This site is intended for US Health Care Professionals

What is SYNERA®?

SYNERA® provides fast, effective needle-stick pain prevention in a simple-to-use patch.

SYNERA® combines two local anesthetic agents along with an advanced and gentle warming technology, delivered in a patch. SYNERA® offers you and your patients:

  • Anesthetics and warming technology: The advanced combination of proven local anesthetic agents (lidocaine and tetracaine) is delivered with a unique warming technology to enhance dermal absorption.1,6
  • Speed: Rapid onset of action takes just 20-30 minutes to effect.1
  • Simplicity: The simple-to-use peel-and-stick patch requires no messy creams or occlusive dressings.
  • Safety and efficacy: Proven safe and effective in children as young as 3 years. Safe use of SYNERA® in infants 4-6 months of age was documented in one study.1

SYNERA® offers faster and more precise dosing than EMLA® numbing cream.1,2

SYNERA® works at least twice as fast and is more convenient to use than topical anesthetic creams such as EMLA®.1,2,3 The unique warming technology in SYNERA® has been proven to enhance the anesthetic effect with a depth of anesthesia of almost 7 mm at 30 minutes, increasing to greater than 8 mm even after patch removal, greater than has been shown in separate published studies with EMLA®.4

EMLA® is a registered trademark of Abraxis Bioscience, Inc.

SYNERA® has a gentle, advanced warming technology that’s proven to enhance anesthetic effect1,6

  • SYNERA® combines lidocaine, tetracaine, and heat, using proprietary CHADD™ [Controlled Heat-Assisted Drug Delivery] technology1
  • Oxygen-activated heating component enhances the delivery of local anesthetics1
  • When removed from the pouch, exposure to oxygen activates the heating element1
  • When applied, skin temperature increases by up to approximately 5°C/9°F to enhance the anesthetic effect by promoting faster dermal absorption of lidocaine and tetracaine1
  • The maximum skin temperature will not exceed 40°C/104°F1

Cross Section Chart

Reduction Arrow

Compared to a patch containing the same anesthetics without the warming technology in a study with adults…

  • SYNERA® significantly reduced pain intensity scores by 31%6
  • Significantly more subjects reported adequate anesthesia with SYNERA®6
  • Significantly more subjects would use SYNERA® for future procedures6

In clinical studies involving 1,449 subjects treated with SYNERA®, the most common local reactions were redness of the skin (71%), pale skin (12%) and swelling (12%); these reactions were generally mild and resolved on their own soon after patch removal. There were no treatment related serious adverse events.1

References

  1. SYNERA® Prescribing Information. Galen US Inc., Souderton, PA; March 2014.
  2. EMLA® Cream 5% Prescribing Information. Akorn Inc., Lake Forest, IL; April 2012.
  3. Sawyer J, Febbraro S, Masud S, Ashburn MA, Campbell JC. Heated lidocaine/tetracaine patch (SYNERA®, Rapydan) compared with lidocaine/prilocaine cream (EMLA) for topical anaesthesia before vascular access. Br J Anaesth. 2009;102(2):210-215.
  4. Wallace MS, Kopecky EA, Ma T, Brophy F, Campbell JC. Evaluation of the depth and duration of anesthesia from heated lidocaine/tetracaine (SYNERA®) patches compared with placebo patches applied to healthy adult volunteers. Reg Anesth Pain Med. 2010;35(6):507-513.
  5. Sethna NF, Verghese ST, Hannallah RS, Solodiuk JC, Zurakowski D, Berde CB. A randomized controlled trial to evaluate S-Caine patch for reducing pain associated with vascular access in children. Anesthesiology. 2005;102(2):403-408.
  6. Masud S, Wasnich RD, Ruckle JL, et al. Contribution of a heating element to topical anesthesia patch efficacy prior to vascular access: results from two randomized, double-blind studies. J Pain Symptom Manage. 2010;40(4):510-519.
  7. Data on file. Galen US Inc. Souderton, PA; 2015.
  8. LMX4- lidocaine cream. DailyMed website. http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=f0e7c92f-8b0b-4045-b659-af9f6e81260f. Updated June 2014. Accessed March 19, 2015.
  9. Miller KA, Balakrishnan G, Eichbauer G, Betley K. 1% lidocaine injection, EMLA cream, or “numby stuff” for topical analgesia associated with peripheral intravenous cannulation. AANA J. 2001;69(3):185-187.
  10. Page DE, Taylor DM. Vapocoolant spray vs subcutaneous lidocaine injection for reducing the pain of intravenous cannulation: a randomized, controlled, clinical trial. Br J Anaesth. 2010;105(4):519-525.
  11. Manabat ER, Pujol LA, Hunt P, Wang D. Judging pain sensitivity with subcutaneous lidocaine injections. Pain Med. 2011;12(4):668-672.
  12. Why use Gebauer’s Pain Ease for emergency procedures [patient brochure]. Cleveland, OH: Gebauer Company; 2008. http://cdn2.hubspot.net/hubfs/150313/docs/Pain_Ease/PE_Frequently_Asked_Questions.pdf. Accessed October 19, 2015.
  13. Gebauer’s Ethyl Chloride [package insert]. Gebauer Company. http://cdn2.hubspot.net/hubfs/150313/docs/Ethyl_Chloride/Application/EC_English_IFU.pdf. Accessed October 19, 2015.
  14. Benefits of J-Tip Needle-Free Injection System. J-Tip Needle-Free Injection System website. http://www.jtip.com/index.html#2. Accessed March 19, 2015.
  15. FAQ. J-TIP Needle-Free Injection System website. http://www.jtip.com/faq.html. Accessed March 19, 2015.

Indication

SYNERA® (lidocaine and tetracaine) Topical Patch is indicated for use on intact skin to provide local dermal analgesia for superficial venous access (apply for 20-30 mins) and superficial dermatological procedures (apply for 30 mins).

Important Safety Information

SYNERA® is contraindicated in patients with a known history of sensitivity to lidocaine, tetracaine, local anesthetics of the amide or ester type, or any other component of the product and in patients with para-aminobenzoic acid (PABA) hypersensitivity.

Keeping a patch on longer than recommended or applying multiple patches simultaneously or sequentially could result in systemic absorption sufficient to result in serious adverse effects that are typical of drugs in this class.

Used SYNERA® patches contain a large amount of lidocaine and tetracaine (at least 90% of the initial amount). Chewing or ingesting a new or used SYNERA® patch may result in serious adverse effects. Store and dispose of SYNERA® out of the reach of children and pets.

SYNERA® should be used with caution in patients who may be more sensitive to the systemic effects of lidocaine and tetracaine, particularly the acutely ill, the debilitated, and those with compromised hepatic function. Patients with severe hepatic disease or pseudocholinesterase deficiency are at greater risk of developing toxic plasma concentrations.

SYNERA® should be used with caution in patients with a history of methemoglobinemia (refer to Full Prescribing Information).

Do not use on mucous membranes or on areas with a compromised skin barrier. Application to broken or inflamed skin may result in toxic blood concentrations of lidocaine and tetracaine.

Allergic or anaphylactoid reactions (urticaria, angioedema, bronchospasm, and shock) to the active or inactive components of SYNERA® can occur and should be managed by conventional means.

Avoid contact of SYNERA® with the eyes due to potential irritation or abrasion. If contact occurs, immediately wash out the eye with water or saline, and protect it until sensation returns.

Safety and effectiveness of SYNERA® have been established in patients 3 years or older.

Simultaneous or sequential application of more than two SYNERA® patches to children is not recommended as it has not been adequately studied.

Lidocaine has been shown to inhibit viral and bacterial growth. The effect of SYNERA® on intradermal injections of live vaccines has not been determined.

The heating component contains iron powder, and the patch must be removed before magnetic resonance imaging.

SYNERA® may lead to diminished or blocked sensation in the treated skin; therefore, patients should avoid inadvertent trauma (rubbing, scratching, or exposure to heat or cold) before complete sensation returns.

SYNERA® should be used with caution in patients receiving class 1 antiarrhythmics and/or other local anesthetics, because the systemic toxic effects may be additive and potentially synergistic with lidocaine and tetracaine.

In clinical studies, the most common local reactions were erythema (71%), blanching (12%), and edema (12%); these reactions were generally mild, resolving spontaneously soon after patch removal.

Do not cut or remove the top cover of the patch as this could result in thermal injury.

Please refer to Full Prescribing Information including Instructions For Use before prescribing SYNERA®.