Otic Solution, USP
Acetic Acid Otic Solution, USP is a solution of acetic 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 acetic acid is CH3COOH, with a molecular weight of 60.05. The structural formula is:
Acetic Acid Otic Solution is available as a nonaqueous otic solution buffered at pH 3 for use in the external ear canal.
What are the possible side effects of acetic acid (Acetasol)?
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
You may feel a slight stinging or burning when you first use acetic acid ear drops.
This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at...
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 Acetic Acid 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.
Acetic Acid Otic Solution, USP, containing 2% acetic acid, is available in 15 mL and 30 mL measured-drop, safety-tip plastic bottles.
Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]. Keep container tightly closed.
Manufactured by: VINTAGE PHARMACEUTICALS, LLC, Huntsville, AL 35811. 8180671 R3/05. FDA Rev date: 2/24/2005
Discontinue promptly if sensitization or irritation occurs.
Transient stinging or burning may be noted occasionally when the solution is first instilled into the acutely inflamed ear.
Safety and effectiveness in pediatric patients below the age of 3 years have not been established.
No information provided.
Hypersensitivity to Acetic Acid 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.
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.
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.