Company:

Anesiva

Local anesthetic

Lidocaine HCl (as monohydrate) 0.5mg/device; pwd for intradermal inj.

To provide local analgesia prior to venipuncture or peripheral intravenous cannulation in children.

Lidocaine is an amide-type local anesthetic agent that works by blocking sodium ion channels required for the initiation and conduction of neuronal impulses.

Zingo delivers lidocaine hydrochloride monohydrate into the dermis via a disposable, needle-free delivery system. The lidocaine hydrochloride monohydrate 0.5mg powder is contained within a drug reservoir cassette in a pressurized helium gas cylinder. Once the device is pressed against the skin, the safety interlock can be released and the drug can be actuated releasing 40 micrometer lidocaine particles into the skin. Local dermal analgesia occurs in 1–3 minutes of application and diminishes within 10 minutes.

The efficacy of Zingo was evaluated in 2 double-blind, parallel-arm, sham-placebo controlled trials involving 1114 patients 3–18 years of age. All patients required peripheral venipuncture or IV cannulation as part of their clinical care. Efficacy was determined by measurements of pain immediately following the venous procedure using the Wong-Baker FACES pain rating scale (a 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 compared to placebo.

Not applicable.

<3 years: not recommended. 3–18 years: Use only on intact skin. Apply one 0.5mg dose to the planned procedure site 1–3 minutes before needle insertion; may repeat once at new site after initial attempt failed. Multiple administrations to same site: not recommended.

Avoid eyes, body orifices, mucous membranes or areas with a compromised skin barrier. Severe hepatic disease or pseudocholinesterase deficiency. Bleeding tendencies or platelet disorders: higher risk of superficial dermal bleeding. Pregnancy (Cat.B). Nursing mothers.

Additive effects with other local anesthetics.

Application-site reactions (eg, erythema, petechiae, edema), systemic reactions (eg, nausea, vomiting).

Single-use device (disposable, needle-free)—12

7/25/08