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Active ingredients
Lidocaine + Prilocaine
Release form
Cream
Composition
1 g; natamycin 10 mg; neomycin (in the form of sulfate) 3500 U; micronized hydrocortisone 10 mg; Auxiliary substances: polyethylene ointment base (95% liquid paraffin, 5% polyethylene).
Pharmacological effect
Preparation for surface anesthesia of the skin and mucous membranes. The action of the drug is provided by its constituent components - lidocaine and prilocaine, which are local anesthetics of the amide type. Local anesthetics, penetrating into the layers of the epidermis and dermis, cause anesthesia of the skin. The degree of anesthesia depends on the dose of the drug and the duration of the application. ; After applying the cream on intact skin for 1-2 hours, the duration of anesthesia after removing the occlusive dressing is 2 hours. With a puncture biopsy, the use of Emla cream provides adequate anesthesia to intact skin in 90% of patients 60 minutes after application. ; Anesthesia of the genital mucosa is achieved faster than intact skin, due to faster absorption of the drug. In women, 5–10 minutes after applying Emla cream to the mucous membrane of the genital organs, anesthesia is achieved, 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). ; When treating trophic ulcers of the lower extremities, the duration of anesthesia after applying the cream is up to 4 hours. No negative effect of the drug on the healing process of the ulcers or in relation to the bacterial flora has been observed.
Pharmacokinetics
Systemic absorption of the cream depends on the dose, the duration of application and the thickness of the skin (depending on the area of the body), as well as on other features of the skin. In adults, after applying 60 g of cream to intact thigh skin with an area of 400 cm2 (0.2 g per 10 cm2) for 3 hours, the systemic absorption of lidocaine is approximately 3%, and prilocainum is 5%. Absorbed slowly. Cmax of lidocaine and prilocaine in the blood plasma was reached after about 4 hours from the moment of applying the cream and was 0.12 mcg / ml for lidocaine and 0.07 mcg / ml for prilocain. ; In the treatment of trophic ulcers of the lower extremities, the time to reach Cmax of lidocaine (0.05–0.84 mcg / ml) and prilocain (0.02–0.8 mcg / ml) in the blood plasma is 1–2.5 h from the moment of application of the drug on the ulcer surface for 30 minutes). With repeated application of the cream on the ulcer surface, cumulation of prilocaine, lidocaine and their metabolites is not observed.; When applying the cream to the mucous membrane of the genital organs, the time to reach Cmax of lidocaine and prilocain (0.18 μg / ml and 1.15 μg / ml, respectively) is approximately 35 minutes after applying the preparation to the mucous membrane of the vagina (10 g of cream for 10 minutes). ; Pharmacokinetics in special clinical situations; In patients with a widespread neurodermatitis, the rate of absorption increases.
Indications
Surface anesthesia: - skin during punctures and vascular catheterization and surface surgeries; - trophic ulcers of the lower extremities during surgical treatment (mechanical cleaning); - the mucous membrane of the genital organs before carrying out painful manipulations and for pain relief 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. ;
Use during pregnancy and lactation
Perhaps the use of the drug Emla during pregnancy and lactation according to the indications and in the recommended doses. ; Lidocaine and prilocaine are excreted in breast milk in amounts that do not pose a risk to the infant.
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 remnants of the cream with ethanol. ; For anesthesia of the skin: adults (for carrying out "small" procedures) apply 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 genital organs - 5-10 g of cream for 5-10 minutes (without a tight dressing). ;
Side effects
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 (<1% -> 0.1%) - slight burning and itching immediately after applying the drug; rarely (<0.1%) - hemorrhagic rash or point hemorrhages, especially after prolonged application in children with common neurodermatitis or molluscum contagiosum. ; Systemic reactions: rarely (<0.1%) - allergic reactions (in severe cases - anaphylactic shock), methemoglobinemia in children.
Overdose
Symptoms: excitation of the central nervous system, in severe cases - depression of the central nervous system and cardiac activity. In some cases, children developed the clinically significant methemoglobinemia.; Application of 125 mg of prilocaine for 5 hours caused the development of moderate methemoglobinemia in a three-month-old baby. The application of lidocaine at a dose of 8.6-17.2 mg / kg caused severe intoxication in the newborn. ; Treatment: should remove non-sucked part of the drug from the skin surface. If symptoms arise from the central nervous system (convulsions, depression of the central nervous system), symptomatic therapy is indicated, including the appointment of anticonvulsant therapy and, if necessary, mechanical ventilation. With the development of methemoglobinemia, methylene blue should be used as an antidote. It is necessary to ensure observation of the patient within a few hours after the start of treatment of intoxication due to the slow systemic absorption of the components of the drug.
Interaction with other drugs
With simultaneous use of the drug Emla with other local anesthetics and structurally similar drugs (including tocainide), the risk of systemic side effects may increase. With simultaneous use of the drug Emla with drugs that induce the development of methemoglobinemia, drugs containing a sulfo group, it is possible to increase the concentration of methhemoglobin in the blood.
special instructions
Care should be taken when applying Emla cream near the eyes, because the drug irritates the cornea. ; Do not use the cream in case of possibility of its penetration into the middle ear. ; Do not apply the cream on open wounds. ; Use in pediatrics; In children under 3 months. safety and effectiveness of Emla cream is determined after applying a single dose. In children of this age, after applying the cream, a temporary increase in the concentration of methemoglobin in the blood of up to 13 hours may be observed, which has no clinical significance. ; The efficacy of the cream in newborns during the heel blood sampling procedure has not been established.