Classes
DEA Class; Rx
Common Brand Names; EMLA, Oraqix
- Anesthetics, Topical
Description
Lidocaine 2.5% and prilocaine 2.5% used for topical and dental anesthesia
Available as a cream and periodontal gel
Cases of methemoglobinemia have been reported in association with lidocaine; prilocaine use; monitoring for signs and symptoms of methemoglobinemia is recommended
Indications
Indicated for use as local anesthesia to provide topical anesthesia.
Contraindications
Hypersensitivity to components, amide-type local anesthetics
Adverse Effects
- Pallor/blanching (37%)
- Application site erythema/pain (30%)
- Genital mucous membrane burning sensation (17%)
- Oral cavity, periodontal formulation (15%)
- 1-10%
- Alterations in temperature sensations (7%)
- Application site edema (6-10%)
- Itching (2%)
- Rash
- Myocardial dysfunction (rare)
- Methemoglobinemia (rare)
- Depression/excitation (rare)
- Seizure (rare)
- Localized discrete purpuric or petechial reactions (rare)
- Localized hyperpigmentation (rare)
- Allergic reactions (eg, urticaria, angioedema, bronchospasm, shock)
Warnings
Do not apply on open wounds
Monitor child closely after administration; if child becomes very dizzy, excessively sleepy, or develops duskiness of the face or lips, remove cream immediately
Exercise caution when applying over large areas for >2 hours due to risk of systemic absorption and adverse effects
Monitor patients treated with class III anti-arrhythmic drugs (eg, amiodarone, bretylium, sotalol, dofetilide) due to additive cardiac effects; consider ECG monitoring
Use of cream is not recommended in any clinical situation when penetration or migration beyond tympanic membrane into middle ear is possible due to ototoxic effects observed in animal studies
Monitor acutely ill, debilitated, or elderly patients closely if administering repeated doses
Lidocaine and prilocaine have been shown to inhibit viral and bacterial growth
Instruct patient to avoid irritating or exposing treated area to extreme temperatures until complete sensation has returned
Allergic and anaphylactic reactions associated with lidocaine or prilocaine can occur; these reactions may be characterized by urticaria, angioedema, bronchospasm, and shock; if reactions occur, they should be managed by conventional means
Not to be used with standard dental syringes; only use with blunt‐tipped applicator and dispenser which is available from DENTSPLY Pharmaceutical
Drug coming in contact with the eye should be avoided; animal studies have demonstrated severe eye irritation; a loss of protective reflexes may allow corneal irritation and potential abrasion; if eye contact occurs, immediately rinse eye with water or saline and protect it until normal sensation returns. In addition, the patient should be evaluated by an ophthalmologist, as indicated
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
Pregnancy and Lactation
Pregnancy Category: B
Lactation: Excreted in breast milk; use not recommended
Maximum Dosage
For pediatric use, the maximum total dose of EMLA should be restricted to that which corresponds to the child’s weight.
The maximum recommended duration of exposure of the EMLA cream or disk is 4 hours; 8.5 grams (5 cartridges) of the Oraqix periodontal gel per treatment session.
The maximum recommended duration of exposure of the EMLA cream or disk is 4 hours; 8.5 grams (5 cartridges) of the Oraqix periodontal gel per treatment session.
The maximum recommended duration of exposure of the EMLA cream or disk is 4 hours; safety and efficacy of the Oraqix periodontal gel has not been established.
7—12 years and > 20 kg: 20 g total dose of the EMLA cream or disk; maximal application area should not exceed 200 cm2 and maximum application time is 4 hours; safety and efficacy of the Oraqix periodontal gel has not been established.
1—6 years and > 10 kg: 10 g total dose of the EMLA cream or disk; maximal application area should not exceed 100 cm2 and maximum application time is 4 hours; safety and efficacy of the Oraqix periodontal gel has not been established.
3—12 months and > 5 kg: 2 g total dose of the EMLA cream or disk; maximal application area should not exceed 20 cm2 and maximum application time is 4 hours; safety and efficacy of the Oraqix periodontal gel has not been established.
up to 3 months or < 5 kg: 1 g total dose of the EMLA cream or disk; maximal application area should not exceed 10 cm2 and maximum application time is 1 hour; safety and efficacy of the Oraqix periodontal gel has not been established.
Neonates > 37 weeks gestational age: 1 g total dose of the EMLA cream or disk; maximal application area should not exceed 10 cm2 and maximum application time is 1 hour; safety and efficacy of the Oraqix periodontal gel has not been established.
Neonates <= 37 weeks gestational age: Use not recommended.
How supplied
Lidocaine/Prilocaine
injectable solution
- 0.25% (Sensorcaine, Marcaine, generic)
- 0.5% (Sensorcaine, Marcaine, generic)
- Contains methylparaben
injectable solution, preservative-free
- 0.25% (Sensorcaine-MPF, Marcaine, generic)
- 0.5% (Sensorcaine-MPF, Marcaine, generic)
- 0.75% (Sensorcaine-MPF, Marcaine Preservative Free, generic)
injection, spinal
- 0.75% (Sensorcaine MPF Spinal, Marcaine Spinal, generic)
- Each 2-mL ampule contains 15 mg bupivacaine HCL with 165 mg dextrose
injection, single-dose vial
- 660mg/5mL (Posimir)
injectable suspension
- 133mg/10mL single-dose vial
- 266mg/20mL single-dose vial
surgical implant
- 100mg/implant
- Each single-dose package (pouch) contains 3 implants totaling 300 mg