Lidocaine and Prilocaine

Dosage Forms

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]

Dolotranz: Lidocaine 2.5% and prilocaine 2.5% (3 x 30 g) [packaged with lidocaine gel 4%] [DSC]

EMLA: Lidocaine 2.5% and prilocaine 2.5% (5 g [DSC], 30 g [DSC])

Leva Set: Lidocaine 2.5% and prilocaine 2.5% (3 x 30 g) [packaged with occlusive dressing] [DSC]

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]

Lidopril XR: Lidocaine 2.5% and prilocaine 2.5% (2 x 30 g) [packaged with occlusive dressing]

LiProZonePak: Lidocaine 2.5% and prilocaine 2.5% (3 x 30 g) [packaged with occlusive dressing]

Livixil Pak: Lidocaine 2.5% and prilocaine 2.5% (3 x 30 g) [packaged with occlusive dressing]

LP Lite Pak: Lidocaine 2.5% and prilocaine 2.5% (2 x 30 g) [packaged with occlusive dressing] [DSC]

Medolor 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]

Prilovix Versipac: Lidocaine 2.5% and prilocaine 2.5% (3 x 30 g) [packaged with occlusive dressing]

Priloxx LP: Lidocaine 2.5% and prilocaine 2.5% [DSC]

Relador Pak: Lidocaine 2.5% and prilocaine 2.5% (3 x 30 g) [packaged with occlusive dressing]

Venipuncture CPI: Lidocaine 2.5% and prilocaine 2.5% (5 g) [DSC]

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)

Pharmacology

Mechanism of Action

Local anesthetic action occurs by stabilization of neuronal membranes and inhibiting the ionic fluxes required for the initiation and conduction of impulses

Pharmacokinetics/Pharmacodynamics

Absorption

EMLA: 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

Onset of Action

EMLA: 1 hour (more rapid in genital mucosa: 5 to 10 minutes); Peak effect: 2 to 3 hours

Oraqix: ≤30 seconds

Duration of Action

EMLA: 1 to 2 hours after removal; Genital mucosa: 15 to 20 minutes after application (range: 5 to 45 minutes)

Oraqix: ~20 minutes

Use: Labeled Indications

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 stains, 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

Contraindications

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.

Dosage and Administration

Dosing: Adult

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 (Oraqix): 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)

Dosing: Geriatric

Smaller areas of treatment may be necessary depending on status of patient (eg, debilitated, impaired hepatic function). Refer to adult dosing.

Dosing: Pediatric

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.

Minor dermal procedures (eg, intravenous access, venipuncture, intramuscular injection); anesthetic:

Topical cream: General dosing information provided, dose should be individualized based on procedure and area to be anesthetized.

Infants and Children: Dosing based on patient weight:

<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:

Topical cream: Adolescents: 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 (eg, pretreatment prior to local anesthetic infiltration): Apply a thick layer of cream (1 g/10 cm²) to the skin surface for 15 minutes. Local anesthetic infiltration should be performed immediately after removal of cream.

Female genital mucous membranes: Minor procedures (eg, removal of condylomata acuminata, pretreatment for local anesthetic infiltration): Apply 5 to 10 g (thick layer) 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.

Topical cream: 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:

Infants <3 months or <5 kg: Apply ≤1 g on up to 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

Infants ≥3 months and >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): 2 g; maximum application area: 20 cm²; maximum application time: 4 hours

Children ≤6 years and >10 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): 10 g; maximum application area: 100 cm²; maximum application time: 5 hours

Children ≥7 years and >20 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): 20 g; maximum application area: 200 cm²; maximum application time: 5 hours

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: 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: Apply 1 to 2 patches for ~1 hour; maximum dose: 2 patches; maximum application time: 4 hours

Children ≤6 years and >10 kg: 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: Apply 1 or more patches for a minimum of 1 hour; maximum dose: 20 patches; maximum application time: 5 hours

Administration

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. Allow at least 1 hour for optimum therapeutic effect. After removing patch or patches, clean treated areas thoroughly prior to procedure.

Oraqix is a viscous liquid. Make sure it 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 which 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.

Storage

Cream:

US labeling: Store between 20°C to 25°C (68°F to 77°F).

Canadian labeling: Store between 15°C to 30°C (59°F to 86°F).

Patch (Canadian availability; not available in the US): Store between 15°C to 30°C (59°F to 86°F); do not freeze.

Periodontal gel: Store at 25°C (77°F); excursions permitted between 15°C and 30°C (59°F and 86°F); do not freeze. May turn opaque at temperature of ≤5°C. 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 periodontal pocket).

Drug Interactions

Antiarrhythmic Agents (Class III): Lidocaine (Topical) may enhance the arrhythmogenic effect of Antiarrhythmic Agents (Class III). Antiarrhythmic Agents (Class III) may increase the serum concentration of Lidocaine (Topical). This mechanism specifically applies to amiodarone and dronedarone. Monitor therapy

Aprepitant: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Monitor therapy

Beta-Blockers: May increase the serum concentration of Lidocaine (Topical). 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. Liposomal bupivacaine may be administered 20 minutes or more after the administration of lidocaine, but the optimal duration of dose separation for other local anesthetics is unknown Avoid combination

Clofazimine: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Monitor therapy

Conivaptan: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Avoid combination

CYP3A4 Inhibitors (Moderate): May decrease the metabolism of CYP3A4 Substrates (High risk with Inhibitors). Monitor therapy

CYP3A4 Inhibitors (Strong): May decrease the metabolism of CYP3A4 Substrates (High risk with Inhibitors). Consider therapy modification

Dapsone (Topical): May enhance the adverse/toxic effect of Methemoglobinemia Associated Agents. Monitor therapy

Disopyramide: May enhance the arrhythmogenic effect of Lidocaine (Topical). Disopyramide may increase the serum concentration of Lidocaine (Topical). Specifically, the unbound/free fraction of lidocaine. Monitor therapy

Duvelisib: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Monitor therapy

Erdafitinib: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Monitor therapy

Fosaprepitant: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Monitor therapy

Fosnetupitant: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Monitor therapy

Fusidic Acid (Systemic): May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Avoid combination

Hyaluronidase: May enhance the adverse/toxic effect of Local Anesthetics. Monitor therapy

Idelalisib: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Avoid combination

Larotrectinib: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Monitor therapy

Local Anesthetics: Methemoglobinemia Associated Agents may enhance the adverse/toxic effect of Local Anesthetics. Specifically, the risk for methemoglobinemia may be increased. 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. Monitor therapy

MiFEPRIStone: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Management: Minimize doses of CYP3A4 substrates, and monitor for increased concentrations/toxicity, during and 2 weeks following treatment with mifepristone. Avoid cyclosporine, dihydroergotamine, ergotamine, fentanyl, pimozide, quinidine, sirolimus, and tacrolimus. Consider therapy modification

Netupitant: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Monitor therapy

Neuromuscular-Blocking Agents: Local Anesthetics may enhance the neuromuscular-blocking effect of Neuromuscular-Blocking Agents. 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. Monitor therapy

Palbociclib: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). 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. Monitor therapy

Simeprevir: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). 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. Monitor therapy

Stiripentol: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Management: Use of stiripentol with CYP3A4 substrates that are considered to have a narrow therapeutic index should be avoided due to the increased risk for adverse effects and toxicity. Any CYP3A4 substrate used with stiripentol requires closer monitoring. Consider therapy modification

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. Monitor therapy

Adverse Reactions

Cream/patch:

>10%:

Dermatologic: Pallor (local: 37%)

Local: Application site erythema (21% to 30%), application site burning (17%)

1% to 10%:

Central nervous system: Local alterations in temperature sensations (7%)

Local: Application site edema (6% to 10%), application site pruritus (2%)

Frequency not defined:

Dermatologic: Hyperpigmentation, stinging of the skin (local), urticaria

Hematologic & oncologic: Local purpuric or petechial reaction

<1%, postmarketing, and/or case reports: Anaphylactic shock, angioedema, application site rash, blistering of foreskin, bronchospasm, central nervous system depression, central nervous system stimulation, central nervous system toxicity (high dose), circulatory shock (high dose), hypotension, local hypersensitivity reaction, methemoglobinemia (high dose)

Periodontal gel:

>10%: Local: Application site reaction (13%, includes abscess, edema, irritation, numbness, pain, ulceration, vesicles)

1% to 10%:

Central nervous system: Bitter taste (2%), fatigue (1%)

Gastrointestinal: Nausea (1%)

Hypersensitivity: Local hypersensitivity reaction

Respiratory: Flu-like symptoms (1%), respiratory tract infection (1%)

Warnings/Precautions

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.

Concurrent drug therapy issues:

• Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information.

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.
• Elderly: 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.

Monitoring Parameters

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).

Pregnancy

Pregnancy Risk Factor

B

Pregnancy Considerations

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.

Patient Education

What is this drug used for?

• It is used to numb an area of the skin before a procedure.
• It is used to lower pain from shots.
• It is used before dental care to numb the area.

Frequently reported side effects of this drug

• Redness
• Pale skin
• Nausea

Other side effects of this drug: Talk with your doctor right away if you have any of these signs of:

• Methemoglobinemia like blue or gray color of the lips, nails, or skin; abnormal heartbeat; seizures; severe dizziness or passing out; severe headache; fatigue; loss of strength and energy; or shortness of breath.
• Slow heartbeat
• Dizziness
• Passing out
• Lightheadedness
• Fatigue
• Confusion
• Blurred vision
• Change in balance
• Agitation
• Anxiety
• Change in speech
• Tremors
• Twitching
• Noise or ringing in the ears
• Depression
• Trouble breathing
• Slow breathing
• Shallow breathing
• Seizures
• Numbness or tingling in mouth
• Change in taste
• Sensation of warmth
• Sensation of cold
• Vomiting
• Severe application site irritation
• Signs of a significant reaction like wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat.

Note: This is not a comprehensive list of all side effects. Talk to your doctor if you have questions.

Consumer Information Use and Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.