Included in the formulation
Emla®
cream
locally externally
АТХ:N.01.B.B.52 Lidocaine in combination with other drugs
Pharmacodynamics:Lidocaine and prilocaine in combination are used as local anesthetics of the amide type. Anesthesia of the skin due to the penetration of lidocaine and prilocaine into the layers of the epidermis and dermis.
Intact skin: after application, the duration of anesthesia after the removal of the occlusive dressing is 2 hours. Due to the effect on the surface vessels, temporary blanching or reddening of the skin is possible. With puncture biopsy, the drug provides adequate anesthesia of the intact skin in 90% of patients 60 minutes after the application of the cream. Anesthesia of the genital mucosa is achieved faster than anesthesia of intact skin due to faster absorption of the drug. After application of the drug in 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 depends on the dose, the duration of the application and the thickness of the skin (depends on the area of the body).
Intact skin: in adults after applying 60 g of cream to the intact skin of the thigh area of 400 cm2 for 3 hours, systemic absorption for lidocaine is approximately 3%, for prilocaine 5%. Suction is slow. The maximum concentration of lidocaine (mean value 0.12 μg / ml) in blood plasma was achieved approximately 4 hours after the application of the cream.
Trophic ulcers of the lower extremities: the time to reach the maximum concentration of lidocaine (0.05-0.84 μg / ml) and prilocaine (0.02-0.8 μg / ml) in blood plasma is 1-2.5 hours from the moment the drug is applied to the ulcer surface (5 -10 g of cream for 30 minutes).
With the repeated application of the cream on the ulcerous surface, there was no cumulation of prilocaine, lidocaine, or their metabolites.
Mucous membranes: The time to reach the maximum concentration of lidocaine and prilocaine in the blood plasma (an average of 0.18 μg / ml and 1.15 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:Surface anesthesia of the skin for puncture and catheterization of vessels with superficial surgical interventions. Surface anesthesia of trophic ulcers of lower extremities during surgical treatment, mechanical cleaning.Surface anesthesia of the genital mucosa before carrying out painful manipulations and for anesthesia before injections of local anesthetics.
XXI.Z40-Z54.Z51.4 Preparatory procedures for subsequent treatment, not elsewhere classified
Contraindications:Hypersensitivity (including local anesthetics of the amide structure). Premature babies born at the gestational age of less than 37 weeks. Methemoglobinemia.
Carefully:When applying the drug near the eyes; before subcutaneous administration of live vaccine (eg BCG); in the case of application to the skin with a common neurodermatitis (atopic dermatitis).
It is not recommended joint use of the drug and drugs that cause methemoglobinemia in children aged 0 to 12 months; in patients with insufficiency of glucose-6-phosphate dehydrogenase.
It is not recommended to apply the drug to open wounds.
Pregnancy and lactation:There was no risk of drug use during pregnancy.
FDA recommendations are not defined.
Dosing and Administration:It is applied externally, applied to the skin or mucous membrane.
Side effects:Skin: pallor, redness and swelling (in the area of application), at the first moment after application, slight burning and itching (in the application area).
General: allergic reactions, in the most severe cases - anaphylactic shock.
Methemoglobinemia in children. Hemorrhagic rash or pinpoint hemorrhage, especially after prolonged use in children with advanced neurodermatitis (atopic dermatitis) or molluscum contagiosum.
Overdose:When observing the recommended dosage regimen, development of signs of systemic toxicity is unlikely. When an overdose occurs such symptoms as excitation of the central nervous system, and in severe cases - oppression of the heart.
In rare cases, children developed clinically significant methemoglobinemia. Prilocaine in high doses can cause an increase in the concentration of methemoglobin.
The application of 125 mg of prilocaine lasting 5 hours caused the development of moderate methaemoglobinemia in a three-month-old child. The application of lidocaine in a dose of 8.6-17.2 mg / kg caused severe intoxication in newborns.
Treatment: remove the unsweetened part of the drug from the skin surface.
Severe neurologic symptoms (seizures, CNS depression) require symptomatic treatment, including the appointment of anticonvulsants and if necessary artificial ventilation. In the case of development of methemoglobinemia, the antidote is methylene blue. It should be ensured that patients are monitored for several hours after initiation of intoxication treatment, due to the slow systemic absorption of the drug.
Interaction:In patients receiving drugs that induce the development of methemoglobinemia, drugs containing a sulfo group may help increase the concentration of methemoglobin in the blood.
When treating other local anesthetics and structurally similar drugs, including tokaine, one should take into account the risk of enhancing systemic effects when using high doses of the drug.
Special instructions:The effectiveness of the cream in newborns is not established in the procedure for taking blood from the heel.
Care should be taken when applying the drug near the eyes, because the drug causes irritation of the cornea.
Care should be taken when applying the drug to the skin with a common neurodermatitis (atopic dermatitis); The time of application should be reduced (15-30 minutes).
In children under 3 months of age, the safety and efficacy of the drug is determined after a single dose. In such children, after applying the cream, a temporary increase in the concentration of methhemoglobin in the blood lasting up to 13 hours is often observed. However, the observed increase in the concentration of methemoglobin in the blood probably does not have clinical significance. Do not use the cream in patients if it is possible to penetrate the middle ear. Do not apply the cream to open wounds.