Version May 2024
Otic pain: Otic: Instill 2 to 3 drops to affected ear no more than 3 to 4 times daily.
There are no dosage adjustments provided in the manufacturer's labeling.
There are no dosage adjustments provided in the manufacturer's labeling.
Refer to adult dosing.
(For additional information see "Lidocaine (otic): Pediatric drug information")
Ear pain:
Note: Not recommended for use in patients who have perforated eardrums or tympanostomy tubes (Bolt 2008; manufacturer's labeling). In clinical trials in patients with acute otitis media, lidocaine was administered in addition to systemic pain relief (eg, acetaminophen, ibuprofen) (AAP [Lieberthal 2013]; Bolt 2008; Kara 2022; Prasad 2008).
Lidocaine 4% otic drops (eg, Ear PainMD for Kids):
Children ≥2 years and Adolescents: Otic: Instill or apply 2 to 3 drops to affected ear(s) 3 to 4 times daily as needed. If symptoms worsen or persist for ≥7 days, discontinue use and consult health care provider (manufacturer's labeling).
Lidocaine 2%: Limited data available: Note: Aqueous formulation used in studies is not commercially available in the United States; 2% lidocaine can be administered by using the parenteral formulation or a compounded aqueous solution if necessary (Prasad 2008).
Children ≥3 years: Otic: Instill 3 drops into affected ear(s) and allow solution to dwell in ear canal for 5 minutes; may repeat every 3 hours as needed for up to 24 hours (Bolt 2008).
Lidocaine 1%: Limited data available: Note: Formulation used in study was 1% otic drop; no details about preparation of formulation were provided (Kara 2022).
Children <5 years: Otic: Instill 4 drops into affected ear(s) up to 4 times daily as needed for up to 48 hours (Kara 2022).
There are no dosage adjustments provided in the manufacturer's labeling.
There are no dosage adjustments provided in the manufacturer's labeling.
There are no adverse reactions listed in the manufacturer's labeling.
OTC labeling: When used for self-medication, do not use if hypersensitivity to lidocaine or any component of the formulation; in large quantities, particularly over raw surfaces or blistered areas; in patients with an ear injury or perforated eardrum, in patients with tubes in the ear.
Dosage form specific issues:
• Benzyl alcohol and derivatives: Some dosage forms may contain benzyl alcohol; large amounts of benzyl alcohol (≥99 mg/kg/day) have been associated with a potentially fatal toxicity (“gasping syndrome”) in neonates; the “gasping syndrome” consists of metabolic acidosis, respiratory distress, gasping respirations, CNS dysfunction (including convulsions, intracranial hemorrhage), hypotension, and cardiovascular collapse (AAP ["Inactive" 1997]; CDC 1982); some data suggests that benzoate displaces bilirubin from protein binding sites (Ahlfors 2001); avoid or use dosage forms containing benzyl alcohol with caution in neonates. See manufacturer's labeling.
Other warnings/precautions:
• Appropriate use: Not for ophthalmic use.
• Self-medication (OTC use): When used for self-medication (OTC), discontinue use and notify health care provider if ear pain worsens or persists for >7 days or if symptoms clear up and occur again within a few days.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product
Drops, Otic, as hydrochloride
Ear Pain MD: 4% (12.5 mL) [contains aloe, benzalkonium chloride, benzyl alcohol]
Ear Pain MD for Kids: 4% (12.5 mL) [contains aloe, benzalkonium chloride, benzyl alcohol]
Otic: Not for ophthalmic use. Do not use in large amounts or on raw or blistered surfaces.
Otic: For external use only; do not apply to areas that are raw or blistered. Patient should lay on their side with affected ear up; dropper should be placed at entrance of ear canal; do not allow applicator tip to enter ear canal; following administration of the dose, patient should remain on their side to ensure adequate exposure of drug; in trials, patient remained on their side for 5 minutes after dose (Bolt 2008). Do not use if the eardrum is not intact or ear tubes are in place.
Otic pain: Temporary relief of otic pain.
None known.
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.
Methemoglobinemia Associated Agents: May enhance the adverse/toxic effect of Local Anesthetics. Specifically, the risk for methemoglobinemia may be increased. Risk C: Monitor therapy
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