Hydrocortisone and Acetic Acid Otic Solution, USP contains Hydrocortisone (1%) and acetic acid, glacial (2%) in a propylene glycol vehicle containing propylene glycol diacetate (3%) and benzethonium chloride (0.02%), sodium acetate (0.015%) and citric acid (0.2%).

Acetic acid has a molecular formula of CH₃COOH with molecular weight of 60.05. The structural formula is:

Hydrocortisone is a Synthetic Steroid used as an anti-inflammatory and antipruritic agent. Its chemical name is Pregn-4-ene-3, 20-dione, 11, 17, 21-trihydroxy-, (11b)-. Hydrocortisone has a molecular formula of C₂₁H₃₀O₅ with molecular weight 362.46. The structural formula is:

Hydrocortisone and acetic acid is available as a nonaqueous otic solution buffered at pH (2.0 to 4.0) for use in the external ear canal.

Last updated on RxList: 12/8/2004

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

 

Carefully remove all cerumen and debris to allow hydrocortisone 1% and acetic acid 2% 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 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.

Hydrocortisone 1% and acetic acid 2% otic solution is available in 10 mL plastic, controlled dropper tip bottle.

10 mL bottle NDC 51672-3007-1

Store at 15°- 30°C (59°- 86°F) [see USP Controlled Room Temperature]. Protect from freezing. Keep container tightly closed.

Mfd. by: Taro Pharmaceuticals Inc.
Brampton, Ontario, Canada L6T 1C1
Dist. by: Taro Pharmaceuticals U.S.A., Inc.
Hawthorne, NY 10532

Issued: June 2004

Last updated on RxList: 12/8/2004

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

 

Hydrocortisone: Substrate of CYP3A4 ( minor); Induces CYP3A4 (weak)

Last updated on RxList: 12/8/2004

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.

PEDIATRIC USE

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

 

Last updated on RxList: 12/8/2004

No Information Provided.

Hypersensitivity to VoSoL HC or any of the ingredients; herpes simplex, vaccinia and varicella. Performated tympanic membrane is considered a contraindication to the use of any medication in the external ear canal.

 

Last updated on RxList: 12/8/2004

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.

 

Last updated on RxList: 12/8/2004

No Information Provided.

Last updated on RxList: 12/8/2004

IMPORTANT NOTE: This is a summary and does not contain all possible information about this product. For complete information about this product or your specific health needs, ask your health care professional. Always seek the advice of your health care professional if you have any questions about this product or your medical condition. This information is not intended as individual medical advice and does not substitute for the knowledge and judgment of your health care professional. This information does not contain any assurances that this product is safe, effective, or appropriate for you.

ACETIC ACID W/HYDROCORTISONE - OTIC

(a-SEE-tik/ HYE-droe-KOR-ti-sone)

COMMON BRAND NAME(S): Acetasol HC, Vosol HC

USES: This combination medication is used to treat outer ear infections (e.g., swimmer's ear). This product contains 2 medications. Acetic acid works by stopping the growth of bacteria and fungus. Hydrocortisone is a steroid that helps to decrease the redness, swelling, and itching from the infection.

HOW TO USE: Clean the ear and carefully remove all earwax and other substances from the outer ear. To apply ear drops, wash your hands first. To avoid contamination, do not touch the dropper tip or let it touch your ear or any other surface.

To make sure that the right amount of medication is given, and to avoid touching the ear with the dropper, have another person insert the drops if possible. To lower the risk of dizziness, hold the container in your hand for a few minutes in order to warm it.

For at least the first 24 hours of treatment or as directed by your doctor, put a cotton plug soaked with the solution in the affected ear(s). You may put the cotton plug in your ear first and then apply the ear drops onto the cotton plug. Keep the plug moist by adding 3 to 5 drops of the medication every 4 to 6 hours or as directed by your doctor.

After removing the plug, continue to apply the medication directly into the ear 3 to 4 times daily as directed by your doctor. Lie on your side or tilt the affected ear upward. Hold the dropper directly over the ear, and place the prescribed number of drops into the ear canal. To help the drops roll into the ear of an adult, hold the earlobe up and back. In children, hold the earlobe down and back. Keep the head tilted for about 2 minutes. Repeat for the other ear if so directed. Do not rinse the dropper. Replace the cap after use.

Use this medication regularly in order to get the most benefit from it. To help you remember, use it at the same times each day. Continue using it for the full time prescribed, even if symptoms disappear after a few days. Stopping this medication too early may allow bacteria to continue to grow, which may result in a return of the infection.

Do not use this medication more often or longer than prescribed. Unnecessary use or misuse of this medication can lead to its decreased effectiveness.

Do not use in the eye.

Inform your doctor if your condition does not improve or worsens.

SIDE EFFECTS: Temporary stinging and burning may occur when the medication is first dropped into the ear. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: increased or new redness/swelling/pain in or around the ears.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any of the following symptoms of a serious allergic reaction: rash, itching, swelling, severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

Contact your doctor for medical advice about side effects. The following numbers do not provide medical advice, but in the US you may report side effects to the Food and Drug Administration (FDA) at 1-800-FDA-1088. In Canada, you may call Health Canada at 1-866-234-2345.

PRECAUTIONS: Before using this medication, tell your doctor or pharmacist if you are allergic to acetic acid or hydrocortisone; or to other corticosteroids (e.g., betamethasone); or if you have any other allergies.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: hole in the eardrum (perforated tympanic membrane), certain viral infections (e.g., herpes simplex, vaccinia, chickenpox).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: ear injuries/surgeries.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with them first.

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: other ear medications.

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

OVERDOSE: This medicine may be harmful if swallowed. If swallowing or overdose is suspected, contact your local poison control center or emergency room immediately. US residents should call the US National Poison Hotline at 1-800-222-1222. Canada residents should call a provincial poison control center.

NOTES: Do not share this medication with others.

This medication has been prescribed for your current condition only. Do not use it later for another infection unless told to do so by your doctor. A different medication may be necessary in that case.

It is important to keep the infected ear(s) clean and dry. Try not to get the infected ear(s) wet when bathing. Avoid swimming unless your doctor tells you otherwise.

MISSED DOSE: If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

STORAGE: Store at room temperature between 68-77 degrees F (20-25 degrees C) away from light. Keep bottle tightly closed. Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

Information last revised July 2008 Copyright(c) 2008 First DataBank, Inc.