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|Lidocaine And Prilocaine Topical

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LIDOCAINE AND PRILOCAINE (Topical)

Some commonly used brand names are:

In the U.S.—

EMLA

In Canada—

EMLA

Another commonly used name for lidocaine is lignocaine .

Description

This medicine contains a mixture of 2 local anesthetics ((an-ess-THET-iks)) , lidocaine (LYE-doe-kane) and prilocaine (PRIL-oh-kane). It is used to produce numbness or loss of feeling before certain painful procedures, such as injections, drawing blood from a vein, or removing small growths (warts, for example) from the skin.

This medicine deadens the nerve endings in the skin. It does not cause unconsciousness as general anesthetics used for surgery do.

In the U.S., this medicine is available only with your doctor"s prescription. In Canada, it is available without a prescription. However, your doctor may have special instructions on the proper use and dose, depending on the reason you are using this medicine.

Topical
Cream (U.S. and Canada)
Disc (U.S. and Canada)

Before Using This Medicine

In deciding to use a medicine, the risks of using 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 lidocaine, prilocaine, or other local anesthetics given by injection or applied to any part of the body as a liquid, cream, ointment, or spray. Also tell your health care professional if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy—This mixture of lidocaine and prilocaine has not been studied in pregnant women. However, lidocaine and prilocaine (separately) have been given to pregnant women and have not been reported to cause birth defects or other problems.

Breast-feeding—Small amounts of lidocaine, and probably of prilocaine also, pass into breast milk. Many medicines that pass into breast milk in small amounts may be used safely while breast-feeding. Mothers who are breast-feeding and who wish to use this medicine should discuss this with their doctor.

Children—This medicine has been tested in children. Very young children (less than 1 year of age) may be especially sensitive to the effects of lidocaine and prilocaine. This may increase the chance of side effects. However, in effective doses, this medicine has not been shown to cause different side effects or problems in children older than 1 year of age than it does in adults.

Young children are often frightened when they receive injections or have other painful procedures done. This medicine helps prevent pain, but it will not calm a frightened child. Parents can help by staying calm and by comforting and reassuring the child.

Older adults—This medicine has not been studied specifically in older people. However, it is possible that the chance of some side effects may be increased in elderly people. Experience with local anesthetics given by injection or applied to other areas of the body (for example, the throat or the inside of the mouth) has shown that elderly people are usually more sensitive than younger adults to the effects of local anesthetics.

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. Before using this medicine, tell your health care professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine, especially:

Sulfonamides (sulfa medicine)—The chance of a side effect (methemoglobinemia) may be increased, especially in infants.

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:

Broken or inflamed skin, burns, or open wounds at place of application or
Atopic dermatitis or
Eczema—More of this medicine can be absorbed into the body quickly, which increases the chance of side effects

Glucose-6-phosphate dehydrogenase (G6PD) deficiency—A possible side effect of this medicine (methemoglobinemia) may be more likely to occur

Liver disease (severe)—The chance of side effects may be increased if large amounts of this medicine are absorbed into the body quickly

Methemoglobinemia—This medicine may make your condition worse

Proper Use of This Medicine

For safe and effective use of this medicine:

Use this medicine only when directed to do so by your health care professional. Do not use it for any other reason without first checking with your doctor . This medicine may be more likely than other topical anesthetics to cause unwanted effects if it is used too much, because more of it is absorbed into the body through the skin.
Unless otherwise directed by your health care professional, do not apply this medicine to open wounds, burns, or broken or inflamed skin .
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 into your eye, do not rub or wipe the eye, even if it hurts. Instead, check with your doctor right away .
Be careful not to get any of this medicine on your lips or in your mouth or ears.
Follow carefully any directions given to you by your health care professional about how this medicine should be used . If you have not received other instructions about how to apply this medicine, follow the patient directions that come with the medicine .
Check with your health care professional if you have any questions about how to apply this medicine, where to apply it, or what time to apply it.

To use:

Cream
Apply a thick layer of medicine to the area or areas where local anesthesia (numbness or loss of feeling) is needed. Do not spread out the medicine .
This medicine is used together with a special bandage (called an occlusive dressing). Check with your health care professional if you did not receive any bandages with the medicine . Cover the medicine with the bandage. Seal the edges of the bandage tightly, making sure that none of the medicine leaks out . Do not lift the bandage or otherwise disturb it. Keeping the medicine tightly covered helps it work properly.
If your health care professional has directed you to remove the bandage and wipe off the medicine after a certain amount of time, follow the directions carefully. Then clean the area with the antiseptic solution recommended by your health care professional. If your health care professional has not directed you to remove the bandage and the medicine, keep them in place until your health care professional removes them .

Disc
Place the disc over the skin area where numbness is needed.
Be sure the disc stays in place and does not become detached from the skin for at least 60 minutes.

Dosing—The dose of this medicine will be different for different patients. Follow your doctor"s orders or the directions that come with the medicine . 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.

For cream dosage form:
- For preventing pain caused by injections or drawing blood from a vein:
  - Adults and children—Apply 2.5 grams of cream (one-half of the amount in a 5-gram tube) in a thick layer to an area about two inches by two inches (twenty to twenty-five square centimeters) in size. Your health care professional may direct you to apply the medicine in two places. The medicine should remain in place, covered by the bandage that comes with it, for at least one hour.
- For preventing pain caused by removal of genital lesions or by injection of local anesthetic before removal of genital lesions (e.g., genital warts):
  - Adults—Apply 2.5 grams of cream (one-half of the amount in a 5-gram tube) in a thick layer to the skin for fifteen minutes. Your health care professional may inject additional local anesthetic immediately after removal of the cream.
- For preventing pain caused by certain procedures:
  - Adults—The size of the area to be covered by a thick layer of this medicine and the amount of time that the medicine must be kept in place depend on the procedure that is being done. The medicine sometimes needs to be kept in place, covered with the bandage, for two hours or more.
  - Children—The size of the area to be covered by a thick layer of this medicine and the amount of time that the medicine must be kept in place depend on the procedure being done. However, the largest area that may be covered by this medicine depends on the child"s weight and must be determined by your doctor. The medicine sometimes needs to be kept in place, covered with the bandage, for two hours or more.
For the disc dosage form:
- For preventing pain caused by injections or drawing blood from a vein:
  - Adults and children—Apply one disc to the skin where numbness is needed. Your health care professional may direct you to apply two discs in two different places. The disc should remain in place for at least one hour.

Storage—To store this medicine:

Keep out of the reach of children.
Store away from heat and direct light.
Keep the medicine from freezing.
Do not keep outdated medicine or medicine no longer needed. Be sure that any discarded medicine is out of the reach of children.

Precautions After Using This Medicine

After applying this medicine to the skin of a child, watch the child carefully to make sure that he or she does not loosen or remove the bandage. Also, keep the child from getting any of the medicine into his or her mouth . This medicine can cause serious side effects, especially in children, if any of it gets into the mouth or is swallowed.

During the time that the area to which the medicine was applied feels numb, serious injury can occur without your knowing about it. Be especially careful to avoid injury until the anesthetic wears off or feeling returns to the area . For example, do not scratch or rub the area or allow very hot or very cold objects to touch it.

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.

The following side effects may mean that a serious allergic reaction is occurring. Check with your doctor or get emergency help immediately if they occur, especially if several of them occur at the same time.

Rare

Coughing, shortness of breath, troubled breathing, tightness in chest, or wheezing; difficulty in swallowing; large, hive-like swellings on eyelids, face, lips, or tongue; severe dizziness or feeling faint; skin rash, itching, or hives; stuffy nose

Also check with your health care professional, or get emergency help right away , if any of the following side effects occur:

Signs of too much medicine being absorbed into the body

Blue or blue-purple color of lips, fingernails, or skin; blurred or double vision; dark urine; dizziness or drowsiness; feeling hot, cold, or numb; headache; irregular or fast heartbeat; muscle twitching or trembling; nausea or vomiting; ringing or buzzing in the ears; shortness of breath or troubled breathing; unusual excitement, nervousness, or restlessness; unusual tiredness or weakness

Note:

The above side effects are not likely to occur when usual amounts of this medicine are used properly. However, they may occur if the medicine is used too often, applied to broken skin (for example, cuts or scrapes), applied to very large areas, or kept on the skin too long.

Other side effects may occur that usually do not need medical attention. However, check with your doctor if any of the following side effects continue or are bothersome:

More common

Burning feeling, swelling, itching, or skin rash at place of application (without other signs of an allergic reaction listed above); white or red skin at place of application

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

Revised: 08/05/1998

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