Hydrocort/acetic Acid Otic Sol(ear)
It is used to treat ear infections.
Drug Class
Otic anti-infective and anti-inflammatory
Pharmacologic Class
Corticosteroid; Acidifying agent/Antiseptic
Pregnancy Category
Category C
FDA Approved
Jan 1970
DEA Schedule
Not Controlled
Overview
What is this medicine?
This ear drop medicine contains two ingredients: acetic acid, which helps to kill bacteria and fungi by making the ear canal more acidic, and hydrocortisone, which reduces swelling, redness, and itching. It is used to treat outer ear infections (otitis externa) and inflammation.
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 upwards.
3. For children under 3 years old, gently pull the outer ear downward and outward. For children 3 years and older, and adults, pull the outer ear upward and outward.
4. 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.
5. 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, away from freezing temperatures. Keep the lid tightly closed and store all medications in a safe location, out of reach of children and pets.
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 scheduled dose, skip the missed dose and resume your regular dosing schedule. Do not take two doses at the same time or use 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 upwards.
3. For children under 3 years old, gently pull the outer ear downward and outward. For children 3 years and older, and adults, pull the outer ear upward and outward.
4. 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.
5. 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, away from freezing temperatures. Keep the lid tightly closed and store all medications in a safe location, out of reach of children and pets.
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 scheduled dose, skip the missed dose and resume your regular dosing schedule. Do not take two doses at the same time or use extra doses.
Lifestyle & Tips
- Keep the ear dry during treatment; avoid swimming or getting water in the ear.
- Do not insert cotton swabs or other objects into the ear canal.
- Complete the full course of treatment, even if symptoms improve.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
4-5 drops into the affected ear(s) 3-4 times daily
Dose Range:
4 - 5 mg
Condition-Specific Dosing:
otitisExterna:
4-5 drops into the affected ear(s) 3-4 times daily for 7-10 days, or as directed by physician.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
4-5 drops into the affected ear(s) 3-4 times daily for 7-10 days, or as directed by physician.
Adolescent:
4-5 drops into the affected ear(s) 3-4 times daily for 7-10 days, or as directed by physician.
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed (minimal systemic absorption)
Moderate:
No adjustment needed (minimal systemic absorption)
Severe:
No adjustment needed (minimal systemic absorption)
Dialysis:
No specific considerations (minimal systemic absorption)
Hepatic Impairment:
Mild:
No adjustment needed (minimal systemic absorption)
Moderate:
No adjustment needed (minimal systemic absorption)
Severe:
No adjustment needed (minimal systemic absorption)
Pharmacology
Mechanism of Action
Hydrocortisone is a corticosteroid that exerts anti-inflammatory, antipruritic, and vasoconstrictive actions. It inhibits the migration of leukocytes and fibroblasts, reverses increased capillary permeability, and lysosomal stabilization. Acetic acid is an acidifying agent that creates an acidic environment in the ear canal, which is unfavorable for the growth of many bacteria and fungi commonly associated with otitis externa. It also has antiseptic properties.
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 (local action)
Elimination:
HalfLife:
Not applicable (local action)
Clearance:
Not applicable (local action)
ExcretionRoute:
Not applicable (local action)
Unchanged:
Not applicable (local action)
Pharmacodynamics
OnsetOfAction:
Within minutes to hours (local symptom relief)
PeakEffect:
Within hours to days (local symptom relief)
DurationOfAction:
Several hours (local effect)
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor immediately or seek emergency medical attention:
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
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Irritation at the site where the medication was applied
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other unusual symptoms that bother you or persist, contact your doctor for advice:
* Burning or stinging
Note: This is not an exhaustive list of all possible side effects. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor immediately or seek emergency medical attention:
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
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Irritation at the site where the medication was applied
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other unusual symptoms that bother you or persist, contact your doctor for advice:
* Burning or stinging
Note: This is not an exhaustive list of all possible side effects. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Worsening ear pain or discharge
- Fever
- New or spreading rash around the ear
- Hearing loss
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.
Certain health conditions, including:
+ Chickenpox
+ Herpes infection
+ Ruptured eardrum
+ Smallpox-like virus
This list is not exhaustive, and it is crucial to discuss all your health problems with your doctor.
Additionally, provide your doctor and pharmacist with a comprehensive list of all the medications you are taking, including:
Prescription medications
Over-the-counter (OTC) medications
Natural products
Vitamins
It is vital to verify that it is safe to take this medication in conjunction with all your other medications and health conditions. Never start, stop, or adjust 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 symptoms you experienced as a result of the allergy.
Certain health conditions, including:
+ Chickenpox
+ Herpes infection
+ Ruptured eardrum
+ Smallpox-like virus
This list is not exhaustive, and it is crucial to discuss all your health problems with your doctor.
Additionally, provide your doctor and pharmacist with a comprehensive list of all the medications you are taking, including:
Prescription medications
Over-the-counter (OTC) medications
Natural products
Vitamins
It is vital to verify that it is safe to take this medication in conjunction with all your other medications and health conditions. Never start, stop, or adjust the dosage of any medication without first consulting your doctor.
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, you must discuss this with your doctor. This conversation will help you understand the potential benefits and risks of this medication to both you and your baby, allowing you to make an informed decision.
Overdose Information
Overdose Symptoms:
- Local irritation
- Burning
- Stinging
- Itching
What to Do:
Discontinue use and rinse the ear with water. If irritation persists, seek medical attention. For accidental ingestion, call a poison control center (1-800-222-1222) or seek immediate medical attention.
Drug Interactions
Monitoring
Routine Monitoring
Clinical symptoms (pain, discharge, redness, swelling)
Frequency: Daily
Target: Improvement
Action Threshold: Worsening symptoms or no improvement after 7-10 days
Symptom Monitoring
- Ear pain
- Itching
- Redness
- Swelling
- Discharge from the ear
Special Patient Groups
Pregnancy
Use with caution during pregnancy. While systemic absorption is minimal, hydrocortisone is a Category C drug. Use only if the potential benefit justifies the potential risk to the fetus.
Trimester-Specific Risks:
First Trimester:
Minimal systemic absorption, but caution advised.
Second Trimester:
Minimal systemic absorption, but caution advised.
Third Trimester:
Minimal systemic absorption, but caution advised.
Lactation
Considered low risk during breastfeeding due to minimal systemic absorption. Hydrocortisone is rated L3 (moderately safe) and acetic acid is L2 (safer). Monitor infant for potential adverse effects, though unlikely.
Infant Risk:
Low
Pediatric Use
Generally safe for use in children, but diagnosis of otitis externa should be confirmed by a healthcare professional. Dosage is similar to adults for children over a certain age (e.g., 3 years old), but specific age-based dosing should be confirmed by a physician.
Geriatric Use
No specific dosage adjustments are typically required for geriatric patients. Use with caution in patients with perforated eardrums.
Clinical Information
Clinical Pearls
- Warm the solution by holding the bottle in your hand for a few minutes before instillation to avoid dizziness.
- Shake the bottle well before each use.
- Do not touch the dropper tip to the ear or any other surface to prevent contamination.
- Lie on your side with the affected ear facing up for 5-10 minutes after instilling drops to allow the medication to penetrate.
- This medication is for external ear use only; do not ingest or use in the eyes.
Alternative Therapies
- Topical antibiotic otic drops (e.g., Ofloxacin, Ciprofloxacin)
- Topical corticosteroid otic drops (e.g., Dexamethasone)
- Oral antibiotics (for severe or spreading infections)
Cost & Coverage
Average Cost:
$20-$50 per 10 mL bottle
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2
General Drug Facts
If your symptoms or health condition do not improve or worsen over time, it is essential to contact your doctor for further evaluation and guidance. To ensure your safety and the effectiveness of your treatment, never share your medication with others or take someone else's medication. Some medications may come with additional patient information leaflets, so it is a good idea to consult with your pharmacist for more information. If you have any questions or concerns about your medication, do not 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 name of the medication taken, the amount, and the time it occurred.