Emla cream tube of 5 g 5 pcs

EMLA cream contains lidocaine and prilocaine – local anesthetics of the amide type. Due to the penetration of lidocaine and prilocaine into the layers of the epidermis and dermis, skin anesthesia occurs. The degree of anesthesia depends on the time of application and dose.

Intact skin. When EMLA cream is applied to intact skin for 1-2 hours, anesthesia lasts for about 2 hours after removal of the occlusive dressing. No differences in efficacy (including time to onset of analgesia) and safety when applied to intact skin have been observed between young and elderly patients.

Due to the effect of the cream on the superficial vessels, temporary blanching or redness of the skin area is possible. Such reactions develop faster (as early as 30-60 minutes after applying the cream) in patients with widespread neurodermatitis (atopic neurodermatitis), which indicates a faster penetration of the cream through the altered skin.

reproductive toxicity

Lidocaine. In embryo-fetal development studies in which rats and rabbits were treated during organogenesis, no teratogenic effects were observed. Embryotoxicity was observed in rabbits at maternally toxic doses. Rat offspring exposed to maternally toxic doses during late pregnancy and lactation showed reduced postnatal survival.

Prilocaine: Reproductive toxicity studies with prilocaine have not been completed.

A combination study in which prilocaine and lidocaine were administered to pregnant rats during the period of organogenesis showed no effects on embryonal/fetal development. However, data on systemic exposure and clinical significance of the latter are insufficient.

Genotoxicity and carcinogenicity

Lidocaine. Genotoxicity studies with lidocaine have been negative. The carcinogenicity of lidocaine has not been studied. The lidocaine metabolite 2,6-xylidine has genotoxic potential in vitro. In a carcinogenicity study of 2,6-xylidine in rats in utero, postnatally and throughout life, tumors were recorded in the nasal cavity, hypodermis and liver. The clinical significance of tumor development with short-term/irregular use of lidocaine is unknown.

Prilocaine. Genotoxicity studies with prilocaine have been negative. The carcinogenicity of prilocaine has not been studied. The prilocaine metabolite orthotoluidine has genotoxic potential in vitro. In a carcinogenicity study of orthotoluidine in rats, mice and hamsters, tumors were recorded in various organs. The clinical significance of tumor development with short-term/irregular use of prilocaine is unknown.

Emla is equally effective regardless of skin color/pigmentation (skin types I-VI).

Emla can be used before subcutaneous or intramuscular vaccination. For intradermal vaccination with a live vaccine, such as BCG, see Method of administration.

Genital mucosa. The anesthetic effect of the mucosa appears earlier, since absorption occurs faster than in cases of application to intact skin.

In women, after applying EMLA cream to the mucous membrane of the genitals, an analgesic effect is achieved in 5-10 minutes, sufficient for manipulations using an argon laser. The duration of anesthesia is 15-20 minutes (taking into account individual characteristics – 5-45 minutes).

Trophic ulcers of the lower extremities. After applying the cream in the treatment of trophic ulcers of the lower extremities, the duration of the analgesic effect is about 4 hours. The cream does not have a negative effect on the wound healing process and bacterial flora.

Systemic absorption depends on the amount of cream, duration of application, skin thickness (which varies in different areas of the body), and other skin characteristics.

Intact skin. In adults, after application of 60 g of EMLA cream to intact skin of the thigh with an area of ​​400 cm2 ⁽ 1.5 g per 10 cm2 ⁾ for 3 hours, systemic absorption was 3% for lidocaine and 5% for prilocaine. Absorption occurs slowly. At the above dose, C _max in the blood plasma of lidocaine (average – 0.12 μg/ml) and prilocaine (average – 0.07 μg/ml) was achieved approximately 4 hours after application. The risk of developing toxic symptoms exists only at a level of 5-10 μg/ml.

Trophic ulcers of the lower extremities. After application of 5-10 g of EMLA cream to trophic ulcers with an exposure of 30 min, C _max of lidocaine and prilocaine in blood plasma was reached after approximately 1-2.5 h (lidocaine concentration within the range of 0.05-0.84 μg/ml, prilocaine – 0.02-0.08 μg/ml).

After repeated application of EMLA cream to trophic ulcers, no significant accumulation of lidocaine, prilocaine or their metabolites in blood plasma was observed (EMLA cream was applied at a rate of 2-10 g for 30-60 min to an area of ​​​​up to 62 ^cm2 15 times a month for 3-7 sessions per week).

Genital mucosa. _Cmax in blood plasma is achieved approximately 35 minutes after application of 10 g of EMLA cream to the vaginal mucosa with an exposure of 10 minutes (on average, the concentration of lidocaine was 0.18 μg/ml; prilocaine – 0.15 μg/ml).

Superficial anesthesia of the skin during punctures, vascular catheterization and superficial surgical interventions.

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

Superficial anesthesia of the genital mucosa.

adults

Trophic ulcers of the lower extremities. During surgical treatment (mechanical cleaning) of trophic ulcers, apply 1-2 g of cream per 10 cm² of surface. The cream is applied in a thick layer to the surface of the ulcer, no more than 10 g of cream per procedure. Cover the surface of the ulcer with an occlusive dressing. Duration of cream application 30 min.

The open tube is intended for single use; after each procedure, unused cream is thrown away.

When treating ulcers in which tissue penetration of the drug is difficult, the duration of application can be increased to 60 minutes. Surgical treatment of the wound surface should begin no later than 10 minutes after removing the cream.

In the treatment of trophic ulcers of the lower extremities, EMLA cream is used up to 15 times for 1-2 months without reducing effectiveness and increasing the frequency of local reactions.

Superficial anesthesia of the genitals

Genital skin. Use before injection of local anesthetics:

• Men: 1 g per 10 cm^2. Apply a thick layer of cream to the skin. Duration of application – 15 minutes;
• Women: 1-2 g per 10 cm^2. Apply a thick layer of cream to the skin. Duration of application – 60 minutes.

Genital mucosa. For removal of warts or before injection of local anesthetics: 5-10 g of cream, depending on the area to be treated, is applied to the entire surface, including the folds of the mucous membrane. An occlusive dressing is not required. Duration of application is 5-10 minutes. The surgical procedure should be started immediately after removal of the cream.

children

When performing injections, removing molluscum contagiosum and other minor superficial surgical procedures: 1 g per 10 cm ² of surface, a thick layer of cream on