Pharmacokinetic Study of Synera™ in Neonates and Infants

A Pharmacokinetic Study of Synera™ (Lidocaine 70 mg and Tetracaine 70 mg Topical Patch) to Evaluate the Systemic Exposure to Lidocaine and Tetracaine in Neonates and Infants

This study will measure the amount of lidocaine and tetracaine in the blood after a 30 minute application of Synera.

Inclusion Criteria:

• Subject must be an infant of 1 to 4 months of age and weigh at least 2.5 kg or a neonate of 0 to 4 weeks postnatal age with a gestation period of at least 37 weeks, and weigh at least 1.8 kg.
• Subject is scheduled to have a medically indicated minor superficial procedure for which topical local anesthesia would provide a benefit.
• Subject has or will have an indwelling vascular access catheter for blood sampling at the time of the procedure visit. The indwelling vascular access catheter placement must be necessary for medical reasons other than the purposes of this study.
• The additional blood draws for the purposes of this study do not pose more than a minor risk to the health and welfare of the subject.

Exclusion Criteria:

• Subject has known allergies or sensitivities to any component of Synera.
• Subject has clinically significant laboratory abnormalities.
• Subject has known multiple allergies that could indicate hypersensitive skin.
• Subject has known active atopic dermatitis at or near the patch application site.