Dermacaine Cream - Topical Anesthetic
lidocaine 2.5% and prilocaine 2.5%
30g
Indications and Usage for Dermacaine
Dermacaine Cream (a eutectic mixture of lidocaine 2.5% and prilocaine 2.5%) is indicated as a topical anesthetic for use on: - normal intact skin for local analgesia. - genital mucous membranes for superficial minor surgery and as pretreatment for infiltration anesthesia.
Dermacaine Cream is not recommended in any clinical situation when penetration or migration beyond the tympanic membrane into the middle ear is possible because of the ototoxic effects observed in animal studies (see WARNINGS). Contraindications
Dermacaine Cream (lidocaine 2.5% and prilocaine 2.5%) is contraindicated in patients with a known history of sensitivity to local anesthetics of the amide type or to any other component of the product.
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Dermacaine Cream (a eutectic mixture of lidocaine 2.5% and prilocaine 2.5%) |
DERMACAINE Indications:
* Needle insertions
* Superficial skin surgery
* Laser treatment
* Split skin grafting
* Dermabrasion
* Removal of genital warts, biopsies of genital mucous
* Plastic surgery
* Circumcision
* Cosmetics treatment
* Leg ulcers
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Warnings
Application of Dermacaine Cream to larger areas or for longer times than those recommended could result in sufficient absorption of lidocaine and prilocaine resulting in serious adverse effects (see Individualization of Dose). Patients treated with class III anti-arrhythmic drugs (eg, amiodarone, bretylium, sotalol, dofetilide) should be under close surveillance and ECG monitoring considered, because cardiac effects may be additive. Studies in laboratory animals (guinea pigs) have shown that Dermacaine Cream has an ototoxic effect when instilled into the middle ear. In these same studies, animals exposed to Dermacaine Cream only in the external auditory canal, showed no abnormality. Dermacaine Cream should not be used in any clinical situation when its penetration or migration beyond the tympanic membrane into the middle ear is possible. Methemoglobinemia: Dermacaine Cream should not be used in those rare patients with congenital or idiopathic methemoglobinemia and in infants under the age of twelve months who are receiving treatment with methemoglobin-inducing agents. Very young patients or patients with glucose-6-phosphate dehydrogenase deficiencies are more susceptible to methemoglobinemia. Patients taking drugs associated with drug-induced methemoglobinemia such as sulfonamides, acetaminophen, acetanilid, aniline dyes, benzocaine, chloroquine, dapsone, naphthalene, nitrates and nitrites, nitrofurantoin, nitroglycerin, nitroprusside, pamaquine, para-aminosalicylic acid, phenacetin, phenobarbital, phenytoin, primaquine, quinine, are also at greater risk for developing methemoglobinemia. There have been reports of significant methemoglobinemia (20-30%) in infants and children following excessive applications of Dermacaine Cream. These cases involved the use of large doses, larger than recommended areas of application, or infants under the age of 3 months who did not have fully mature enzyme systems. In addition, a few of these cases involved the concomitant administration of methemoglobin-inducing agents. Most patients recovered spontaneously after removal of the cream. Treatment with IV methylene blue may be effective if required. Physicians are cautioned to make sure that parents or other caregivers understand the need for careful application of Dermacaine Cream, to ensure that the doses and areas of application recommended in Table 2 are not exceeded (especially in children under the age of 3 months) and to limit the period of application to the minimum required to achieve the desired anesthesia. Neonates and infants up to 3 months of age should be monitored for Met-Hb levels before, during, and after the application of Dermacaine Cream, provided the test results can be obtained quickly.
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