Emla

Emla

lidocaine + prilocaine

Manufacturer:

Aspen

Distributor:

Zuellig
Full Prescribing Info
Contents
Lidocaine, prilocaine HCl.
Description
Each gram of Emla cream contains lidocaine 25 mg and prilocaine 25 mg.
Emla cream is an oil-in-water emulsion system in which the oil phase consists of a eutectic mixture of the base forms of lidocaine and prilocaine in the ratio of 1:1.
Action
Pharmacology: Pharmacodynamics: Emla cream contains lidocaine and prilocaine, which are local anesthetics of the amide type. On penetration into the epidermis and dermis, these substances produce dermal anesthesia. The degree of anesthesia 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.
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 Precautions).
A study in healthy volunteers with intact skin shows that in 90%, the anesthesia 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 cream is independent of the color of the skin/pigmentation of the skin (skin types I-IV).
Genital Mucosa: The time to onset of the necessary anesthesia 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 anesthetic 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 systematic absorption of Emla depends on the amount of cream, application time, thickness of the skin (which varies in different areas of the body) and the skin's condition otherwise.
Intact Skin: After application of Emla 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.
Leg Ulcers: After application to leg ulcers of 5-10 g Emla 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 cream 2-10 g was applied for 30-60 min to a maximal surface of 62 cm2, in total of 15 times during a period of 1 month, 3-7 sessions a week.
Genital Mucosa: After application of cream 10 g to vaginal mucosa for 10 min, peak plasma concentrations were measured after approximately 35 min (Mean Values: Lidocaine 0.18 mcg/mL, prilocaine 1.15 mcg/mL).
Indications/Uses
Surface anesthesia of the skin in connection with needle insertion and for superficial surgical procedures; leg ulcers prior to cleaning and superficial procedures eg, removal of fibrin, pus and necroses; and genital mucosa.
Dosage/Direction for Use
Adults: Intact Skin: Needle Insertion (eg, Insertion of IV Lines, Taking Blood Samples): ½ tube (approximately 2 g)/10 cm2. A thick layer of cream is applied to the skin and covered with an occlusive dressing. Application Time: 1 hr. Maximum: 5 hrs.
Minor Superficial Surgical Procedures (eg, Curettage of Molluscs): 1.5-2 g/10 cm2. A thick layer of cream is applied to the skin and covered with an occlusive dressing. Application Time: 1 hr. Maximum: 5 hrs.
Superficial Surgical Procedures on Larger Areas (eg, Split Skin Grafting): 1.5-2 g/10 cm2. A thick layer of cream is applied to the skin and covered with an occlusive dressing. Application Time: 2 hrs. Maximum: 5 hrs.
Leg Ulcers: Cleaning: Approximately 1-2 g/10 cm2. The cream is applied in a thick layer to the surface of the ulcer, but not ≥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 anesthetics. 1 g/10 cm2 for men and 1-2 g/10 cm2 for women. A thick layer of cream is applied to the skin.
Application Time: 15 min for men and 60 min for women.
Genital Mucosa: 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 begin immediately after removal of the cream.
Children: Needle Insertion, Curettage of Molluscs 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: Maximum Dose: Children 6-12 years: 200 cm2 (total of 20 g). Application Time: 1 hr; Maximum: 5 hrs; 1-6 years: 100 cm2 (total of 10 g). Application Time: 1 hr; Maximum: 5 hrs; 3-12 months: 20 cm2 (total of 2 g). Application Time: 1 hr; 0-3 months: 10 cm2 (total of 1 g) (maximum daily dose). Application Time: Not >1 hr.
After a longer application time, the anesthesia decreases.
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 methemoglobinemia in children have been reported. Prilocaine in high doses can increase the methemoglobin level.
Topical administration of prilocaine 125 mg for 5 hrs caused moderate methemoglobinemia in children 3-month of age. 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 methemoglobinemia, methylthionium 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
Hypersensitivity to local anesthetics of the amide type. Methemoglobinemia. Premature infants (born before week 37 of pregnancy).
Special Precautions
Studies have been unable to demonstrate the efficacy of Emla for heel lancing in neonates.
Caution when using near the eyes, as Emla cream causes corneal irritation.
Patients treated with antiarrhythmic drugs class III (eg, amiodarone) should be under close surveillance and ECG monitoring considered, since cardiac effects may be additive.
Caution when using on areas with atopic dermatitis; the application time should be reduced (15-30 min).
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.
It must not be used in connection with intracutaneous injections of live vaccine eg, Bacillus Calmette-Guerin (BCG) as interaction between the active substance in Emla and the vaccine cannot be excluded.
Effects on the Ability to Drive or Operate Machinery: Reaction capacity is not affected by treatment with Emla.
Use in pregnancy: No known risks during pregnancy.
Use in lactation: 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: In children <3 months, safety and efficacy have only been studied with application of a single dose. In these children, a transient increase in methemoglobin 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.
Emla should not be applied to 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 methemoglobin-inducing drugs (see Overdosage).
Use In Pregnancy & Lactation
Use in pregnancy: No known risks during pregnancy.
Use in lactation: 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 anesthetics in the actual sense of the term occur in <1/1,000 patients treated.
Common (>1/100): Skin: Local paleness, redness, edema (at the application site).
Less Common: Skin: Initially a slight burning sensation, itching (at the application site).
Rare (<1/1000): General: Allergic reactions, in the most severe cases anaphylactic shock. Methemoglobinemia in children.
Rare cases of discrete reactions at the application site eg, purpura or petechiae, have been reported, especially following longer application times in children with atopic dermatitis or molluscs.
Drug Interactions
Emla can potentiate the formation of methemoglobin in patients who are being treated with certain methemoglobin-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 anesthetics or preparations that are structurally similar to local anesthetics eg, tocainide.
Specific interaction studies with lidocaine/prilocaine and antiarrhythmic drugs class III (eg, amiodarone) have not been performed, but caution is advised (see Precautions).
Caution For Usage
Instructions for Application: Press out a sufficient quantity of the cream (about 2 g or 1/2 of 5 g tube) at the site of the procedure.
Take 1 of the enclosed occlusive dressings and remove the center cut-out-piece.
Peel the paper liner from the paper framed dressing.
Cover Emla to get a thick layer underneath. Do not spread out the cream. Smooth down the dressing edges carefully to avoid leakage.
Remove the paper frame. The time of application can easily be marked directly on the occlusive dressing. Emla cream must be applied at least 1-2 hrs before the start of the procedure and may be left on for several hours with remaining effect.
Remove the occlusive dressing, wipe off Emla cream, clean the entire area with alcohol and prepare the patient for the procedure. Duration of effective skin anesthesia will be approximately 2 hrs after removal of the occlusive dressing.
Storage
Store below 30°C. Avoid freezing.
ATC Classification
N01BB20 - 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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