Synera
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Questions & Answers
Side Effects & Adverse Reactions
WARNINGS
Application of Synera (lidocaine 70 mg and tetracaine 70 mg) topical patch for longer duration than recommended, or the simultaneous or sequential application of multiple Synera patches, could result in sufficient absorption of lidocaine and tetracaine to result in serious adverse effects (see Overdosage).
Even a used Synera patch contains a large amount of lidocaine and tetracaine (at least 90% of the initial amount). The potential exists for a child or pet to suffer serious adverse effects from chewing or ingesting a new or used Synera patch. It is important for patients to store and dispose of Synera out of the reach of children and pets.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
INDICATIONS AND USAGE
Synera 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).
History
There is currently no drug history available for this drug.
Other Information
DESCRIPTION
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.
Lidocaine is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl), has an octanol:water partition ratio of 182 at pH 7.3 and has the following structure:
MM1
Tetracaine is chemically designated as 2-(dimethylamino)ethyl p-(butylamino)benzoate, has an octanol:water partition ratio of 5370 at pH 7.3 and has the following structure:
MM2
Each Synera patch contains lidocaine 70 mg and tetracaine 70 mg in a eutectic mixture. The Synera formulation also contains the following inactive ingredients: polyvinyl alcohol, sorbitan monopalmitate, water, methylparaben and propylparaben.
The Synera heating component generates a mild warming that is intended to enhance the delivery of the local anesthetic. Synera begins to heat once the patch is removed from the pouch and is exposed to oxygen in the air. Although the patch may increase skin temperature by up to approximately 5ºC, maximum skin temperature will not exceed 40ºC. The heating component is composed of iron powder, activated carbon, sodium chloride, wood flour, water and filter paper.
Sources
Synera Manufacturers
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Zars Pharma, Inc.
![Synera (Lidocaine And Tetracaine) Patch [Zars Pharma, Inc.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Synera | Zars Pharma, Inc.
DOSAGE AND ADMINISTRATIONSynera 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 20-30 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.
In general, 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.
If irritation or a burning sensation occurs during application, remove the patch.
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.
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Galen Us Incorporated
Synera | Galen Us Incorporated
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.
![Synera (Lidocaine And Tetracaine) Patch [Galen Us Incorporated]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=5f86a348-2274-4945-8694-4c1f0050bf02&name=Back-pouch.jpg)
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