Consumer medicine information

EMLA®; Eutectic Mixture of Local Anaesthetics

Lidocaine (lignocaine); Prilocaine

BRAND INFORMATION

Brand name

EMLA Cream

Active ingredient

Lidocaine (lignocaine); Prilocaine

Schedule

S2

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using EMLA®; Eutectic Mixture of Local Anaesthetics.

What is in this leaflet

This leaflet answers some common questions about EMLA. It does not contain all the available information that is known about EMLA. It does not take the place of talking to your doctor or pharmacist.

All medicines have risks and benefits. Your doctor has weighed the risks of you or your child using EMLA against the benefits they expect it will have for you.

If you have any concerns about taking this medicine, ask your doctor or pharmacist.

Keep this leaflet with the medicine.

You may need to read it again.

What EMLA is used for

EMLA is a mixture of two local anaesthetics, lignocaine and prilocaine.

These local anaesthetics are combined with special agents which allow the products to pass through the skin. Once through the skin the numbing effect they produce allows minor surgical procedures to be performed with a complete or significant reduction in pain.

These procedures can include taking blood samples, vaccination, skin grafting, cleaning leg ulcers, inserting an intravenous catheter, minor superficial cosmetic procedures and procedures on genital skin.

EMLA is available as a cream which is applied then covered with a dressing, or as a patch, which has the cream and dressing already to use.

Follow all directions given to you by your doctor carefully. They may differ from the information contained in this leaflet.

Your doctor or pharmacist may prescribe this medicine for another use. Ask your doctor or pharmacist if you want more information.

EMLA is not addictive.

Before you use EMLA

When you must not use it

Do not apply EMLA cream to any open wounds except leg ulcers.

Do not use EMLA if you are pregnant or breastfeeding unless your doctor says it is safe.

The ingredients in EMLA have been used for many years and no ill effects have been shown if they are used while you are pregnant.
Only very small amounts of EMLA get into the blood so even though your baby can take in EMLA from breast milk if you are breastfeeding, it is unlikely to cause any problems.

Ask your doctor about the risks and benefits of using this medicine while you are pregnant or breastfeeding.

EMLA should not be used in premature babies.

We do not have enough knowledge yet to be sure it is safe in premature babies.

Do not use after the use by (expiry) date printed on the pack or the packaging is torn or shows signs of tampering.

If it has expired or is damaged, return it to your pharmacist for disposal.

Do not use it to treat any other complaints unless your doctor says it is safe.

Do not give this medicine to anyone else.

Before you start to use it

You must tell your doctor or pharmacist about any of these:

  1. allergies you or your child have to any
  • ingredients listed at the end of this leaflet
  • local anaesthetic, for example those used at the dentist
  • adhesives or sticking plasters.
    If you or your child have an allergic reaction, you may get a skin rash, hay fever or an asthma attack.
  1. any of these medical conditions
  • dermatitis
  • methaemoglobinaemia
  • glucose-6-phosphate dehydrogenase deficiency
  • mollusca contagiosa.

It may not be safe for you or your child to use EMLA if you have any of these conditions.

Taking other medicines

Tell your doctor or pharmacist if you are taking any other medicines, including

  • a sulphonamide antibiotic eg sulfatrimoxazole
  • medicines used to treat irregular heartbeat such as amiodarone
  • medicines that you buy at your pharmacy, supermarket or health food shop
  • other local anaesthetics.

These medicines may affect the way EMLA works or may cause adverse effects.

Your doctor or pharmacist can tell you what to do if you are taking any of these medicines.

How to use EMLA

How to use it

EMLA is available as a cream or a patch.

Instructions on how to use it are included in the box. Please read them carefully. The instructions also give maximum doses for adults and children. Do not exceed the maximum doses.

On intact skin
The most important thing to do is to be sure that you apply EMLA at least one hour before you are due to have the procedure except for skin grafting where a two hour application time is required or for procedures on male genital skin where only fifteen minutes is required.

Leg ulcers
If you are using EMLA on leg ulcers you only need to apply the cream 30 minutes before your ulcer is going to be cleaned.

EMLA can be left on for several hours and still work.

If you forget to use it

Apply EMLA as soon as you realise it if it is less than an hour until you are supposed to have the procedure. Tell your doctor exactly when you put EMLA on and they will decide when the procedure can take place.

If you have trouble remembering when to use your medicine, ask your pharmacist for some hints.

If you take too much (overdose)

Telephone your doctor or Poisons Information Centre (13 11 26), or go to Accident and Emergency at your nearest hospital immediately if you think that you or anyone else may have used too much EMLA even if there are no signs of discomfort or poisoning.

For most procedures, it is very difficult to use too much EMLA. Be careful not to use too much in procedures where larger amounts may be required, such as cosmetic hair removal (see Package Insert for maximum amounts). Using too much EMLA may cause unwanted side effects. Some of these can be serious, such as methaemoglobinaemia (a condition where the blood cannot take enough oxygen to your body) or cardiovascular effects (effects on your heart and lungs). If you use too much EMLA, you may notice the following:

  • nervousness
  • dizziness
  • difficulty breathing
  • numbness of the mouth
  • your skin turning blue (a symptom of methaemoglobinaemia)
  • blurred vision
  • shaky hands
  • a rash where EMLA has not been applied.

While you are using EMLA

Things you must do

Remember to apply EMLA on intact skin at least one hour before your procedure is due. For leg ulcers remember to apply EMLA 30 minutes before your ulcer is due to be cleaned. Apply EMLA two hours before split skin grafting and at least fifteen minutes before a procedure on male genital skin.

If you do not, your or your child's appointment may have to be delayed, or the procedure may hurt more than it would otherwise.

If you or your child are using EMLA on leg ulcers, only use the tube once. Throw out any cream left in the tube after use.

Things to be careful of

Do not use EMLA cream on leg ulcers for longer than 2 months without checking with your doctor or pharmacist.

Be sure to follow the instructions in the pack on how to apply EMLA cream or patch carefully.

Make sure the patch or the dressing covering the cream is firmly fixed, especially on young children.

If EMLA is not covered carefully it may not work effectively.

Be careful not to let EMLA get into the eyes.

It may cause eye irritation. If EMLA does get into your eyes, immediately rinse them with large amounts of water and contact your doctor or pharmacist for advice.

Side effects

Tell your doctor or pharmacist as soon as possible if you or your child do not feel well while using EMLA.

EMLA helps most people to undergo minor procedures without feeling pain, but it may have unwanted side-effects in a few people. All medicines can have side effects. Sometimes they are serious, most of the time they are not.

You may need medical treatment if you or your child get some of the side effects.

Ask your doctor or pharmacist to answer any questions you may have.

Tell your doctor or pharmacist if you notice any of the following and they worry you:

  • any local reaction such as itching, swelling, paleness, redness or a burning sensation.

These are all mild side effects of EMLA.

If any of the following happen, remove EMLA and tell your doctor immediately or go to casualty at your nearest hospital.

  • a rash at a spot where EMLA is not being used
  • difficulty breathing
  • dizziness
  • shaky hands
  • blurred vision
  • areas of skin becoming blue

These are very serious side effects. If you or your child have them, you or your child may have had a serious reaction to EMLA and urgent medical attention or hospitalisation may be required.

All of these side effects are very rare.

Tell your doctor or pharmacist if you notice anything else that is making you or your child feel unwell.

Some people may get other side effects while using EMLA.

After using EMLA

Storage

Keep your cream or patches in the pack until it is time to use them.

If you squeeze EMLA out of the tube or open the patches it will not keep well.

Keep EMLA cream in a cool dry place where the temperature stays below 30°C. Do not let it freeze.

Keep EMLA patches in a cool dry place where the temperature stays below 25°C. Do not let them freeze.

Do not store EMLA or any other medicine in the bathroom or near a sink. Do not leave it on a window sill or in the car.

Heat and dampness can destroy some medicines.

Keep it where young children cannot reach it.

A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.

Disposal

Ask your pharmacist what to do with any EMLA you have left over if your doctor tells you to stop using it, or you find that it has expired.

Product description

EMLA Cream and Patch contain as the active ingredients:

  • lignocaine 25 mg/g and
  • prilocaine 25 mg/g

Plus,

  • carbomer 934P
  • polyoxyethylene
  • castor oil - ethoxylated
  • hydrogenated sodium hydroxide

EMLA Cream

  • 5 x 5 g tubes (with 10 dressings)
  • 1 x 5 g tube (with 2 dressings)
  • or 30 g tube.

EMLA Patch
packs of 2 or 20 patches.

Manufacturer

AstraZeneca Pty Ltd
ABN 54 009 682 311
Alma Road
NORTH RYDE NSW 2113

This leaflet was prepared in Feb 2013.

Australian Registration Number (ARTG)

  • EMLA Cream
    1 or 5 x 5 g - 12046
    30 g - 12886
  • EMLA Patch - 60820

® Trade Marks herein are the property of the AstraZeneca group.

BRAND INFORMATION

Brand name

EMLA Cream

Active ingredient

Lidocaine (lignocaine); Prilocaine

Schedule

S2

 

Name of the medicine

Lidocaine (lignocaine) 25 mg/g, prilocaine 25 mg/g.

Excipients.

Carbomer 934P, polyoxyethylene hydrogenated castor oil, sodium hydroxide to a pH of approximately 9.2, purified water; nonsterile, preservative free.

Description

EMLA (Eutectic Mixture of Local Anaesthetics) is a 1:1 oil/water emulsion of an eutectic mixture of lidocaine (lignocaine) and prilocaine.
Lidocaine is the new medicine ingredient name for lignocaine and is mostly used in this product information.

Lidocaine.

Molecular formula: C14H22N2O. MW: 234.3. CAS: 137-58-6.

Prilocaine.

Molecular formula: C13H20N2O. MW: 220.3. CAS: 721-50-6.
When lidocaine and prilocaine are mixed in equal amounts, the solid pure bases of lidocaine and prilocaine form an oil at temperatures above 16°C (i.e. a eutectic mixture). By avoiding the need for a nonaqueous solvent, higher concentrations of local anaesthetic in the cream can be achieved and maintained during application.
EMLA Cream 5% contains in 1 g lidocaine 25 mg, prilocaine 25 mg as the active ingredients; and carbomer 934P, polyoxyethylene hydrogenated castor oil, sodium hydroxide to a pH of approximately 9.2 and purified water to 1 g.
EMLA Patch 5% is a single dose unit in the form of an occlusive dressing. It is composed of a laminate backing, an absorbent cellulose disc and an adhesive tape ring. The disc provides a contact area of approximately 10 cm2 and contains 1 g of EMLA emulsion. Each 1 g of EMLA emulsion contains lidocaine 25 mg and prilocaine 25 mg as active ingredients, and excipients as for EMLA cream 5%. The emulsion contains a lower concentration of the thickening agent, carbomer 934P.
EMLA is non-sterile and does not contain preservatives.

Pharmacology

Lidocaine and prilocaine are both amide type local anaesthetic agents. Both agents stabilise the neuronal membrane preventing the initiation and conduction of nerve impulses thereby effecting local anaesthetic action.
EMLA provides dermal anaesthesia. The depth and quality of anaesthesia depends upon the application time and the applied dose.
Local anaesthesia with EMLA is achieved after 60 minutes application. EMLA should be applied as EMLA patch; or EMLA cream should be applied under an occlusive, impermeable dressing. Following the application of EMLA cream for 1-2 hours, the duration of anaesthesia is at least 2 hours after removal of the occlusive dressing.
Reliable anaesthesia for the cleansing of leg ulcers is achieved after an application time of 30 minutes in most patients. An application time of 60 minutes may improve the anaesthesia. The cleansing procedure should start within 10 minutes of removal of the cream. There is no clinical data regarding cleaning started after 10 minutes of cream removal.
A reduced number of cleansing sessions are required to achieve a clean ulcer when EMLA is used compared to a placebo.
No negative effects on ulcer healing or bacterial flora have been observed when EMLA has been used.
EMLA may cause transient local peripheral vasoconstriction or vasodilation, observed as transient paleness or redness, at the treated area.

Pharmacokinetics.

Systemic absorption and anaesthetic efficacy of lidocaine and prilocaine from EMLA is dependent upon the characteristics of the leg ulcer, the applied dose, total application area, application time, thickness of the skin (which varies between different areas of the body), other conditions such as skin diseases, and shaving.

Intact skin.

The extent of systemic absorption was approximately 10% following application to the face (10 g/100 cm2 for 2 hours). Maximum plasma levels (mean 0.16 and 0.06 microgram/mL of lidocaine and prilocaine, respectively) were reached after approximately 2.5 hours.
After application to the thigh in adults (60 g cream/400 cm2 for 3 hours) the extent of absorption was approximately 5% of lidocaine and prilocaine. Maximum plasma concentrations (mean 0.12 and 0.07 microgram/mL) were reached approximately 2-6 hours after the application.
In adults, a thick layer of EMLA Cream 5% (corresponding to approximately 150 g) has been applied to intact skin areas of up to 1,300 cm2 for application times of up to 7 hours. The highest individual plasma levels observed to date were 1.1 microgram/mL lidocaine and 0.2 microgram/mL prilocaine. These levels were below those at which symptoms of toxicity would be expected to occur (5-10 microgram/mL of either agent; see also Adverse Effects).

Leg ulcers.

Following a single application for 30 minutes of 5 to 10 g of EMLA cream to leg ulcers, the maximum plasma levels of lidocaine (range 0.05-0.25 microgram/mL, one individual value of 0.84 microgram/mL) and of prilocaine (0.02-0.08 microgram/mL) were reached within 1-2.5 hours.
After an application time of 24 hours the maximum plasma levels of lidocaine (0.19-0.71 microgram/mL) and of prilocaine (0.06-0.28 microgram/mL) were usually reached within 2-4 hours.
Following repeated applications for 30-60 minutes of 2-10 g EMLA cream 3-7 times a week for up to 15 doses, during a period of one month, there was no apparent accumulation in plasma of lidocaine and its metabolites monoglycinexylidide and 2,6-xylidine or of prilocaine and its metabolite ortho-toluidine. The maximum observed plasma levels for lidocaine, monoglycinexylidide and 2,6-xylidine were 0.41, 0.03 and 0.01 microgram/mL respectively. The maximum observed plasma levels for prilocaine and ortho-toluidine were 0.08 and 0.01 microgram/mL respectively.

Children.

Following the application of 1.0 g of EMLA cream in neonates below 3 months of age, to approximately 10 cm2 for one hour, the maximum plasma concentrations of lidocaine and prilocaine were 0.135 microgram/mL and 0.107 microgram/mL, respectively.
Following the application of 2.0 g of EMLA cream in infants between 3 and 12 months of age, to approximately 16 cm2 for four hours, the maximum plasma concentrations of lidocaine and prilocaine were 0.155 microgram/mL and 0.131 microgram/mL, respectively.
Following the application of 10.0 g of EMLA cream in children between 2 and 3 years of age, to approximately 100 cm2 for two hours, the maximum plasma concentrations of lidocaine and prilocaine were 0.315 microgram/mL and 0.215 microgram/mL, respectively.
Following the application of 10.0-16.0 g of EMLA cream in children between 6 and 8 years of age, to approximately 100-160 cm2 for two hours, the maximum plasma concentrations of lidocaine and prilocaine were 0.299 microgram/mL and 0.110 microgram/mL, respectively.

Clinical Trials

In clinical trials, venepuncture or venous catheterisation was pain free in 50-59% patients, slightly painful in 35-40% and painful in 3-6%. Anaesthesia may be less for skin structures below the deep fascia.
In clinical trials in adults assessing pain associated with intramuscular influenza vaccination and intramuscular and subcutaneous injections of saline solution, EMLA significantly reduced injection pain relative to placebo.
In clinical trials in infants and children assessing pain associated with subcutaneous and intramuscular vaccination, EMLA significantly reduced injection pain behaviours and pain scores relative to placebo.
In clinical trials assessing the effects of EMLA on intramuscular and subcutaneous, live and nonlive vaccines, it was demonstrated that EMLA does not adversely affect antibody response. A clinical trial assessing the effect of EMLA application prior to intracutaneous BCG injection demonstrated that EMLA did not affect the immunisation response.

Indications

EMLA Cream and EMLA Patch.

Topical anaesthesia of the skin prior to insertion of i.v. catheters, blood sampling; vaccination; superficial surgical procedures, including split skin grafting.

EMLA Cream.

Topical anaesthesia of leg ulcers to facilitate mechanical cleansing or debridement.
Topical anaesthesia of genital skin prior to superficial surgical procedures or infiltration anaesthesia.
Topical anaesthesia of the skin prior to minor superficial cosmetic procedures.

Contraindications

Hypersensitivity to prilocaine, lidocaine or any local anaesthetics of the amide type.
Hypersensitivity to any of the excipients of EMLA cream or emulsion, or to the adhesive used in the patch.
Glucose-6-phosphate dehydrogenase deficiency or congenital or idiopathic methaemoglobinaemia.

Precautions

1. Open wounds.

EMLA should not be applied to open wounds other than leg ulcers due to insufficient data on absorption from these sites.

2. Atopic dermatitis.

Care should be taken when applying EMLA to skin areas with atopic dermatitis. A shorter application time (15-30 minutes) may be sufficient.

3. Eyes.

EMLA should not be applied to or near to the eyes since it causes corneal irritation. Damage to the eye may also occur from undetected foreign bodies. Special care should be employed to reduce the risk of rubbing the eyes with EMLA. It is therefore important that the patch or occlusive dressing should be secured against accidental dislocation, especially in young children.

4. Middle ear.

EMLA is not recommended in any clinical situation in which its penetration into the middle ear is possible. In studies in rodents (guinea pigs), EMLA was found to have an ototoxic effect when instilled directly into the middle ear, however no abnormalities were observed when EMLA was applied to the animals' external auditory canal. EMLA cream 5% caused minor structural damage to the tympanic membrane in rats when applied directly to the membrane. The relevance of these findings to the clinical situation is unknown.

5. Genital mucosa.

EMLA is presently not recommended for use on genital mucosa. Available data suggest that the anaesthetic efficacy of EMLA on genital mucosa may be variable.

6. Application of EMLA patch 5%.

Care should be taken that the patch does not become detached (especially in young children) during the 60 minute wait. The possibility that this may occur can be reduced if the patch is applied to the nondominant hand, or lightly bandaged if applied to the antecubital fossa to protect it from lifting if rubbed by clothing.

7. Paediatric use.

Until further clinical data are available, EMLA should not be used in infants between 0 and 12 months of age receiving treatment with methaemoglobin-inducing agents such as sulphonamides (see also Overdosage) or in preterm infants with a gestational age less than 37 weeks.
Studies have been unable to demonstrate the efficacy of EMLA for heel lancing in neonates.
EMLA should not be applied to the genital mucosa of children owing to insufficient data on absorption. However, when used in neonates for circumcision (genital skin), a dose of 1.0 g EMLA on the prepuce has proven to be safe.
In children/neonates younger than 3 months of age, a transient increase in methaemoglobin is commonly observed up to 12 hours after an application of EMLA. Caution is required in those at risk of tissue hypoxia, e.g. those with anaemia, respiratory and/or cardiac conditions. Prolonged exposure, e.g. greater than 60 minutes application, significantly increases the risk of methaemoglobinaemia. Repeated applications of EMLA in neonates and infants have not been studied and should be avoided.

8. Vaccination.

Lidocaine and prilocaine have bactericidal and antiviral properties in concentrations above 0.5-2%. A clinical trial with MMR vaccine administered subcutaneously demonstrated that EMLA does not adversely affect antibody response. There are no data on effects of EMLA on other live viral vaccines administered subcutaneously. When EMLA is used prior to intradermal BCG vaccination, the results of vaccination should be monitored.

9. Antiarrhythmic drugs class III.

Patients treated with antiarrhythmic drugs class III (e.g. amiodarone) should be kept under close surveillance and ECG monitoring considered, since cardiac effects may be additive.

10. Drugs reducing clearance of lidocaine.

Drugs that reduce the clearance of lidocaine (for example, cimetidine or betablockers) may cause potentially toxic plasma concentrations when lidocaine (e.g. EMLA) is given in repeated high doses over a long time period. Such interactions should therefore be of no clinical importance following short term treatment with lignocaine (e.g. EMLA) at recommended doses.

Carcinogenic and mutagenic potential.

Genotoxicity tests with lidocaine are inconclusive. In genotoxicity studies, a metabolite of lidocaine, 2,6 xylidine, showed evidence of activity in some tests but not in other tests. This metabolite has been shown to have carcinogenic potential (nasal and subcutaneous tumours) in preclinical toxicological studies evaluating chronic exposure. A metabolite of prilocaine, o-toluidine, has also shown evidence of mutagenic activity in some genotoxicity tests but not others. o-toluidine has also been shown to have carcinogenic potential (e.g. renal, bladder, spleen, subcutaneous tumours) in preclinical toxicological studies.

Use in pregnancy.

(Category A)
Although the safety of EMLA during pregnancy has not been established in animal reproductive toxicology studies, lidocaine and prilocaine have been used by a large number of pregnant women and women of childbearing age without an increased incidence of malformations or other direct or indirect harmful effects on the foetus having been observed.

Use in lactation.

No information is available on the excretion of lidocaine, prilocaine or their metabolites into breast milk following the administration of EMLA.
Following parenteral administration, lidocaine is excreted into breast milk. Because of low maternal systemic absorption following application of recommended doses of EMLA, the amount of lidocaine and prilocaine that may be ingested by the breastfed infant would be extremely small.

Interactions

1. Methaemaglobinaemia-inducing agents.

EMLA may accentuate the formation of methaemoglobin in patients treated with other drugs known to induce methaemaglobinaemia (e.g. sulphonamides).

2. Other local anaesthetic agents.

With large doses of EMLA, the risk of additional systemic toxicity should be considered in patients receiving other local anaesthetics or agents structurally related to local anaesthetics e.g. mexiletine.

3. Anti-arrhythmic drugs class III.

Specific interaction studies with lidocaine and anti-arrhythmic drugs class III (e.g. amiodarone) have not been performed, but caution is advised.

4. Drugs reducing clearance of lidocaine.

Drugs that reduce the clearance of lidocaine (for example, cimetidine or betablockers) may cause potentially toxic plasma concentrations when lidocaine (e.g. EMLA) is given in repeated high doses over a long time period. Such interactions should therefore be of no clinical importance following short term treatment with lidocaine (e.g. EMLA) at recommended doses.

Adverse Effects

Frequency of adverse events.

Intact skin.

Common events (≥ 1% and < 10%).

Skin.

Transient local reactions at the application site such as paleness, erythema (redness) and oedema.

Uncommon events (≥ 0.1% and < 1%).

Skin.

Skin sensations (an initial, usually mild burning sensation, itch or warmth at the application site).

Rare events (< 0.1%).

General.

In rare cases local anaesthetic preparations have been associated with allergic reactions, in the most severe instances anaphylactic shock.
Rare cases of discrete local lesions at the application site, described as purpuric or petechial, have been reported, especially after longer application times in children with atopic dermatitis or mollusca contagiosa.
Increased methaemoglobin level.
Methaemoglobinaemia and/or cyanosis.
Corneal irritation after accidental eye exposure.

Leg ulcer.

Common events (≥ 1% and < 10%).

Skin.

Transient local reactions at the application site such as paleness, erythema (redness) and oedema.
Skin sensations (an initial, usually mild burning sensation, itch or warmth at the application site).

Uncommon events (≥ 0.1% and < 1%).

Skin.

Skin irritation at the application site.

Rare events (< 0.1%).

General.

In rare cases, local anaesthetic preparations have been associated with allergic reactions (in the most severe instances anaphylactic shock).

Dosage and Administration

In order to avoid cross contamination, infection control procedures and principles should be strictly adhered to during application of EMLA.
Pharmacokinetic data for application longer than 4 hours is not available in children. In adults, there is no benefit in application times longer than 5 hours, as the analgesic effectiveness of the cream dissipates over time.

Use in the elderly.

No dosage adjustment is required when EMLA is applied to intact skin in the elderly.

Use in premature infants.

Use in premature infants with a gestational age of less than 37 weeks is not recommended (see Precautions).

EMLA Cream 5%.

The protective membrane of the tube is perforated by reversing the cap and piercing the membrane. When used on leg ulcers discard the tube with any remaining EMLA after each occasion that a patient is treated.
See Table 1 for dosing instructions.
A 1 g dose of EMLA cream is achieved by squeezing EMLA from the tube into a circular area with diameter of approximately 20 mm (the size of a 2 dollar coin) to a depth of approximately 4 mm. Keep the tube in close contact with the skin until the correct amount has been applied.
A 1 g dose of EMLA cream can also be achieved by squeezing a length of EMLA of approximately 3.5 cm from the tube.

EMLA Patch 5%.

Maximum doses.

Neonates and infants up to 3 months old should not have more than 1 patch applied at the same time.
Infants aged 3 months up to 12 months old should not have more than 2 patches applied at the same time.
Children aged 1 year up to 12 years old should not have more than 5 patches applied at the same time.

Minor procedures (e.g. needle insertion).

The patch is applied to the skin area selected. Care should be taken that the patch does not become detached during the minimum application time of 60 minutes (see Precautions).
The EMLA patch should be applied at least 1 hour prior to the start of the procedure.

Overdosage

In the event of an overdose, contact the Poisons Information Centre on 13 11 26.
Rare cases of methaemoglobinaemia have been reported.
Prilocaine in high doses may cause an increase in the methaemoglobin level particularly in conjunction with methaemoglobin inducing agents (e.g. sulphonamides). Clinically significant methaemoglobinaemia should be treated with a slow intravenous injection of methylene blue.
In the unlikely event of systemic toxicity following epidermal application of EMLA, the signs and symptoms anticipated would be similar in nature to those observed following other routes of administration of local anaesthetics. Owing to slow absorption into the circulation from intact skin, a patient with signs of toxicity should be observed for several hours after treatment.
Systemic toxicity to amide type local anaesthetics is initially manifested as CNS excitation and may result in a slow onset of nervousness, dizziness, blurred vision and tremors followed by drowsiness, convulsions, unconsciousness and possibly respiratory arrest.
Toxic cardiovascular reactions to local anaesthetics are usually depressant in nature, may occur rapidly and with little warning and can lead to peripheral vasodilation, hypotension, myocardial depression, bradycardia and possible cardiac arrest. Severe neurological symptoms (convulsions, CNS depression) must be treated symptomatically by respiratory support and the administration of anticonvulsive drugs.

Presentation

EMLA cream 5%.

Containing lidocaine 25 mg and prilocaine 25 mg per gram.
5 g tubes in packs of 5 with 10 occlusive dressings or packs of 1 with 2 occlusive dressings.
5g and 30 g tube.

EMLA patch 5%.

Patches containing 1 g of EMLA emulsion in packs of 2 or 20.

Storage

EMLA cream 5%.

Store below 30°C.

EMLA patch 5%.

Store below 25°C.

Poison Schedule

S2.