![]() Twenty-nine patients received 10 g of EMLA Cream applied for 10 to 60 minutes in the vaginal fornices. The absorption of EMLA Cream applied to genital mucous membranes was studied in two open-label clinical trials. The application of EMLA Cream to broken or inflamed skin, or to 2,000 cm 2 or more of skin where more of both anesthetics are absorbed, could result in higher plasma levels that could, in susceptible individuals, produce a systemic pharmacologic response. Plasma concentrations of lidocaine and prilocaine following EMLA Cream application in this study were consistently low (2.5 to 16 ng/mL for lidocaine and 2.5 to 7 ng/mL for prilocaine). In a pharmacokinetic study, EMLA Cream was applied to penile skin in 20 adult male patients in doses ranging from 0.5 g to 3.3 g for 15 minutes. Likewise, the maximum prilocaine level is about 1/36 the toxic level. When 60 g of EMLA Cream was applied over 400 cm 2 for 24 hours, peak blood levels of lidocaine are approximately 1/20 the systemic toxic level. The results from these studies are summarized below. The subjects were then randomized such that one-half of the subjects had the occlusive dressing and residual cream removed after 3 hours, while the remainder left the dressing in place for 24 hours. In two pharmacokinetic studies, 60 g of EMLA Cream (1.5 g lidocaine and 1.5 g prilocaine) was applied to 400 cm 2 of intact skin on the lateral thigh and then covered by an occlusive dressing. In this eutectic mixture, both anesthetics are liquid at room temperature (see DESCRIPTION) and the penetration and subsequent systemic absorption of both prilocaine and lidocaine are enhanced over that which would be seen if each component in crystalline form was applied separately as a 2.5% topical cream.Ībsorption: The amount of lidocaine and prilocaine systemically absorbed from EMLA Cream is directly related to both the duration of application and to the area over which it is applied. ![]() Pharmacokinetics: EMLA Cream is a eutectic mixture of lidocaine 2.5% and prilocaine 2.5% formulated as an oil in water emulsion. After a 5 to 10 minute application of EMLA Cream to female genital mucosa, the average duration of effective analgesia to an argon laser stimulus (which produced a sharp, pricking pain) was 15 to 20 minutes (individual variations in the range of 5 to 45 minutes).ĭermal application of EMLA Cream may cause a transient, local blanching followed by a transient, local redness or erythema. Absorption from the genital mucosa is more rapid and onset time is shorter (5 to 10 minutes) than after application to intact skin. Satisfactory dermal analgesia is achieved 1 hour after application, reaches maximum at 2 to 3 hours, and persists for 1 to 2 hours after removal. To provide dermal analgesia for clinical procedures such as split skin graft harvesting, EMLA Cream should be applied under occlusive dressing for at least 2 hours. ![]() To provide sufficient analgesia for clinical procedures such as intravenous catheter placement and venipuncture, EMLA Cream should be applied under an occlusive dressing for at least 1 hour. The onset, depth and duration of dermal analgesia on intact skin provided by EMLA Cream depend primarily on the duration of application. Both lidocaine and prilocaine stabilize neuronal membranes by inhibiting the ionic fluxes required for the initiation and conduction of impulses, thereby effecting local anesthetic action. Lidocaine and prilocaine are amide-type local anesthetic agents. Mechanism of Action: EMLA Cream (lidocaine 2.5% and prilocaine 2.5%), applied to intact skin under occlusive dressing, provides dermal analgesia by the release of lidocaine and prilocaine from the cream into the epidermal and dermal layers of the skin and by the accumulation of lidocaine and prilocaine in the vicinity of dermal pain receptors and nerve endings. ![]()
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