Lidocaine/Prilocaine

DEA Class;  Rx

Common Brand Names; EMLA, Oraqix

  • Anesthetics, Topical

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

Indicated for use as local anesthesia to provide topical anesthesia.

For the treatment of premature ejaculation.

Hypersensitivity to components, amide-type local anesthetics

  • 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)

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 Category: B

Lactation: Excreted in breast milk; use not recommended

For pediatric use, the maximum total dose of EMLA should be restricted to that which corresponds to the child’s weight.

Adults

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.

Elderly

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.

Adolescents

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.

Children

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.

Infants

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

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.

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

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