Zingo

Zingo is an amide local anesthetic indicated for use on intact skin to provide local analgesia prior to venipuncture or peripheral intravenous cannulation in children 3-18 years of age. The brand Zingo (lidocaine) has been discontinued, but generic lidocaine topical products are available

Important Limitations:

• For use on intact skin only
• For external use only

• 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. Remove Zingo from the pouch, being careful not to touch the purple outlet (open end) to avoid contamination.
• Position Zingo: Grip Zingo and place on the application site, with one hand, or with both hands. 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 as gaps will impede drug delivery.
• 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. Zingo cannot be actuated without releasing the internal safety interlock.
• Administer Zingo: While maintaining downward pressure, administer the dose by pressing the green start button. Do not move Zingo during administration. Actuation is accompanied by a "popping" sound, indicating that the dose has been discharged.
• 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.

• Use on intact skin only
• Avoid contact with the eye
• Do not use if device is dropped or the pouch is damaged or torn
• Patients with bleeding tendencies or platelet disorders could have a higher risk of superficial dermal bleeding
• Excessive Dosing: Applying lidocaine to larger areas or for longer than recommended can lead to increased absorption and serious side effects.
• Methemoglobinemia: Use of local anesthetics may cause a serious blood condition called methemoglobinemia. Stop use and seek immediate medical attention if you experience pale, gray, or blue colored skin, headache, rapid heart rate, shortness of breath, lightheadedness, or fatigue.
• Life-threatening events in infants and young children: Seizures, cardiopulmonary arrest, and death have been reported in children under 3 years of age using oral viscous lidocaine products. Do not use oral viscous lidocaine for teething pain.

The most common adverse reactions (>5%) are skin reactions at the site of administration: erythema, petechiae, edema.

To report Suspected Adverse Reactions, contact the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

• 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.

Zingo is a sterile, single-use, powder intradermal injection system containing 0.5 mg lidocaine hydrochloride monohydrate.

Zingo utilizes a helium-powered delivery system.

Zingo is contraindicated in patients with a known history of sensitivity to local anesthetics of the amide type.

Zingo (lidocaine hydrochloride monohydrate) powder intradermal injection system contains 0.5 mg of sterile lidocaine hydrochloride monohydrate. Zingo is a singleuse device packaged in an individual foil/clear pouch placed inside a bubble-wrap sleeve. Twelve sleeves are placed in labeled cartons. Cartons are stored at controlled room temperature (15 - 30C, 59-86F).

Patients should be made aware that a sound similar to that of a popping balloon is emitted at the time Zingo is actuated. Patients should be informed that skin reactions including erythema, petechiae and edema may occur.