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SYNERA®—It’s a simple-to-use patch

Opening Package

SYNERA® is applied just like an adhesive bandage; however, it should only be applied to healthy, unbroken skin. The pouch is simply opened, the backing removed, and then the SYNERA® patch is placed directly over the area where the needle will be inserted.

Applied Bandage

Some possible areas may include the back of your hand or the inside of your arm just below the elbow. Your doctor or nurse will decide the best spot for your SYNERA® patch to be placed, depending on where they need to use the needle.

Applying Bandage

When the SYNERA® patch is placed on your skin, you will begin to feel gentle and gradual warming. The temperature of your skin will increase just slightly. The warming increases blood flow in that area to better deliver the numbing medications into your skin to help prevent the needle-stick pain. The SYNERA® patch will only need to be left in place for 20-30 minutes. If you feel any irritation or burning, tell your doctor or nurse immediately.

After just 20-30 minutes, the SYNERA® patch will be removed. Before the needle stick, the used patch is properly disposed of away from children and pets and the area on the skin is cleaned to prepare for the needle stick.

Ask your doctor or nurse about SYNERA®

  • SYNERA® should only be applied to healthy, unbroken skin.
  • Avoid contact of SYNERA® with the eyes due to potential irritation or abrasion.
  • The heating component in SYNERA® contains iron powder, and the patch must be removed before some diagnostic procedures, such as magnetic resonance imaging (MRI).
  • Do not cut or remove the top cover of the patch as this could result in a burn injury.
  • Used SYNERA® patches contain a large amount of lidocaine and tetracaine (at least 90% of the initial amount). Chewing or swallowing 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.

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. 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.
  3. EMLA® Cream 5% Prescribing Information. Akorn Inc., Lake Forest, IL; April 2012.
  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. 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.

Indication

SYNERA® (lidocaine and tetracaine) Topical Patch is indicated for use on unbroken skin to help prevent the pain of needle sticks into superficial veins (apply for 20-30 mins) and some superficial skin procedures (apply for 30 mins).

Important Safety Information

SYNERA® is not to be used in patients with a known history of sensitivity to lidocaine, tetracaine, numbing medications 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 at the same time or one right after the other could result in absorption of sufficient amounts of drug to result in serious adverse effects. Patients should not use SYNERA® if they have a history of methemoglobinemia.

Used SYNERA® patches contain a large amount of lidocaine and tetracaine (at least 90% of the initial amount). Chewing or swallowing 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 general effects on the body of lidocaine and tetracaine, particularly those who are seriously ill or weakened by illness, and those with reduced liver function. Patients with severe liver disease or missing adequate blood plasma enzymes are at greater risk of developing toxic plasma concentrations.

Do not use on body passages such as inside the nose or mouth or on areas with unhealthy, broken skin.

Application to broken or inflamed skin may result in toxic blood concentrations of lidocaine and tetracaine.

Allergic or extreme sensitivity (skin rash, swelling or hives, narrowing of airways, and shock) to the active or inactive components of SYNERA® can occur and should be managed by a medical professional. Seek immediate emergency help if any of these occur.

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.

The application of more than two SYNERA® patches at the same time or one right after another to children is not recommended as it has not been fully studied. Safety and effectiveness of SYNERA® have been established in patients 3 years of age and older.

Lidocaine, one of the numbing medications in SYNERA®, has been shown to prevent the growth of viruses and bacteria. The effect of SYNERA® on needle sticks into the skin for certain vaccines has not been determined.

The heating component contains iron powder, and the patch must be removed before some diagnostic procedures, including magnetic resonance imaging (MRI).

SYNERA® may lead to little or no feeling in the area of the skin where it is applied; therefore, patients should avoid trauma (rubbing, scratching, or exposure to heat or cold) before complete feeling returns.

SYNERA® should be used with caution in patients receiving certain heart medications and/or other local pain-preventing medications, because there may be additional toxic effects 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

SYNERA® should be applied immediately after opening the pouch. Do not cut or remove the top cover of the patch as this could result in a burn injury.

If skin irritation or a burning sensation occurs during application, remove the patch and inform your doctor or nurse immediately.

Please see Full Prescribing Information including Instructions For Use before using 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.