Synera

Get emergency medical help if you have signs of an allergic reaction: hives; wheezing, difficulty breathing; swelling of your face, lips, tongue, or throat.

Tell your caregivers or call your doctor right away if you have:

• severe burning, stinging, or other irritation where the medicine was applied;
• sudden dizziness or drowsiness after the medicine is applied;
• a nervous or restless feeling;
• headache, confusion, nausea;
• blurred vision, ringing in your ears; or
• unusual sensations of temperature.

Common side effects include:

• skin redness;
• skin swelling; or
• changes in skin color where the medicine was applied.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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).

Do not allow this medicine to come into contact with your eyes. If it does, rinse with water.

Avoid using the medicine on skin that is raw or blistered.

Do not use a skin patch if it has been cut or damaged.

Avoid touching the sticky side of a skin patch while applying it.

It is not likely that other drugs you take orally or inject will have an effect on topically applied lidocaine and tetracaine. However, some drugs can cause conditions that may make it harmful for you to use lidocaine and tetracaine topical. Tell each of your health care providers about all medicines you use, including prescription and over-the-counter medicines, vitamins, and herbal products.

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.

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. When you are receiving 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 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.

• Amiodarone

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.

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.

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
• Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Check with your pharmacist about how to throw out unused drugs.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about this medicine, please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take Synera or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Synera. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.

Review Date: October 4, 2017

• Synera is contraindicated in patients with a known history of sensitivity to lidocaine, tetracaine, or local anesthetics of the amide or ester type.
• Synera is also contraindicated in patients with para-aminobenzoic acid (PABA) hypersensitivity and in patients with a known history of sensitivity to any other component of the product.

In adults the maximum peak plasma concentrations of lidocaine and tetracaine following application of two to four Synera patches for 30-60 minutes were less than 9 ng/mL and tetracaine levels were not detectable. In children, the maximum observed peak plasma concentrations of lidocaine were 63 ng/mL and 331 ng/mL after the application of one or two Synera patches, respectively. Higher maximum concentrations of lidocaine were observed for younger children when compared to older children. The maximum concentration of tetracaine observed in children was 65 ng/mL, and most values obtained were <0.9 ng/mL. Signs of CNS toxicity may start at plasma concentrations of lidocaine as low as 1000 ng/mL, and the risk of seizures generally increases with increasing plasma levels.

Very high levels of lidocaine can cause respiratory arrest, coma, decreases in cardiac output, total peripheral resistance and mean arterial pressure, ventricular arrhythmias and cardiac arrest. Tetracaine is associated with a profile of systemic CNS and cardiovascular adverse events similar to lidocaine, although toxicity associated with tetracaine is thought to occur at lower doses compared to lidocaine. The toxicity of co-administered local anesthetics is thought to be at least additive. In the absence of massive topical overdose or oral ingestion, other etiologies for the clinical effects or overdosage from other sources of lidocaine, tetracaine or other local anesthetics should be considered. The management of overdosage includes close monitoring, supportive care and symptomatic treatment. Dialysis is of negligible value in the treatment of acute overdosage of lidocaine.

Since Synera is used as a single dose, it does not have a daily dosing schedule.

Do not allow this medicine to come into contact with your eyes. If it does, rinse with water.

Avoid using the medicine on skin that is raw or blistered.

Do not use a skin patch if it has been cut or damaged.

Avoid touching the sticky side of a skin patch while applying it.

It is not likely that other drugs you take orally or inject will have an effect on topically applied lidocaine and tetracaine. However, some drugs can cause conditions that may make it harmful for you to use Synera. Tell each of your health care providers about all medicines you use, including prescription and over-the-counter medicines, vitamins, and herbal products.