No

Local Anesthetic

Dental: Amide-type topical anesthetic for use on normal intact skin to provide local analgesia for minor procedures such as I.V. cannulation or venipuncture

Medical: Topical anesthetic for use on normal intact skin to provide local analgesia for minor procedures such as I.V. cannulation or venipuncture; has also been used for painful procedures such as lumbar puncture and skin graft harvesting; for superficial minor surgery of genital mucous membranes and as an adjunct for local infiltration anesthesia in genital mucous membranes.

B

Children <1 month of age

Administration on mucous membranes

Administration on broken or inflamed skin

Children with congenital or idiopathic methemoglobinemia, or in children who are receiving medications associated with drug-induced methemoglobinemia [ie, acetaminophen (overdosage), benzocaine, chloroquine, dapsone, nitrofurantoin, nitroglycerin, nitroprusside, phenazopyridine, phenelzine, phenobarbital, phenytoin, quinine, sulfonamides]

Patients with a documented hypersensitivity to amide type anesthetic agents [ie, lidocaine, prilocaine, dibucaine, mepivacaine, bupivacaine, etidocaine]

Patients with a documented hypersensitivity to any components of EMLA® cream or Tegaderm®

Use with caution in patients receiving class I antiarrhythmic drugs, since systemic absorption occurs and synergistic toxicity is possible

1% to 10%:

Dermatologic: Angioedema, contact dermatitis

Local: Burning, stinging

<1%: Bradycardia, hypotension, shock, edema, nervousness, euphoria, confusion, dizziness, drowsiness, convulsions, CNS excitation, erythema, itching, rash, urticaria, methemoglobinemia in infants, blanching, alteration in temperature sensation, tenderness, tremors, blurred vision, tinnitus, respiratory depression, bronchospasm

Increased toxicity:

Drugs known to induce methemoglobinemia

Store at room temperature

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

Onset of action: 1 hour for sufficient dermal analgesia

Peak effect: 2-3 hours

Duration: 1-2 hours after removal of the cream

Absorption: Related to the duration of application and to the area over which it is applied

3-hour application: 3.6% lidocaine and 6.1% prilocaine were absorbed

24-hour application: 16.2% lidocaine and 33.5% prilocaine were absorbed

Distribution: Both cross the blood-brain barrier

V_d:

Lidocaine: 1.1-2.1 L/kg

Prilocaine: 0.7-4.4 L/kg

Protein binding:

Lidocaine: 70%

Prilocaine: 55%

Metabolism:

Lidocaine: Metabolized by the liver to inactive and active metabolites

Prilocaine: Metabolized in both the liver and kidneys

Half-life:

Lidocaine: 65-150 minutes, prolonged with cardiac or hepatic dysfunction

Prilocaine: 10-150 minutes, prolonged in hepatic or renal dysfunction

Although the incidence of systemic adverse effects with EMLA® is very low, caution should be exercised, particularly when applying over large areas and leaving on for >2 hours

Dosing is based on child's age and weight:

Age 0-3 months or <5 kg: Apply a maximum of 1 g over no more than 10 cm² of skin and leave on for no longer than 1 hour.

Age 3 months to 12 months and >5 kg: Apply no more than a maximum 2 g total over no more than 20 cm² of skin and leave on for no longer than 4 hours.

Age 1-6 years and >10 kg: Apply no more than a maximum of 10 g total over no more than 100 cm² of skin and leave on for no longer than 4 hours.

Age 7-12 years and >20 kg: Apply no more than a maximum 20 g total over no more than 200 cm² of skin and leave on for no longer than 4 hours.

Note: If a patient greater than 3 months old does not meet the minimum weight requirement, the maximum total dose should be restricted to the corresponding maximum based on patient weight.

Adults (intact skin):

EMLA® cream and EMLA® anesthetic disc: A thick layer of EMLA® cream is applied to intact skin and covered with an occlusive dressing, or alternatively, an EMLA® anesthetic disc is applied to intact skin

Minor dermal procedures (eg, I.V. cannulation or venipuncture): apply 2.5 g of cream (1/2 of the 5 g tube) over 20-25 cm of skin surface area, or 1 anesthetic disc (1 g over 10 cm²) for at least 1 hour. Note: In clinical trials, 2 sites were usually prepared in case there was a technical problem with cannulation or venipuncture at the first site.

EMLA® cream: A thick layer of cream is applied to intact skin and covered with an occlusive dressing

Major dermal procedures (eg, more painful dermatological procedures involving a larger skin area such as split thickness skin graft harvesting): Apply 2 g of cream 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 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 EMLA® cream.

Note: Dermal analgesia can be expected to increase for up to 3 hours under occlusive dressing and persist for 1-2 hours after removal of the cream

Adult females: Genital mucous membranes: Minor procedures (eg, removal of condylomata acuminata, pretreatment for local anesthetic infiltration): Apply 5-10 g (thick layer) of cream for 5-10 minutes

No information available to require special precautions

No effects or complications reported

This drug will block sensation to the applied area. Report irritation, pain, burning at application site.

In small infants and children, an occlusive bandage should be placed over the EMLA® cream to prevent the child from placing the cream in his mouth

Cream: Lidocaine 2.5% and prilocaine 2.5% [2 Tegaderm® dressings] (5 g, 30 g)

Disc, anesthetic: 1 g

Broadman LM, Soliman IE, Hannallah RS, et al, "Analgesic Efficacy of Eutectic Mixture of Local Anesthetics (EMLA®) vs Intradermal Infiltration Prior to Venous Cannulation in Children," Am J Anaesth, 1987, 34:S56.

Halperin DL, Koren G, Attias D, et al, "Topical Skin Anesthesia for Venous Subcutaneous Drug Reservoir and Lumbar Puncture in Children," Pediatrics, 1989, 84(2):281-4.

Robieux I, Kumar R, Radhakrishnan S, et al, "Assessing Pain and Analgesia With a Lidocaine-Prilocaine Emulsion in Infants and Toddlers During Venipuncture," J Pediatr, 1991, 118(6):971-3.

Taddio A, Shennan AT, Stevens B, et al, "Safety of Lidocaine-Prilocaine Cream in the Treatment of Preterm Neonates," J Pediatr, 1995, 127(6):1002-5.

Vickers ER, Mazbani N, Gerzina TM, et al, "Pharmacokinetics of EMLA Cream 5% Application to Oral Mucosa," Anesth Prog, 1997, 44:32-7.