Emla - Instructions For Use, Price, Analogues, Reviews, Cream

2024 Author: Rachel Wainwright | [email protected]. Last modified: 2023-12-15 07:39

Emla

Emla: instructions for use and reviews

1. 1. Release form and composition
2. 2. Pharmacological properties
3. 3. Indications for use
4. 4. Contraindications
5. 5. Method of application and dosage
6. 6. Side effects
7. 7. Overdose
8. 8. Special instructions
9. 9. Application during pregnancy and lactation
10. 10. Use in childhood
11. 11. Drug interactions
12. 12. Analogs
13. 13. Terms and conditions of storage
14. 14. Terms of dispensing from pharmacies
15. 15. Reviews
16. 16. Price in pharmacies

Latin name: Emla

ATX code: N01BB20

Active ingredient: lidocaine (lidocaine) + prilocaine (prilocaine)

Manufacturer: Recipharm Karlskoga AB (Sweden)

Description and photo updated: 2018-26-11

Prices in pharmacies: from 664 rubles.

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Emla is a local anesthetic drug.

Release form and composition

Emla dosage forms:

• cream for local and external use: uniform, white (5 g in an aluminum tube, in a cardboard box 5 tubes complete with occlusive stickers; 30 g each in an aluminum tube, in a cardboard box 1 tube);
• therapeutic system (TS): adhesive medicinal part - a cellulose, round, white or off-white disc, 3.5 cm in diameter, impregnated with EMLA emulsion 5% at a dose of 1 g; rounded flexible backing with protrusions - plastic / aluminum / plastic laminate; an adhesive tape in the form of a square with rounded edges is placed around the circumference of the cellulose disk (1 vehicle in a non-cell contour packaging, in a cardboard box with first opening control of 2 or 20 packages).

1 TC (1 g of emulsion) / 1 g of cream contains:

• active substances: prilocaine - 25 mg, lidocaine - 25 mg;
• additional components: carboxypolymethylene (carbomer 974 R), macrogol glyceryl hydroxystearate (Arlaton 289), purified water, sodium hydroxide (to bring the pH to 8.7-9.7).

Pharmacological properties

Pharmacodynamics

Emla's active ingredients are local anesthetics of the amide type - lidocaine and prilocaine. Penetrating into the layers of the epidermis and dermis, the active components of the drug provide anesthesia of the skin. The degree of anesthetic effect depends on the dose of the agent and the duration of the application.

With the duration of the application 1–2 hours after the removal of the therapeutic system or occlusive dressing, under which the cream was applied, the anesthetic effect of Eml in intact skin is noted for 2 hours. No differences were found in the effectiveness of the drug (including the period required to achieve the required pain relief) and the safety of its use in intact skin between patients aged 65–96 years and younger.

As a result of Emla's influence on superficial vessels, transient redness or paleness of the skin may appear. The fastest (already after 30-60 minutes after treatment with the drug) these phenomena can occur in patients suffering from widespread neurodermatitis (atopic dermatitis), which indicates a more rapid penetration of their active substances into the skin.

In the course of studies, when performing a puncture biopsy (with a diameter of 4 mm) in 90% of patients, the use of Eml for 60 minutes provided anesthesia of intact skin, which was necessary to insert a needle to a depth of 2 mm, and after an application lasting 120 minutes, to a depth of 3 mm. The color (pigmentation) of the skin does not affect the effectiveness of the drug.

The use of Eml does not affect the average value of the antibody titer, the rate of occurrence or disappearance of specific antibodies in the blood serum, or the number of patients who have achieved a positive (protective) antibody titer after immunization. The drug can be used for anesthesia during vaccination against the following infectious diseases: mumps, rubella, measles, whooping cough, diphtheria, tetanus, poliomyelitis, hepatitis B, infections caused by Haemophilius influenzae.

Due to the faster absorption of the cream by the genital mucosa compared to intact skin, the period required to achieve anesthesia in this area is shorter. In women, after applying the cream to the mucous membrane of the genital organs, after 5-10 minutes, it is possible to achieve anesthesia sufficient to relieve the pain syndrome caused by the use of an argon laser. The duration of loss of sensitivity to pain in this case can be, depending on individual characteristics, from 5 to 45 minutes.

After applying a cream to relieve pain when treating trophic ulcers of the lower extremities, the duration of anesthesia reaches 4 hours. No negative effect of the agent on the bacterial flora or ulcer healing was observed.

Pharmacokinetics

Systemic absorption of Emla depends on the dose, duration of application, skin thickness (body area is taken into account) and other features of the skin. In adults, after treatment of intact skin with the drug for 3 hours, systemic absorption for prilocaine and lidocaine is approximately 5% and 3%, respectively. The absorption of active substances is slow.

In blood plasma, the maximum concentration (C _max) of both active substances of the Emla preparation is observed approximately 4 hours after the moment of its application and is 0.12 μg / ml for lidocaine and 0.07 μg / ml for prilocaine. The threat of the appearance of toxic symptoms occurs only when the plasma concentration of active substances is from 5 to 10 μg / ml.

Against the background of the therapy of trophic ulcers of the lower extremities, the time to reach in blood plasma C _max (T _Cmax) of prilocaine (0.02–0.8 μg / ml) and lidocaine (0.05–0.84 μg / ml) is 1–2, 5 hours from the moment of applying the cream for 30 minutes at a dose of 5–10 g. In the case of repeated use of the cream on the ulcerative surface, the accumulation of its active substances and their metabolites is not recorded.

When applied for 10 minutes, 10 g of cream on the vaginal mucosa, T _{Cmax of} prilocaine and lidocaine (0.15 μg / ml and 0.18 μg / ml, respectively) is approximately 35 minutes from the moment of application.

In patients with advanced neurodermatitis, the absorption rate increases.

Indications for use

According to the instructions, Emla is recommended for use for surface anesthesia of the skin before superficial surgical interventions, punctures and vascular catheterization, injections.

A cream for topical and external use, in addition, is used in the following cases:

• mucous membranes of the genital organs: before performing painful manipulations in adult patients or for the purpose of pain relief before the introduction of a local anesthetic;
• trophic ulcers of the lower extremities: before surgical treatment (mechanical cleaning), including when removing pus, fibrin, necrotic tissues.

Contraindications

Absolute:

• prematurity in children (born less than 37 weeks of gestation);
• body weight of newborns less than 3 kg (for cream);
• hypersensitivity to any of Emla's constituents or other amide local anesthetics.

In addition, the TS is not recommended for the following conditions / diseases:

• combined use with drugs that cause methemoglobinemia in children from birth to 12 months (due to lack of data);
• insufficiency of glucose-6-phosphate dehydrogenase;
• the presence of open wounds in the treated area.

A relative contraindication (it is required to use Emla with extreme caution) for both forms of the drug is common neurodermatitis (atopic dermatitis).

Additional relative contraindications for Emla cream:

• methemoglobinemia (hereditary / idiopathic);
• insufficiency of glucose-6-phosphate dehydrogenase (since the risk of drug-dependent methemoglobinemia is aggravated);
• combined use with class III antiarrhythmic drugs, including amiodarone (requires constant monitoring and ECG monitoring, due to the possible effect on cardiac activity).

Additional relative contraindications for Emla's TS:

• subcutaneous administration of a live vaccine, for example, BCG (active substances in concentrations above 0.5–2% exhibit bactericidal and antiviral properties);
• application in the eye area (if the product gets into the eyes, irritation occurs).

Instructions for use of Emla: method and dosage

Topical and topical cream

Emla cream is applied externally, applied to the skin or mucous membrane.

For adults, for the purpose of surface anesthesia of intact skin, the drug is applied in a thick layer to the skin under an occlusive dressing.

The recommended doses of Emla and the duration of the application, depending on the performed manipulation:

• minor surgical interventions (including removal of warts and curettage of molluscum contagiosum): 1.5–2 g / 10 cm² for 1 hour (maximum 5 hours);
• needle insertion (including during puncture or catheterization of a vessel): 2 g / 10 cm² for 1 hour (maximum 5 hours);
• surface treatments on large areas (including skin grafting with a split graft): 1.5–2 g / 10 cm² for 2 hours (maximum 5 hours).

Before surgical treatment (mechanical cleaning) of trophic ulcers of the lower extremities for the implementation of surface anesthesia, a cream is applied to the ulcer surface in a thick layer at a dose of 1-2 g / 10 cm² (maximum 10 g per procedure) under a PVC occlusive dressing. It is required to gently smooth the edges of the dressing to prevent the cream from dripping. The duration of the application is at least 30 minutes, in the case when the penetration of the ulcer into the tissue is difficult - up to 60 minutes. Cleaning of ulcers should be started no later than 10 minutes after removing the cream.

To anesthetize the genitals, a thick layer of the agent is applied to the skin before local anesthetics are injected, for men for 15 minutes at a dose of 1-2 g / 10 cm², for women for 60 minutes at a dose of 1 g / 10 cm².

Before removing genital warts or administering local anesthetics for surface anesthesia of the genital mucosa, a cream in a dose of 5 to 10 g (the exact amount of cream depends on the area to be treated) is applied to the entire surface of the mucous membrane, including folds. The duration of the application is 5-10 minutes, after removing the cream, the procedure must be carried out immediately.

For children, to anesthetize intact skin, before inserting a needle or conducting superficial surgical procedures, a thick layer of cream is applied to the skin and covered with an occlusive dressing. The dose of Eml should not be more than 1 g / 10 cm² per day, and should also be selected taking into account the area of the treated surface.

The recommended total doses of Emla cream (maximum application area) and the duration of application, depending on the age of the child:

• from 0 to 3 months: 1 g (10 cm² - maximum daily dose), duration - no more than 1 hour;
• from 3 to 12 months: 2 g (20 cm²), duration - 1 hour;
• from 1 year to 6 years: 10 g (100 cm²), duration - 1 hour (maximum - 5 hours);
• from 6 to 12 years: 20 g (200 cm²), duration 1 hour (maximum 5 hours).

It should be borne in mind that an increase in the duration of the application reduces the anesthetic effect of Emla. In the presence of widespread neurodermatitis (atopic dermatitis), especially in children, the application time should be reduced to 15-30 minutes.

To apply the drug, use a screw cap, pierce the protective membrane of the tube and, after squeezing out the required amount of cream, apply it to the area of the proposed procedure. To numb the skin, you can use the occlusive stickers supplied with the 5 g package. Before applying the sticker, you need to remove its central part, and then separate the paper backing from the edging from the back of the bandage.

Transdermal Therapeutic System (TS)

A cellulose disc impregnated with Emla emulsion is applied externally to the skin.

Recommended daily doses with simultaneous use and application time, depending on the patient's age:

• from 0 to 3 months: maximum dose - 1 vehicle, duration - no more than 1 hour;
• from 3 to 12 months: 1–2 vehicles (maximum 2), duration - 1 hour;
• from 1 year and older: 1 or more vehicles, duration - at least 1 hour.

An increase in the duration of application by more than 5 hours does not increase the anesthetic effect. In children with widespread neurodermatitis, the treatment time with the drug must be reduced to 30 minutes.

Side effects

• local reactions (at the site of application of the product): often - redness, pallor, swelling; sometimes - itching and slight burning sensation (noted immediately after application); isolated cases - punctate hemorrhages or hemorrhagic rash, recorded mainly in children with molluscum contagiosum or widespread neurodermatitis after prolonged application;
• systemic reactions: rarely - methemoglobinemia in children, allergic reactions, with possible anaphylactic shock in severe cases.

There are reports of corneal irritation in case of accidental contact of Emla in the eyes.

Overdose

Systemic toxicity is unlikely if the recommended doses and duration of Eml application are observed. Possible symptoms of Emla's intoxication may be disorders observed with an overdose of other local anesthetics, such as excitation of the central nervous system (CNS), and with severe intoxication, depression of the central nervous system and the activity of the heart muscle. Rare cases of the development of clinically significant methemoglobinemia in children have been recorded. The increase in methemoglobin levels may be due to excessively high doses of prilocaine. Superficial application of this active substance in a dose of 125 mg for 5 hours in a three-month-old child led to the onset of moderate methemoglobinemia. Topical application of lidocaine at a dose of 8.6-17.2 mg / kg caused serious intoxication in newborns.

With the development of severe neurological symptoms due to an overdose (depression of the central nervous system, convulsions), symptomatic treatment is required, including the use of anticonvulsant drugs and artificial ventilation (if necessary). For the treatment of methemoglobinemia, methylene blue is used as an antidote. After the start of relief of symptoms of toxicity, due to the slow systemic absorption of Emla, the patient needs to be monitored for several hours.

special instructions

If the cream accidentally gets into the eyes, they must be urgently rinsed with saline (water) or the eyes must be protected until protective reflexes are restored, since the loss of the latter can lead to irritation and damage to the cornea.

In children, due to insufficient data on the absorption of the drug, it is not recommended to apply the cream to the mucous membrane of the genital organs.

Emla should not be used to treat areas of a damaged eardrum, or in other situations if there is a threat of getting the product into the middle ear.

Influence on the ability to drive vehicles and complex mechanisms

Emla does not affect the ability to drive vehicles and work with complex, potentially dangerous mechanisms.

Application during pregnancy and lactation

There is not enough information on the use of the product by pregnant women. According to the data obtained in animal studies, Emla does not have a direct or indirect negative effect on the intrauterine development of the fetus, the course of pregnancy, the course of labor, and postnatal development. The active substances of the drug pass through the placental barrier and are able to be absorbed into the tissues of the fetus. There are no reports of any specific reproductive disorders (including an increase in the frequency of malformations) or other direct / indirect negative effects on the fetus. Despite this, pregnant women need to be careful when using Emla.

The active substances of the local anesthetic, when used in therapeutic doses, are excreted in breast milk in quantities that do not pose a threat to the health of the child.

Pediatric use

The use of Emla is contraindicated in premature babies born at a gestational age of less than 37 weeks.

The use of the cream is contraindicated in newborns whose weight does not reach 3 kg.

In children under the age of three months, the effectiveness and safety of using Emla is established after applying a single dose. As a result of the application in such children, in many cases, for no more than 13 hours, a temporary increase in the concentration of methemoglobin in the blood was noted, which probably has no clinical significance.

When taking a blood test from the heel of newborns, the effectiveness of the cream has not been established.

Drug interactions

• drugs that cause the occurrence of methemoglobinemia (including drugs containing a sulfo group): the level of methemoglobin in the blood increases;
• other local anesthetics and drugs structurally similar to them (including tocainide): the threat of developing systemic effects increases (especially when using these drugs in high doses).

Analogs

Emla's analogues are Acriol Pro, Lidocaine, Lidocaine-VIAL, Gelikain, Luan, etc.

Terms and conditions of storage

Store out of the reach of children, at a temperature not exceeding 30 ° C, without freezing.

The shelf life of the cream for local and external use is 3 years, the transdermal therapeutic system is 2 years.

Terms of dispensing from pharmacies

Available without a prescription.

Reviews about Emla

Reviews about Emla (mainly in the form of a cream) on medical sites are in most cases positive. Many patients report the efficacy and convenient method of using local anesthetic when using it to relieve skin pain. The drug has proven itself first of all for waxing, shugaring, laser hair removal, etc.

There are not so many reviews about the use of anesthesia for the mucous membranes of the genital organs, and they are not so unambiguous. Some patients indicate a complete lack of anesthetic effect of the drug or a very short-term effect after its application. The disadvantages of Eml include high cost and small volume of packaging. There are very few complaints about the occurrence of irritation after using the drug.

Price for Emla in pharmacies

The price of Emla (cream for local and external use) for a package containing 1 tube of 30 g each can be 1670-1920 rubles; for a package containing 5 tubes of 5 g - 1600-1820 rubles.

Emla: prices in online pharmacies

Drug name Price Pharmacy

Emla cream for local and external use 30 g 1 pc. 664 RUB Buy

Emla cream for local and external use 5 g 5 pcs. 1297 RUB Buy

Emla cream 5g 5 pcs. 1463 RUB Buy

Emla cream 30g 1538 RUB Buy

Maria Kulkes Medical journalist About the author

Education: First Moscow State Medical University named after I. M. Sechenov, specialty "General Medicine".

Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!