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SYNERA® is proven to help prevent needle-stick pain with effective local analgesia within 20 to 30 minutes1

View Adult EfficacyView Pediatric Efficacy

In a randomized, double-blind, placebo-controlled crossover study conducted among 24 adult healthy volunteers…

  • SYNERA® produced local analgesia up to a depth of almost 7 mm after 30 minutes4
  • Analgesia continued to deepen for an additional hour after the patch was removed to a depth of >8 mm (8.2 mm)4
  • Mean pain depth (depth at which pain was first felt) was significantly deeper for SYNERA® than for a placebo patch at each time point4

Anesthesia depth over time4

Crossover Study Chart

SYNERA® provided greater depth and duration of local analgesia vs a placebo patch4

  • Up to 8.22 mm at 90 minutes4
  • Analgesic effect continued for at least 100 minutes after patch removal4

Depth of analgesia at 30 minutes, as measured by mean sensory and pain depths (mm)4

Mean sensory and pain depths chart

SYNERA®–Proven to prevent needle-stick pain in children5

File Card Bar Chart

In the same randomized trial…

  • Investigator assessments indicated that 76% of SYNERA®-treated patients experienced no pain during venipuncture versus 20% in the placebo group (P=0.001)5
  • Independent observer assessments indicated that 76% of SYNERA®-treated patients experienced no pain during venipuncture versus 15% in the placebo group (P<0.001)5
  • In the 7-to-17-year-old group, the results were considered to be clinically meaningful, but treatment differences in this group did not reach statistical significance versus placebo7

Patient-reported pain scores7

File Card Bar Chart

 

Proven safe and effective in children as young as 3 years of age1

  • Safe use of SYNERA® in infants 4 to 6 months of age was documented in one study1
  • Significantly shorter application time before procedures than lidocaine 2.5%/prilocaine 2.5% cream (formerly EMLA® Cream) – 20-30 minutes vs at least 1 hour1,2

Elimination Chart

SYNERA® is more convenient than lidocaine 2.5%/prilocaine 2.5% cream (formerly EMLA® Cream)

  • Quick, simple peel-and-stick patch application
  • Applies just like an adhesive bandage
  • No occlusive dressing required
  • Ensures no mess
  • Eliminates the need for additional wraps
  • Easier for parents, patients, and nurses
  • Based on discussions with clinicians and nurses…simplifies the procedure, with less prep work, less prep time, and less wait time

Other topical anesthetic approaches

Vapocoolants

  • Vapocoolants reduce pain on the skin through evaporation-induced cooling which numbs the pain receptors in the skin to produce an anesthetic effect12
  • Duration of effect is also short, usually lasting only 1 minute12,13
  • Freezing can occasionally alter skin pigmentation12,13
  • Some children may not like the cooling effect

 

Subcutaneous (SC) lidocaine

  • SC lidocaine is commonly used to reduce the pain associated with cannulation of intravenous catheters and all types of nerve blocks
  • Requires an often-painful injection to prevent pain—patients report moderate-to-severe pain and many patients experience a burning sensation9,10,11

 

LMX-4®

  • LMX-4 is indicated for minor wounds, burns, abrasions or insect bites8
  • LMX-4 is not approved for venipuncture8

 

J-Tip®

  • J-Tip is a needle-free injection system that uses pressurized CO2  gas to propel medication through the skin and into the subcutaneous structures of the skin14
  • If the injection site is near a vein, the skin above the vein must be moved to the side during the injection and allowed to return once the injection has been given. However, if the vein rolls with the skin, choose an injection site not directly over a vein instead15
  • J-Tip is contraindicated for use in patients receiving chemotherapeutic agents and in patients who are allergic to lidocaine. J-Tip is not recommended for patients receiving anticoagulants or persons with hemophilia, or other coagulation disorders.16

EMLA® is a registered trademark of Abraxis Bioscience, Inc.
LMX-4 is a registered trademark of Ferndale Laboratories, Inc.
J-Tip is a registered trademark of National Medical Products Inc.

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

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; November 2018.
  2. Lidocaine 2.5% and Prilocaine 2.5% Cream Prescribing Information. Akorn Inc., Lake Forest, IL; February 2013.
  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; 2019.
  8. LMX4- lidocaine cream. DailyMed website. http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=f0e7c92f-8b0b-4045-b659-af9f6e81260f. Updated June 2014. Accessed February 21, 2019.
  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 February 21, 2019.
  13. Gebauer’s Ethyl Chloride [package insert]. Gebauer Company. http://cdn2.hubspot.net/hubfs/150313/docs/Ethyl_Chloride/Application/EC_English_IFU.pdf. Accessed February 21, 2019.
  14. What is J-Tip? J-Tip Needle-Free Injection system website: https://jtip.com/what-is-jtip. Accessed February 21, 2019.
  15. J-Tip User Guide. J-Tip Needle-Free Injection system website: https://jtip.com/needle-free-injector-simple-steps-for-painless-iv/. Accessed February 21, 2019.
  16. J-Tip Recommendations and Precautions. J-Tip Needle-Free Injection system website: https://jtip.com/frequently-asked-questions-needle-free-anesthesia/#toggle-id-11. Accessed February 21, 2019.

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.

Patients should not use SYNERA® if they have a history of methemoglobinemia. If SYNERA® must be used in patients who are more susceptible to developing the condition, they should be closely monitored for signs and symptoms, which may occur immediately or may be delayed some hours, and must be treated immediately. SYNERA® and any other oxidizing agents should be discontinued.

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.

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 and 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®.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.