Emla

Lidocaine and prilocaine topical is a local anesthetic (numbing medication). It works by blocking nerve signals in your body.

Lidocaine and prilocaine topical is used to numb the skin, or surfaces of the penis or vagina, in preparation for a medical procedure or to lessen the pain of inserting a medical instrument such as a tube or speculum.

Lidocaine and prilocaine topical may also be used for other purposes not listed in this medication guide.

An overdose of numbing medications can cause fatal side effects if too much of the medicine is absorbed through your skin and into your blood.

Overdose is more likely to occur when using a numbing medicine without the advice of a medical doctor (such as during a cosmetic procedure like laser hair removal). However, overdose has also occurred in women treated with a numbing medicine before having a mammography. Symptoms may include uneven heartbeats, seizure (convulsions), coma, slowed breathing, or respiratory failure (breathing stops).

Do not use lidocaine and prilocaine topical if you have a blood cell disorder called methemoglobinemia.

Before lidocaine and prilocaine topical is applied, tell your doctor if you have:

• liver disease;
• a history of allergic reaction to lidocaine or prilocaine; or
• a personal or family history of methemoglobinemia, or any genetic enzyme deficiency.

If you have any of these conditions, you may need a dose adjustment or special tests to safely use lidocaine and prilocaine topical.

FDA pregnancy category B. This medication is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

Lidocaine and prilocaine topical can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

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 and teenagers—Apply 1 to 2.5 grams 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.

Follow all directions on your prescription label. Do not apply this medicine in larger amounts than recommended.

You may need to apply lidocaine and prilocaine topical at home up to 4 hours before your surgery or procedure. You will be given instructions about how much medicine to use and how long to leave it on the skin. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

Use the smallest amount of medicine needed to numb the skin. Your body may absorb too much of this medicine if you use too much, if you apply it over large skin areas, or if you apply heat, bandages, or plastic wrap to treated skin areas. Skin that is cut or irritated may also absorb more topical medication than healthy skin.

You may need to cover the skin to help keep the medicine in place. Do not cover treated skin unless your doctor has told you to.

Carefully follow dosing instructions when applying this medicine to a child. Lidocaine and prilocaine topical doses are based on weight in children. Do not allow a child to use this medicine without adult supervision.

Store at room temperature away from moisture and heat. Do not allow the cream to freeze.

• If you have an allergy to lidocaine, prilocaine, or any other part of EMLA (lidocaine and prilocaine cream).
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
• If you have methemoglobinemia.
• If you are using this medicine in the ear and you have a ruptured ear drum. Do not use in the ear if you have a ruptured ear drum.

This is not a list of all drugs or health problems that interact with EMLA.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this medicine with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

EMLA Cream (lidocaine 2.5% and prilocaine 2.5%) is an emulsion in which the oil phase is a eutectic mixture of lidocaine and prilocaine in a ratio of 1:1 by weight. This eutectic mixture has a melting point below room temperature and therefore both local anesthetics exist as a liquid oil rather than as crystals. It is packaged in 5 gram and 30 gram tubes. Lidocaine is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl), has an octanol: water partition ratio of 43 at pH 7.4, and has the following structure:

Prilocaine is chemically designated as propanamide, N-(2-methylphenyl)-2-(propylamino), has an octanol: water partition ratio of 25 at pH 7.4, and has the following structure:

Each gram of EMLA Cream contains lidocaine 25 mg, prilocaine 25 mg, polyoxyethylene fatty acid esters (as emulsifiers), carboxypolymethylene (as a thickening agent), sodium hydroxide to adjust to a pH approximating 9, and purified water to 1 gram. EMLA Cream contains no preservative, however it passes the USP antimicrobial effectiveness test due to the pH. The specific gravity of EMLA Cream is 1.00.

EMLA Cream (lidocaine 2.5% and prilocaine 2.5%) is contraindicated in patients with a known history of sensitivity to local anesthetics of the amide type or to any other component of the product.

Adult Patients-Intact Skin

A thick layer of EMLA Cream is applied to intact skin and covered with an occlusive dressing (see INSTRUCTIONS FOR APPLICATION).

Minor Dermal Procedures: For minor procedures such as intravenous cannulation and venipuncture, apply 2.5 grams of EMLA Cream (1/2 the 5 g tube) over 20 to 25 cm2 of skin surface for at least 1 hour. In controlled clinical trials using EMLA Cream, two sites were usually prepared in case there was a technical problem with cannulation or venipuncture at the first site.

Major Dermal Procedures: For more painful dermatological procedures involving a larger skin area such as split thickness skin graft harvesting, apply 2 grams of EMLA Cream per 10 cm2 of skin and allow to remain in contact with the skin for at least 2 hours.

Adult Male Genital Skin: As an adjunct prior to local anesthetic infiltration, apply a thick layer of EMLA Cream (1 g/10 cm2) to the skin surface for 15 minutes. Local anesthetic infiltration should be performed immediately after removal of EMLA Cream.

Dermal analgesia can be expected to increase for up to 3 hours under occlusive dressing and persist for 1 to 2 hours after removal of the cream. The amount of lidocaine and prilocaine absorbed during the period of application can be estimated from the information in Table 2, ** footnote, in Individualization of Dose.

Adult Female Patients-Genital Mucous Membranes

For minor procedures on the female external genitalia, such as removal of condylomata acuminata, as well as for use as pretreatment for anesthetic infiltration, apply a thick layer (5 to 10 grams) of EMLA Cream for 5 to 10 minutes.

Occlusion is not necessary for absorption, but may be helpful to keep the cream in place. Patients should be lying down during the EMLA Cream application, especially if no occlusion is used. The procedure or the local anesthetic infiltration should be performed immediately after the removal of EMLA Cream.

Pediatric Patients-Intact Skin

The following are the maximum recommended doses, application areas and application times for EMLA Cream based on a child's age and weight:

Please note: If a patient greater than 3 months old does not meet the minimum weight requirement, the maximum total dose of EMLA Cream should be restricted to that which corresponds to the patient's weight (see INSTRUCTIONS FOR APPLICATION).

Practitioners should carefully instruct caregivers to avoid application of excessive amounts of EMLA Cream (see PRECAUTIONS).

When applying EMLA Cream to the skin of young children, care must be taken to maintain careful observation of the child to prevent accidental ingestion of EMLA Cream or the occlusive dressing. A secondary protective covering to prevent inadvertent disruption of the application site may be useful.

EMLA Cream should not be used in neonates with a gestational age less than 37 weeks nor in infants under the age of 12 months who are receiving treatment with methemoglobin-inducing agents (see Methemoglobinemia subsection of WARNINGS).

When EMLA Cream (lidocaine 2.5% and prilocaine 2.5%) is used concomitantly with other products containing local anesthetic agents, the amount absorbed from all formulations must be considered (see Individualization of Dose). The amount absorbed in the case of EMLA Cream is determined by the area over which it is applied and the duration of application under occlusion (see Table 2, ** footnote, in Individualization of Dose).

Although the incidence of systemic adverse reactions with EMLA Cream is very low, caution should be exercised, particularly when applying it over large areas and leaving it on for longer than 2 hours. The incidence of systemic adverse reactions can be expected to be directly proportional to the area and time of exposure (see Individualization of Dose).

EMLA Cream is available as the following:

NOT FOR OPHTHALMIC USE.

KEEP CONTAINER TIGHTLY CLOSED AT ALL TIMES WHEN NOT IN USE.

Store at 20° to 25°C (68° to 77°F)[see USP Controlled Room Temperature].

Rx only

Keep out of the reach of children.

For all medical inquiries contact:
ACTAVIS
Medical Communications
Parsippany, NJ 07054
1-800-272-5525

Manufactured By:
IGI Laboratories Inc.
Buena, NJ 08310 USA

Distributed By:
Actavis Pharma, Inc.
Parsippany, NJ 07054 USA

Content Updated: December 2014
76621

NDC 61874-002-72        5 Grams
EMLA®
CREAM (lidocaine 2.5%
and prilocaine 2.5%)
For Topical Use Only
Rx only

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. Symptoms may include uneven heartbeats, seizure (convulsions), slowed breathing, coma, or respiratory failure (breathing stops).

Lidocaine and prilocaine applied to the skin is not likely to cause an overdose unless you apply more than the recommended dose.

Tell your doctor about all medicines you use, and those you start or stop using during your treatment with Emla, especially:

• chloroquine, dapsone, nitrofurantoin, isosorbide dinitrate, nitroglycerin, nitroprusside, quinine;

• heart rhythm medication - amiodarone, dofetilide, dronedarone, mexiletine, sotalol, tocainide, and others;

• seizure medicine - phenobarbital, phenytoin, primaquine; or

• a sulfa drug - Bactrim, Septra, SMX-TMP or SMZ-TMP, and others.

This list is not complete. Other drugs may interact with lidocaine and prilocaine topical, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.