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Acetic acid (otic): Pediatric drug information

Acetic acid (otic): Pediatric drug information
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For additional information see "Acetic acid (otic): Drug information" and "Acetic acid (otic): Patient drug information"

For abbreviations, symbols, and age group definitions show table
Therapeutic Category
  • Otic Agent, Anti-infective
Dosing: Pediatric
Otitis externa, acute

Otitis externa, acute: Children ≥3 years and Adolescents: Otic: Insert saturated wick of cotton; keep moist 24 hours by adding 3 to 5 drops every 4 to 6 hours; remove wick after 24 hours and instill 5 drops 3 to 4 times daily. Note: In children, 3 to 4 drops may be sufficient due to the smaller capacity of the ear canal

Dosing: Kidney Impairment: Pediatric

Children ≥3 years and Adolescents: There are no dosing adjustments provided in the manufacturer's labeling.

Dosing: Liver Impairment: Pediatric

Children ≥3 years and Adolescents: There are no dosing adjustments provided in the manufacturer's labeling.

Dosing: Adult

(For additional information see "Acetic acid (otic): Drug information")

Otitis externa, acute

Otitis externa, acute: Otic: Insert saturated wick of cotton; keep moist 24 hours by adding 3 to 5 drops every 4 to 6 hours. Remove wick after 24 hours and instill 5 drops 3 to 4 times daily. Treatment duration is usually 7 days and may be extended an additional 7 days if symptoms are improving but not yet resolved (Ref).

Dosing: Kidney Impairment: Adult

There are no dosage adjustments provided in the manufacturer’s labeling. However, dosage adjustment unlikely due to low systemic absorption.

Dosing: Liver Impairment: Adult

There are no dosage adjustments provided in the manufacturer’s labeling. However, dosage adjustment unlikely due to low systemic absorption.

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Frequency not defined.

Central nervous system: Localized burning, stinging sensation

Local: Local irritation

Contraindications

Hypersensitivity to acetic acid or any component of the formulation; perforated tympanic membrane

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Solution, Otic:

Generic: 2% (15 mL)

Generic Equivalent Available: US

Yes

Pricing: US

Solution (Acetic Acid Otic)

2% (per mL): $2.67 - $7.60

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Administration: Pediatric

Otic: For otic use only. After removing cerumen and debris, saturate a cotton wick with the solution and insert into the ear canal (alternatively, wick may be saturated after insertion). Wick should remain in place for ≥24 hours and then removed; however, drops should continue to be instilled into ear canal as long as indicated.

Administration: Adult

Otic: For otic use only. After removing cerumen and debris, saturate a cotton wick with the solution and insert into the ear canal (alternatively, wick may be saturated after insertion). Wick should remain in place for ≥24 hours and then removed; however, drops should continue to be instilled into ear canal as long as indicated.

Storage/Stability

Store at room temperature at 20°C to 25°C (68°F to 77°F).

Use

Otic solution: Treatment of superficial infections of the external auditory canal (FDA approved in ages ≥3 years and adults)

Medication Safety Issues
International issues:

Vosol [Puerto Rico] may be confused with Vexol brand name for rimexolone [multiple international markets]

Metabolism/Transport Effects

None known.

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the drug interactions program

There are no known significant interactions.

Pregnancy Considerations

Animal reproduction studies have not been conducted.

Brand Names: International
International Brand Names by Country
For country code abbreviations (show table)

  • (AR) Argentina: Otopreven;
  • (EG) Egypt: Otosol;
  • (GR) Greece: Instaret;
  • (IN) India: Acetik | Audotic ac | Otimac ac;
  • (NL) Netherlands: Zure;
  • (PR) Puerto Rico: Acetasol | Vosol
  1. Acetic Acid [prescribing information]. Levittown, PA: Bio-Pharm Inc; May 2018.
  2. Acetic Acid otic solution, USP [prescribing information]. Hauppauge, NJ: Saptalis Pharmaceuticals, LLC; March 2020.
  3. Rosenfeld RM, Schwartz SR, Cannon CR, et al. Clinical practice guideline: acute otitis externa. Otolaryngol Head Neck Surg. 2014;150(1 suppl):S1-S24. doi:10.1177/0194599813517083 [PubMed 24491310]
Topic 103461 Version 111.0