Version May 2024
Anesthetic: Topical:
Cream (intact skin): Note: Apply a thick layer to intact skin and cover with an occlusive dressing. Dermal analgesia can be expected to increase for up to 3 hours under occlusive dressing and persist for 1 to 2 hours after removal of the cream.
US labeling:
Minor dermal procedures (eg, IV cannulation or venipuncture): Apply 2.5 g (1/2 of the 5 g tube) over 20 to 25 cm2 of skin surface area) for at least 1 hour
Major dermal procedures (eg, more painful dermatological procedures involving a larger skin area such as split thickness skin graft harvesting): Apply 2 g per 10 cm2 of skin and allow to remain in contact with the skin for at least 2 hours.
Adult male genital skin (eg, pretreatment prior to local anesthetic infiltration): Apply 1 g per 10 cm2 to the skin surface for 15 minutes. Local anesthetic infiltration should be performed immediately after removal of cream.
Adult female genital mucous membranes: Minor procedures (eg, removal of condylomata acuminata, pretreatment for local anesthetic infiltration): Apply 5 to 10 g for 5 to 10 minutes. The local anesthetic infiltration or procedure should be performed immediately after removal of cream.
Canadian labeling:
Minor dermal procedures (eg, IV cannulation, venipuncture, surgical or laser treatment): Apply 2 g (~1/2 of the 5 g tube) over ~13.5 cm2 for at least 1 hour but no longer than 5 hours
Major dermal procedures (eg, split-skin grafting): 1.5 to 2 g per 10 cm2 (maximum: 60 g per 400 cm2) for at least 2 hours but no longer than 5 hours
Genital mucosa (eg, surgical procedures ≤10 minutes such as localized wart removal, and prior to local anesthetic infiltration): Apply 2 g (~1/2 of 5 g tube) per lesion (maximum: 10 g) for 5 to 10 minutes. Initiate procedure immediately after removing cream.
Leg ulcers (eg, mechanical cleansing/surgical debridement): Apply ~1 to 2 g per 10 cm2 (maximum: 10 g) for at least 30 minutes and up to 60 minutes for necrotic tissue that is more difficult to penetrate. Initiate procedure immediately after removing cream.
Periodontal gel: Apply on gingival margin around selected teeth using the blunt-tipped applicator included in package. Wait 30 seconds, then fill the periodontal pockets using the blunt-tipped applicator until gel becomes visible at the gingival margin. Wait another 30 seconds before starting treatment. May reapply; maximum recommended dose: One treatment session: 5 cartridges (8.5 g)
Transdermal patch [Canadian product]: Minor procedures (eg, needle insertion): Apply 1 or more patches to intact skin surface area <10 cm2 for at least 1 hour (maximum application time: 5 hours)
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
There are no dosage adjustments provided in the manufacturer labeling. Lidocaine and prilocaine primarily undergo hepatic metabolism and their pharmacokinetics are not expected to be changed significantly in renal impairment.
Smaller areas of treatment are recommended for patients with severe hepatic impairment.
Refer to adult dosing. Initiate at the low end of the dosing range; use with caution.
(For additional information see "Lidocaine and prilocaine: Pediatric drug information")
Note: Smaller areas of treatment recommended in smaller or debilitated patients or patients with impaired elimination; decreasing the duration of application may decrease analgesic effect, however maximum application duration times should not be exceeded.
US labeling:
Minor dermal procedures (eg, IV access, venipuncture, IM injection); anesthetic: Note: General dosing information provided, dose should be individualized based on procedure and area to be anesthetized.
Infants and Children: Topical:
<5 kg: Apply ≤1 g per 10 cm2 area; cover with an occlusive dressing for usual duration of application of 60 minutes prior to procedure. Maximum dosing information for a 24-hour period: Maximum total dose (for all sites combined): 1 g; maximum application area: 10 cm2; maximum application time: 1 hour.
5 kg to 10 kg: Apply 1 to 2 g per 10 cm2 area; cover with occlusive dressing for at least 60 minutes. Maximum dosing information for a 24-hour period: Maximum total dose (for all sites combined): 2 g; maximum application area: 20 cm2; maximum application time: 4 hours.
>10 kg to 20 kg: Apply 1 to 2 g per 10 cm2 area; cover with occlusive dressing for at least 60 minutes. Maximum dosing information for a 24-hour period: Maximum total dose (for all sites combined): 10 g; maximum application area: 100 cm2; maximum application time: 4 hours.
>20 kg: Apply 1 to 2 g per 10 cm2 area; cover with occlusive dressing for at least 60 minutes. Maximum dosing information for a 24-hour period: Maximum total dose (for all sites combined): 20 g; maximum application area: 200 cm2; maximum application time: 4 hours.
Adolescents: Apply 2.5 g of cream (1/2 of the 5 g tube) over 20 to 25 cm2 of skin surface area for at least 1 hour.
Major dermal procedures (eg, more painful dermatological procedures involving a larger skin area such as split thickness skin graft harvesting); anesthetic: Adolescents: Topical: Apply 2 g of cream per 10 cm2 of skin and allow to remain in contact with the skin for at least 2 hours.
Male genital skin, pretreatment prior to local anesthetic infiltration: Adolescents: Topical: Apply 1 g per 10 cm2 to the skin surface for 15 minutes. Local anesthetic infiltration should be performed immediately after removal of cream.
Female genital mucous membranes, anesthetic: Minor procedures (eg, removal of condylomata acuminata, pretreatment for local anesthetic infiltration): Adolescents: Topical: Apply 5 to 10 g of cream for 5 to 10 minutes.
Canadian labeling:
Local anesthetic: General dosing information provided, dose should be individualized based on procedure and area to be anesthetized.
Transdermal patch [Canadian product]: Note: Dosing is based on child's age and weight; if a patient is ≥3 months and is smaller than weight requirement, defer to maximum dose for the patient's weight.
Apply patch(es) to skin area(s) <10 cm2:
Infants <3 months or <5 kg: Topical: Apply 1 patch and leave on for ~1 hour; maximum dose: 1 patch; maximum application time: 1 hour. Do not apply more than 1 patch at same time.
Infants ≥3 months and >5 kg: Topical: Apply 1 to 2 patches for ~1 hour; maximum dose: 2 patches; maximum application time: 4 hours.
Children ≤6 years and >10 kg: Topical: Apply 1 or more patches for minimum of 1 hour; maximum dose: 10 patches; maximum application time: 5 hours.
Children ≥7 years and >20 kg and Adolescents: Topical: Apply 1 or more patches for a minimum of 1 hour; maximum dose: 20 patches; maximum application time: 5 hours.
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
There are no dosage adjustments provided in the manufacturer labeling. Lidocaine and prilocaine primarily undergo hepatic metabolism and their pharmacokinetics are not expected to be changed significantly in renal impairment.
Smaller areas of treatment are recommended for patients with severe hepatic impairment.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Also see individual agents.
Cream:
>10%:
Local: Application-site reaction (41% to 56%; including application-site burning [17%], application-site edema [6% to 10%], application-site erythema [21% to 30%], application-site local purpuric or petechial reaction, application-site pruritus [2%], application-site rash [<1%], local alterations in temperature sensations [7%], local skin hyperpigmentation, localized blanching [37%])
Postmarketing: Genitourinary: Blistering of foreskin
Periodontal gel:
>10%: Local: Application-site reaction (13%, includes application-site edema, application-site erythema, application-site irritation, application-site pain, application-site vesicles, oral mucosa ulcer, oral paresthesia, periodontal abscess)
1% to 10%:
Gastrointestinal: Bitter taste (2%), nausea (1%)
Nervous system: Fatigue (1%)
Respiratory: Flu-like symptoms (1%), respiratory tract infection (1%)
Hypersensitivity to local anesthetics of the amide type or any component of the formulation
Canadian labeling: Additional contraindications (not in US labeling): Congenital or idiopathic methemoglobinemia.
Cream and patch only: Infants ≤12 months of age who require treatment with methemoglobin-inducing agents; preterm infants (gestational age <37 weeks); procedures requiring large amounts over a large body area that are not conducted in a facility with health care professionals trained in the diagnosis and management of dose-related toxicity and other acute emergencies, and with appropriate resuscitative treatments and equipment.
Concerns related to adverse effects:
• Hypersensitivity: Allergic and anaphylactic reactions may occur. Patients allergic to paraaminobenzoic acid derivatives (eg, procaine, tetracaine, benzocaine) have not shown cross sensitivity to lidocaine and/or prilocaine; use with caution in patients with a history of drug sensitivities.
• Methemoglobinemia: Has been reported with local anesthetics; clinically significant methemoglobinemia requires immediate treatment along with discontinuation of the anesthetic and other oxidizing agents. Onset may be immediate or delayed (hours) after anesthetic exposure. Patients with glucose-6-phosphate dehydrogenase deficiency, congenital or idiopathic methemoglobinemia, cardiac or pulmonary compromise, exposure to oxidizing agents or their metabolites, or infants <6 months of age are more susceptible and should be closely monitored for signs and symptoms of methemoglobinemia (eg, cyanosis, headache, rapid pulse, shortness of breath, lightheadedness, fatigue).
Disease-related concerns:
• Atopic dermatitis: Use with caution; rapid and greater absorption through the skin is observed in these patients; a shorter application time should be used.
• Cardiovascular disease: Use with caution in patients with severe impairment of impulse initiation and conduction in the heart (eg, grade II and III AV block, pronounced bradycardia).
• Glucose-6-phosphate dehydrogenase (G6PD) deficiency: Patients with G6PD may be more susceptible to drug-induced methemoglobinemia.
• Hepatic impairment: Use with caution in patients with severe hepatic impairment; risk of increased systemic exposure. Smaller treatment area may be required.
Special populations:
• Acutely ill patients: Use with caution in acutely ill; smaller treatment area may be required consistent with age and physical status.
• Debilitated patients: Use with caution in debilitated patients; smaller treatment area may be required consistent with age and physical status.
• Older adult: Use with caution in elderly patients; smaller treatment area may be required consistent with age and physical status.
Dosage forms specific issues:
• Periodontal gel: Do not use with standard dental syringes; only use with the supplied blunt-tipped applicator.
Other warnings/precautions:
• Appropriate use: Although the incidence of systemic adverse reactions with use of the cream is very low, caution should be exercised, particularly when applying over large areas and leaving on for longer than 2 hours. When used prior to cosmetic or medical procedures, the smallest amount of cream necessary for pain relief should be applied. High systemic levels and toxic effects (eg, methemoglobinemia, irregular heartbeats, respiratory depression, seizures, death) have been reported in patients who (without supervision of a trained professional) have applied topical anesthetics in large amounts (or to large areas of the skin), left these products on for a prolonged time, or have used wraps/dressings to cover the skin following application. Do not apply to broken or inflamed skin, open wounds, or near the eyes. Avoid use in situations where penetration or migration past the tympanic membrane into the middle ear is possible; ototoxicity has been observed in animal studies. Avoid inadvertent trauma to the treated area (eg, scratching, rubbing, exposure to extreme hot or cold temperatures) until complete sensation has returned.
Adjust dose in patients with increased risk for methemoglobinemia; use smaller areas for application in small children (especially infants <3 months of age). In small infants and children, an occlusive bandage may prevent the child from placing the cream in his/her mouth or smearing the cream on the eyes.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product
Cream, topical:
AgonEaze: Lidocaine 2.5% and prilocaine 2.5% (2 x 30 g) [packaged with occlusive dressing]
Anodyne LPT: Lidocaine 2.5% and prilocaine 2.5% (3 x 30 g) [packaged with occlusive dressing]
DermacinRx Empricaine: Lidocaine 2.5% and prilocaine 2.5% (1 x 30 g) [packaged with occlusive dressing]
DermacinRx Prizopak: Lidocaine 2.5% and prilocaine 2.5% (3 x 30 g) [packaged with occlusive dressing]
Lido BDK: Lidocaine 2.5% and prilocaine 2.5% (5 g)
Lidopril: Lidocaine 2.5% and prilocaine 2.5% (3 x 30 g) [packaged with occlusive dressing] [DSC]
Lidopril XR: Lidocaine 2.5% and prilocaine 2.5% (2 x 30 g) [packaged with occlusive dressing] [DSC]
Livixil Pak: Lidocaine 2.5% and prilocaine 2.5% (3 x 30 g) [packaged with occlusive dressing]
Prikaan: Lidocaine 2.5% and Prilocaine 2.5% (3 x 30 g) [packaged with occlusive dressing]
Prikaan Lite: Lidocaine 2.5% and Prilocaine 2.5% (1 x 30 g) [packaged with occlusive dressing]
Prilolid: Lidocaine 2.5% and prilocaine 2.5% (1 x 30 g) [packaged with occlusive dressing] [DSC]
Prilovix Versipac: Lidocaine 2.5% and prilocaine 2.5% (3 x 30 g) [packaged with occlusive dressing]
Prizotral II: Lidocaine 2.5% and prilocaine 2.5% (3 x 30 g) with lidocaine HCl 3.88% (85 g)
Relador Pak: Lidocaine 2.5% and prilocaine 2.5% (3 x 30 g) [packaged with occlusive dressing]
Generic: Lidocaine 2.5% and prilocaine 2.5% (5 g, 30 g, 5800 g, 18,000 g)
Gel, periodontal:
Oraqix: Lidocaine 2.5% and prilocaine 2.5% (1.7 g)
Yes: Cream
Cream (Lidocaine-Prilocaine External)
2.5-2.5% (per gram): $1.84 - $1.98
Kit (Aprizio Pak External)
2.5-2.5% (per each): $2,025.00
Kit (CadiraMD External)
2.5-2.5% (per each): $259.00
Kit (Lido BDK External)
2.5-2.5% (per each): $249.00
Kit (Lidocaine-Prilocaine External)
2.5-2.5% (per each): $49.58
Kit (Lidotor External)
2.5-2.5% (per each): $2,275.00
Kit (Livixil Pak External)
2.5-2.5% (per each): $1,743.37
Kit (Prilo Patch External)
2.5-2.5 & 5% (per each): $4,623.00
Kit (Relador Pak External)
2.5-2.5% (per each): $1,651.86
Kit (Relador Pak Plus External)
2.5-2.5% (per each): $1,675.86
Kit (SkyaDerm-LP External)
2.5-2.5% (per each): $1,825.00
Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Patch, transdermal:
EMLA Patch: Lidocaine 2.5% and prilocaine 2.5% per patch (2s, 20s) [active contact surface area of each 1 g patch: 10 cm2; surface area of entire patch: 40 cm2]
Topical:
Cream: For external use only. Avoid application to open wounds or near the eyes. Avoid use in situations where penetration or migration past the tympanic membrane into the middle ear is possible. In small infants and children, observe patient to prevent accidental ingestion of cream or dressing. To obtain 1 g of cream, squeeze narrow strip ~1.5 inches long and 0.2 inches wide from tube. Repeat as necessary to obtain quantity needed for dose (eg, 2 strips = 2 g dose). Apply a thick layer of cream to designated site of intact skin. Cover site with occlusive dressing. Mark the time on the dressing. Allow at least 1 hour (mild dermatologic procedures) or at least 2 hours (major dermal procedures) for optimum therapeutic effect. Remove the dressing and wipe off excess cream (gloves should be worn). Smaller areas of treatment are recommended for small children, debilitated patients, or patients with severe hepatic impairment.
Periodontal gel: Make sure gel is in the liquid form before administration. If semisolid gel forms, refrigerate until becomes liquid again (do not freeze). Do not use dental cartridge warmers; heat will cause product to gel prematurely (product is a microemulsion that is intended to form a gel in the periodental pocket). Apply slowly and evenly on gingival margin around selected teeth using the provided blunt-tipped applicator. Wait 30 seconds, then fill the periodontal pockets using the blunt-tipped applicator until gel becomes visible at the gingival margin. Wait another 30 seconds before starting treatment.
Transdermal patch [Canadian product]: Apply patch or patches to intact skin. Allow at least 1 hour for optimum therapeutic effect. After removing patch or patches, clean treated areas thoroughly prior to procedure.
Topical:
Cream: For external use only. Avoid application to open wounds or near the eyes. Avoid use in situations where penetration or migration past the tympanic membrane into the middle ear is possible. In small infants and children, observe patient to prevent accidental ingestion of cream or dressing. To obtain 1 g of cream, squeeze narrow strip ~1.5 inches long and 0.2 inches wide from tube. Repeat as necessary to obtain quantity needed for dose (eg, 2 strips = 2 g dose). Apply a thick layer of cream to designated site of intact skin. Cover site with occlusive dressing. Mark the time on the dressing. Allow at least 1 hour (mild dermatologic procedures) or at least 2 hours (major dermal procedures) for optimum therapeutic effect. Remove the dressing and wipe off excess cream (gloves should be worn). Smaller areas of treatment are recommended for small children, debilitated patients, or patients with severe hepatic impairment.
Transdermal patch [Canadian product]: Apply patch or patches to intact skin. After removing patch or patches, clean treated areas thoroughly prior to procedure.
US labeling:
Cream: Topical anesthetic for use on normal intact skin to provide local analgesia; for use on genital mucous membranes for superficial minor surgery; and as pretreatment for infiltration anesthesia.
Periodontal gel: Topical anesthetic for use in periodontal pockets during scaling and/or root planing procedures
Canadian labeling:
Cream: Topical anesthetic for use on intact skin in connection with: IV cannulation or venipuncture; superficial surgical procedures (eg, split skin grafting, electrolysis, removal of molluscum contagiosum); laser treatment for superficial skin surgery (eg, telangiectasia, port wine birthmarks, warts, moles, skin nodules, scar tissue); surgical procedures of genital mucosa (≤10 minutes) on small superficial localized lesions (eg, removal of condylomata by laser or cautery, biopsies); local infiltration anesthesia in genital mucous membranes; mechanical cleansing/debridement of leg ulcers; vaccination with measles-mumps-rubella (MMR), diphtheria-pertussis-tetanus-poliovirus (DPTP), Haemophilus influenzae b, and hepatitis B.
Patch: Topical anesthetic for use on intact skin in connection with IV cannulation or venipuncture; vaccination with measles-mumps-rubella (MMR), diphtheria-pertussis-tetanus-poliovirus (DPTP), Haemophilus influenzae b, and hepatitis B.
Periodontal gel: Topical anesthetic for use in periodontal pockets during scaling and/or root planing procedures
Anacin [Korea] may be confused with Anacin 3 brand name for acetaminophen [Taiwan]; Anacin 81 brand name for aspirin [Puerto Rico]; Anacin New brand name for acetaminophen/caffeine [India]
Refer to individual components.
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.
Antiarrhythmic Agents (Class IB): Lidocaine (Topical) may enhance the adverse/toxic effect of Antiarrhythmic Agents (Class IB). Risk C: Monitor therapy
BUPivacaine: Local Anesthetics may enhance the adverse/toxic effect of BUPivacaine. Management: Avoid using any additional local anesthetics within 96 hours after insertion of the bupivacaine implant (Xaracoll) or bupivacaine and meloxicam periarticular solution (Zynrelef) or within 168 hours after subacromial infiltration (Posimir brand). Risk C: Monitor therapy
BUPivacaine (Liposomal): Local Anesthetics may enhance the adverse/toxic effect of BUPivacaine (Liposomal). Management: Liposomal bupivacaine should not be administered with local anesthetics, but may be administered 20 minutes or more after lidocaine. Avoid all local anesthetics within 96 hours after administration of liposomal bupivacaine. Risk X: Avoid combination
Cimetidine: May increase the serum concentration of Lidocaine (Topical). Risk C: Monitor therapy
Dapsone (Topical): May enhance the adverse/toxic effect of Methemoglobinemia Associated Agents. Risk C: Monitor therapy
Hyaluronidase: May enhance the adverse/toxic effect of Local Anesthetics. Risk C: Monitor therapy
Local Anesthetics: Methemoglobinemia Associated Agents may enhance the adverse/toxic effect of Local Anesthetics. Specifically, the risk for methemoglobinemia may be increased. Risk C: Monitor therapy
Methemoglobinemia Associated Agents: May enhance the adverse/toxic effect of Prilocaine. Combinations of these agents may increase the likelihood of significant methemoglobinemia. Management: Monitor patients for signs of methemoglobinemia (e.g., hypoxia, cyanosis) when prilocaine is used in combination with other agents associated with development of methemoglobinemia. Avoid lidocaine/prilocaine in infants receiving such agents. Risk C: Monitor therapy
Neuromuscular-Blocking Agents: Local Anesthetics may enhance the neuromuscular-blocking effect of Neuromuscular-Blocking Agents. Risk C: Monitor therapy
Nitric Oxide: May enhance the adverse/toxic effect of Methemoglobinemia Associated Agents. Combinations of these agents may increase the likelihood of significant methemoglobinemia. Risk C: Monitor therapy
Prilocaine: Methemoglobinemia Associated Agents may enhance the adverse/toxic effect of Prilocaine. Combinations of these agents may increase the likelihood of significant methemoglobinemia. Management: Monitor patients for signs of methemoglobinemia (e.g., hypoxia, cyanosis) when prilocaine is used in combination with other agents associated with development of methemoglobinemia. Avoid lidocaine/prilocaine in infants receiving such agents. Risk C: Monitor therapy
Sodium Nitrite: Methemoglobinemia Associated Agents may enhance the adverse/toxic effect of Sodium Nitrite. Combinations of these agents may increase the likelihood of significant methemoglobinemia. Risk C: Monitor therapy
Technetium Tc 99m Tilmanocept: Local Anesthetics may diminish the diagnostic effect of Technetium Tc 99m Tilmanocept. Management: Avoid mixing and simultaneously co-injecting technetium Tc 99m tilmanocept with local anesthetics. This interaction does not appear to apply to other uses of these agents in combination. Risk C: Monitor therapy
Animal reproduction studies have not been conducted with this combination. Lidocaine and prilocaine cross the placenta. Their use is not contraindicated during labor and delivery. Refer to individual agents.
Lidocaine is excreted in breast milk; excretion of prilocaine in breast milk unknown; however, systemic absorption following topical application is expected to be low. The manufacturer recommends that caution be exercised when administering to nursing women. Refer to individual agents.
Serum methemoglobin before, during, and after use in neonates and infants up to 3 months of age. Consider ECG monitoring in patients treated with Class III antiarrhythmic drugs (eg, amiodarone).
Local anesthetic action occurs by stabilization of neuronal membranes and inhibiting the ionic fluxes required for the initiation and conduction of impulses
Also see individual agents.
Cream:
Onset of action: 1 hour (more rapid in genital mucosa: 5 to 10 minutes)
Peak effect: 2 to 3 hours
Duration: 1 to 2 hours after removal; Genital mucosa: 15 to 20 minutes after application (range: 5 to 45 minutes)
Absorption: Related to duration of application and area where applied
3-hour application: 3.6% lidocaine and 6.1% prilocaine
24-hour application: 16.2% lidocaine and 33.5% prilocaine
Periodontal gel:
Onset of action: ≤30 seconds
Duration: ~20 minutes
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