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lidocaine and prilocaine

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Overview

What is DermacinRx Empricaine?

Lidocaine 2.5% and Prilocaine 2.5% Cream, USP is an emulsion in which the oil phase is a eutectic mixture of lidocaine and prilocaine cream in a ratio of 1:1 by weight. This eutectic mixture has a melting point below room temperature and therefore both local anesthetics exist as a liquid oil rather than as crystals. It is packaged in 5 gram and 30 gram tubes.

Lidocaine is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl), has an octanol: water partition ratio of 43 at pH 7.4, and has the following structure:

Prilocaine is chemically designated as propanamide, N-(2-methylphenyl)-2-(propylamino), has an octanol: water partition ratio of 25 at pH 7.4, and has the following structure:

Each gram of lidocaine and prilocaine cream contains lidocaine 25 mg, prilocaine 25 mg, polyoxyethylene fatty acid esters (as emulsifiers), carboxypolymethylene (as a thickening agent), sodium hydroxide to adjust to a pH approximating 9, and purified water to 1 gram. Lidocaine and prilocaine cream contains no preservative, however it passes the USP antimicrobial effectiveness test due to the pH. The specific gravity of lidocaine and prilocaine cream is 1.00.



What does DermacinRx Empricaine look like?



What are the available doses of DermacinRx Empricaine?

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What should I talk to my health care provider before I take DermacinRx Empricaine?

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How should I use DermacinRx Empricaine?

Lidocaine and prilocaine cream (a eutectic mixture of lidocaine 2.5% and prilocaine 2.5%) is indicated as a topical anesthetic for use on:

    - for local analgesia.

    - for superficial minor surgery and as pretreatment for infiltration anesthesia.

Lidocaine and prilocaine 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 ).

A thick layer of lidocaine and prilocaine cream is applied to intact skin and covered with an occlusive dressing (see ).

Minor Dermal Procedures:

Major Dermal Procedures:

Adult Male Genital Skin:


What interacts with DermacinRx Empricaine?

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What are the warnings of DermacinRx Empricaine?

If CDAD is suspected or confirmed, ongoing antibiotic use not directed against may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of , and surgical evaluation should be instituted as clinically indicated.

Application of lidocaine and prilocaine 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 ).

Patients treated with class III anti-arrhythmic drugs (e.g., 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 lidocaine and prilocaine cream has an ototoxic effect when instilled into the middle ear. In these same studies, animals exposed to lidocaine and prilocaine cream only in the external auditory canal, showed no abnormality. Lidocaine and prilocaine 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:

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 to 30%) in infants and children following excessive applications of lidocaine and prilocaine 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 orother caregivers understand the need for careful application of lidocaine and prilocaine 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 lidocaine and prilocaine cream, provided the test results can be obtained quickly.


What are the precautions of DermacinRx Empricaine?

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What are the side effects of DermacinRx Empricaine?

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What should I look out for while using DermacinRx Empricaine?

Lidocaine and prilocaine 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.

Application of lidocaine and prilocaine 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 ).

Patients treated with class III anti-arrhythmic drugs (e.g., 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 lidocaine and prilocaine cream has an ototoxic effect when instilled into the middle ear. In these same studies, animals exposed to lidocaine and prilocaine cream only in the external auditory canal, showed no abnormality. Lidocaine and prilocaine cream should not be used in any clinical situation when its penetration or migration beyond the tympanic membrane into the middle ear is possible.


What might happen if I take too much DermacinRx Empricaine?

Peak blood levels following a 60 g application to 400 cm of intact skin for 3 hours are 0.05 to 0.16 μg/mL for lidocaine and 0.02 to 0.10 μg/mL for prilocaine. Toxic levels of lidocaine (>5 μg/mL) and/or prilocaine (>6 μg/mL) cause decreases in cardiac output, total peripheral resistance and mean arterial pressure. These changes may be attributable to direct depressant effects of these local anesthetic agents on the cardiovascular system. In the absence of massive topical overdose or oral ingestion, evaluation should include evaluation of other etiologies for the clinical effects or overdosage from other sources of lidocaine, prilocaine or other local anesthetics. Consult the package inserts for parenteral Xylocaine (lidocaine HCl) or Citanest (prilocaine HCl) for further information for the management of overdose.


How should I store and handle DermacinRx Empricaine?

Store at 20 to 25°C (68 to 77°F) [See USP Controlled Room Temperature]. Preserve in tight, light-resistant containers. Protect from moisture.Lidocaine 2.5% and Prilocaine 2.5% Cream, USP is available as the following:NDC 0591-2070-30 30 gram/tube packed individually, in a child-resistant tube.KEEP CONTAINER TIGHTLY CLOSED AT ALL TIMES WHEN NOT IN USE.NOT FOR OPHTHALMIC USE.Storage: Rx onlyKeep out of the reach of children.For all medical inquiries contact:ACTAVISMedical CommunicationsParsippany, NJ 070541-800-272-5525Manufactured By:IGI Laboratories Inc.Buena, NJ 08310 USALidocaine 2.5% and Prilocaine 2.5% Cream, USP is available as the following:NDC 0591-2070-30 30 gram/tube packed individually, in a child-resistant tube.KEEP CONTAINER TIGHTLY CLOSED AT ALL TIMES WHEN NOT IN USE.NOT FOR OPHTHALMIC USE.Storage: Rx onlyKeep out of the reach of children.For all medical inquiries contact:ACTAVISMedical CommunicationsParsippany, NJ 070541-800-272-5525Manufactured By:IGI Laboratories Inc.Buena, NJ 08310 USALidocaine 2.5% and Prilocaine 2.5% Cream, USP is available as the following:NDC 0591-2070-30 30 gram/tube packed individually, in a child-resistant tube.KEEP CONTAINER TIGHTLY CLOSED AT ALL TIMES WHEN NOT IN USE.NOT FOR OPHTHALMIC USE.Storage: Rx onlyKeep out of the reach of children.For all medical inquiries contact:ACTAVISMedical CommunicationsParsippany, NJ 070541-800-272-5525Manufactured By:IGI Laboratories Inc.Buena, NJ 08310 USALidocaine 2.5% and Prilocaine 2.5% Cream, USP is available as the following:NDC 0591-2070-30 30 gram/tube packed individually, in a child-resistant tube.KEEP CONTAINER TIGHTLY CLOSED AT ALL TIMES WHEN NOT IN USE.NOT FOR OPHTHALMIC USE.Storage: Rx onlyKeep out of the reach of children.For all medical inquiries contact:ACTAVISMedical CommunicationsParsippany, NJ 070541-800-272-5525Manufactured By:IGI Laboratories Inc.Buena, NJ 08310 USALidocaine 2.5% and Prilocaine 2.5% Cream, USP is available as the following:NDC 0591-2070-30 30 gram/tube packed individually, in a child-resistant tube.KEEP CONTAINER TIGHTLY CLOSED AT ALL TIMES WHEN NOT IN USE.NOT FOR OPHTHALMIC USE.Storage: Rx onlyKeep out of the reach of children.For all medical inquiries contact:ACTAVISMedical CommunicationsParsippany, NJ 070541-800-272-5525Manufactured By:IGI Laboratories Inc.Buena, NJ 08310 USALidocaine 2.5% and Prilocaine 2.5% Cream, USP is available as the following:NDC 0591-2070-30 30 gram/tube packed individually, in a child-resistant tube.KEEP CONTAINER TIGHTLY CLOSED AT ALL TIMES WHEN NOT IN USE.NOT FOR OPHTHALMIC USE.Storage: Rx onlyKeep out of the reach of children.For all medical inquiries contact:ACTAVISMedical CommunicationsParsippany, NJ 070541-800-272-5525Manufactured By:IGI Laboratories Inc.Buena, NJ 08310 USALidocaine 2.5% and Prilocaine 2.5% Cream, USP is available as the following:NDC 0591-2070-30 30 gram/tube packed individually, in a child-resistant tube.KEEP CONTAINER TIGHTLY CLOSED AT ALL TIMES WHEN NOT IN USE.NOT FOR OPHTHALMIC USE.Storage: Rx onlyKeep out of the reach of children.For all medical inquiries contact:ACTAVISMedical CommunicationsParsippany, NJ 070541-800-272-5525Manufactured By:IGI Laboratories Inc.Buena, NJ 08310 USALidocaine 2.5% and Prilocaine 2.5% Cream, USP is available as the following:NDC 0591-2070-30 30 gram/tube packed individually, in a child-resistant tube.KEEP CONTAINER TIGHTLY CLOSED AT ALL TIMES WHEN NOT IN USE.NOT FOR OPHTHALMIC USE.Storage: Rx onlyKeep out of the reach of children.For all medical inquiries contact:ACTAVISMedical CommunicationsParsippany, NJ 070541-800-272-5525Manufactured By:IGI Laboratories Inc.Buena, NJ 08310 USALidocaine 2.5% and Prilocaine 2.5% Cream, USP is available as the following:NDC 0591-2070-30 30 gram/tube packed individually, in a child-resistant tube.KEEP CONTAINER TIGHTLY CLOSED AT ALL TIMES WHEN NOT IN USE.NOT FOR OPHTHALMIC USE.Storage: Rx onlyKeep out of the reach of children.For all medical inquiries contact:ACTAVISMedical CommunicationsParsippany, NJ 070541-800-272-5525Manufactured By:IGI Laboratories Inc.Buena, NJ 08310 USA