Synera (Lidocaine / Tetracaine Topical) - Indications and Dosage

INDICATIONS AND USAGE

SYNERA is a combination amide and ester local anesthetic 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 ].

DOSAGE AND ADMINISTRATION

SYNERA 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 to intact skin for 20 to 30 minutes.
• Superficial Dermatological Procedures: For superficial dermatological procedures such as superficial excision or shave biopsy, apply SYNERA 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 in infants 4 to 6 months of age was documented in one study.

Simultaneous or sequential application of multiple SYNERA patches is not recommended. However, application of one additional patch at a new location to facilitate venous access is acceptable after a failed attempt.  When SYNERA 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.  If irritation or a burning sensation occurs during application, remove the patch.

DOSAGE FORMS AND STRENGTHS

SYNERA topical patch contains 70 mg lidocaine and 70 mg tetracaine, has a total skin contact area of 50 cm², and an active drug-containing area of 10 cm².

HOW SUPPLIED/STORAGE AND HANDLING

How Supplied

SYNERA is available as the following:
NDC 10885-002-01     One individually packaged SYNERA patch
NDC 10885-002-10     Box of 10 individually packaged SYNERA patches

Storage and Handling

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

Keep out of reach of children and pets.

Apply SYNERA immediately upon removal from the protective pouch.

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.

Hands should be washed after handling SYNERA, and eye contact with SYNERA 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.