Emla Special Precautions

Patients with glucose-6-phosphate dehydrogenase deficiency or congenital or idiopathic methaemoglobinaemia are more susceptible to drug-induced methaemoglobinaemia.
Studies have been unable to demonstrate the efficacy of Emla for heel lancing in neonates.
Caution when using near the eyes, as Emla may cause eye irritation. Also the loss of protective reflexes may allow corneal irritation and potential abrasion. If eye contact occurs, immediately rinse the eye in water or sodium chloride solution and protect until sensation returns.
Caution when using on areas on skin with atopic dermatitis; the application time should be reduced (15-30 min). Application times of longer than 30 min in patients with atopic dermatitis may result in an increased incidence of local vascular reactions, particularly application site redness and in some cases petechia and purpura (see Adverse Reactions).
Prior to removal of molluscs in children with atopic dermatitis it is recommended to apply the cream for 30 min.
In children <3 months, safety and efficacy have only been studied with application of a single dose. In these children, a transient increase in methaemoglobin levels is often seen for up to 13 hrs after Emla has been applied. However, the increases that have been observed are probably of no clinical significance.
Patients treated with class III antiarrhythmic drugs (eg, amiodarone) should be under close surveillance and ECG monitoring considered, since cardiac effects may be additive. (See Interactions.)
Emla should not be used on damaged tympanic membrane or in other situations where penetration into the middle ear may occur.
Emla should not be applied to open wounds.
Lidocaine and prilocaine have bacteriocidal and antiviral properties in concentrations above 0.5-2%. For this reason, the result of intracutaneous injections of live vaccines (eg, BCG) should be monitored.
Emla cream contains macrogol glycerol hydroxystearate which can cause skin reactions.
Effects on the Ability to Drive or Operate Machinery: Reaction capacity is not affected by treatment with Emla.
Use in pregnancy & lactation: Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development. In both animals and humans, lidocaine and prilocaine cross the placental barrier and may be absorbed by the foetal tissue. It is reasonable to assume that lidocaine and prilocaine have been used in a large number of pregnant woman and women of childbearing potential. No specific disturbances to the reproductive process have so far been reported, eg, an increased incidence of malformations or other directly or indirectly harmful effects on the foetus. However, caution should be exercised when used in pregnant women.
Lidocaine and prilocaine pass into the breast milk, but the risk of an effect on the child appears unlikely with therapeutic doses.
Use in children: Emla should not be used on the genital mucosa in children on account of incomplete data of absorption.
Until further clinical experience is available, Emla should not be used for children 0-12 months during concomitant treatment with methaemoglobin-inducing drugs (see Overdosage).