Synera

Generic Name: lidocaine and tetracaine (Topical application route)

LYE-doe-kane, TE-tra-kane

Commonly used brand name(s):

In the U.S.

• Synera

Available Dosage Forms:

• Patch, Extended Release

Therapeutic Class: Anesthetic Combination

Chemical Class: Amino Amide

Uses For Synera

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.

Before Using Synera

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

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.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of lidocaine and tetracaine combination in the elderly.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Infection at or near the place of application or
• Large sores, broken skin, or severe injury at the area of application—Use with caution. The chance of side effects may be increased.

• Liver disease, severe or
• Pseudocholinesterase deficiency (enzyme problem)—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Proper Use of Synera

A nurse or other trained health care professional will apply this medicine before your medical procedure.

The patch is applied to your skin about 20 to 30 minutes before your procedure. Tell your doctor if you still have feeling in the skin after 30 minutes have passed.

Be careful not to get any of this medicine in your eyes, because it can cause severe eye irritation. If any of the medicine does get in your eyes, wash the eyes with water and check with your doctor right away.

Precautions While Using Synera

It is very important that your doctor check you closely for any problems or unwanted effects that may be caused by this medicine.

This medicine may cause a serious type of allergic reaction called anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor right away if you have itching; hives; hoarseness; trouble with breathing; trouble with swallowing; or any swelling of your hands, face, or mouth while you are using this medicine.

Check with your doctor right away if you have a skin rash, burning, stinging, swelling, or irritation of your skin.

Lidocaine and tetracaine combination cause numbness or loss of feeling in the skin. Be careful not to injure the treated skin by rubbing, scratching, or exposing the skin to extreme cold or heat.

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:

• Flushing or redness of the skin
• swelling
• unusually warm skin

• 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

• 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

• 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:

• 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:

• Headache
• nausea
• sleepiness or unusual drowsiness
• vomiting

• 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.

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