Drug Class Description

Generic Name

Drug Description

Presentation

Indications

Adult Dosage

Paediatric population

Adolescents 12 years:

As for adults (approximately 2 g EMLA applied under an occlusive dressing for a minimum of 60 minutes, maximum 5 hours).

Term newborn infants, infants and children 11 years:

For dose, application area, application time and dose interval by age and weight see Table 2 below.

Table 2: Dose, application time and dose interval by age and weight

In term newborn infants and infants < 3 months, only one single dose should be applied in any 24 hour period.

For children aged 3 months and above, a maximum of 2 doses, separated by at least 12 hours can be given within any 24 hour period. If, based on clinical need, a decision is nevertheless taken to use two applications in children under the age of 3 months.

The safety of EMLA in pre-term newborn infants has not been established. Use of EMLA is not recommended in pre-term infants.

Use of EMLA is not recommended in infants less than 12 months of age receiving treatment with methaemoglobin-inducing drugs.

Prior to curettage of mollusca in children with atopic dermatitis, an application time of 30 minutes is recommended.

For all age groups analgesic efficacy may decline if the skin application time is more than 5 hours. Procedures on intact skin should begin soon after the occlusive dressing is removed.

On the genital mucosa analgesic efficacy declines after 10-15 minutes and therefore the procedure should be commenced immediately.

Methods of dose estimation

EMLA is available in 5 g and 30 g tubes. To dispense 1 g of EMLA from either tube size, apply the cream to a circular area with a diameter of approx. 18 mm (a 1 pence coin) and depth of approx. 4 to 5 mm.

If high levels of accuracy in dosing are required to prevent overdose (i.e. at doses approaching the maximum in neonates or if two applications may be required in a 24 h period), a syringe can be used where 1 ml = 1 g.

A string of cream can be used to define the quantity of EMLA administered from the 30 g tube where 1 g = 3.5 cm; however, a string of cream may not be appropriate for all application needs, e.g. when administering a low dose to small surface areas.

Child Dosage

Contra Indications

Known hypersensitivity to anaesthetics of the amide type or to any other component of the product.

Special Precautions

EMLA should not be used in the following cases:

(a) in pre-term neonates i.e. gestational age less than 37 weeks.

(b) in infants/neonates between 0 and 12 months of age receiving treatment with methaemoglobin-inducing agents due to the possible additive effects.

In infants/neonates younger than 12 months a transient, clinically insignificant increase in methaemoglobin level is commonly observed up to 12 hours after an application of EMLA.

Patients with glucose-6-phosphate dehydrogenase deficiency or congenital or idiopathic methaemoglobinaemia are more susceptible to drug induced methaemoglobinaemia.

In term newborn infants, infants and children, EMLA should only be used on intact skin and should not be applied to genital mucosa.

In term neonates and infants < 3 months, only one single dose should be applied in any 24 hour period. If, based on clinical need, a decision is nevertheless taken to use two applications in children under the age of 3 months, the child should be clinically monitored for systemic adverse reactions.

Consideration should be given to the fact that pulse oximeter values may overestimate the actual oxygen saturation in case of increased methaemoglobin fraction; therefore, in cases of suspected methaemoglobinaemia, it may be more helpful to monitor oxygen saturation by co-oximetry.

Care must be taken to limit the dose and area of application and to prevent accidental ingestion.

Due to insufficient data on absorption, EMLA should not be applied to open wounds.

Care should be taken when applying EMLA to patients with atopic dermatitis. A shorter application time, 15-30 minutes, may be sufficient. Prior to curettage of mollusca in children with atopic dermatitis, an application time of 30 minutes is recommended.

Care should be taken not to allow EMLA to come in contact with the eyes as it may cause eye irritation. Also the loss of protective reflexes may allow corneal irritation and potential abrasion. If contact with the eye occurs, immediately rinse the eye with water or sodium chloride solution and protect it until sensation returns.

EMLA, like other local anaesthetics may be ototoxic and should not be instilled in the middle ear nor should it be used for procedures which might allow penetration into the middle ear.

Although the systemic availability of prilocaine by percutaneous absorption of EMLA is low, caution should be exercised in patients with anaemia, congenital or acquired methaemoglobinaemia or patients on concomitant therapy known to produce such conditions.

Patients treated with anti-arrhythmic drugs class III (eg, amiodarone) should be under close surveillance and ECG monitoring considered, since cardiac effects may be additive.

Lidocaine and prilocaine have bacteriocidal and antiviral properties in concentrations above 0.5 – 2%. For this reason, although one clinical study suggests that the immunization response is not affected when EMLA Cream is used prior to BCG vaccination, the results of intracutaneous injections of live vaccines should be monitored.

Interactions

Methaemoglobinaemia may be accentuated in patients already taking drugs known to induce the condition, e.g. sulphonamides, acetanilid, aniline dyes, benzocaine, chloroquine, dapsone, metoclopramide, naphthalene, nitrates and nitrites, nitrofurantoin, nitroglycerin, nitroprusside, pamaquine, para-aminosalicylic acid, phenacetin, phenobarbital, phenytoin, primaquine, quinine.

The risk of additional systemic toxicity should be considered when large doses of EMLA are applied to patients already using other local anaesthetics or structurally related drugs e.g. class I anti-arrhythmics such as mexiletine.

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

Adverse Reactions

Transient local reactions at the application site, most commonly erythema, paleness and/or oedema, may occur in >1% of patients treated with EMLA. Other types of reactions, such as allergic reactions or methaemoglobinaemia, occur in <0.1% of patients.

Paediatric population

In clinical trials 298 neonates and infants aged up to 12 months were treated with EMLA (Table 3). A large number of infants and children aged 1 year and older have been treated with EMLA in clinical trials and in clinical practice since 1984.

Table 3. Number of paediatric patients, up to 12 months old, included in clinical studies with EMLA, by age group

Frequency, type and severity of adverse reactions are similar in the paediatric and adult age groups, except for methaemoglobinaemia, which is more frequently observed, often in connection with overdose, in neonates and infants aged 0 to 12 months.

Rare cases of clinically significant methaemoglobinaemia in children have been reported in literature. Prilocaine, one of the components of EMLA, may in high doses cause an increase in the methaemoglobin level, particularly in susceptible individuals and in conjunction with other methaemoglobin-inducing agents. Clinically significant methaemoglobinaemia should be treated with a slow intravenous injection of methylthioninium chloride.

Manufacturer

Drug Availability

Updated