Vosol HC Otic Solution 10ml (ear)
It is used to treat ear infections.
Drug Class
Otic anti-infective and anti-inflammatory
Pharmacologic Class
Corticosteroid (otic), Acidifying agent (otic)
Pregnancy Category
Category C
FDA Approved
Jan 1970
DEA Schedule
Not Controlled
Overview
What is this medicine?
Vosol HC Otic Solution is an ear drop medication that contains two active ingredients: acetic acid and hydrocortisone. Acetic acid helps kill bacteria and fungi and restores the natural acidity of the ear canal, which discourages germ growth. Hydrocortisone is a steroid that reduces swelling, redness, and itching in the ear. It is used to treat outer ear infections (swimmer's ear) and reduce 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 up.
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.
Missing a Dose
If you miss a dose, take it as soon as you remember. However, if it's 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 up.
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.
Missing a Dose
If you miss a dose, take it as soon as you remember. However, if it's 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
- Shake the bottle well before each use.
- Lie down with the affected ear facing upwards. Administer the prescribed number of drops into the ear canal.
- Remain in this position for a few minutes to allow the drops to penetrate.
- Avoid touching the dropper tip to the ear or any other surface to prevent contamination.
- Do not rinse the dropper.
- Do not use if the eardrum is perforated (a hole in the eardrum).
- Keep the ear dry during treatment; avoid swimming or getting water in the ear.
- Complete the full course of treatment as prescribed, even if symptoms improve.
Available Forms & Alternatives
Available Strengths:
Generic Alternatives:
Dosing & Administration
Adult Dosing
Standard Dose:
4 drops into the affected ear(s) 3 to 4 times a day
Dose Range:
3 - 4 mg
Condition-Specific Dosing:
otitisExterna:
4 drops into the affected ear(s) 3 to 4 times a day
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established, consult pediatrician. Use with caution.
Child:
3 to 4 drops into the affected ear(s) 3 to 4 times a day, or as directed by physician.
Adolescent:
4 drops into the affected ear(s) 3 to 4 times a day
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 antibacterial and antifungal agent that also helps restore the normal acidic pH of the ear canal, inhibiting microbial growth. Hydrocortisone is a corticosteroid that provides anti-inflammatory, antipruritic, and vasoconstrictive actions, reducing swelling, redness, and itching associated with ear infections.
Pharmacokinetics
Absorption:
Bioavailability:
Minimal systemic absorption from otic application
Tmax:
Not applicable for local otic effect
FoodEffect:
Not applicable
Distribution:
Vd:
Not applicable for local otic effect
ProteinBinding:
Not applicable for local otic effect
CnssPenetration:
No
Elimination:
HalfLife:
Not applicable for local otic effect
Clearance:
Not applicable for local otic effect
ExcretionRoute:
Not applicable for local otic effect
Unchanged:
Not applicable for local otic effect
Pharmacodynamics
OnsetOfAction:
Within hours to days for symptomatic relief
PeakEffect:
Within 2-3 days of consistent use
DurationOfAction:
Dependent on dosing frequency, typically 6-8 hours per dose
Safety & Warnings
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
- 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. Contact your doctor 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 medical advice. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
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
- 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. Contact your doctor 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 medical advice. 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
- New onset of fever or chills
- Increased redness or swelling around the ear
- Hearing loss or ringing in the ears
- Signs of an allergic reaction (rash, itching, severe dizziness, trouble breathing)
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.
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 combination 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 allergic reaction you experienced, including any symptoms that occurred.
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 combination 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 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:
- Systemic effects are unlikely due to minimal absorption. Local irritation may occur with excessive use.
What to Do:
Discontinue use and rinse ear with warm water if irritation occurs. For accidental ingestion or significant systemic exposure (highly unlikely with otic use), call a poison control center (1-800-222-1222) or seek immediate medical attention.
Drug Interactions
Monitoring
Baseline Monitoring
Otoscopic examination of ear canal and tympanic membrane
Rationale: To assess the extent of inflammation, presence of infection, and integrity of the tympanic membrane (perforation is a contraindication).
Timing: Prior to initiation of therapy
Routine Monitoring
Clinical symptoms (pain, itching, discharge)
Frequency: Daily by patient, periodically by clinician
Target: Improvement or resolution of symptoms
Action Threshold: Worsening symptoms or no improvement after 7-10 days; re-evaluate diagnosis and treatment.
Otoscopic examination
Frequency: As clinically indicated, or at follow-up visit
Target: Reduction in inflammation, swelling, and discharge
Action Threshold: Persistent inflammation, signs of fungal superinfection, or new symptoms.
Symptom Monitoring
- Ear pain
- Ear itching
- Ear discharge
- Redness or swelling of the ear canal
- Hearing changes
Special Patient Groups
Pregnancy
Category C. Use only if the potential benefit justifies the potential risk to the fetus. Minimal systemic absorption is expected with otic use, but caution is advised.
Trimester-Specific Risks:
First Trimester:
Potential risk, but minimal systemic exposure limits concern.
Second Trimester:
Potential risk, but minimal systemic exposure limits concern.
Third Trimester:
Potential risk, but minimal systemic exposure limits concern.
Lactation
L3 (Moderately Safe). Hydrocortisone is excreted in breast milk, but systemic absorption from otic application is minimal, making infant exposure unlikely to be significant. Acetic acid is generally considered safe. Use with caution.
Infant Risk:
Low risk of adverse effects to the infant due to minimal systemic absorption.
Pediatric Use
Generally safe for use in children, but dosage may vary by age and weight. Not recommended for neonates or infants without specific medical guidance. Prolonged use of corticosteroids in children should be avoided due to potential for systemic effects, though rare with otic preparations.
Geriatric Use
No specific dosage adjustments are typically required for geriatric patients. Use with caution if there is a history of perforated tympanic membrane or other ear conditions.
Clinical Information
Clinical Pearls
- Ensure the tympanic membrane is intact before administering, as corticosteroids can be ototoxic if they enter the middle ear.
- Patients should be instructed on proper administration technique to maximize efficacy and minimize contamination.
- If symptoms do not improve within 7-10 days, re-evaluate the diagnosis and consider alternative treatments or further investigation.
- This solution is for external ear use only; do not ingest or use in the eyes.
- Store at room temperature and keep the bottle tightly closed.
Alternative Therapies
- Topical fluoroquinolone otic drops (e.g., Ofloxacin, Ciprofloxacin) for bacterial otitis externa
- Topical antifungal otic drops (e.g., Clotrimazole) for fungal otitis externa
- Plain acetic acid otic solution (e.g., Vosol) for mild cases or prophylaxis
- Oral antibiotics for severe or spreading infections
Cost & Coverage
Average Cost:
$20 - $50 per 10ml bottle
Generic Available:
Yes
Insurance Coverage:
Tier 1 or 2 (Generic), Tier 3 (Brand)
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. If you have any questions or concerns about your medication, don't hesitate to reach out to 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 substance taken, the amount, and the time it occurred.