Synera (Lidocaine / Tetracaine Topical) - Summary

SYNERA SUMMARY

SYNERA consists of a thin, uniform layer of a local anesthetic formulation with an integrated, oxygen-activated heating component that is intended to enhance the delivery of the local anesthetic. The drug formulation is an emulsion in which the oil phase is a eutectic mixture of lidocaine 70 mg and tetracaine 70 mg. The eutectic mixture has a melting point below room temperature and therefore exists as a liquid oil rather than as crystals. The surface area of the entire SYNERA patch is approximately 50 cm², 10 cm² of which is active.

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 ].

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NEWS HIGHLIGHTS

Published Studies Related to Synera (Lidocaine / Tetracaine Topical)

Lidocaine/tetracaine peel in topical anesthesia prior to laser-assisted hair removal: Phase-II and Phase-III study results. [2014]
peel"), which air-dries and can be peeled off 30 min post-application... CONCLUSIONS: After a 30-min application, LT peel was effective and well-tolerated

Lidocaine/tetracaine patch (Rapydan) for topical anaesthesia before arterial access: a double-blind, randomized trial. [2012]
non-inferior to subcutaneous local anaesthetic... CONCLUSIONS: Both the lidocaine/tetracaine patch and subcutaneous injection of

Evaluation of the depth and duration of anesthesia from heated lidocaine/tetracaine (Synera) patches compared with placebo patches applied to healthy adult volunteers. [2010.11]
BACKGROUND: The heated lidocaine/tetracaine patch (Synera; ZARS Pharma, Inc, Salt Lake City, UT) is among the local topical anesthetic formulations used to prevent procedural pain. This study was conducted to determine the depth and duration of anesthesia provided by the patch and to evaluate safety and tolerability... CONCLUSIONS: The heated lidocaine/tetracaine patch is well tolerated, and it provides favorable depth and duration of anesthesia without significant sensory loss for superficial venous access and minor dermatological procedures after a 30-min application.

Warm lidocaine/tetracaine patch versus placebo before pediatric intravenous cannulation: a randomized controlled trial. [2008.07]
STUDY OBJECTIVE: We compare the pain of intravenous (IV) cannulation in pediatric emergency department (ED) patients after applying a topical lidocaine/tetracaine patch versus placebo. We hypothesized that application of the active patch would reduce the pain of IV cannulation by at least 15 mm... CONCLUSION: Application of a topical lidocaine/tetracaine patch resulted in a modest reduction in the pain of IV cannulation in pediatric ED patients and did not alter the rate of successful cannulations.

Brief Report: A randomized controlled trial of SyneraTM versus lidocaine for epidural needle insertion in labouring parturients: [Compte-rendu court : Une etude randomisee controlee du SyneraTM vs lidocaine dans l'insertion de l'aiguille peridurale chez les parturientes en travail]. [2008.03]
PURPOSE: Skin infiltration with lidocaine, although brief, can be very stressful, painful, and may perpetuate anxiety. Syneratrade mark, a local anesthetic patch, which contains an oxygen-activated heating component to enhance the delivery of a eutectic mixture of lidocaine (70 mg) and tetracaine (70 mg), has provided analgesia for minor, dermatological procedures. We hypothesized that the analgesic effect of Syneratrade mark, for pain in labouring parturients, would be superior to the traditional infiltration of lidocaine prior to epidural needle insertion... CONCLUSION: The Syneratrade mark patch provided inferior analgesia, for performing epidural labour analgesia in labouring parturients, compared to traditional infiltration with 2% lidocaine.

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