Emla

Emla

lidocaine + prilocaine

Manufacturer:

Aspen Asia

Distributor:

Cordial Trading
/
Primal
Full Prescribing Info
Contents
Lidocaine, prilocaine.
Description
Each gram of cream contains lidocaine 25 mg and prilocaine 25 mg. It also contains the following excipients: Carbomer, macrogol glycerol hydroxystearate, sodium hydroxide to adjust pH (8.7-9.7) and water. Excipient with known effect: Emla cream contains macrogol glycerol hydroxystearate which can cause skin reactions.
Emla is an oil/water emulsion in which the oil phase consists of a eutectic mixture of lidocaine and prilocaine in the ratio 1:1.
Action
Pharmacotherapeutic Group: Local anaesthetics of the amide type. ATC Code: N01BB20.
Pharmacology: Pharmacodynamics: Emla cream contains lidocaine and prilocaine, which are local anaesthetics of the amide type. On penetration into the epidermis and dermis, these substances produce dermal anaesthesia. The degree of anaesthesia depends on application time and dose.
Intact Skin: With an application time of 1-2 hrs, the effect lasts for approximately 2 hrs after the occlusive dressing has been removed.
In clinical studies of Emla on intact skin, no differences in safety or efficacy (including anaesthetic onset time) were observed between geriatric patients (aged 65-96 years) and younger patients.
The superficial vascular bed is affected by Emla and this can cause transient paleness or redness. These reactions appear to occur more rapidly in atopic dermatitis, after only 30-60 min, indicating more rapid absorption through the skin (see also Precautions).
A study in healthy volunteers with intact skin shows that in 90%, the anaesthesia is sufficient for use of biopsy punch (4 mm in diameter) to an insertion depth of 2 mm, following 60 min application time and to a depth of 3 mm following 120 min application time.
The effectiveness of Emla is independent of the colour of the skin/pigmentation of the skin (skin types I-IV).
Emla can be used prior to vaccination with SC or IM vaccine. For intracutaneous vaccination with live vaccine eg, BCG, see Warnings and Precautions.
Genital Mucosa: The time to onset of the necessary anaesthesia is shorter, as absorption is more rapid than with application to intact skin.
Following 5-10 min application of Emla to the genital mucosa in women, the anaesthetic effect against argon laser-induced pain lasted for 15-20 min (with an interindividual variation from 5-45 min).
Leg Ulcers: No negative effect on ulcer healing or bacterial flora has been observed. When cleaning leg ulcers, Emla has analgesic effect for up to 4 hrs after application.
Pharmacokinetics: The systemic absorption of Emla depends on the amount of cream, application time, thickness of the skin (which varies on different surfaces of the body) and condition of the skin in other respects such as skin diseases (eg, absorption increases in atopic dermatitis, see Warnings and Precautions) and shaving. When used on leg ulcers, the characteristics of the leg ulcer can affect absorption, eg, absorption increases with increased size of the leg ulcer.
Intact Skin: After application of Emla cream 60 g/400 cm2 (1.5 g/10 cm2) for 3 hrs to intact skin (the thigh) in adults, systemic absorption was measured as 3% for lidocaine and 5% for prilocaine. Absorption takes place slowly. With the previously mentioned dose, peak plasma concentrations for lidocaine (mean 0.12 mcg/mL) and prilocaine (mean 0.07 mcg/mL) were reached within approximately 4 hrs after application. Only at levels of 5-10 mcg/mL are there risks of toxic symptoms. In this case, shaving of the skin took place 8-12 hrs before application of the cream.
Plasma levels of lidocaine and prilocaine in both geriatric and non-geriatric patients following application of Emla to intact skin are very low and well below potentially toxic levels.
Leg Ulcers: After application to leg ulcers of Emla 5-10 g for 30 min, peak plasma levels of lidocaine and prilocaine were reached after approximately 1-2.5 hrs (for lidocaine within the range 0.05-0.84 mcg/mL and for prilocaine 0.02-0.8 mcg/mL).
Following repeated application of Emla to leg ulcers, there was no apparent accumulation in plasma of lidocaine, prilocaine or their metabolites. Emla 2-10 g was applied for 30-60 min to a maximal surface of 62 cm2, in total 15 times during a period of 1 month, 3-7 sessions a week.
Genital Mucosa: After application of Emla 10 g cream to vaginal mucosa for 10 min, peak plasma concentrations were measured after approximately 35 min (mean values: Lidocaine 0.18 mcg/mL, prilocaine 0.15 mcg/mL).
Indications/Uses
Surface anaesthesia of the skin in connection with needle insertion and for superficial surgical procedures.
Surface anaesthesia of leg ulcers prior to cleaning and superficial surgical procedures eg, removal of fibrin, pus and necroses.
Surface anaesthesia of the genital mucosa.
Dosage/Direction for Use
Adults: Intact Skin: See Table 1.

Click on icon to see table/diagram/image

Leg Ulcers: For Cleaning of Leg Ulcers: Approximately 1-2 g/10 cm2. The cream is applied in a thick layer to the surface of the ulcer, but not more than 10 g per treatment procedure. Cover the surface of the ulcer with an occlusive dressing. An opened tube is intended for a single use and any remaining cream must therefore be discarded after each treatment procedure.
Application Time: At least 30 min.
For leg ulcers with tissue that is particularly difficult to penetrate, the application time may be extended to 60 min. Cleaning of the ulcer should begin within 10 min after the cream has been removed.
Emla has been used for up to 15 treatment procedures over a period of 1-2 months without a decline in effect or an increase in the number of local reactions.
Genital Use: Skin: Use prior to injection of local anaesthetics: Men: 1 g/10 cm2. A thick layer of cream is applied to the skin. Application Time: 15 min.
Women: 1-2 g/10 cm2. A thick layer of cream is applied to the skin. Application Time: 60 min.
Genital Mucosa: For Removal of Condyloma or Prior to Injection of Local Anaesthetics: Approximately 5-10 g, depending on the area to be treated. The whole surface, including the mucosal folds, must be covered. Occlusion is not necessary.
Application Time: 5-10 min. The surgery must be begun immediately after removal of the cream.
Children: For Needle Insertion, Curettage of the Lesions Caused by Mollusca contagiosum and Other Minor Surgical Procedures: 1 g/10 cm2.
A thick layer of cream is applied to the skin and covered with an occlusive dressing. The dose should not exceed 1 g/10 cm2 and must be adjusted according to the application area: See Table 2.

Click on icon to see table/diagram/image

A longer application time decreases the anaesthesia.
Children with Atopic Dermatitis: Reduce application time to 30 min.
Overdosage
Systemic toxicity is very unlikely with normal use of Emla. In the event of toxicity, the symptoms are expected to be similar to those seen after local anaesthesia treatment ie, excitatory central nervous system (CNS) symptoms and in severe cases, CNS depression and myocardial depression.
Rare cases of clinically significant methaemoglobinaemia have been reported (see Adverse Reactions). Prilocaine in high doses can increase the methaemoglobin level.
Topical administration of prilocaine 125 mg for 5 hrs caused moderate methaemoglobinaemia in a 3-month old child. Topical administration of lidocaine 8.6-17.2 mg/kg caused very serious intoxication in infants.
Severe neurological symptoms (convulsions, CNS depression) require symptomatic treatment eg, assisted ventilation and anticonvulsant therapy.
In the event of methaemoglobinaemia, methyl thionine is the antidote. On account of a slow systemic absorption, a patient with symptoms of toxicity should be kept under observation for several hours following any treatment of these symptoms.
Contraindications
Known hypersensitivity to local anaesthetics of the amide-type, or to any of the excipients. Emla may not be used in premature infants (born before week 37 of pregnancy).
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).
Use In Pregnancy & Lactation
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.
Adverse Reactions
Adverse events with local anaesthetics in the actual sense of the term occur in <1/1000 patients treated. (See Table 3.)

Click on icon to see table/diagram/image

Rare cases of discrete reactions at the application site eg, purpura or petechia, have been reported, especially following longer application times in children with atopic dermatitis or molluscs. Corneal irritation after accidental eye exposure.
Drug Interactions
Emla can potentiate the formation of methaemoglobin in patients who are being treated with certain methaemoglobin-inducing preparations (eg, sulfa preparations).
With high doses of Emla, the risk of additive systemic effects should be taken into account in patients who are given local anaesthetics or preparations that are structurally similar to local anaesthetics eg, tocainide.
Specific interaction studies with lidocaine/prilocaine and class III antiarrhythmic drugs (eg, amiodarone) have not been performed, but caution is advised. (See Precautions.)
Medicinal products that reduce the clearance of lidocaine (eg, cimetidine or β-blockers) may cause potentially toxic plasma levels when lidocaine is given in repeated high doses for prolonged periods of time. Such interactions are not clinically significant in short-term treatment with lidocaine at recommended doses.
Caution For Usage
Instructions for Use and Handling: Information for the user and instructions for use are contained in every pack. Use the tube cap in order to perforate the membrane covering the tip of the tube.
Storage
Do not store above 30°C. Do not freeze.
ATC Classification
N01BB52 - lidocaine, combinations ; Belongs to the class of amides. Used as local anesthetics.
Presentation/Packing
Cream 5% x 5 g x 5's.
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