Pronunciation:

LYE-doe-kane, PRIL-oh-kane

Brand Names:

• AgonEaze
• Emla

Dosage Forms:

• Cream

Classifications:

Therapeutic—

Anesthetic Combination

Chemical—

Amino Amide

Uses of This Medicine:

Lidocaine and prilocaine topical cream is used on the skin or in the genital area to cause numbness or loss of feeling before certain medical procedures. It is also used to prevent pain caused by an injection, the drawing of blood from a vein, or minor surgeries such as removing warts. This medicine contains a mixture of two topical local anesthetics (numbing medicines). It deadens the nerve endings in the skin.

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 prilocaine topical cream in children. However, because of this medicine's toxicity, it should be used with caution, after other medicines have been considered or found ineffective. Recommended doses should not be exceeded, and the patient should be carefully monitored during treatment.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of lidocaine and prilocaine topical cream in the elderly. However, elderly patients are more likely to have age-related liver, kidney, or heart problems, which may require caution and an adjustment in the dose for patients receiving lidocaine and prilocaine topical cream.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while 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.

• 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.

• Acecainide
• Amifampridine
• Amiodarone
• Amprenavir
• Arbutamine
• Bretylium
• Bupivacaine Liposome
• Bupropion
• Cobicistat
• Darunavir
• Dasabuvir
• Delavirdine
• Disopyramide
• Dofetilide
• Donepezil
• Dronedarone
• Encainide
• Etravirine
• Flecainide
• Fosamprenavir
• Fosphenytoin
• Hyaluronidase
• Ibutilide
• 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 (G6PD) deficiency, history of 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.

• Heart rhythm problems or
• Infection at or near the place of application or
• Large sores, broken skin, or severe injury at the area of application—May cause side effects to become worse.

• Liver disease, severe—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 to you or your child before a medical procedure in a medical facility.

You may be taught how to apply this medicine to yourself or your child at home before the medical procedure. Use this medicine exactly as directed by your doctor. Do not use it for any other condition without first checking with your doctor. This medicine may cause unwanted effects if too much is used, because more of it is absorbed through the skin.

Do not apply this medicine to open wounds, burns, or broken or inflamed skin, unless directed otherwise by your doctor.

Be careful not to get any of this medicine in the eyes, because it can cause severe eye irritation. If any of the medicine does get into your eye, do not rub or wipe the eye, even if it hurts. Wash the eye with water and call your doctor right away.

Be careful not to get any of this medicine in the ears (especially in the middle ear), because it can cause serious hearing problems. If any of the medicine does get into your ear, wash the ear with water and call your doctor right away.

Be careful not to get any of this medicine in the mouth. Serious unwanted effects may occur if the medicine is swallowed.

To use:

• Wash your hands with soap and water before and after applying the medicine.
• Apply a thick layer of medicine to the area where numbness is needed. Do not spread the medicine on the skin.
• Cover the medicine with a special bandage called an occlusive dressing. This will keep the medicine in place. Your doctor will give you the bandage or tell you what to use.
• Seal the edges of the bandage to keep the medicine from leaking. Do not lift the bandage or disturb it. Keeping the medicine tightly covered helps it work properly.
• For babies or young children, a second covering may be used to prevent them from touching the medicine.
• Carefully watch your baby or child while the medicine is in place. Do not let them loosen or remove the bandage, touch the medicine, or put it in the mouth, eyes, nose, or ears.
• Keep the bandage in place until you or your child arrive at the hospital or clinic.
• Your doctor will remove the bandage and wipe the medicine off the skin before the medical procedure.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For topical dosage form (cream):
  • For preventing pain caused by medical procedures:
    • Adults—Apply 1 to 2.5 grams (g) in a thick layer to the skin area. The size of the area to be covered and the length of time the medicine is kept in place will depend on the procedure. Cover the area with a bandage. The medicine may need to stay on the skin for up to 2 hours. Your doctor will remove the bandage and wipe the medicine off the skin before the medical procedure.
    • Children—Dose is based on body weight and must be determined by your doctor. The cream is applied in a thick layer to the skin area. The size of the area to be covered and the length of time the medicine is kept in place will depend on the procedure. Cover the area with a bandage. Your doctor will remove the bandage and wipe the medicine off the skin before the medical procedure.

Storage—

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using This Medicine:

It is very important that your doctor check your or your child's progress closely to make sure this medicine is working properly. Blood tests may be needed to check for unwanted effects.

Do not use this medicine on a baby younger than 3 months of age unless your child's doctor tells you to. Young babies may have more unwanted effects if too much is used and absorbed through the skin. If you use this medicine on a baby younger than 3 months of age, blood tests may be needed to check for unwanted effects.

This medicine may cause serious types of allergic reactions, including anaphylaxis, which can be life-threatening and require immediate medical attention. Call your doctor right away if you or your child have a rash, itching, hoarseness, trouble with breathing or swallowing or any swelling of the hands, face, or mouth after you receive the medicine.

This medicine may cause a rare, but serious blood problem called methemoglobinemia. Call your doctor right away if you or your child develop a blue or bluish purple color on the lips, fingernails, or skin, or have headaches, dizziness, fainting, sleepiness, or trouble with breathing.

Using too much of this medicine or using it on a large area of your skin can cause serious unwanted effects. Remove the cream and contact your doctor right away if you or your child have any of these symptoms: lightheadedness, dizziness, vision problems, an irregular or slow heartbeat, difficulty with breathing, or convulsions (seizures).

During the time that the skin feels numb, serious injury can occur. Be especially careful to avoid injury until the numbness wears off and you or your child have normal feeling in the area. Do not scratch or rub the area, and do not allow very hot or very cold objects to touch it.

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 immediately if any of the following side effects occur:

Rare

Cough

difficulty with swallowing

large, hive-like swellings on the eyelids, face, lips, tongue, or genitals

severe dizziness or feeling faint

skin rash, itching, or hives

stuffy nose

tightness in the chest

troubled breathing

Incidence not known

Blisters on the skin at application site

blue or blue-purple color of lips, fingernails, mouth, or skin

blurred or double vision

dark urine

dizziness or drowsiness

fainting

feeling hot, cold, or numb

headache

irregular or fast heartbeat

muscle twitching or trembling

nausea

ringing or buzzing in the ears

seizures

unusual excitement, nervousness, or restlessness

unusual tiredness or weakness

vomiting

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:

More common

Burning, swelling, itching, or skin rash at application site

white or red skin at the application site

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.