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lidocaine 2.5% and prilocaine 2.5%
Overview
What is LIVIXIL PAK?
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 LIVIXIL PAK look like?
What are the available doses of LIVIXIL PAK?
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What should I talk to my health care provider before I take LIVIXIL PAK?
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How should I use LIVIXIL PAK?
Lidocaine and prilocaine cream (a eutectic mixture of lidocaine 2.5% and prilocaine 2.5%) is indicated as a topical anesthetic for use on:
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for local analgesia.
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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 WARNINGS).
A thick layer of lidocaine and prilocaine cream is applied to intact skin and covered with an occlusive dressing (see INSTRUCTIONS FOR APPLICATION).
Minor Dermal Procedures:
Major Dermal Procedures:
Adult Male Genital Skin:
What interacts with LIVIXIL PAK?
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What are the warnings of LIVIXIL PAK?
In patients with impaired mechanisms for excreting potassium, the administration of potassium salts can produce hyperkalemia and cardiac arrest. This occurs most commonly in patients given potassium intravenously, but may also occur in patients given potassium orally. Potentially fatal hyperkalemia can develop rapidly and can be asymptomatic. The use of potassium salts in patients with chronic renal disease, or any other condition which impairs potassium excretion, requires particularly careful monitoring of the serum potassium concentration and appropriate dosage adjustment.
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 Individualization of Dose).
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 LIVIXIL PAK?
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What are the side effects of LIVIXIL PAK?
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What should I look out for while using LIVIXIL PAK?
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 Individualization of Dose).
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 LIVIXIL PAK?
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 LIVIXIL PAK?
Store VPRIV at 2 °C to 8°C (36°F to 46°F). Do not use VPRIV after the expiration date on the vial. Do not freeze.Protect vial from light.Store VPRIV at 2 °C to 8°C (36°F to 46°F). Do not use VPRIV after the expiration date on the vial. Do not freeze.Protect vial from light.LIVIXIL Pak (Lidocaine 2.5% and Prilocaine 2.5% Cream, USP) with Occlusive Dressing Contains:NOT FOR OPHTHALMIC USE.KEEP CONTAINER TIGHTLY CLOSED AT ALL TIMES WHEN NOT IN USE.Storage: Rx onlyKeep out of the reach of children.Manufactured By:ORFougera Pharmaceuticals, Inc.Melville, NY 11747Packaged By:Alvix Laboratories, LLC6601 Sunplex DriveOcean springs, MS 395641-888-526-5449www.alvix.comLIVIXIL Pak (Lidocaine 2.5% and Prilocaine 2.5% Cream, USP) with Occlusive Dressing Contains:NOT FOR OPHTHALMIC USE.KEEP CONTAINER TIGHTLY CLOSED AT ALL TIMES WHEN NOT IN USE.Storage: Rx onlyKeep out of the reach of children.Manufactured By:ORFougera Pharmaceuticals, Inc.Melville, NY 11747Packaged By:Alvix Laboratories, LLC6601 Sunplex DriveOcean springs, MS 395641-888-526-5449www.alvix.comLIVIXIL Pak (Lidocaine 2.5% and Prilocaine 2.5% Cream, USP) with Occlusive Dressing Contains:NOT FOR OPHTHALMIC USE.KEEP CONTAINER TIGHTLY CLOSED AT ALL TIMES WHEN NOT IN USE.Storage: Rx onlyKeep out of the reach of children.Manufactured By:ORFougera Pharmaceuticals, Inc.Melville, NY 11747Packaged By:Alvix Laboratories, LLC6601 Sunplex DriveOcean springs, MS 395641-888-526-5449www.alvix.comLIVIXIL Pak (Lidocaine 2.5% and Prilocaine 2.5% Cream, USP) with Occlusive Dressing Contains:NOT FOR OPHTHALMIC USE.KEEP CONTAINER TIGHTLY CLOSED AT ALL TIMES WHEN NOT IN USE.Storage: Rx onlyKeep out of the reach of children.Manufactured By:ORFougera Pharmaceuticals, Inc.Melville, NY 11747Packaged By:Alvix Laboratories, LLC6601 Sunplex DriveOcean springs, MS 395641-888-526-5449www.alvix.comLIVIXIL Pak (Lidocaine 2.5% and Prilocaine 2.5% Cream, USP) with Occlusive Dressing Contains:NOT FOR OPHTHALMIC USE.KEEP CONTAINER TIGHTLY CLOSED AT ALL TIMES WHEN NOT IN USE.Storage: Rx onlyKeep out of the reach of children.Manufactured By:ORFougera Pharmaceuticals, Inc.Melville, NY 11747Packaged By:Alvix Laboratories, LLC6601 Sunplex DriveOcean springs, MS 395641-888-526-5449www.alvix.comLIVIXIL Pak (Lidocaine 2.5% and Prilocaine 2.5% Cream, USP) with Occlusive Dressing Contains:NOT FOR OPHTHALMIC USE.KEEP CONTAINER TIGHTLY CLOSED AT ALL TIMES WHEN NOT IN USE.Storage: Rx onlyKeep out of the reach of children.Manufactured By:ORFougera Pharmaceuticals, Inc.Melville, NY 11747Packaged By:Alvix Laboratories, LLC6601 Sunplex DriveOcean springs, MS 395641-888-526-5449www.alvix.comLIVIXIL Pak (Lidocaine 2.5% and Prilocaine 2.5% Cream, USP) with Occlusive Dressing Contains:NOT FOR OPHTHALMIC USE.KEEP CONTAINER TIGHTLY CLOSED AT ALL TIMES WHEN NOT IN USE.Storage: Rx onlyKeep out of the reach of children.Manufactured By:ORFougera Pharmaceuticals, Inc.Melville, NY 11747Packaged By:Alvix Laboratories, LLC6601 Sunplex DriveOcean springs, MS 395641-888-526-5449www.alvix.comLIVIXIL Pak (Lidocaine 2.5% and Prilocaine 2.5% Cream, USP) with Occlusive Dressing Contains:NOT FOR OPHTHALMIC USE.KEEP CONTAINER TIGHTLY CLOSED AT ALL TIMES WHEN NOT IN USE.Storage: Rx onlyKeep out of the reach of children.Manufactured By:ORFougera Pharmaceuticals, Inc.Melville, NY 11747Packaged By:Alvix Laboratories, LLC6601 Sunplex DriveOcean springs, MS 395641-888-526-5449www.alvix.comLIVIXIL Pak (Lidocaine 2.5% and Prilocaine 2.5% Cream, USP) with Occlusive Dressing Contains:NOT FOR OPHTHALMIC USE.KEEP CONTAINER TIGHTLY CLOSED AT ALL TIMES WHEN NOT IN USE.Storage: Rx onlyKeep out of the reach of children.Manufactured By:ORFougera Pharmaceuticals, Inc.Melville, NY 11747Packaged By:Alvix Laboratories, LLC6601 Sunplex DriveOcean springs, MS 395641-888-526-5449www.alvix.comLIVIXIL Pak (Lidocaine 2.5% and Prilocaine 2.5% Cream, USP) with Occlusive Dressing Contains:NOT FOR OPHTHALMIC USE.KEEP CONTAINER TIGHTLY CLOSED AT ALL TIMES WHEN NOT IN USE.Storage: Rx onlyKeep out of the reach of children.Manufactured By:ORFougera Pharmaceuticals, Inc.Melville, NY 11747Packaged By:Alvix Laboratories, LLC6601 Sunplex DriveOcean springs, MS 395641-888-526-5449www.alvix.comLIVIXIL Pak (Lidocaine 2.5% and Prilocaine 2.5% Cream, USP) with Occlusive Dressing Contains:NOT FOR OPHTHALMIC USE.KEEP CONTAINER TIGHTLY CLOSED AT ALL TIMES WHEN NOT IN USE.Storage: Rx onlyKeep out of the reach of children.Manufactured By:ORFougera Pharmaceuticals, Inc.Melville, NY 11747Packaged By:Alvix Laboratories, LLC6601 Sunplex DriveOcean springs, MS 395641-888-526-5449www.alvix.comLIVIXIL Pak (Lidocaine 2.5% and Prilocaine 2.5% Cream, USP) with Occlusive Dressing Contains:NOT FOR OPHTHALMIC USE.KEEP CONTAINER TIGHTLY CLOSED AT ALL TIMES WHEN NOT IN USE.Storage: Rx onlyKeep out of the reach of children.Manufactured By:ORFougera Pharmaceuticals, Inc.Melville, NY 11747Packaged By:Alvix Laboratories, LLC6601 Sunplex DriveOcean springs, MS 395641-888-526-5449www.alvix.comLIVIXIL Pak (Lidocaine 2.5% and Prilocaine 2.5% Cream, USP) with Occlusive Dressing Contains:NOT FOR OPHTHALMIC USE.KEEP CONTAINER TIGHTLY CLOSED AT ALL TIMES WHEN NOT IN USE.Storage: Rx onlyKeep out of the reach of children.Manufactured By:ORFougera Pharmaceuticals, Inc.Melville, NY 11747Packaged By:Alvix Laboratories, LLC6601 Sunplex DriveOcean springs, MS 395641-888-526-5449www.alvix.comLIVIXIL Pak (Lidocaine 2.5% and Prilocaine 2.5% Cream, USP) with Occlusive Dressing Contains:NOT FOR OPHTHALMIC USE.KEEP CONTAINER TIGHTLY CLOSED AT ALL TIMES WHEN NOT IN USE.Storage: Rx onlyKeep out of the reach of children.Manufactured By:ORFougera Pharmaceuticals, Inc.Melville, NY 11747Packaged By:Alvix Laboratories, LLC6601 Sunplex DriveOcean springs, MS 395641-888-526-5449www.alvix.comLIVIXIL Pak (Lidocaine 2.5% and Prilocaine 2.5% Cream, USP) with Occlusive Dressing Contains:NOT FOR OPHTHALMIC USE.KEEP CONTAINER TIGHTLY CLOSED AT ALL TIMES WHEN NOT IN USE.Storage: Rx onlyKeep out of the reach of children.Manufactured By:ORFougera Pharmaceuticals, Inc.Melville, NY 11747Packaged By:Alvix Laboratories, LLC6601 Sunplex DriveOcean springs, MS 395641-888-526-5449www.alvix.comLIVIXIL Pak (Lidocaine 2.5% and Prilocaine 2.5% Cream, USP) with Occlusive Dressing Contains:NOT FOR OPHTHALMIC USE.KEEP CONTAINER TIGHTLY CLOSED AT ALL TIMES WHEN NOT IN USE.Storage: Rx onlyKeep out of the reach of children.Manufactured By:ORFougera Pharmaceuticals, Inc.Melville, NY 11747Packaged By:Alvix Laboratories, LLC6601 Sunplex DriveOcean springs, MS 395641-888-526-5449www.alvix.com
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Mechanism of Action:
The onset, depth and duration of dermal analgesia on intact skin provided by lidocaine and prilocaine cream depend primarily on the duration of application. To provide sufficient analgesia for clinical procedures such as intravenous catheter placement and venipuncture, lidocaine and prilocaine cream should be applied under an occlusive dressing for at least 1 hour. To provide dermal analgesia for clinical procedures such as split skin graft harvesting, lidocaine and prilocaine cream should be applied under occlusive dressing for at least 2 hours. 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. Absorption from the genital mucosa is more rapid and onset time is shorter (5 to 10 minutes) than after application to intact skin. After a 5 to 10 minute application of lidocaine and prilocaine 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).
Dermal application of lidocaine and prilocaine cream may cause a transient, local blanching followed by a transient, local redness or erythema.
Non-Clinical Toxicology
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 Individualization of Dose).
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.
Drug Interactions:
Prilocaine may contribute to the formation of methemoglobin in patients treated with other drugs known to cause this condition
Specific interaction studies with lidocaine/prilocaine and class III anti-arrhythmic drugs (e.g., amiodarone, bretylium, sotalol, doetilide) have not been performed, but caution is advised (see WARNINGS).
Should lidocaine and prilocaine cream be used concomitantly with other products containing lidocaine and/or prilocaine, cumulative doses from all formulations must be considered.
General:
Lidocaine and prilocaine cream should not be applied to open wounds.
Care should be taken not to allow lidocaine and prilocaine cream to come in contact with the eye because animal studies have demonstrated severe eye irritation. Also the loss of protective reflexes can permit corneal irritation and potential abrasion. Absorption of lidocaine and prilocaine cream in conjunctival tissues has not been determined. If eye contact occurs, immediately wash out the eye with water or saline and protect the eye until sensation returns.
Patients allergic to paraaminobenzoic acid derivatives (procaine, tetracaine, benzocaine, etc.) have not shown cross sensitivity to lidocaine and/or prilocaine, however, lidocaine and prilocaine cream should be used with caution in patients with a history of drug sensitivities, especially if the etiologic agent is uncertain.
Patients with severe hepatic disease, because of their inability to metabolize local anesthetics normally, are at greater risk of developing toxic plasma concentrations of lidocaine and prilocaine.
Lidocaine and prilocaine have been shown to inhibit viral and bacterial growth. The effect of lidocaine and prilocaine cream on intradermal injections of live vaccines has not been determined.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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