Pronunciation:

LYE-doe-kane, TE-tra-kane

Brand Names:

• Synera

Dosage Forms:

• Cream
• Patch, Extended Release

Classifications:

Therapeutic—

Dermatological Agent

Chemical—

Amino Amide

Uses of This Medicine:

Lidocaine and tetracaine combination is used on the skin to cause numbness or loss of feeling for patients before drawing blood or placing an intravenous (IV) line or having certain medical or skin procedures (eg, excision, electrodessication, shave biopsy).

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 This Medicine:

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.

Children—

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of lidocaine and tetracaine combination in children 3 years of age and older. Safety and efficacy have not been established in children younger than 3 years of age.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of lidocaine and tetracaine combination in the elderly. However, elderly patients are more sensitive to the effects of this medicine than younger adults.

Breast-feeding—

Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.

Other 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. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Dihydroergotamine
• Dronedarone
• Saquinavir
• Vernakalant

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Amifampridine
• Amiodarone
• Amprenavir
• Arbutamine
• Bupivacaine Liposome
• Bupropion
• Cobicistat
• Darunavir
• Dasabuvir
• Delavirdine
• Disopyramide
• Donepezil
• Encainide
• Etravirine
• Flecainide
• Fosamprenavir
• Fosphenytoin
• Hyaluronidase
• Lopinavir
• Metoprolol
• Mexiletine
• Moricizine
• Nadolol
• Phenytoin
• Procainamide
• Propafenone
• Quinidine
• Sotalol
• Succinylcholine
• Telaprevir
• Tocainide

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Cimetidine

Other interactions—

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:

• Glucose-6-phosphate dehydrogenase deficiency (G6PD) or
• Heart problems or
• Lung or breathing problems or
• Methemoglobinemia (blood disorder), hereditary or idiopathic (unknown cause)—Use with caution. May increase risk of having methemoglobinemia.

• 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 This Medicine:

A nurse or other trained health care professional will apply this medicine before your medical procedure. You may be taught how to give your medicine at home. Make sure you understand all instructions before you apply the patch. Do not use more medicine or use it more often than your doctor tells you to.

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.

To apply the patch:

• Wash your hands with soap and water before and after applying a patch.
• This medicine is for use only on the skin. Be careful not to get any of this medicine into your eyes, because it can cause severe eye irritation. If any of the medicine does get into your eyes, wash your eyes with water or saline solution and check with your doctor right away.
• Leave the patch in its sealed wrapper until you are ready to put it on. Tear the wrapper open carefully. Never cut the wrapper or the patch with scissors. Do not use any patch that has been cut by accident.
• Do not cut the patch or tear it apart in any way. This could cause medicine to leak out of the patch and burn your skin.
• Do not apply this medicine to open wounds, burns, broken, irritated, or inflamed skin, or to a large area of the skin, unless directed by your doctor.
• Do not keep a patch on longer than what your doctor ordered or apply multiple patches at the same time and application site as the first patch.
• After using the medicine, fold the used patch in half with the sticky sides together. Throw any used patch away so that children or pets cannot get to it.

Precautions While Using This Medicine:

It is very important that your doctor check you or your child's progress closely while receiving the medicine to make sure this medicine is working properly. Blood tests may be needed to check for any problems or unwanted effects that may be caused by this medicine.

This medicine may cause a rare, but serious blood problem called methemoglobinemia. The risk may be increased in children younger than 6 months of age, elderly patients, or patients with certain inborn defects. It is more likely to occur in patients receiving too much of the medicine, but can also occur with small amounts. Make sure you store this medicine out of reach of children. Call your doctor right away if you or your child has the following symptoms after receiving this medicine: pale, gray, or blue-colored skin, lips, or nails, confusion, headache, lightheadedness, fast heartbeat, or unusual tiredness or weakness.

This medicine may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and require immediate medical attention. Call your doctor right away if you have itching, hives, hoarseness, trouble with breathing or 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 rash, burning, stinging, swelling, or irritation of your skin after using this medicine.

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.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects of This Medicine:

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

chills

cough

fainting or loss of consciousness

fast or irregular breathing

fever

hives or welts

hoarseness

lower back or side pain

painful or difficult urination

swelling of the eyes or eyelids

tightness in the chest

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 suddenly from a lying or sitting position

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 genitals

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

slow heart rate

sweating

trembling or shaking of the hands or feet

twitching

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 the 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.