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Emla

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Emla

Emla

Emla Side Effects Center

Medical Editor: Charles Patrick Davis, MD, PhD

Emla (lidocaine 2.5% and prilocaine 2.5%) Cream is a drug used as a topical anesthetic for use on normal intact skin for local analgesia of intact skin and to prevent pain associated with IV cannulation, needle insertion, and superficial surgery on skin and genital mucosous membranes.. Some side effects include but are not limited to mild burning or changes in skin color where Emla is applied, or skin redness.

Emla contains 25 mg each of lidocane and prilocane per gram. For application and dosing information foror adult and pediatric patients; apply only as prescribed by the physician. Emla should be used with caution in patients receiving Class 1 antiarrhythmic drugs (Tonocard [tocainide] and Mexitil [mexiletine]) since the toxic effects are additive and potentially synergistic. There are no adequate and well controlled studies in pregnant women. Emla should be used during pregnancy only if clearly needed. Lidocaine and prilocaine are excreted in human milk. Caution should be exercised when Emla is administered to a nursing mother.

Our Emla (lidocaine 2.5% and prilocaine 2.5%) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

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 Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Emla in Detail - Patient Information: Side Effects

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.

Read the entire detailed patient monograph for Emla (Lidocaine and Prilocaine) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Emla Overview - Patient Information: Side Effects

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.

Read the entire patient information overview for Emla (Lidocaine and Prilocaine)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Emla FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

Localized Reactions: During or immediately after treatment with EMLA (lidocaine and prilocaine) Cream on intact skin, the skin at the site of treatment may develop erythema or edema or may be the locus of abnormal sensation. Rare cases of discrete purpuric or petechial reactions at the application site have been reported. Rare cases of hyperpigmentation following the use of EMLA (lidocaine and prilocaine) Cream have been reported. The relationship to EMLA (lidocaine and prilocaine) Cream or the underlying procedure has not been established. In clinical studies on intact skin involving over 1,300 EMLA (lidocaine and prilocaine) Cream-treated subjects, one or more such local reactions were noted in 56% of patients, and were generally mild and transient, resolving spontaneously within 1 or 2 hours. There were no serious reactions that were ascribed to EMLA (lidocaine and prilocaine) Cream.

Two recent reports describe blistering on the foreskin in neonates about to undergo circumcision. Both neonates received 1.0 g of EMLA (lidocaine and prilocaine) Cream.

In patients treated with EMLA (lidocaine and prilocaine) Cream on intact skin, local effects observed in the trials included: paleness (pallor or blanching) 37%, redness (erythema) 30%, alterations in temperature sensations 7%, edema 6%, itching 2% and rash, less than 1%.

In clinical studies on genital mucous membranes involving 378 EMLA (lidocaine and prilocaine) Cream-treated patients, one or more application site reactions, usually mild and transient, were noted in 41% of patients. The most common application site reactions were redness (21%), burning sensation (17%) and edema (10%).

Allergic Reactions: Allergic and anaphylactoid reactions associated with lidocaine or prilocaine can occur. They are characterized by urticaria, angioedema, bronchospasm, and shock. If they occur they should be managed by conventional means. The detection of sensitivity by skin testing is of doubtful value.

Systemic (Dose Related) Reactions: Systemic adverse reactions following appropriate use of EMLA (lidocaine and prilocaine) Cream are unlikely due to the small dose absorbed (see Pharmacokinetics subsection of CLINICAL PHARMACOLOGY). Systemic adverse effects of lidocaine and/or prilocaine are similar in nature to those observed with other amide local anesthetic agents including CNS excitation and/or depression (light-headedness, nervousness, apprehension, euphoria, confusion, dizziness, drowsiness, tinnitus, blurred or double vision, vomiting, sensations of heat, cold or numbness, twitching, tremors, convulsions, unconsciousness, respiratory depression and arrest). Excitatory CNS reactions may be brief or not occur at all, in which case the first manifestation may be drowsiness merging into unconsciousness. Cardiovascular manifestations may include bradycardia, hypotension and cardiovascular collapse leading to arrest.

Read the entire FDA prescribing information for Emla (Lidocaine and Prilocaine) »

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Emla - User Reviews

Emla User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Emla sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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