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 IN SPECIFIC POPULATIONS
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.
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.
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.
Pediatric Use
Safety and effectiveness in pediatric patients below the age of 3 years have not been established.
Geriatric Use
Of the 693 patients evaluated in a Phase 3 randomized, double blind, sham-placebo-controlled trial in adults, 17% were of 65 and over. The safety and effectiveness of Zingo™ in geriatric patients were similar to that of Zingo™ in adults under 65 years of age
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