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Vosol HC (Hydrocortisone and Acetic Acid Otic Solution, USP): Side Effects, Uses, Dosage, Interactions, Warnings

Vosol HC

Medical Editor: John P. Cunha, DO, FACOEP Last updated on RxList: 12/17/2024

Drug Summary

What Is Vosol HC?

Vosol HC (hydrocortisone and acetic acid otic solution) is an anti-inflammatory, antiallergic, and anti-itch medication combined with an antibacterial and antifungal medication indicated for the treatment of superficial infections of the external auditory canal caused by organisms susceptible to the action of the antimicrobial, complicated by inflammation.

What Are Side Effects of Vosol HC?

Side effects of Vosol HC include:

  • temporary stinging or burning when the solution is first instilled into an acutely inflamed ear and
  • local irritation (rare).

Seek medical care or call 911 at once if you have the following serious side effects:

  • Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
  • Serious heart symptoms such as fast, irregular, or pounding heartbeats; fluttering in your chest; shortness of breath; and sudden dizziness, lightheadedness, or passing out;
  • Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors.

This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects.

Dosage for Vosol HC

Carefully remove all cerumen and debris from the ear to allow Vosol HC to contact infected surfaces directly. To promote continuous contact, insert a wick of cotton saturated with Vosol HC 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 Hydrocortisone and Acetic Acid every 4 to 6 hours. The wick may be removed after 24 hours but the patient should continue to instill 5 drops of Vosol HC 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.

Vosol HC In Children

Safety and effectiveness of Vosol HC in pediatric patients below the age of 3 years have not been established.

What Drugs, Substances, or Supplements Interact with Vosol HC?

Vosol HC may interact with other medicines.

Tell your doctor all medications and supplements you use.

Vosol HC During Pregnancy and Breastfeeding

Tell your doctor if you are pregnant or plan to become pregnant before using Vosol HC.

Consult your doctor before breastfeeding.

Additional Information

Our Vosol HC (hydrocortisone and acetic acid otic solution) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Description for Vosol HC

Hydrocortisone and Acetic Acid Otic Solution, USP is a solution containing hydrocortisone (1%) and acetic acid (2%), in a propylene glycol vehicle containing benzethonium chloride (0.02%), citric acid (0.05%), propylene glycol diacetate (3%) and sodium acetate (0.015%). The empirical formulas for acetic acid and hydrocortisone are CH3COOH, and C21H30O5, with a molecular weight of 60.05 and 362.46, respectively. The structural formulas are:

Hydrocortisone and Acetic Acid Otic Solution, USP Structural Formula Illustration

Hydrocortisone and Acetic Acid is available as a nonaqueous otic solution buffered at pH 3 for use in the external ear canal.

Uses for Vosol HC

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

Dosage for Vosol HC

Carefully remove all cerumen and debris to allow Hydrocortisone and Acetic Acid to contact infected surfaces directly. To promote continuous contact, insert a wick of cotton saturated with Hydrocortisone and Acetic Acid 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 Hydrocortisone and Acetic Acid every 4 to 6 hours. The wick may be removed after 24 hours but the patient should continue to instill 5 drops of Hydrocortisone and Acetic Acid 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

Hydrocortisone and Acetic Acid Otic Solution, USP, containing hydrocortisone (1%) and acetic acid (2%), is available in 10 mL, measured-drop, safety-tip plastic bottles (NDC 71656-064-10).

Storage

Store at room temperature, 20°C to 25°C (68°F to 77°F). Keep container tightly closed.

Distributed by: Saptalis Pharmaceuticals, LLC., Hauppauge, NY 11788. Revised: May 2024

Side Effects for Vosol HC

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

To report SUSPECTED ADVERSE REACTIONS, contact Saptalis Pharmaceuticals, LLC at 1-833-727-8254 or FDA at 1800FDA1088 or www.fda.gov/medwatch.

Drug Interactions for Vosol HC

No Information provided

Warnings for Vosol HC

Included as part of the PRECAUTIONS section.

Discontinue promptly if sensitization or irritation occurs.

Precautions for Vosol HC

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 Information for Vosol HC

No Information provided

Contraindications for Vosol HC

Hypersensitivity to Hydrocortisone and Acetic Acid or any of the ingredients; herpes simplex, vaccinia and varicella. Perforated tympanic membrane is considered a contraindication to the use of any medication in the external ear canal.

Clinical Pharmacology for Vosol HC

Acetic acid is antibacterial and antifungal; hydrocortisone is antiinflammatory, antiallergic and antipruritic; 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.

Patient Information for Vosol HC

No information provided. Please refer to the WARNINGS AND PRECAUTIONS section.

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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.