Synera (lidocaine and tetracaine) is indicated for use on intact skin to provide local dermal analgesia for superficial venous access and superficial dermatological procedures such as excision, electrodessication and shave biopsy of skin lesions (see Clinical Studies section).

Synera (lidocaine and tetracaine) should only be applied to intact skin.

Use immediately after opening the pouch.

For adults and children 3 years of age and older:

Venipuncture or Intravenous Cannulation: Prior to venipuncture or intravenous cannulation, apply Synera (lidocaine and tetracaine) to intact skin for 20-30 minutes.

Superficial Dermatological Procedures: For superficial dermatological procedures such as superficial excision or shave biopsy, apply Synera (lidocaine and tetracaine) to intact skin for 30 minutes prior to the procedure.

While efficacy has not been established for children less than 3 years of age, safe use of Synera (lidocaine and tetracaine) in infants 4 to 6 months of age was documented in one study.

In general, simultaneous or sequential application of multiple Synera (lidocaine and tetracaine) patches is not recommended. However, application of one additional patch at a new location to facilitate venous access is acceptable after a failed attempt.

If irritation or a burning sensation occurs during application, remove the patch.

When Synera (lidocaine and tetracaine) is used concomitantly with other products containing local anesthetic agents, the amount absorbed from all formulations should be considered, as local anesthetics are thought to have at least additive toxicities.

Handling and Disposal

Hands should be washed after handling Synera (lidocaine and tetracaine) , and eye contact with Synera (lidocaine and tetracaine) should be avoided. The used patch should be disposed of immediately. The adhesive sides of the patch should be folded together and the patch should then be thrown away in a location that is out of the reach of children and pets.

Do not cut the patch or otherwise remove the top cover as this could cause the patch to heat to temperatures that could cause thermal injury. Do not cover the holes on the top side of the patch as this could cause the patch not to heat.

Access to Synera (lidocaine and tetracaine) by children or pets should be prevented during usage and storage of the product.

Synera (lidocaine and tetracaine) is available as the following:

NDC 43469-864-01 box of 10 individually packaged Synera (lidocaine and tetracaine) patches

Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].

Not for home use by patient.

Manufactured for: ZARS Pharma, Inc. Salt Lake City, UT 84119. Manufactured by: Tapemark Company, West St. Paul, MN 55118. FDA Rev date: 6/23/2005

Last reviewed on RxList: 1/23/2009
This monograph has been modified to include the generic and brand name in many instances.