Use
Prepare the Treatment Site and Device: Examine the treatment site to ensure that the skin is intact. Clean the site, according to standard practice.
Visually inspect the pouch. Do not use if the pouch has been torn, or damaged or if the device has been dropped.
Tear open the pouch using the notch provided (Figure 1a). Remove Zingo™ from the pouch, being careful not to touch the purple outlet (open end) to avoid contamination (Figure 1b).
Figure 1a
Figure 1b
Position Zingo™: Grip Zingo™ and place on the application site, with one hand, as illustrated in Figure 2, or with both hands, as shown in Figure 3.
Figure 2
Figure 3
Ensure that the patient’s treatment site is supported to prevent movement. Seal the purple Zingo™ outlet against the patient’s skin. Hold the device perpendicular to the skin, making sure that your thumb can reach the green start button.
Avoid gaps between the skin and the Zingo™ outlet, like the one illustrated in Figure 4, as gaps will impede drug delivery. Figure 4
Release the Safety Interlock: Apply adequate downward pressure to release the safety interlock, while maintaining the seal between Zingo™ and the skin.
Zingo™ is ready for administration when the green start button has moved into the upward position, as illustrated in Figure 5a.
Figure 5a
Zingo™ cannot be actuated without releasing the internal safety interlock, as illustrated in Figure 5b.
Figure 5b
Administer Zingo™: While maintaining downward pressure, administer the dose by pressing the green start button, as illustrated in Figure 6. Do not move Zingo™ during administration. Actuation is accompanied by a “popping” sound, indicating that the dose has been discharged.
Figure 6
Remove Zingo™: Remove Zingo from the application site and dispose.
Begin Procedure: Start the venipuncture or intravenous cannulation procedure 1–3 minutes after Zingo™ administration. -
Medline Industries, Inc.
Zingo | Medline Industries, Inc.
Apply one Zingo™ (0.5 mg lidocaine hydrochloride monohydrate) to the site planned for venipuncture or intravenous cannulation, one to three minutes prior to needle insertion.
Perform the procedure within 10 minutes after Zingo™ administration.
Use Zingo™ only on intact skin.
Application of one additional Zingo™ at a new location is acceptable after a failed attempt at venous access. Multiple administrations of Zingo™ at the same location are not recommended.
When Zingo™ is used concomitantly with other products containing local anesthetic agents, the amount absorbed from all sources should be considered, as local anesthetics are thought to have at least additive toxicities.
2.1 Instructions for UsePrepare the Treatment Site and Device:
Examine the treatment site to ensure that the skin is intact. Clean the site, according to standard practice.
Visually inspect the pouch. Do not use if the pouch has been torn, or damaged or if the device has been dropped.
Tear open the pouch using the notch provided (Figure 1a). Remove Zingo™ from the pouch, being careful not to touch the purple outlet (open end) to avoid contamination (Figure 1b).Figure 1a
Figure 1bPosition Zingo™: Grip Zingo™ and place on the application site, with one hand, as illustrated in Figure 2, or with both hands, as shown in Figure 3.
Figure 2
Figure 3
Ensure that the patient’s treatment site is supported to prevent movement. Seal the purple Zingo™ outlet against the patient’s skin. Hold the device perpendicular to the skin, making sure that your thumb can reach the green start button.
Avoid gaps between the skin and the Zingo™ outlet, like the one illustrated in Figure 4, as gaps will impede drug delivery.Figure 4
Release the Safety Interlock: Apply adequate downward pressure to release the safety interlock, while maintaining the seal between Zingo™ and the skin.
Zingo™ is ready for administration when the green start button has moved into the upward position, as illustrated in Figure 5a.Figure 5a
Zingo™ cannot be actuated without releasing the internal safety interlock, as illustrated in Figure 5b.
Figure 5b.
Administer Zingo™: While maintaining downward pressure, administer the dose by pressing the green start button, as illustrated in Figure 6. Do not move Zingo™ during administration. Actuation is accompanied by a “popping” sound, indicating that the dose has been discharged.
Figure 6
Remove Zingo™: Remove Zingo from the application site and dispose.
Begin Procedure: Start the venipuncture or intravenous cannulation procedure 1–3 minutes after Zingo™ administration.
2.1 Instructions for UsePrepare the Treatment Site and Device:
Examine the treatment site to ensure that the skin is intact. Clean the site, according to standard practice.
Visually inspect the pouch. Do not use if the pouch has been torn, or damaged or if the device has been dropped.
Tear open the pouch using the notch provided (Figure 1a). Remove Zingo™ from the pouch, being careful not to touch the purple outlet (open end) to avoid contamination (Figure 1b).Figure 1a
Figure 1bPosition Zingo™: Grip Zingo™ and place on the application site, with one hand, as illustrated in Figure 2, or with both hands, as shown in Figure 3.
Figure 2
Figure 3
Ensure that the patient’s treatment site is supported to prevent movement. Seal the purple Zingo™ outlet against the patient’s skin. Hold the device perpendicular to the skin, making sure that your thumb can reach the green start button.
Avoid gaps between the skin and the Zingo™ outlet, like the one illustrated in Figure 4, as gaps will impede drug delivery.Figure 4
Release the Safety Interlock: Apply adequate downward pressure to release the safety interlock, while maintaining the seal between Zingo™ and the skin.
Zingo™ is ready for administration when the green start button has moved into the upward position, as illustrated in Figure 5a.Figure 5a
Zingo™ cannot be actuated without releasing the internal safety interlock, as illustrated in Figure 5b.
Figure 5b.
Administer Zingo™: While maintaining downward pressure, administer the dose by pressing the green start button, as illustrated in Figure 6. Do not move Zingo™ during administration. Actuation is accompanied by a “popping” sound, indicating that the dose has been discharged.
Figure 6
Remove Zingo™: Remove Zingo from the application site and dispose.
Begin Procedure: Start the venipuncture or intravenous cannulation procedure 1–3 minutes after Zingo™ administration.
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