Emla cream, 30 g

In adults:

Ј Surface anesthesia of the skin during injections (including vaccination), punctures and catheterization of blood vessels and superficial surgical interventions, including minor cosmetic procedures and epilation;

Ј Surface anesthesia of trophic ulcers of the lower extremities during surgical treatment (mechanical cleaning), for example, to remove fibrin, pus and necrotic tissues;

Ј Surface anesthesia of the genital mucosa before painful manipulations and for pain relief before injections of local anesthetics.

In children:

Ј Surface anesthesia of the skin during injections (including during vaccination), punctures and catheterization of blood vessels and superficial surgical interventions (including when removing molluscum contagiosum).

Adults

Superficial anesthesia of intact skin.

When inserting a needle, for example, during vascular catheterization and when taking blood samples

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

Application time

1 hour, maximum 5 hours

For minor surgical procedures, such as scraping molluscum contagiosum, removing warts, minor cosmetic procedures, and epilation

Apply a thick layer of 1.5-2 g / 10 cm2 to the skin and cover with an occlusive dressing

Application time

1 hour, maximum 5 hours

On large areas of freshly shaved skin (on an outpatient basis), including before epilation

the maximum recommended dose is 60 g, the maximum recommended application area is 600 cm2;

apply a thick layer to the skin and cover with an occlusive dressing

Application time

1 hour, maximum 5 hours

For superficial procedures on large areas (in stationary conditions), for example, skin sampling with a split graft

1.5-2 g / 10 cm2

apply a thick layer to the skin and cover with an occlusive dressing

Application time

2 hours, maximum 5 hours

Superficial anesthesia of trophic ulcers of the lower extremities:

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

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

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

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

Genital surface anesthesia:

Genital skin:

Pain relief before local anesthetic injections:

Men: 1 g / 10 cm2. Apply the cream in a thick layer to the skin. Application time: 15 min.

Women: 1-2 g / 10 cm2. Apply the cream in a thick layer to the skin. Application time: 60 min.

Superficial anesthesia of the genital mucosa:

When removing genital warts and for anesthesia before injections of 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. No occlusive dressing is required. Application time: 5-10 min. Carry out the procedure immediately after removing the cream.

Children

Anesthesia with the introduction of a needle (including during vaccination), with curettage of molluscum contagiosum and with other small superficial surgical procedures.

Apply the cream in a thick layer to 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 cm2.

0-3 months

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

Duration of application

1 hour (important: no more than 1 hour)

3-12 months

maximum 20 cm2 (total 2 g cream)

Duration of application

1 hour

1-6 years old

maximum 100 cm2 (total 10 g of cream)

Duration of application

1 hour, maximum 4 hours

6-12 years old

maximum 200 cm2 (total 20 g cream)

Duration of application

1 hour, maximum 4 hours

Composition (for 1 g of cream)

active ingredients: lidocaine 25.0 mg, prilocaine 25.0 mg;

excipients: macrogol glyceryl hydroxystearate (ARLATON 289) 19.0 mg, carbomer 974 R (carboxypolymethylene) 10.0 mg, sodium hydroxide 5.2 mg to adjust the pH to 8.7 - 9.7, purified water to 1.0 g ...

- Hypersensitivity to local anesthetics of the amide type or any other component of the drug;

- premature infants born at a gestational age of less than 37 weeks;

- newborns weighing less than 3 kg.

Carefully

Insufficiency of glucose-6-phosphate dehydrogenase, hereditary or idiopathic methemoglobinemia, widespread neurodermatitis (atopic dermatitis), patients taking class III antiarrhythmic drugs (eg, amiodarone) (see section 'Special instructions').

Pharmacodynamics

EMLA cream contains lidocaine and prilocaine as active ingredients, which are local anesthetics of the amide type. Skin anesthesia 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 intact skin for 1-2 hours, the duration of anesthesia after removing the occlusive dressing is 2 hours. There were no differences in efficacy (including the time to achieve an analgesic effect) and safety when applying the cream to intact skin between elderly (65-96 years old) and younger patients.

Due to the action of the EMLA cream on the superficial vessels, temporary blanching or reddening of the skin is possible. Similar reactions in patients with widespread neurodermatitis (atopic dermatitis) may occur more quickly, within 30-60 minutes after applying the cream, which indicates 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 for intact skin in 90% of patients 60 minutes after applying 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 EMLA cream does not depend on the color or pigmentation of the skin (skin types I-IV).

When using combination vaccines against infections such as measles, rubella, mumps, or intramuscular combination vaccines against diphtheria, pertussis, tetanus, poliomyelitis and Haemophilius influenzae type b infection, as well as with hepatitis B vaccination, the use of EMLA cream did not affect on the average titer of antibodies, the rate of appearance or disappearance of specific antibodies in the blood serum, or the number of patients who have achieved a protective or positive antibody titer after immunization.

Genital mucosa

Anesthesia of the genital mucosa is achieved faster than anesthesia of intact skin due to the faster absorption of the drug.

In women, 5-10 minutes after applying the EMLA cream to the genital mucosa, anesthesia is achieved sufficient to relieve pain caused by the use of an argon laser; duration of anesthesia is 15-20 minutes (taking into account individual characteristics from 5 to 45 minutes).

Trophic ulcers of the lower extremities

After applying the cream when treating trophic ulcers of the lower extremities, the duration of anesthesia is up to 4 hours. There was no negative effect of the drug on the healing process of ulcers or in relation to the bacterial flora.

Pharmacokinetics

The systemic absorption of EMLA cream depends on the dose, the duration of application and the thickness of the skin (depends on the area of ??the body), as well as other skin characteristics such as skin diseases and shaving. When applied to the ulcerative surface of the lower extremities, the absorption of the drug can be influenced by the characteristics of the ulcers, for example, the size (with an increase in the area of ??the ulcer, absorption increases).

Intact skin:

In adults, after applying 60 g of the cream to intact thigh skin with an area of ??400 cm2 (1.5 g per 10 cm2) for 3 hours, systemic absorption for lidocaine was approximately 3% and for prilocaine 5%. Absorption is slow. The maximum concentration of lidocaine (average value 0.12 ?g / ml) and prilocaine (average value 0.07 ?g / ml) in blood plasma was reached approximately 4 hours after application of the cream. The risk of toxic symptoms exists only when the concentration of active substances in the blood plasma is 5-10 ?g / ml. When EMLA cream is applied to intact skin 8-12 hours after shaving, the maximum plasma concentration of lidocaine and prilocaine in both young and elderly 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 ?g / ml) and prilocaine (0.02-0.08 ?g / ml) in blood plasma is 1-2.5 hours from the moment the drug is applied to the ulcer surface (5 -10 g cream for 30 minutes).

With repeated application of the cream to the ulcerative surface, there was no accumulation in the blood plasma of prilocaine, lidocaine or their metabolites. 2-10 g of EMLA cream were applied to the ulcer surface with an area of ??up to 62 cm2 for 30-60 minutes from 3 to 7 times a week (15 times a month).

Genital mucosa:

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

Pregnancy and lactation

Pregnancy.

There is insufficient data on the use of EMLA cream in pregnant women. In the course of animal studies, no direct or indirect negative effects of the drug on pregnancy, intrauterine development of the fetus, on the process of childbirth or postnatal development were revealed. Lidocaine and prilocaine cross the placental barrier and can be absorbed into the tissues of the fetus. No specific reproductive disorders have been reported, such as an increase in the incidence of malformations or other direct or indirect adverse effects on the fetus.

Lactation.

Lidocaine and prilocaine are excreted in breast milk in amounts that do not pose a risk to the child when using the drug in therapeutic doses.

Overdose

Subject to the recommended dosage regimen of the drug, the development of signs of systemic toxicity is unlikely. Symptoms of intoxication are probably the same as with other local anesthetics, for example, excitation of the central nervous system (CNS), and in severe cases, depression of the central nervous system and cardiac activity.

In rare cases, the development of clinically significant methemoglobinemia was noted. Prilocaine in high doses can cause an increase in the content of methemoglobin.

Topical application of 125 mg of prilocaine for 5 hours caused the development of moderate methemoglobinemia in a 3-month-old baby. Superficial application of lidocaine at a dose of 8.6-17.2 mg / kg caused serious intoxication in newborns.

Treatment

Severe neurological symptoms (convulsions, depression of the central nervous system) require symptomatic treatment, including the appointment of anticonvulsants and, if necessary, mechanical 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 for several hours after the start of treatment for intoxication.

Interaction with other medicinal products and other forms of interaction

In patients receiving drugs that induce the development of methemoglobinemia (for example, drugs containing a sulfo group), EMLA cream may increase the concentration of methemoglobin in the blood.

When treating with other local anesthetics and drugs structurally similar to them (including tocainide), the risk of increased systemic effects when using high doses of EMLA cream should be taken into account.

Special studies to assess the interaction of lidocaine / prilocaine with class III antiarrhythmic drugs have not been conducted, caution should be exercised when drugs are used together.

Pharmaceutical interactions: not found.

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 over an extended period of time. This interaction has no clinical significance with short-term therapy with lidocaine (for example, EMLA cream) at the recommended doses.

special instructions

Patients with glucose-6-phosphate dehydrogenase deficiency or hereditary or idiopathic methemoglobinemia are more prone to drug-dependent methemoglobinemia.

The effectiveness of using the cream in newborns during the procedure for taking blood samples from the heel has not been established.

Care should be taken when applying EMLA cream around the eyes as it irritates the eyes. Eliminating protective reflexes can irritate or damage the cornea. If the cream gets in the eyes, immediately flush the eyes with water or 0.9% sodium chloride solution, and protect the eyes until the protective reflexes are restored.

Care must be taken when applying the drug to the skin with atopic dermatitis; application time should be reduced (15-30 minutes).

In children under the age of 3 months, the safety and efficacy of the use of EMLA cream was determined after applying a single dose. In such children, after applying the cream, a temporary increase in the content of methemoglobin in the blood was often observed, lasting up to 13 hours. However, the observed increase in the content of methemoglobin in the blood is probably not of clinical significance.

Patients taking class III antiarrhythmic drugs (eg, amiodarone) should be monitored and monitored by ECG. possible influence on cardiac activity.

Do not apply EMLA cream on a damaged eardrum or in other cases of possible penetration of the cream into the middle ear.

Do not apply cream to open wounds.

Due to the lack of data on the absorption of the drug, it is not recommended to apply the cream to the genital mucosa in children.

Lidocaine and prilocaine in concentrations above 0.5-2% have bactericidal and antiviral properties. In this regard, it is recommended to take special care when applying the cream before the subcutaneous administration of a live vaccine (for example, BCG).

Due to the lack of data, the combined use of EMLA cream and drugs that cause methemoglobinemia in children aged 0 to 12 months is not recommended.

Impact on the ability to drive vehicles and work with equipment

Does not affect the ability to drive vehicles and work with equipment.