Emla

DRUG DESCRIPTION

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:

Lidocaine Structural Formula Illustration

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 (lidocaine and prilocaine) 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 (lidocaine and prilocaine) Cream contains no preservative, however it passes the USP antimicrobial effectiveness test due to the pH. The specific gravity of EMLA (lidocaine and prilocaine) Cream is 1.00.

What are the possible side effects of lidocaine and prilocaine topical (Emla)?

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

Stop using lidocaine and prilocaine topical and call your doctor at once if you have any of these serious side effects:

  • severe burning, stinging, or sensitivity where the medicine is applied;
  • swelling or redness;
  • sudden dizziness or sleepiness after medicine is applied;
  • bruising or purple appearance of the skin;...

Read All Potential Side Effects and See Pictures of Emla

What are the precautions when taking lidocaine and prilocaine (Emla)?

Before using this product, tell your doctor or pharmacist if you are allergic to lidocaine or prilocaine; or to any other amide anesthetics (e.g., bupivacaine); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: certain blood disorder (methemoglobinemia).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: certain blood disorder (G6PD deficiency, especially in children), heart disease (e.g., irregular heartbeat), kidney disease, liver...

Read All Potential Precautions of Emla


Emla Consumer (continued)

SIDE EFFECTS: Redness, swelling, tingling/burning, or lightening of the skin may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Notify your doctor immediately if you develop blistering of the skin where the medication is applied.

Remove the cream and get medical help right away if any of these rare but very serious side effects occur: slow/shallow breathing, pale/bluish skin around the mouth/lips, dizziness, fainting, fast/slow/irregular heartbeat, mental/mood changes (e.g., confusion, nervousness), seizures, severe drowsiness.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before using this product, tell your doctor or pharmacist if you are allergic to lidocaine or prilocaine; or to any other amide anesthetics (e.g., bupivacaine); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: certain blood disorder (methemoglobinemia).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: certain blood disorder (G6PD deficiency, especially in children), heart disease (e.g., irregular heartbeat), kidney disease, liver disease.

Caution is advised when using this drug in the elderly because they may be more sensitive to the effects of the drug, especially the dizziness effect.

Caution is advised when using this drug in children, especially if your child is younger than 3 months or small for their age. These children are at greater risk for a certain rare blood problem (methemoglobinemia). Contact the doctor immediately in the unlikely event your child has symptoms such as pale/bluish skin around the mouth/lips or fast heartbeat. The risk for serious side effects (including methemoglobinemia) is increased if this medication is applied over too large an area at one time in young children.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding.


Emla Patient Information Including Side Effects

Brand Names: Emla

Generic Name: lidocaine and prilocaine topical (Pronunciation: LY doh kayn and PRIL oh kayn TOP ik al)

  • What is lidocaine and prilocaine topical (Emla)?
  • What are the possible side effects of lidocaine and prilocaine topical (Emla)?
  • What is the most important information I should know about lidocaine and prilocaine (Emla)?
  • What should I discuss with my health care provider before using lidocaine and prilocaine topical (Emla)?
  • How should I use lidocaine and prilocaine topical (Emla)?
  • What happens if I miss a dose (Emla)?
  • What happens if I overdose (Emla)?
  • What should I avoid while taking lidocaine and prilocaine topical (Emla)?
  • What other drugs will affect lidocaine and prilocaine topical (Emla)?
  • Where can I get more information?

What is lidocaine and prilocaine topical (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.

What are the possible side effects of lidocaine and prilocaine topical (Emla)?

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

Stop using lidocaine and prilocaine topical and call your doctor at once if you have any of these serious side effects:

  • severe burning, stinging, or sensitivity where the medicine is applied;
  • swelling or redness;
  • sudden dizziness or sleepiness after medicine is applied;
  • bruising or purple appearance of the skin; or
  • unusual sensations of temperature.

Less serious side effects may include:

  • mild burning where the medicine is applied;
  • skin redness; 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.

What is the most important information I should know about lidocaine and prilocaine (Emla)?

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

Your body may absorb more of this medication 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.

Use the smallest amount of this medication needed to numb the skin or relieve pain. Do not use large amounts of lidocaine and prilocaine topical, or cover treated skin areas with a bandage or plastic wrap without medical advice. Be aware that many cosmetic procedures are performed without a medical doctor present.

Do not use lidocaine and prilocaine topical if you have had an allergic reaction to a numbing medicine in the past.

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.

Lidocaine and prilocaine topical is for use only on the surface of your body. Avoid getting this medication in your eyes.

Avoid accidentally injuring treated skin areas while they are numb. Avoid coming into contact with very hot or very cold surfaces.

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