Vosol 2% Otic Solution 15ml (ear)

Manufacturer ECR PHARMACEUTICALS Active Ingredient Acetic Acid (Otic)(a SEE tik AS id) Pronunciation a-SEE-tik AS-id
It is used to treat ear infections.
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Drug Class
Otic anti-infective
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Pharmacologic Class
Acidifying agent; Antibacterial; Antifungal
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Pregnancy Category
Category C
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FDA Approved
Jan 1970
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Acetic acid otic solution is an ear drop used to treat ear infections, often called 'swimmer's ear'. It works by making the ear canal more acidic, which helps to stop the growth of bacteria and fungi that cause the infection.
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How to Use This Medicine

Taking Your Medication Correctly

To use this medication effectively, follow your doctor's instructions and read all the information provided. Continue using the medication as directed, even if your symptoms improve. This medication is for ear use only.

Administration Instructions

1. Wash your hands before and after using the medication.
2. Lie on your side with the affected ear facing up.
3. For children 3 years of age and older, and adults, gently pull the outer ear outward and upward.
4. For children younger than 3 years of age, gently pull the outer ear outward and downward.
5. Place the drops in your ear without touching the dropper to the ear.
6. Remain on your side for 2 minutes or insert a cotton plug into your ear.

If your doctor has instructed you to use a cotton wick to administer the medication, follow their specific guidance.

Storage and Disposal

Store the medication at room temperature with the lid tightly closed. Keep all medications in a safe location, out of the reach of children and pets. Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so. If you have questions about disposal, consult your pharmacist. You may also have access to drug take-back programs in your area.

Missing a Dose

If you miss a dose, take it as soon as you remember. However, if it is close to the time for your next dose, skip the missed dose and resume your regular schedule. Do not take two doses at the same time or use extra doses.
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Lifestyle & Tips

  • Keep the ear dry during treatment; avoid swimming or getting water in the ear.
  • Use earplugs when showering or bathing.
  • Do not insert cotton swabs or other objects into the ear canal.
  • Complete the full course of treatment, even if symptoms improve.
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Available Forms & Alternatives

Dosing & Administration

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Adult Dosing

Standard Dose: Instill 4-5 drops into the affected ear(s) 3-4 times daily
Dose Range: 4 - 5 mg

Condition-Specific Dosing:

otitisExterna: Instill 4-5 drops into the affected ear(s) 3-4 times daily for 7-10 days, or until infection is cleared.
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Pediatric Dosing

Neonatal: Not established
Infant: Instill 3-4 drops into the affected ear(s) 3-4 times daily (consult pediatrician)
Child: Instill 4-5 drops into the affected ear(s) 3-4 times daily
Adolescent: Instill 4-5 drops into the affected ear(s) 3-4 times daily
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Dose Adjustments

Renal Impairment:

Mild: No adjustment needed
Moderate: No adjustment needed
Severe: No adjustment needed
Dialysis: No adjustment needed

Hepatic Impairment:

Mild: No adjustment needed
Moderate: No adjustment needed
Severe: No adjustment needed

Pharmacology

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Mechanism of Action

Acetic acid is an acidifying agent that lowers the pH of the ear canal, creating an unfavorable environment for the growth of most bacteria and fungi commonly associated with otitis externa. It also has mild astringent and antiseptic properties.
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Pharmacokinetics

Absorption:

Bioavailability: Minimal systemic absorption
Tmax: Not applicable (local action)
FoodEffect: Not applicable

Distribution:

Vd: Not applicable (local action)
ProteinBinding: Not applicable (local action)
CnssPenetration: No

Elimination:

HalfLife: Not applicable (local action)
Clearance: Not applicable (local action)
ExcretionRoute: Not applicable (local action)
Unchanged: Not applicable (local action)
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Pharmacodynamics

OnsetOfAction: Rapid (local pH change)
PeakEffect: Within minutes (local pH change)
DurationOfAction: Hours (until pH normalizes or reapplication)

Safety & Warnings

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Side Effects

Urgent Side Effects: Seek Medical Help Right Away
If you experience any of the following symptoms, call your doctor immediately or seek emergency medical attention, as they may be signs of a severe and potentially life-threatening reaction:
- Signs of an allergic reaction, such as rash, hives, itching, red, swollen, blistered, or peeling skin (with or without fever), wheezing, tightness in the chest or throat, difficulty breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat
- Ear irritation

Other Possible Side Effects
Like all medications, this drug can cause side effects, although not everyone will experience them. If you encounter any of the following side effects, or if you have any other concerns, contact your doctor for advice:
- Burning or stinging sensations

Important Note: This list does not include all possible side effects. If you have questions or concerns about side effects, consult your doctor. For medical advice regarding side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
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Seek Immediate Medical Attention If You Experience:

  • Worsening ear pain or discharge
  • Fever
  • Rash or swelling spreading beyond the ear
  • New or worsening hearing loss
  • Dizziness
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Before Using This Medicine

Before Taking This Medication: Important Information to Share with Your Doctor

It is essential to inform your doctor about the following:

Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced as a result of the allergy.
If you have a perforated eardrum.

This is not an exhaustive list of potential interactions. Therefore, it is crucial to discuss all of your medications (including prescription and over-the-counter drugs, natural products, and vitamins) and health conditions with your doctor and pharmacist. This will help ensure that it is safe for you to take this medication in conjunction with your other treatments. Never start, stop, or adjust the dosage of any medication without first consulting your doctor.
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Precautions & Cautions

It is essential to inform all of your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. If you are pregnant, planning to become pregnant, or are breast-feeding, be sure to discuss this with your doctor. You and your doctor will need to carefully weigh the benefits and risks of this medication to both you and your baby.
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Overdose Information

Overdose Symptoms:

  • Not expected with topical otic use due to minimal systemic absorption.
  • Local irritation, burning, or stinging if excessive amounts are used or if the eardrum is perforated.

What to Do:

Discontinue use. Rinse ear with clean water if irritation is severe. Seek medical attention if symptoms persist or worsen. Call 1-800-222-1222 for poison control advice.

Drug Interactions

Monitoring

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Routine Monitoring

Clinical symptoms of otitis externa (pain, discharge, itching, redness)

Frequency: Daily

Target: Improvement

Action Threshold: Worsening symptoms or no improvement after 7-10 days; consider re-evaluation and alternative treatment.

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Symptom Monitoring

  • Ear pain
  • Ear discharge
  • Ear itching
  • Redness or swelling of the ear canal
  • Hearing changes

Special Patient Groups

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Pregnancy

Generally considered safe for topical otic use during pregnancy due to minimal systemic absorption. Consult with a healthcare provider.

Trimester-Specific Risks:

First Trimester: Low risk
Second Trimester: Low risk
Third Trimester: Low risk
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Lactation

Considered compatible with breastfeeding due to minimal systemic absorption and unlikely transfer into breast milk in clinically significant amounts.

Infant Risk: Low risk
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Pediatric Use

Commonly used in pediatric patients for otitis externa. Dosing may be slightly adjusted for infants. Ensure eardrum integrity before use.

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Geriatric Use

No specific dose adjustments are typically needed for geriatric patients. Use with caution if eardrum perforation is suspected.

Clinical Information

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Clinical Pearls

  • Ensure the ear canal is clean and free of excessive cerumen or debris before instillation for optimal drug contact.
  • Warm the solution by holding the bottle in your hand for a few minutes before instillation to prevent dizziness.
  • Lie on your side with the affected ear facing up for 5 minutes after instillation to allow the drops to penetrate.
  • Do not use if there is a perforated eardrum or tympanostomy tubes, as it can cause severe pain and ototoxicity. Always confirm eardrum integrity before prescribing.
  • If irritation or sensitivity develops, discontinue use.
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Alternative Therapies

  • Ciprofloxacin otic solution
  • Ofloxacin otic solution
  • Neomycin/polymyxin B/hydrocortisone otic solution
  • Colistin/neomycin/hydrocortisone/thonzonium bromide otic solution
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Cost & Coverage

Average Cost: Low (e.g., $10-$30) per 15ml bottle
Generic Available: Yes
Insurance Coverage: Tier 1 (Preferred Generic)
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General Drug Facts

If your symptoms or health issues persist or worsen, it is essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so it's a good idea to check with your pharmacist for more information. If you have any questions or concerns about this medication, don't hesitate to discuss them with your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When seeking help, be prepared to provide details about the overdose, including the medication taken, the amount, and the time it occurred.