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warnings and cautions
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. Use on intact skin only ( 2.1 , 5 ) Avoid contact with the eye ( 2.1 , 5 ) Do not use if device is dropped or the pouch is damaged or torn ( 2.1 ) Patients with bleeding tendencies or platelet disorders could have a higher risk of superficial dermal bleeding ( 5 )
6 ADVERSE REACTIONS The most common adverse reactions (>5%) are skin reactions at the site of administration: erythema, petechiae, edema. ( 6.1 ) Revised: April 2008 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%).