Acetic Acid
- Generic Name: acetic acid
- Brand Name: Acetic Acid
- Drug Class: Antibacterials, Topical, Antifungals, Topical
Patient Information
No information provided. Please refer to the WARNINGS and PRECAUTIONS sections.
Description
Acetic Acid Otic Solution, USP is a solution of this acid (2%), in a propylene glycol vehicle containing propylene glycol diacetate (3%), benzethonium chloride (0.02%), sodium acetate (0.015%), and citric acid. The empirical formula for this acid is CH3COOH, with a molecular weight of 60.05. The structural formula is:
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This Otic Solution is available as a nonaqueous otic solution buffered at pH 3 for use in the external ear canal.
Indications
For the treatment of superficial infections of the external auditory canal caused by organisms susceptible to the action of the antimicrobial.
Dosage And Administration
Carefully remove all cerumen and debris to allow Acetic Acid Otic Solution to contact infected surfaces directly. To promote continuous contact, insert a wick of cotton saturated with this Otic Solution into the ear canal; the wick may also be saturated after insertion. Instruct the patient to keep the wick in for at least 24 hours and to keep it moist by adding 3 to 5 drops of Acetic Acid Otic Solution every 4 to 6 hours. The wick may be removed after 24 hours but the patient should continue to instill 5 drops of Acetic Acid Otic Solution 3 or 4 times daily thereafter, for as long as indicated. In pediatric patients, 3 to 4 drops may be sufficient due to the smaller capacity of the ear canal.
How Supplied
Acetic Acid Otic Solution, USP, containing 2%, is available in 15 mL and 30 mL measured-drop, safety-tip plastic bottles.
Storage
Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]. Keep the container tightly closed.
Manufactured by: VINTAGE PHARMACEUTICALS, LLC, Huntsville, AL 35811. 8180671 R3/05. FDA Rev date: 2/24/2005
Side Effects
Stinging or burning may be noted occasionally; local irritation has occurred very rarely.
Drug Interactions
No information was provided.
Warnings
Discontinue promptly if sensitization or irritation occurs.
Precautions
Transient stinging or burning may be noted occasionally when the solution is first instilled into the acutely inflamed ear.
Pediatric Use
Safety and effectiveness in pediatric patients below the age of 3 years have not been established.
Overdose
No information provided.
Contraindications
Hypersensitivity to this Otic Solution or any of the ingredients. Perforated tympanic membrane is considered a contraindication to the use of any medication in the external ear canal.
Clinical Pharmacology
Acetic acid is antibacterial and antifungal; propylene glycol is hydrophilic and provides a low surface tension; benzethonium chloride is a surface active agent that promotes contact of the solution with tissues.