Otic Domeboro® solution contains 2% acetic acid as the active ingredient, in modified Burow' solution (water, aluminum acetate, and sodium acetate) with boric acid as a stabilizer. Otic Domeboro® solution is instilled in the external auditory canal. Acetic acid is an astringent and antimicrobial agent. The pH range is from 4.5 to 6.0.
Chemically, acetic acid is C 2 H 4 O 2 and has the following structural formula:
Molecular weight of acetic acid is 60.05.
Acetic acid is antibacterial and antifungal; and is effective against microorganisms (bacteria and fungi) that infect the ears of patients with acute diffuse external otitis. In in vitro tests, minimum lethal-time was less than 0.25 minutes when bacteria and fungi isolated from patients with otitis externa were exposed to 2% acetic acid. Quantitative absorption of acetic acid 2% from external auditory canal is not known.
Otic Domeboro® solution is indicated for the treatment of superficial infections of the external auditory canal caused by organisms susceptible to the action of the antimicrobial.
Hypersensitivity to acetic acid or any of the ingredients of this product. Perforated tympanic membrane is considered a contraindication to the use of any medication in the external ear canal.
Avoid use or use with caution in patients with perforated tympanic membrane (see CONTRAINDICATIONS ).
NOT FOR OPHTHALMIC USE.
Care should be taken to assure that the Otic Domeboro® solution gets into the ear canal and stays in contact with the affected area long enough for the drug to act.
Discontinue promptly if sensitization or irritation occurs.
Carcinogenesis, Mutagenesis, Impairment of Fertility: No long term studies in animals have been performed to evaluate the carcinogenic potential of Otic Domeboro® solution.
Irritation may occur.
No toxic effect has been reported with overdosage of Otic Domeboro® solution.
Patient should lie on his side with affected ear uppermost. Instill 4 to 6 drops into the external auditory canal and maintain this position for five minutes. Repeat the procedure every 2 to 3 hours.
Otic Domeboro® solution (Acetic Acid 2% in Aqueous Aluminum Acetate Otic solution) is supplied in 2 fl. oz. dropper bottle.
Store below (30°C), 86°F, avoid freezing.
Otic Domeboro® Solution is a clear colorless liquid.
400 Morgan Lane
West Haven, CT 06516 USA
CAUTION: Federal (USA) law prohibits dispensing without prescription.
PD500003 2/95 ©1995 Bayer Corporation 4787