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AMERICAINE Otic, topical anesthetic ear drops, contain benzocaine 20% (w/w) in a water soluble base of glycerin 1% (w/w) and polyethylene glycol 300 with benzethonium chloride 0.1% as a preservative.
Benzocaine, a local anesthetic, is chemically ethyl p -aminobenzoate, C 9 H 11 NO 2 , with a molecular weight of 165.19 and has the following structural formula:
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Benzocaine reversibly stabilizes the neuronal membrane which decreases its permeability to sodium ions. Depolarization of the neuronal membrane is inhibited thereby blocking the initiation and conduction of nerve impulses.
AMERICAINE Otic is indicated for relief of pain and pruritus in acute congestive and serous otitis media, acute swimmer's ear, and other forms of otitis externa.
In the presence of a perforated tympanic membrane or ear discharge.
Known allergy or hypersensitivity to benzocaine.
Indiscriminate use of anesthetic ear drops may mask symptoms of fulminating infection of the middle ear.
General: Medication should be discontinued if sensitivity or irritation occurs.
Carcinogenesis, Mutagenesis, Impairment of Fertility: Long-term studies in animals or humans to evaluate the carcinogenic and mutagenic potential or the effect on fertility have not been conducted.
Pregnancy: Pregnancy Category C. Animal reproduction studies have not been conducted with AMERICAINE Otic. It is also not known whether AMERICAINE Otic can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. AMERICAINE Otic should be given to a pregnant woman only if clearly needed.
Nursing Mothers: It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when AMERICAINE Otic is administered to a nursing woman.
Pediatric Use: Do not use in infants under 1 year of age.
Contact dermatitis and/or hypersensitivity to benzocaine can cause burning, stinging, pruritus, tenderness, erythema, rash, urticaria and edema. Rarely, benzocaine may induce methemoglobinemia causing respiratory distress and cyanosis. Intravenous methylene blue is the specific therapy for this condition.
Instill 4-5 drops of AMERICAINE Otic in the external auditory canal, then insert a cotton pledget into the meatus. Application may be repeated every one to two hours if necessary.
AMERICAINE Otic (benzocaine), topical anesthetic ear drops, is available in dropper-top bottles.
NDC 53014-377-51 15 mL bottle
Keep bottle tightly closed. Store at 15°-30°C (59°-86°F).
Keep out of the reach of children.
Rx only
Marketed by:
MEDEVA PHARMACEUTICALS
Medeva Pharmaceuticals, Inc.
Rochester, NY 14623 USA
Manufactured by:
Taylor Pharmaceuticals
Decatur, IL 62525 USA
® Ciba-Geigy Corporation
© 1999, Medeva Pharmaceuticals, Inc.
Rev. 8/99
R248