Get your patient on Acetic Acid - Acetic Acid solution (Acetic Acid)

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Acetic Acid - Acetic Acid solution prescribing information

Indications & Usage

INDICATIONS AND USAGE

For the treatment of superficial infections of the external auditory canal caused by organisms susceptible to the action of the antimicrobial.

Dosage & Administration

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 the 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 the 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.

Contraindications

CONTRAINDICATIONS

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.

Adverse Reactions

ADVERSE REACTIONS

Stinging or burning may be noted occasionally; local irritation has occurred very rarely.

Description

DESCRIPTION

Acetic Acid Otic Solution, USP is a colorless to pale yellow color nonaqueous solution of glacial acetic acid (2%), in a propylene glycol vehicle containing benzethonium chloride, propylene glycol diacetate, and sodium acetate trihydrate. It may also contain citric acid anhydrous.

The molecular formula for acetic acid is CH 3 COOH, with a molecular weight of 60.05. The structural formula is:

Referenced Image

Acetic Acid Otic Solution, USP is available as a nonaqueous otic solution buffered at pH 3 for use in the external ear canal.

Pharmacology

CLINICAL PHARMACOLOGY

Acetic acid is anti-bacterial and anti-fungal; 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.

How Supplied/Storage & Handling

HOW SUPPLIED

Acetic Acid Otic Solution, USP, 2% is a colorless to pale yellow color solution supplied in 15 mL bottle with dropper plug and extended TIP closure.

They are available as follows:

Bottle of 15 mL – NDC 62135-801-51

Data SourceWe receive information directly from the FDA and PrescriberPoint is updated as frequently as changes are made available
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