Prescription Drug Information: Zingo

ZINGO- lidocaine hydrochloride powder
Anesiva, Inc.

1 INDICATIONS AND USAGE

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.

2 DOSAGE AND ADMINISTRATION

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 Image from Drug Label Content Figure 1b Image from Drug Label Content
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 Image from Drug Label Content Figure 3 Image from Drug Label Content
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 Image from Drug Label Content
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 Image from Drug Label Content
Zingo™ cannot be actuated without releasing the internal safety interlock, as illustrated in Figure 5b.
Figure 5b
Image from Drug Label Content
(click image for full-size original)
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 Image from Drug Label Content
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.

3 DOSAGE FORMS AND STRENGTHS

Zingo™ (lidocaine hydrochloride monohydrate) powder intradermal injection system contains 0.5 mg of sterile lidocaine hydrochloride monohydrate.

4 CONTRAINDICATIONS

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

5 WARNINGS AND PRECAUTIONS

Do not use around the eyes.

Do not use Zingo™ on body orifices, mucous membranes, or on areas with a compromised skin barrier. Only use Zingo™ on skin locations where an adequate seal can be maintained.

Patients with severe hepatic disease or pseudocholinesterase deficiency, because of their inability to metabolize local anesthetics normally, are at a greater risk of developing toxic plasma concentrations of lidocaine.

Patients with bleeding tendencies or platelet disorders could have a higher risk of superficial dermal bleeding.

6 ADVERSE REACTIONS

6.1 Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

The safety of Zingo™ was evaluated in five randomized, double-blind, parallel-arm, sham-placebo controlled trials in which 1761 patients, ages 3 to 18, received either Zingo™ or a sham placebo device. A total of 906 received active treatment, while 855 received placebo.

Application S ite Reaction

The application site was specifically assessed for four categories of skin site reaction (erythema, edema, pruritus, and petechiae). Erythema occurred in 53% of Zingo-treated patients, and in 27% of placebo-treated patients. Petechiae occurred in 44% of Zingo-treated patients, and in 5% of placebo-treated patients. Edema occurred in 8% of Zingo-treated patients, and in 3% of placebo-treated patients. Pruritus occurred in 1% of patients in both treatment groups.

Adverse Reactions

Amongst the 906 pediatric patients receiving active treatment and 855 pediatric patients receiving sham placebo treatment, the percentage of pediatric patients with any adverse reactions was approximately 9% in each treatment group.

Most adverse reactions were application-site related (i.e., bruising, burning, pain, contusion, hemorrhage), occurring in 4% of pediatric patients in each treatment group.

The most common systemic adverse reactions were nausea (2%) and vomiting (1%).

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Zingo™ was not formally evaluated for effects on reproduction. Significant systemic exposure to lidocaine is not expected under recommended conditions of use of Zingo™ as lidocaine levels were below the limit of detection in human studies. Lidocaine has been previously tested for reproductive toxicity in animal studies, however. The following ratios are based on the assumption that the applied dose is completely absorbed through the skin.

Teratogenic Effects

Pregnancy Category B. Lidocaine was not teratogenic in rats given subcutaneous doses up to 60 mg/kg [360 mg/m2 or 1200-fold the single dermal administration (SDA) of 0.5 mg lidocaine in a 60 kg individual (0.3 mg/m2)] or in rabbits up to 15 mg/kg (180 mg/m2 or 600-fold the SDA). There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, Zingo™ should be used during pregnancy only if clearly needed.

Nonteratogenic Effects

Lidocaine, containing 1:100,000 epinephrine, at a dose of 6 mg/kg (36 mg/m2 or 120-fold the SDA) injected into the masseter muscle of the jaw or into the gum of the lower jaw of Long-Evans hooded pregnant rats on gestation day 11 led to developmental delays in neonatal behavior among offspring. Developmental delays were observed for negative geotaxis, static righting reflex, visual discrimination response, sensitivity and response to thermal and electrical shock stimuli, and water maze acquisition. The developmental delays of the neonatal animals were transient with responses becoming comparable to untreated animals later in life. The clinical relevance of the animal data is uncertain. No adequate and well–controlled studies have been conducted in pregnant women. Because animal studies are not always predictive of human response, Zingo™ should be used during pregnancy only if the potential benefit justifies risk to the fetus.

8.2 Labor and Delivery

Lidocaine is not contraindicated in labor and delivery. In humans, the use of lidocaine for labor conduction analgesia has not been associated with an increased incidence of adverse fetal effects either during delivery or during the neonatal period. Should Zingo™ be used concomitantly with other products containing lidocaine, total doses contributed by all formulations must be considered.

8.3 Nursing Mothers

Lidocaine is excreted into human milk; therefore, caution should be exercised when Zingo™ is administered to a nursing mother. Because no plasma concentrations of lidocaine are detected after topical administration of Zingo™ in recommended doses, the small amount of lidocaine that would be ingested orally by a suckling infant is unlikely to cause adverse effects.

8.4 Pediatric Use

Safety and effectiveness in pediatric patients below the age of 3 years have not been established.

8.5 Geriatric Use

Safety and effectiveness in geriatric patients have not been established.

9 DRUG ABUSE AND DEPENDENCE

Zingo™ is not known to possess drug abuse or dependence potential.

10 OVERDOSAGE

In adults following a single administration of Zingo™ the plasma levels of lidocaine were below the limit of detection (5 ng/mL). Signs of central nervous system (CNS) toxicity may start at plasma concentrations of lidocaine as low as 1000 ng/mL, and the risk of seizures generally increases with increasing plasma levels. Very high levels of lidocaine can cause respiratory arrest, coma, decreases in cardiac output, total peripheral resistance, and mean arterial pressure, ventricular arrhythmias, and cardiac arrest. The toxicity of coadministered local anesthetics is thought to be at least additive. In the absence of massive topical overdose or oral ingestion, other etiologies for the clinical effects or overdosage from other sources of lidocaine or other local anesthetics should be considered. The management of overdosage includes close monitoring, supportive care, and symptomatic treatment. Dialysis is of negligible value in the treatment of acute overdosage of lidocaine.

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