Emla® (Emla®)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceLidocaine + PrilocaineLidocaine + Prilocaine
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  • Acryol Pro
    cream locally externally 
    AKRIKHIN HFK, JSC     Russia
  • Emla®
    cream locally externally 
    AstraZeneca AB     Sweden
  • Emla®
    patch externally 
    AstraZeneca AB     Sweden
    • Dosage form: & nbspCream for local and external use.
    Composition:For 1 g of cream
    active substances: lidocaine 25.0 mg, prilocaine 25.0 mg;
    auxiliary substances: macrogol glyceryl hydroxy stearate (ARLATON 289) 19.0 mg, carbomer 974 P (carboxypolymethylene) 10.0 mg, sodium hydroxide 5.2 mg to adjust the pH to 8.7 -9.7, water purified to 1.0 g .
    Description:A homogeneous cream of white color.
    Pharmacotherapeutic group:Local anesthetic
    ATX: & nbsp

    N.01.B.B.52   Lidocaine in combination with other drugs

    Pharmacodynamics:EMLA cream contains as active ingredients lidocaine and prilocaine, which are local anesthetics of the amide type. Anesthesia of the skin is caused by the penetration of lidocaine and prilocaine into the layers of the epidermis and dermis. The degree of anesthesia depends on the dose of the drug and the duration of the application.
    Intact skin
    After applying EMLA® cream to the intact skin for 1-2 hours, the duration of anesthesia after the removal of the occlusive dressing is 2 hours. There were no differences in efficacy (including the time to achieve an analgesic effect) and safety when applying cream to intact skin between the elderly (65-96 years) and younger patients.
    Due to the action of the cream of EMLA® on the surface vessels, temporary blanching or reddening of the skin is possible. Similar reactions in patients with advanced neurodermatitis (atopic dermatitis) can occur more quickly, within 30 to 60 minutes after the application of the cream, indicating a faster penetration of the cream through the skin.
    With a puncture biopsy (4 mm in diameter), the use of EMLA® cream provides adequate anesthesia of the intact skin in 90% of patients 60 minutes after application of the cream when the needle is inserted at a depth of 2 mm and after 120 minutes when the needle is inserted at a depth of 3 mm. The effectiveness of the cream of EMLA® does not depend on the color or skin pigmentation (skin type I-IV).
    When using combined vaccines against infections such as measles, rubella, mumps, or intramuscular combined vaccines against diphtheria, whooping cough, tetanus, poliomyelitis and infection caused by Haemophilius influenzae type b, and when vaccinating against hepatitis B, the use of the EMLA cream is not influenced the average antibody titer, the rate of appearance or disappearance of specific antibodies in the serum, or the number of patients who achieved a protective or positive titer of antibodies after immunization.
    Mucous membrane of genital organs
    Anesthesia of the mucous membrane of the genital organs is achieved faster in comparison with anesthesia of intact skin due to faster absorption of the drug.
    In women, 5-10 minutes after the application of the EMLA® cream on the mucous membrane of the genital organs, anesthesia is obtained sufficient for the relief of pain caused by the use of an argon laser; The duration of anesthesia is 15-20 minutes (taking into account individual characteristics from 5 to 45 minutes).
    Trophic ulcers of lower extremities
    After the application of cream during the treatment of trophic ulcers of the lower limbs, the duration of anesthesia is up to 4 hours. There was no adverse effect of the drug on the healing process of ulcers or against bacterial flora.
    Pharmacokinetics:

    Systemic absorption of the cream of EMLA depends on the dose, duration of application and thickness of the skin (depends on the area of ​​the body), as well as other skin features such as skin diseases and shaving. When applied to the ulcerous surface of the lower limbs, the absorption of the preparation may be affected by ulcer features, for example, the magnitude (as the area of ​​the ulcer increases, the absorption increases).

    Intact skin:

    In adults, after applying 60 g of cream to the intact skin of the thigh area of ​​400 cm2 (1.5 g per 10 cm2) at 3 hours the systemic absorption for lidocaine was approximately 3% and for prilocaine 5%. Suction - slow. The maximum concentration of lidocaine (mean value 0.12 μg / ml) and prilocaine (mean value 0.07 μg / ml) in blood plasma was achieved approximately 4 hours after the application of the cream. The risk of toxic symptoms exists only when the concentration of active substances in the blood plasma is 5-10 μg / ml. When applying EMLA® cream to intact skin 8-12 hours after shaving, the maximum plasma concentration of lidocaine and prilocaine in both young and old patients is very low and significantly lower than the possible toxic level.

    Trophic ulcers of the lower extremities:

    The time to reach the maximum concentration of lidocaine (0.05-0.84 μg / ml) and prilocaine (0.02-0.08 μg / ml) in blood plasma is 1-2.5 hours from the moment application of the drug on the ulcerous surface (5 - 10 g of cream for 30 minutes). With the repeated application of the cream to the ulcerous surface, there was no cumulation in the blood plasma of prilocaine, lidocaine, or their metabolites. 2-10 g of EMLA® cream were applied to a ulcerous area of ​​up to 62 cm2 for 30-60 minutes from 3 to 7 times a week (15 times a month).

    Mucous membrane of genital organs:

    The time to reach the maximum concentration of lidocaine and prilocaine in the blood plasma (an average of 0.18 μg / ml and 0.15 μg / ml, respectively) is approximately 35 minutes from the time the drug is applied to the vaginal mucosa (10 g of cream for 10 minutes).

    Indications:In adults:
    -Surface skin anesthesia for punctures (including vaccination), puncture and catheterization of vessels and surface surgical interventions, including small cosmetic procedures and hair removal;
    -Surface anesthesia of trophic ulcers of the lower limbs during surgical treatment (mechanical cleaning), for example, to remove fibrin, pus and necrotic tissues;
    -Surface anesthesia of the mucous membrane of the genital organs before carrying out painful manipulations and for anesthesia before injections of local anesthetics.
    Children:
    - superficial anesthesia of the skin with injections (including vaccination), puncture and catheterization of vessels and surface surgical interventions (including, when removing molluscum contagiosum).
    Contraindications:- hypersensitivity to local anesthetics of the amide type or any other component of the preparation;
    - premature newborns born at the gestational age of less than 37 weeks;
    - newborns with a body weight of less than 3 kg.
    Carefully:Insufficiency of glucose-6-phosphate dehydrogenase, hereditary or idiopathic methemoglobinemia, common neurodermatitis (atopic dermatitis), patients taking antiarrhythmic drugs of class III (for example, amiodarone) (see section "Special instructions").
    Pregnancy and lactation:Pregnancy.
    There is insufficient data on the use of EMLA® cream in pregnant women. In animal studies, there was no direct or indirect adverse effect of the drug on pregnancy, fetal development, on the process of labor or postnatal development. Lidocaine and prilocaine penetrate the placental barrier and can be absorbed in the fetal tissues. No specific violations of the reproductive process have been reported, such as an increase in the frequency of malformations or other direct or indirect adverse effects on the fetus.
    Lactation.
    Lidocaine and prilocaine are excreted in breast milk in quantities that do not pose a risk to the child when the drug is used in therapeutic doses.
    Dosing and Administration:

    Externally, on the skin or mucous membrane.

    Adults

    Surface anesthesia of intact skin

    Indication

    Dose and method of application

    Time of application

    When the needle is inserted, for example, during catheterization of blood vessels and when taking blood samples

    half 5 g tube (about 2 g) per 10 cm2 apply a thick layer on the skin and cover with an occlusive dressing

    1 hour, maximum 5 hours

    At small surgical manipulations, for example, at a scraping out of a contagious molluscum, removal of warts, small cosmetic procedures and epilation

    1.5-2 g / 10 cm2 apply a thick layer on the skin and cover with an occlusive dressing

    1 hour, maximum 5 hours

    On large areas of freshly shaved skin (in outpatient settings), including, before epilation

    the maximum recommended dose is 60 g, the maximum recommended area of ​​application is 600 cm2; apply a thick layer on the skin and cover with an occlusive dressing

    1 hour, maximum 5 hours

    With surface procedures on large areas (in stationary conditions), for example, taking a rut by the method of a split flap

    1.5-2 g / 10 cm2 apply a thick layer on the skin and cover with an occlusive dressing

    2 hours, maximum 5 hours

    Surface anesthesia of trophic ulcers of lower extremities:

    When surgical treatment (mechanical cleaning) of trophic ulcers of the lower extremities: a single dose of about 1-2 g / 10 cm2; apply a thick layer of cream on the ulcer surface, no more than 10 g of cream per procedure. Apply an occlusive dressing. Time of application: at least 30 minutes.

    The opened tube with a cream is intended for single use, the tube with the remains of the cream should be discarded after use in one patient.

    In the case of treatment of ulcers in the tissues of which penetration of the drug is difficult, the duration of the application can be increased to 60 minutes. Mechanical cleaning should be started no later than 10 minutes after removing the cream.

    When manipulating ulcers of the lower extremities, the EMLA® cream was applied up to 15 times within 1-2 months without reducing the efficiency and increasing the frequency of local reactions.

    Superficial anesthesia of genital organs:

    Genital skin:

    Anesthesia before injections of local anesthetics:

    Men: 1g / 10cm2. Apply a thick layer of cream on the skin. Time of application: 15 min.
    Women: 1-2g / 10cm2. Apply a thick layer of cream on the skin. Time of application: 60 min.
    Surface anesthesia of the mucous membrane of the genital organs:
    When removing genital warts and for anesthesia before injecting local anesthetics: about 5-10 g of cream, depending on the area of ​​the treated surface. The cream should be applied to the entire surface of the mucous membrane, including the folds of the mucous membrane.
    An occlusive dressing is not required. Application time: 5-10 min. Carry out the procedure immediately after removing the cream.

    Children

    Anesthesia with the introduction of a needle (including when vaccinated), with scraping molluscum contagiosum and other small superficial surgical manipulations.
    Apply a thick layer of cream on the skin and cover with an occlusive dressing. The dose should correspond to the surface to be treated and should not exceed 1 g of cream per 10 cm.

    Age

    Area of ​​application

    Duration of application

    0-3 months

    maximum 10cm2 (total 1 g of cream) (the maximum daily dose)

    1 hour (important: not more than 1 hour)

    3-12 months

    maximum 20 cm2 (total 2 g of cream)

    1 hour

    1-6 years old

    as much as 100 cm2 (total 10 g of cream)

    1 hour, maximum 4 hours

    6-12 years old

    maximum 200 cm2 (total 20 g of cream)

    1 hour, maximum 4 hours

    A strip of EMLA® cream 3.5 cm long corresponds approximately to a dose of 1 g.

    Increasebapplication time reduces anesthesia. In children with atopic dermatitis, the time of application should be reduced to 30 minutes.

    Apply a thick layer of cream on the skin and cover with an occlusive dressing.

    Recommendations for application of the drug

    1. Pierce the protective membrane of the aluminum tube, using screw the cap, squeeze out a sufficient amount of cream from the tube and apply it to the place of the proposed procedure. With anesthesia of the skin, occlusal stickers can be used (attached to the package 5 x 5 g).

    2. a. Take one of the occlusal stickers and remove the center piece. b. Separate the paper backing from the paper edging on the back of the dressing.

    3. When anesthesia of trophic ulcers of the lower extremities, use an occlusive dressing made of PVC.

    4. Cover the applied cream with a bandage so that the layer of cream under it was thick and not squeezed out from under the bandage. Gently smooth the edges of the dressing to avoid leakage of the cream.

    5. If using an occlusal sticker attached to the packaging, remove the paper frame. The time of application can be written directly on the bandage.

    6. After the recommended time, remove the dressing and the cream residues from the surface.

    Side effects:

    When applied to intact skin

    Frequent (≥1%, <10%): Skin: Transient local reactions in the application area, such as pallor, redness and swelling.

    Infrequent (≥0,1%,<1%): Skin: at the first moment after application, slight burning, itching and sensation of heat (in the area of ​​application of the drug).

    Rare (<0.1%): General: allergic reactions, in the most severe cases - anaphylactic shock. Methemoglobinemia and / or cyanosis. Reactions in the application area, such as hemorrhagic rash or pinpoint hemorrhage, especially after prolonged use in children with atopic dermatitis or molluscum contagiosum. Irritation of the cornea due to accidental contact of the cream in the eyes.

    When applied to trophic ulcers of the lower extremities

    Frequent (≥1%, <10%): Skin: transient local reactions in the application area, such as pallor, redness and swelling; at the first moment after application, slight burning, itching and sensation of heat (in the area of ​​application of the drug).

    Infrequent (≥0,1%,<1%): Skin: skin irritation (in the area of ​​application).

    Frequent (> 1%, <10%): General: allergic reactions, in the most severe cases - anaphylactic shock.

    Overdose:When observing the recommended dosage regimen, development of signs of systemic toxicity is unlikely. Symptoms of intoxication are probably the same as when using other local anesthetics, for example, excitation of the central nervous system (CNS), and in severe cases, CNS depression and heart activity.
    In rare cases, the development of clinically significant methemoglobinemia was noted. Prilokain in high doses can cause an increase in the content of methaemoglobin.
    Surface application of 125 mg of prilocaine lasting 5 hours caused the development of moderate methaemoglobinemia in a 3 month old child. Surface application of lidocaine in a dose of 8.6 - 17.2 mg / kg caused severe intoxication in newborns.
    Treatment
    Severe neurological symptoms (convulsions, central nervous system depression) require symptomatic treatment, including the appointment of anticonvulsants and if necessary artificial ventilation. In the case of development of methemoglobinemia, the antidote is methylthioninium chloride (methylene blue).
    Due to the slow systemic absorption of the drug, patients should be monitored within a few hours of initiating treatment for intoxication.
    Interaction:In patients receiving drugs that induce development
    methemoglobinemia (eg, preparations containing a sulfo group), the EMLA® cream can help increase the concentration of methemoglobin in the blood.
    When treating other local anesthetics and structurally similar drugs (including tokaine), the risk of enhancing systemic effects when applying high doses of EMLA cream should be taken into account.
    Special studies to assess the interaction of lidocaine / prilokain with antiarrhythmic drugs of the III class have not been conducted, caution should be exercised when using drugs together.
    Pharmaceutical interaction: not detected.
    Drugs that reduce the clearance of lidocaine (for example, cimetidine or beta-blockers) can cause potentially toxic plasma concentrations when repeated high doses of lidocaine are used for an extended period of time.This interaction is not clinically relevant for short-term therapy with lidocaine (eg, EMLA® cream) at the recommended doses.
    Special instructions:Patients with glucose-6-phosphate dehydrogenase deficiency or hereditary or idiopathic methemoglobinemia are more susceptible to drug-dependent methaemoglobinaemia.
    The effectiveness of the cream in newborns is not established in the procedure for taking blood samples from the heel.
    Care should be taken when applying EMLA® cream around the eyes, as the product causes eye irritation. Elimination of protective reflexes can cause irritation or damage to the cornea. In case of contact with eyes, immediately flush eyes with water or 0.9% solution of sodium chloride, and protect eyes until protective reflexes are restored.
    Care should be taken when applying the drug to the skin in atopic dermatitis; The time of application should be reduced (15-30 minutes).
    In children under the age of 3 months, the safety and efficacy of the application of the EMLA® cream was determined after a single dose. In such children, after the application of the cream, a temporary increase in the content of methemoglobin in the blood lasting up to 13 hours was often observed.However, the observed increase in methaemoglobin in the blood probably does not have clinical significance.
    Patients taking antiarrhythmic drugs of grade III (for example, amiodarone), should be under constant supervision and ECG monitoring, because possibly affecting cardiac activity.
    Do not apply EMLA® cream on the damaged eardrum or in other cases of possible penetration of the cream into the middle ear.
    Do not apply the cream to open wounds.
    Due to a lack of data on the absorption of the drug, it is not recommended to apply the cream to the mucous membrane of the genital organs in children.
    Lidocaine and prilocaine in concentrations above 0.5-2% have bactericidal and pruotovirus properties. In connection with
    Therefore, it is recommended to pruyavyat special attention when applying the cream before subcutaneous injection of live vaccine (for example, BCG).
    In the absence of data, the combined use of the cream of EMLA and the drugs that cause methemoglobinemia is not recommended in children aged 0 to 12 months.
    Effect on the ability to drive transp. cf. and fur:Does not affect the ability to drive vehicles and work with machinery.
    Form release / dosage:Cream for local and external use (aluminum tubes) for 5 g and 30 g.
    Packaging:For 5 grams in an aluminum tube sealed with an aluminum membrane and closed with a screw cap. For 5 tubes together with occlusal stickers and instructions for use in a cardboard bundle with the control of the first autopsy.
    For 30 grams in an aluminum tube sealed with an aluminum membrane and closed with a screw cap. 1 tube with instructions for use in a cardboard pack.
    Storage conditions:Store at temperatures below 30 ° C, in a place inaccessible to children. Do not freeze.
    Shelf life:3 years. Do not use after the expiry date printed on the package.
    Terms of leave from pharmacies:Without recipe
    Registration number:П N014033 / 01
    Date of registration:23.12.2008
    Expiration Date:Unlimited
    The owner of the registration certificate:AstraZeneca ABAstraZeneca AB Sweden
    Manufacturer: & nbsp
    Representation: & nbspAstraZeneca Pharmaceuticals Ltd.AstraZeneca Pharmaceuticals Ltd.
    Information update date: & nbsp2016-08-19
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