Acetic Acid 2% Otic Soln 15ml (ear)
It is used to treat ear infections.
Drug Class
Otic anti-infective; Acidifying agent
Pharmacologic Class
Acidifying agent; Antibacterial; Antifungal
Pregnancy Category
Category C
FDA Approved
Jan 1970
DEA Schedule
Not Controlled
Overview
What is this medicine?
Acetic acid ear drops are used to treat ear infections, especially swimmer's ear (otitis externa). They work by making the ear canal more acidic, which helps stop the growth of bacteria and fungi.
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. Remain on your side for 2 minutes or insert a cotton plug into your ear.
6. 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 want to check if there are drug take-back programs in your area.
Missed Dose Instructions
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 take extra doses.
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. Remain on your side for 2 minutes or insert a cotton plug into your ear.
6. 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 want to check if there are drug take-back programs in your area.
Missed Dose Instructions
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 take extra doses.
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 as prescribed, even if symptoms improve.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
Instill 4-6 drops into the affected ear(s) 3-4 times daily.
Dose Range:
4 - 6 mg
Condition-Specific Dosing:
otitisExterna:
Instill 4-6 drops into the affected ear(s) 3-4 times daily. May be used with an ear wick for the first 24 hours if severe edema is present.
Pediatric Dosing
Neonatal:
Not established
Infant:
Instill 3-4 drops into the affected ear(s) 3-4 times daily.
Child:
Instill 3-4 drops into the affected ear(s) 3-4 times daily.
Adolescent:
Instill 4-6 drops into the affected ear(s) 3-4 times daily.
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed
Moderate:
No adjustment needed
Severe:
No adjustment needed
Dialysis:
No specific considerations; minimal systemic absorption.
Hepatic Impairment:
Mild:
No adjustment needed
Moderate:
No adjustment needed
Severe:
No adjustment needed
Pharmacology
Mechanism of Action
Acetic acid is an acidifying agent that lowers the pH of the external auditory canal, creating an unfavorable environment for the growth of bacteria and fungi commonly associated with otitis externa. It has bactericidal and fungicidal properties.
Pharmacokinetics
Absorption:
Bioavailability:
Minimal systemic absorption from topical otic administration.
Tmax:
Not applicable (minimal systemic absorption)
FoodEffect:
Not applicable
Distribution:
Vd:
Not applicable (minimal systemic absorption)
ProteinBinding:
Not applicable (minimal systemic absorption)
CnssPenetration:
No
Elimination:
HalfLife:
Not applicable (minimal systemic absorption)
Clearance:
Not applicable (minimal systemic absorption)
ExcretionRoute:
Not applicable (minimal systemic absorption)
Unchanged:
Not applicable (minimal systemic absorption)
Pharmacodynamics
OnsetOfAction:
Rapid (acidifying effect is immediate upon application)
PeakEffect:
Within hours of initial application (reduction of microbial growth)
DurationOfAction:
Maintained with repeated dosing (e.g., 6-8 hours per dose)
Confidence:
Medium
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. Immediately contact your doctor or seek medical attention if you notice any of the following symptoms, which could indicate a serious allergic reaction:
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
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 many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. Contact your doctor or seek medical help if you experience any of the following side effects or if they persist or bother you:
* Burning or stinging
Note: This list is not exhaustive, and you may experience other side effects not mentioned here. If you have questions or concerns about side effects, consult your doctor for guidance.
Reporting Side Effects
To report side effects, you can contact the FDA at 1-800-332-1088 or visit their website at https://www.fda.gov/medwatch. Your doctor is also available to provide medical advice and support regarding side effects.
While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. Immediately contact your doctor or seek medical attention if you notice any of the following symptoms, which could indicate a serious allergic reaction:
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
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 many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. Contact your doctor or seek medical help if you experience any of the following side effects or if they persist or bother you:
* Burning or stinging
Note: This list is not exhaustive, and you may experience other side effects not mentioned here. If you have questions or concerns about side effects, consult your doctor for guidance.
Reporting Side Effects
To report side effects, you can contact the FDA at 1-800-332-1088 or visit their website at https://www.fda.gov/medwatch. Your doctor is also available to provide medical advice and support regarding side effects.
Seek Immediate Medical Attention If You Experience:
- Increased ear pain or discomfort after applying drops
- Severe burning or stinging sensation
- New or worsening ear discharge
- Rash or itching around the ear
- Signs of allergic reaction (e.g., swelling, difficulty breathing - seek immediate medical attention)
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 allergic reaction you experienced, including any symptoms that occurred.
If you have a perforated eardrum.
This list is not exhaustive, and it is crucial to discuss all your medications (including prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist. They will help determine if it is safe to take this medication with your other medications and health conditions.
Remember, do not start, stop, or change the dosage of any medication without first consulting 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 allergic reaction you experienced, including any symptoms that occurred.
If you have a perforated eardrum.
This list is not exhaustive, and it is crucial to discuss all your medications (including prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist. They will help determine if it is safe to take this medication with your other medications and health conditions.
Remember, do not start, stop, or change the dosage of any medication without first consulting your doctor.
Precautions & Cautions
It is essential to inform all 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, you must discuss this with your doctor. This conversation will help you understand the benefits and risks of taking this drug, both for you and your baby, allowing you to make an informed decision.
Overdose Information
Overdose Symptoms:
- Severe local irritation
- Burning
- Stinging
- Pain in the ear
What to Do:
Discontinue use and rinse the ear with clean water. If irritation persists, seek medical attention. For accidental ingestion, call a poison control center (1-800-222-1222) or seek emergency medical attention.
Drug Interactions
Monitoring
Baseline Monitoring
Ear examination (otoscopy)
Rationale: To assess the extent of inflammation, presence of discharge, and integrity of the tympanic membrane.
Timing: Prior to initiation of therapy
Routine Monitoring
Clinical response (symptom improvement)
Frequency: Daily
Target: Reduction in pain, itching, discharge, and inflammation
Action Threshold: Lack of improvement or worsening symptoms after 48-72 hours may indicate need for re-evaluation or alternative therapy.
Local irritation/adverse effects
Frequency: Daily
Target: Absence of increased pain, burning, stinging, or rash
Action Threshold: Discontinue if severe irritation or allergic reaction occurs.
Symptom Monitoring
- Ear pain
- Itching
- Discharge from the ear
- Redness or swelling of the ear canal
- Hearing changes
Special Patient Groups
Pregnancy
Generally considered safe for topical otic use during pregnancy due to minimal systemic absorption. Use only if clearly needed and potential benefits outweigh potential risks.
Trimester-Specific Risks:
First Trimester:
Low risk due to minimal systemic absorption.
Second Trimester:
Low risk due to minimal systemic absorption.
Third Trimester:
Low risk due to minimal systemic absorption.
Lactation
Considered compatible with breastfeeding due to minimal systemic absorption. Risk to the infant is unlikely.
Infant Risk:
Low risk
Pediatric Use
Commonly used in pediatric patients for otitis externa. Dosage adjustments based on age/weight are typically for drop count rather than concentration. Ensure tympanic membrane integrity before use.
Geriatric Use
No specific dosage adjustments or precautions are generally required for geriatric patients. Use with caution if the tympanic membrane is perforated.
Clinical Information
Clinical Pearls
- Before instilling drops, warm the solution by holding the bottle in your hand for a few minutes to prevent dizziness.
- Lie on your side with the affected ear facing up for 5-10 minutes after instilling drops to allow the medication to penetrate.
- Do not use if the tympanic membrane (eardrum) is perforated, as it can cause pain and potential ototoxicity.
- Clean the ear canal gently before application if there is excessive discharge, but avoid vigorous cleaning.
- If an ear wick is used, ensure it is saturated with the solution and remains in place for the prescribed duration.
Alternative Therapies
- Topical fluoroquinolone otic drops (e.g., ciprofloxacin, ofloxacin)
- Topical aminoglycoside otic drops (e.g., neomycin, gentamicin)
- Topical antifungal otic drops (e.g., clotrimazole)
Cost & Coverage
Average Cost:
$10 - $30 per 15ml bottle
Generic Available:
Yes
Insurance Coverage:
Tier 1 or 2 (Generic)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. 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. 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 detailed information about the overdose, including the medication taken, the amount, and the time it occurred.