Zingo

Appropriate studies have not been performed on the relationship of age to the effects of lidocaine injection in children younger than 3 years of age. Safety and efficacy have not been established.

Lidocaine is a prescription medication used to prevent pain before procedures or to relieve pain due to certain conditions. Lidocaine belongs to a group of drugs called local anesthetics. These stop nerves from sending pain signals to the brain.

This medication comes in several topical forms, including a patch to be applied to the skin (transdermal), ointment, cream, and oral solution. Lidocaine is an ingredient in some over-the-counter topical pain relievers. This page refers to the prescription forms of lidocaine.

This medication is also available in an injectable form to be given directly into a vein (IV) or for infiltration and nerve block by a healthcare professional.

Common side effects of topical lidocaine include irritation at site of application. Common side effects of injectable lidocaine include confusion, nervousness, and numbness. Lidocaine may also cause dizziness and drowsiness. Do not drive or operate heavy machinery until you know how this medication affects you. 

Zingo is part of the drug classes:

• Amides

• Analgesics and anesthetics

• Anesthetics for topical use

• Anesthetics, local

• Antiarrhythmics, class Ib

Topical:

Serious side effects have been reported with topical lidocaine including the following:

Allergic reactions. Tell your healthcare provider right away if you have some or all of the following symptoms of an allergic reaction.

• Difficulty breathing or swallowing
• Swelling of the face, throat, tongue, lips, eyes, hands, feet, ankles, or lower legs
• Hives or skin rash
• Fast heartbeat
• Fast breathing
• Nausea or vomiting
• Confusion
• Weakness
• Fainting
• Seizures or convulsions

Injectable:

Serious side effects have been reported with injectable lidocaine including the following:

Allergic reactions. Tell your healthcare provider right away if you have some or all of the following symptoms of an allergic reaction.

• Difficulty breathing or swallowing
• Swelling of the face, throat, tongue, lips, eyes, hands, feet, ankles, or lower legs
• Hives or skin rash
• Fast pulse
• Fast breathing
• Nausea or vomiting
• Confusion
• Weakness
• Fainting
• Seizures or convulsions

Injectable lidocaine may also affect the central nervous system, including lightheadedness, nervousness, blurred or double vision, altered sensations, and changes in respiration.

Injectable lidocaine may also affect the cardiovascular system, including changes in heartbeat, decreased blood pressure, and cardiac arrest.

Lidocaine can cause drowsiness and dizziness. Do not drive or operate heavy machinery until you know how lidocaine affects you.

Do not take lidocaine if you:

• are allergic to lidocaine or to any of its ingredients
• are allergic to other local anesthetics, including bupivacaine (Marcaine), etidocaine (Duranest), mepivacaine (Carbocaine, Prolocaine), or prilocaine (Citanest)

Additionally, do not take injectable lidocaine if you:

• have Stokes-Adams syndrome or Wolff-Parkinson-White syndrome
• have sinoatrial, atrioventricular, or intraventricular block

Before taking lidocaine, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to lidocaine or to any of its ingredients
• are allergic to other local anesthetics, including bupivacaine (Marcaine), etidocaine (Duranest), mepivacaine (Carbocaine, Prolocaine), or prilocaine (Citanest)
• have Stokes-Adams syndrome or Wolff-Parkinson-White syndrome
• have sinoatrial, atrioventricular, or intraventricular block
• have or have had liver disease
• are having surgery, including dental surgery
• are pregnant or breastfeeding

For all uses of Zingo:

• Tell all of your health care providers that you take Zingo. This includes your doctors, nurses, pharmacists, and dentists.
• Avoid driving and doing other tasks or actions that call for you to be alert until you see how this medicine affects you.
• You may hear a sound like a popping balloon when Zingo is used. This is normal.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using this medicine while you are pregnant.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

Numbing of an area:

• If you are going home before the numbness wears off, protect the treated area from injury until you can feel it again.
• Do not take Zingo by mouth. Use on your skin only. Keep out of your mouth, nose, ears, and eyes (may burn).
• Do not put on open sores or broken skin.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

For all uses of Zingo:

• Pinpoint red spots on the skin.

Numbing of an area:

• Irritation where this medicine is used.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

Efficacy in Adults

The efficacy of Zingo™ in adults was evaluated in a randomized, double-blind, parallel-arm, sham-placebo controlled trial in which adult patients who required a venipuncture or peripheral venous cannulation received either Zingo™ or a sham placebo device.

Patients were treated with Zingo™ or a placebo device at the antecubital fossa or back of the hand, between one and three minutes prior to venipuncture or peripheral venous cannulation. Measurements of pain were made immediately following the procedure. Efficacy was measured using a continuous 100 mm visual analogue scale ranging from 0 (“no pain”) to 100 (“worst possible pain”).

Many of the patients had chronic medical problems such as depression, hypertension, hypothyroidism, and hyperlipidemia and over one fourth of the population may have been at higher than average risk of dermal bleeding due to use of concomitant medications such as NSAIDs, aspirin, and corticosteroids.

Treatment with active drug resulted in less pain compared with placebo (see Table 1).

Table 1: Visual Analogue Scale Score (Full Safety/Efficacy Population)

1 least squares mean 2 standard error

However, efficacy was primarily seen in patients undergoing venipuncture at the antecubital fossa, while patients undergoing cannulation at the back of the hand did not demonstrate a difference between active and sham administrations.

Efficacy in Pediatric Patients

The efficacy of Zingo™ in patients 3–18 years of age was evaluated in two randomized, double-blind, parallel-arm, sham-placebo controlled trials in which pediatric patients received either Zingo™ or a sham placebo device.

The overall patient population consisted of healthy pediatric patients as well as those with acute and chronic medical conditions (i.e., diabetes, asthma, seizure disorder, juvenile rheumatoid arthritis and renal or hepatic transplantation) ages 3–18 years. All patients required peripheral venipuncture or intravenous cannulation as part of their clinical care.

Two efficacy trials (Studies 1 and 2) were conducted during which patients were treated with Zingo™ or a placebo device at the back of hand or antecubital fossa, between one and three minutes prior to venipuncture or peripheral venous cannulation. Measurements of pain were made immediately following the venous procedure. Efficacy was measured using a modified version of the Wong-Baker FACES pain rating scale [a categorical 6-point scale containing 6 faces ranging from 0 (“no hurt”) to 5 (“hurts worst”)].

In both studies, treatment with active drug resulted in less pain, from venipuncture or peripheral IV cannulation, compared with placebo (See Table 2).

Table 2: Modified FACES Scale Score (ITT Population), Studies 1 and 2

1 least squares mean2 standard error

The U.S. Food and Drug Administration (FDA) has approved Zingo (lidocaine hydrochloride monohydrate) powder intradermal injection system, which provides rapid, topical, local analgesia to reduce the pain associated with venous access procedures, such as IV insertions or blood draws, in children three to 18 years of age.

Zingo is a ready-to-use, easy-to-administer, single-use, needle-free system that delivers sterile lidocaine powder into the epidermis of the skin. Zingo provides topical local analgesia in one to three minutes after administration allowing uninterrupted care during intravenous line placement or venipuncture procedures.

Guidelines and recommendations from the American Academy of Pediatrics, the American Pain Society and the Infusion Nurses Society all call for the use of topical anesthetics prior to venous access procedures.

Venous access procedures, like IV insertions and blood draws, are among the most common interventions performed at a hospital, with more than 18 million pediatric venous access procedures and 400 million total procedures per year in the U.S. Needlesticks are also a source of deep anxiety. An Impulse Research survey conducted last year by Anesiva found that 70 percent of children experience fear and stress during a visit to the doctor or hospital that involves a needlestick procedure, and more than half of all children -- even those older than seven -- cry during these procedures. The problem is compounded in children with chronic illnesses who must undergo frequent IV insertions.

Data from two pivotal, placebo-controlled, Phase 3 clinical studies, which collectively enrolled 1,109 patients across 15 U.S. clinical centers, demonstrated that Zingo provided statistically significant pain relief in children ages three to 18 undergoing venous access procedures, such as IV line placements. These data indicated that treatment with Zingo quickly and effectively reduced pain when given just one to three minutes prior to the venous access procedure. Zingo was well-tolerated. The most common adverse reactions were redness (erythema), red dots (petechiae) and swelling (edema) at the site of administration.

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

To report Suspected Adverse Reactions, contact Anesiva, Inc. at 1-650-624-9600 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

• 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.