Synera

Name: Synera

Descriptions

Lidocaine and tetracaine combination is used on the skin to cause numbness or loss of feeling for patients having certain medical or skin procedures.

Lidocaine and tetracaine combination belongs to a group of medicines known as topical local anesthetics. It deadens the nerve endings in the skin. This medicine does not cause unconsciousness as general anesthetics do when used for surgery.

This medicine is available only with your doctor's prescription.

This product is available in the following dosage forms:

  • Patch, Extended Release
  • Cream

Warnings

Included as part of the PRECAUTIONS section.

Patient information

Leave the patch in the foil pouch until you read this leaflet

WHAT THE PATCH DOES:

The medicine on this patch is used to numb the skin that it covers. The safety and effectiveness of SYNERA® have been established in adults and children 3 years of age and older.

FOLLOW THE INSTRUCTIONS BELOW, AND THESE SAFETY TIPS:

  • Do not put the patch on your lips or near your eyes. If you get medicine from the patch in your eye, rinse your eye with water and protect it until the numbness goes away.
  • Do not cut or tear the patch.
  • Do not get water on the patch.
  • Keep the patch away from children and pets at all times.

STEP 1: Check the skin where the patch will be worn

  • Keep the patch in the unopened foil pouch until you are ready to put it on.
  • Check the skin where your doctor or health care professional told you to wear it.
  • Do not put the patch on skin that is cut, scratched or red (like a rash).
  • Do not shave the area or you may hurt the skin.

STEP 2: Open the foil pouch and remove the patch. Save the foil pouch.

  • TO TEAR OPEN THE FOIL POUCH - fold the upper right corner toward you. (See picture A)

  • Press the corner flat to form a small triangle.
  • Tear the foil pouch in the middle of the fold along the pre-cut slit. (See picture B)

  • TO CUT OPEN WITH SCISSORS - cut carefully along the edge of the package.
  • SAVE THE FOIL POUCH.

STEP 3: Put the patch on your skin

  • DO NOT TOUCH THE MEDICINE IN THE MIDDLE - touch only the sticky edges of the patch. Never touch the center area.

  • Peel the patch off of the hard plastic backing.
  • Put the sticky side of the patch on your skin, where you were told to wear it. Press the edges to make sure the patch will stick to your skin.

  • Wash your hands.

STEP 4: IMPORTANT — How to remove and discard the patch

  • Do not leave the patch on the skin for longer than 30 minutes.

  • Carefully peel the patch off your skin, touching only the sticky edges of the patch - DO NOT TOUCH THE MEDICINE IN THE MIDDLE.
  • PRESS THE STICKY SIDE OF THE USED PATCH ONTO THE FOIL POUCH.

  • THROW FOIL POUCH WITH PATCH ATTACHED, AND HARD PLASTIC BACKING, IN THE GARBAGE so children and pets cannot reach it.
  • Wash your hands.

While Wearing the Patch:

  • Do not put the patch on your lips or near your eyes.
  • If you get medicine from the patch in your eye, rinse it with water until the numbness goes away.
  • Do not cut or tear the patch.
  • Do not get water on the patch. Keep the patch dry. Do not cover the small holes on the outside of the patch. If you applied the patch to the back of your hand, wash your hands carefully.
  • If your skin hurts or burns too much, you should take the patch off.
    It is normal for the skin to feel warm, but it should not burn.

After the patch is removed:

Be careful with your skin after the patch is removed. The skin that was covered by the patch stays numb and you won't be able to feel pain right away. Do not scratch or let this skin touch hot or cold things.

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of lidocaine and tetracaine combination in children. However, safety and efficacy have not been established in children below 3 years of age.

Synera Drug Class

Synera is part of the drug classes:

  • Anesthetics for topical use

  • Esters of aminobenzoic acid

  • Amides

  • Analgesics and anesthetics

  • Anesthetics, local

  • Antiarrhythmics, class Ib

Synera Dosage

Follow all directions on your prescription label. Never use this medicine in larger amounts, or for longer than prescribed.

Lidocaine and tetracaine topical is usually applied 20 to 30 minutes before your procedure (or 60 minutes before tattoo removal).

If you use this medicine at home, read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.

Lidocaine and tetracaine topical comes in a cream or a skin patch.

Do not take by mouth. Topical medicine is for use only on the skin. If this medicine gets in your mouth, nose, rectum, or vagina, rinse with water.

The lidocaine and tetracaine topical cream should not be used on a child younger than 3 years old. The skin patch is not approved for use by anyone younger than 18 years old.

For a cosmetic procedure, a healthcare professional or other care provider will apply lidocaine and tetracaine topical cream to your skin.

As it dries, the cream turns into a film that can be peeled off after the prescribed amount of numbing time. Your care provider will remove the cream and clean your skin before your procedure.

If you use a lidocaine and tetracaine topical skin patch, apply it only to clean, dry, healthy skin on the area to be numbed. Press firmly into place. You may begin to feel a warming sensation. Mild warmth from the skin patch is normal, but it should not feel unpleasantly hot.

Wash your hands after applying a skin patch.

After your prescribed amount of numbing time, remove the skin patch, then clean and disinfect the skin as recommended by your doctor.

After removing a skin patch: fold it in half with the sticky side in, and throw it away in a place out of the reach of children or pets.

Store unused skin patches at room temperature away from moisture and heat.

Both used and unused skin patches should be kept out of the reach of children or pets. The amount of medicine in the skin patches could be harmful to a child or pet who accidentally sucks on or swallows a patch. Seek emergency medical attention if this happens.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of numbing medicine can cause fatal side effects if too much of the medicine is absorbed through your skin and into your blood.

Your body may absorb too much of this medicine if:

  • you apply more than the recommended dose;
  • you apply the medicine to skin that is cut or irritated; or
  • you leave a skin patch on your skin for too long.

Overdose symptoms may include numbness or tingling in your face, ringing in your ears, drowsiness, nausea, and slurred speech. Serious complications of lidocaine or tetracaine overdose may include seizure (convulsions), slowed breathing, coma, heart failure, or respiratory failure (breathing stops).

Since lidocaine and tetracaine topical is used as a single dose, it does not have a daily dosing schedule.

What is lidocaine and tetracaine topical?

Lidocaine and tetracaine are local anesthetics (numbing medicines). They work by blocking nerve signals in your body.

Lidocaine and tetracaine topical (for use on the skin) is a combination medicine used to numb a small area of your skin. This can help prevent pain during certain medical procedures such as a skin biopsy, minor skin surgery, insertion of an intravenous (IV) needle, or other needle-stick procedures.

Lidocaine and tetracaine topical is also used to numb a skin area during minor cosmetic procedures such as a Botox injection, laser treatment, or tattoo removal.

Lidocaine and tetracaine topical may also be used for purposes not listed in this medication guide.

What happens if I miss a dose?

Since lidocaine and tetracaine topical is used as a single dose, it does not have a daily dosing schedule.

Synera Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

More common
  • Flushing or redness of the skin
  • swelling
  • unusually warm skin
Less common
  • Blistering, burning, crusting, dryness, or flaking of the skin
  • change in the color of treated skin
  • itching, scaling, severe redness, soreness, or swelling of the skin
  • rash
Rare
  • Burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
  • cough or hoarseness
  • fainting or loss of consciousness
  • fast or irregular breathing
  • fever or chills
  • hives or welts
  • lower back or side pain
  • painful or difficult urination
  • swelling of the eyes or eyelids
  • tightness in the chest or wheezing
  • trouble with breathing
Incidence not known
  • Blurred vision
  • chest pain or discomfort
  • cold, clammy, or pale skin
  • confusion
  • difficulty with breathing
  • difficulty with swallowing
  • dizziness
  • dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly
  • fast, slow, or irregular heartbeat
  • feelings of coldness, heat, or numbness
  • irregular, fast or slow, or shallow breathing
  • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
  • no breathing
  • noisy breathing
  • pale or blue lips, fingernails, or skin
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • seizures
  • shakiness in the legs, arms, hands, or feet
  • shortness of breath
  • slow heart rate
  • sweating
  • trembling or shaking of the hands or feet
  • twitching
  • unconsciousness
  • unusual tiredness or weakness

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose
  • Change in consciousness
  • fast, pounding, or irregular heartbeat or pulse
  • no blood pressure or pulse
  • stopping of heart

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Rare
  • Headache
  • nausea
  • sleepiness or unusual drowsiness
  • vomiting
Incidence not known
  • Continuing ringing or buzzing or other unexplained noise in the ears
  • depression
  • double vision
  • drowsiness
  • false or unusual sense of well-being
  • fear
  • hearing loss
  • nervousness

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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

Uses of Synera

  • It is used to numb an area of the skin before care.

Dosage formsand strengths

Synera topical patch contains 70 mg lidocaine and 70 mg tetracaine, has a total skin contact area of 50 cm 2, and an active drug-containing area of 10 cm 2.

For Healthcare Professionals

Applies to lidocaine / tetracaine topical: topical cream, topical film

Local

Local side effects have included erythema , blanching, edema, or abnormal sensation at the site of treatment. The most common of the local reactions were erythema (71%), blanching (12%), and edema (12%). These reactions were generally mild, and resolved spontaneously soon after treatment.[Ref]

Hypersensitivity

Hypersensitivity side effects have included allergic or anaphylactoid reactions to the active or inactive ingredients. They may be characterized by urticaria, angioedema, bronchospasm, and shock.[Ref]

Nervous system

Nervous system side effects are unlikely with appropriate use of lidocaine-tetracaine topical. Potential side effect include CNS excitation and/or depression (light-headedness, nervousness, apprehension, euphoria, confusion, dizziness, drowsiness, tinnitus, blurred or double vision, vomiting, sensations of heat, cold, or numbness, twitching, tremors, convulsions, unconsciousness, respiratory depression and arrest). Excitatory CNS reactions may be brief or not occur at all, in which case the first manifestation may be drowsiness developing into unconsciousness. Signs of CNS toxicity may start at plasma concentrations of lidocaine as low as 1000 ng/mL. The plasma concentrations at which tetracaine toxicity may occur are less well characterized; however, systemic toxicity with tetracaine is thought to occur with much lower plasma concentrations compared with lidocaine. The toxicity of co-administered local anesthetics is thought to be at least additive.[Ref]

Cardiovascular

Cardiovascular side effects are unlikely with appropriate use of lidocaine-tetracaine topical. Potential side effects include bradycardia, hypotension and cardiovascular collapse leading to arrest.[Ref]

Some side effects of Synera may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

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