Synera

DRUG DESCRIPTION

Syneraź (lidocaine and tetracaine) 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 (lidocaine and tetracaine) 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:

Lidocaine Structural Formula Illustration

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:

Each Synera patch contains lidocaine 70 mg and tetracaine 70 mg in a eutectic mixture. The Synera (lidocaine and tetracaine) formulation also contains the following inactive ingredients: polyvinyl alcohol, sorbitan monopalmitate, water, methylparaben and propylparaben.

The Synera (lidocaine and tetracaine) heating component generates a mild warming that is intended to enhance the delivery of the local anesthetic. Synera (lidocaine and tetracaine) 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 5??C, maximum skin temperature will not exceed 40??C. The heating component is composed of iron powder, activated carbon, sodium chloride, wood flour, water and filter paper.

What are the precautions when taking lidocaine and tetracaine (Synera)?

Before using hyaluronate, tell your doctor or pharmacist if you are allergic to it; or to bird proteins, feathers, or egg products; or if you have any other allergies. This product may contain inactive ingredients (such as latex found in the rubber syringe cap of some brands), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: knee joint infections, skin infections/problems in the area around the injection site, circulation problems in the legs.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is unknown whether this drug passes into breast milk....

Read All Potential Precautions of Synera »


Synera Consumer (continued)

SIDE EFFECTS: See also How to Use section.

Pain, swelling, redness/warmth/bruising at the injection site, or headache may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: back pain, severe headache, fast/pounding heartbeat, fever, tingling skin.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before using hyaluronate, tell your doctor or pharmacist if you are allergic to it; or to bird proteins, feathers, or egg products; or if you have any other allergies. This product may contain inactive ingredients (such as latex found in the rubber syringe cap of some brands), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: knee joint infections, skin infections/problems in the area around the injection site, circulation problems in the legs.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is unknown whether this drug passes into breast milk. Consult your doctor before breast-feeding.



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