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Antipyrine and Benzocaine

Pronunciation

(an tee PYE reen & BEN zoe kane)

Index Terms

  • Auralgan
  • Benzocaine and Antipyrine

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Solution, otic [drops]:

Aurodex™: Antipyrine 5.4% and benzocaine 1.4% (10 mL [DSC])

Generic: Antipyrine 5.4% and benzocaine 1.4% (10 mL [DSC], 15 mL [DSC]), Antipyrine 5.5% and benzocaine 1.4% (14 mL [DSC])

Brand Names: U.S.

  • Aurodex [DSC]

Pharmacologic Category

  • Otic Agent, Analgesic
  • Otic Agent, Cerumenolytic

Pharmacology

Antipyrine has analgesic properties; benzocaine is a local anesthetic; the glycerin base provides decreased middle ear pressure by osmosis.

Onset of Action

Pain relief: ~30 minutes (Hoberman 1997)

Use: Labeled Indications

Temporary relief of pain and reduction of swelling associated with acute congestive and serous otitis media; facilitates ear wax removal

Contraindications

Hypersensitivity to antipyrine, benzocaine, or any component of the formulation; perforated tympanic membrane; ear discharge

Dosing: Adult

Pain and swelling associated with otitis media: Otic: Fill ear canal with solution; moisten cotton pledget with antipyrine and benzocaine solution, place in external ear, repeat every 1-2 hours until pain and congestion are relieved

Ear wax removal: Otic: Instill drops 3 times/day for 2-3 days; before and after ear wax removal, moisten cotton pledget with antipyrine and benzocaine solution and place in external ear after solution instillation.

Dosing: Geriatric

Refer to adult dosing.

Dosing: Pediatric

Refer to adult dosing.

Dosing: Renal Impairment

No dosage adjustment provided in manufacturer’s labeling.

Dosing: Hepatic Impairment

No dosage adjustment provided in manufacturer’s labeling.

Administration

Otic: Patient should lie down with affected ear upward and medication instilled; remain in the position to allow penetration of solution. Avoid touching dropper to ears or fingers. Do not rinse dropper after use.

Otitis media: Fill ear canal with antipyrine and benzocaine solution. Moisten cotton pledget with solution and place in external ear.

Ear wax removal: Moisten cotton pledget with antipyrine and benzocaine solution and place in external ear after solution instillation.

Storage

Store at 15°C to 30°C (59°F to 86°F); protect from heat. Protect from light. Do not use if solution is brown or contains a precipitate. Discard 6 months after placing dropper into solution.

Drug Interactions

Dapsone (Topical): May enhance the adverse/toxic effect of Methemoglobinemia Associated 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. Management: Monitor patients for signs of methemoglobinemia (e.g., hypoxia, cyanosis) when nitric oxide is used in combination with other agents associated with development of methemoglobinemia. Avoid lidocaine/prilocaine. 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

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

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

Adverse Reactions

No adverse reactions are reported in the manufacturer’s labeling. Refer to Benzocaine monograph.

Warnings/Precautions

Concerns related to adverse effects:

• Irritation: Discontinue if sensitization or irritation occur.

• Methemoglobinemia: Rare with combination product; has been reported with some topical products containing higher concentrations (14% to 20%) of benzocaine.

Other warnings/precautions:

• Appropriate use: For otic use only, do not apply to eyes.

Pregnancy Risk Factor

C

Pregnancy Considerations

Animal reproduction studies have not been conducted with this combination.

Patient Education

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Have patient report immediately to prescriber ear irritation (HCAHPS).

• Educate patient about signs of a significant reaction (eg, 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. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for healthcare professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience and judgment in diagnosing, treating and advising patients.

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