Emla cream 5g №5

Dosage form

Cream for local and external use.

Packaging

5 tubes, 5 g each

Mechanism of action

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.
After applying EMLA cream on 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 on intact skin between the elderly (65-96 years) and younger patients.
Due to the effect of EMLA cream on superficial vessels, temporary blanching or reddening of the skin is possible. Such reactions in patients with widespread neurodermatitis (atopic dermatitis) may occur faster, within 30-60 minutes after applying the cream, which indicates a more rapid penetration of the cream through the skin.
For needle biopsy (4 mm diameter), EMLA cream provides adequate anesthesia to intact skin in 90% of patients 60 minutes after applying the cream when the needle is inserted to a depth of 2 mm and after 120 minutes when the needle is inserted to a depth of 3 mm. The effectiveness of EMLA cream does not depend on the color or pigmentation of the skin (skin type I-IV).
When using combination vaccines against such infections as measles, rubella, mumps, or intramuscular combination vaccines against diphtheria, whooping cough, tetanus, poliomyelitis and infections caused by Haemophilius influenzae type b, as well as with vaccination against hepatitis B, the use of EMLA cream did not affect the average antibody titer, the appearance or disappearance of specific antibodies in the serum, or the number of patients who have achieved a protective or positive antibody titer after immunization.
Anesthesia of the mucous membrane of the genital organs is achieved faster than anesthesia of intact skin due to faster absorption of the drug. In women, after 5-10 minutes after applying EMLA cream on the mucous membrane of the genital organs, anesthesia is achieved which is sufficient to relieve the 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).
After applying the cream during the treatment of trophic ulcers of the lower extremities, the duration of anesthesia is up to 4 hours.No negative effect of the drug on the healing process of ulcers or in relation to the bacterial flora.

- Surface anesthesia of the skin with injections, punctures and vascular catheterization and surface surgeries.
- Surface anesthesia of trophic ulcers of the lower extremities during surgical treatment (mechanical cleaning), for example, to remove fibrin, pus and necrotic tissue.
- Surface anesthesia of the mucous membrane of the genital organs before carrying out painful manipulations (only in adults) and for anesthesia before injections of local anesthetics.

Contraindications

- Hypersensitivity to local anesthetics of the amide type or any other component of the drug.
- Premature newborns born with a gestation period of less than 37 weeks.
- Newborns weighing less than 3 kg.

Not enough data on the use of EMLA cream in pregnant women. In the course of animal studies, no direct or indirect negative effect of the drug on pregnancy, fetal development, on the process of childbirth or postnatal development was detected. Lidocaine and prilocaine penetrate the placental barrier and can be absorbed in the tissues of the fetus. No specific violations of the reproductive process, such as an increase in the frequency of malformations or other direct or indirect adverse effects on the fetus, were reported.
Lidocaine and prilocaine are excreted in breast milk in amounts that do not represent a risk to the child, when using the drug in therapeutic doses.

Dosage and administration

Outwardly, on the skin or mucous membrane.

The cream is applied under the occlusive dressing (available in the package) at least 1 hour before the start of the procedure, the time of application of the drug is recorded on the dressing, and after removing the dressing, wipe the rest of the cream with ethanol.

For anesthesia of the skin: adults (for carrying out "small" procedures) are applied 1.5 g / 10 sq. cm for 1-5 hours, on large surfaces - 1.5-2 g / 10 sq. cm for 2-5 hours; children from 3 to 11 months - up to 1 g / 20 sq. cm. Children over 1 year old - 1 g / 10 sq. Cm.

Anesthesia of the genitals - 5-10 g of cream for 5-10 minutes (without a tight dressing).

Adverse reactions

Local reactions: often (> 1%) - pallor, hyperemia and swelling at the site of application of the drug (due to the action on the superficial vessels); sometimes (0.1%) - slight burning and itching immediately after applying the drug; seldom (Systemic reactions: seldom (

Cautions

Patients with glucose-6-phosphate dehydrogenase deficiency or hereditary or idiopathic methemoglobinemia are more susceptible to drug-dependent methemoglobinemia.
The efficacy of using the cream in newborns during the procedure of taking blood samples from the heel has not been established
Care should be taken when applying EMLA cream around the eyes, as the drug causes eye irritation. Also, the loss of protective reflexes can make corneal irritation and damage possible.If the cream gets into the eyes, immediately rinse the eyes with water or saline, or protect the eyes until the protective reflexes are restored.
Care must be taken when applying the drug to the skin with widespread neurodermatitis (atopic dermatitis); application time should be reduced (15-30 minutes).
In children under the age of 3 months, the safety and efficacy of using EMLA cream was determined after applying a single dose. In these children, after applying the cream, a temporary increase in blood levels of methemoglobin up to 13 hours was often observed. However, the observed increase in blood levels of methemoglobin probably has no clinical significance.
Patients taking class III antiarrhythmic drugs (eg, amiodarone) should be monitored and monitored ECG, as may affect the heart 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 the cream on open wounds. Due to the lack of data on the absorption of the drug is not recommended to apply the cream on the mucous membrane of the genital organs 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).
Does not affect the ability to drive vehicles and work with equipment.

Store at temperatures below 30 ° C. Do not freeze.