Fluocinolone 0.01% Oil Drops (ear)
It is used to treat a certain type of skin problem in the ear.
Drug Class
Corticosteroid, Otic
Pharmacologic Class
Glucocorticoid
Pregnancy Category
Category C
FDA Approved
Mar 2003
DEA Schedule
Not Controlled
Overview
What is this medicine?
Fluocinolone 0.01% Oil Drops are an ear medication containing a steroid. It works by reducing swelling, redness, and itching in the ear canal caused by a type of chronic ear eczema. It helps calm down the inflammation so your ear can heal.
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. Use the medication as directed, even if your symptoms improve.
Apply the medication only to the affected ear.
Avoid getting the medication in your eyes.
Wash your hands before and after using the medication.
To administer the drops:
+ For children under 3 years old, gently pull the outer ear downward and outward.
+ For children 3 years old and above, and adults, gently pull the outer ear upward and outward.
+ Place the drops in your ear without touching the dropper to the ear canal.
+ Remain on your side for 2 minutes or insert a cotton plug into your ear to help the medication stay in place.
Storing and Disposing of Your Medication
Store the medication at room temperature with the lid tightly closed.
Be aware of the medication's expiration date or the length of time you can store it before disposal.
* Keep all medications in a safe location, out of the reach of children and pets.
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 take extra doses.
To use this medication effectively, follow your doctor's instructions and read all the information provided. Use the medication as directed, even if your symptoms improve.
Apply the medication only to the affected ear.
Avoid getting the medication in your eyes.
Wash your hands before and after using the medication.
To administer the drops:
+ For children under 3 years old, gently pull the outer ear downward and outward.
+ For children 3 years old and above, and adults, gently pull the outer ear upward and outward.
+ Place the drops in your ear without touching the dropper to the ear canal.
+ Remain on your side for 2 minutes or insert a cotton plug into your ear to help the medication stay in place.
Storing and Disposing of Your Medication
Store the medication at room temperature with the lid tightly closed.
Be aware of the medication's expiration date or the length of time you can store it before disposal.
* Keep all medications in a safe location, out of the reach of children and pets.
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 take extra doses.
Lifestyle & Tips
- Shake the bottle well before each use.
- Warm the bottle by holding it in your hand for a few minutes before use to prevent dizziness.
- Lie on your side with the affected ear facing up. Gently pull the earlobe up and back to straighten the ear canal.
- Instill the prescribed number of drops into the ear canal.
- Remain in the lying position for a few minutes (e.g., 5 minutes) to allow the oil to penetrate.
- Do not rinse the ear or insert cotton into the ear canal unless directed by your doctor.
- Avoid getting water in the ear during treatment (e.g., use cotton balls coated with petroleum jelly when showering).
- Do not use for longer than prescribed (typically 14 days) without consulting your doctor.
- Do not use if you have a perforated eardrum or ear tubes, unless specifically instructed by your doctor.
Available Forms & Alternatives
Available Strengths:
- Fluocinolone 0.01% Cream 60gm
- Fluocinolone Acet 0.025% Oint 60gm
- Fluocinolone Acet 0.025% Oint 15gm
- Fluocinolone Acet 0.01% Crm 15gm
- Fluocinolone Acet 0.01% Crm 60gm
- Fluocinolone Acet 0.01% Soln 60ml
- Fluocinolone Acetonide Body Oil
- Fluocinolone Acet 0.01% Scalp Oil
- Fluocinolone 0.01% Oil Drops (ear)
- Fluocinolone Acet 0.025% Crm 15gm
- Fluocinolone Acet 0.025% Crm 60gm
- Fluocinolone Acet 0.025% Oint 15gm
- Fluocinolone Acet 0.025% Oint 60gm
- Fluocinolone Acet 0.01% Scalp Oil
Dosing & Administration
Adult Dosing
Standard Dose:
5 drops into the affected ear canal twice daily for up to 14 days
Dose Range:
5 - 5 mg
Condition-Specific Dosing:
chronic eczematous external otitis:
5 drops into the affected ear canal twice daily for up to 14 days
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established for children under 2 years of age
Child:
2 years and older: 5 drops into the affected ear canal twice daily for up to 14 days
Adolescent:
5 drops into the affected ear canal twice daily for up to 14 days
Dose Adjustments
Renal Impairment:
Mild:
No adjustment typically required due to minimal systemic absorption
Moderate:
No adjustment typically required due to minimal systemic absorption
Severe:
No adjustment typically required due to minimal systemic absorption
Dialysis:
No specific considerations due to minimal systemic absorption
Hepatic Impairment:
Mild:
No adjustment typically required due to minimal systemic absorption
Moderate:
No adjustment typically required due to minimal systemic absorption
Severe:
No adjustment typically required due to minimal systemic absorption
Pharmacology
Mechanism of Action
Fluocinolone acetonide is a corticosteroid that exerts anti-inflammatory, antipruritic, and vasoconstrictive actions. It inhibits the release of hydrolytic enzymes from leukocytes, prevents tissue macrophage accumulation, reduces leukocyte adhesion to capillary endothelium, reduces capillary wall permeability and edema formation, and reduces the synthesis and release of various inflammatory mediators (e.g., prostaglandins, kinins, histamine, liposomal enzymes).
Pharmacokinetics
Absorption:
Bioavailability:
Minimal systemic absorption through intact skin/mucosa; increased with inflammation, prolonged use, or occlusive dressings.
Tmax:
Not applicable for otic topical application (systemic Tmax not well-defined for this route).
FoodEffect:
Not applicable for otic topical application.
Distribution:
Vd:
Not well-defined for otic topical application (minimal systemic distribution).
ProteinBinding:
Not well-defined for otic topical application (minimal systemic protein binding).
CnssPenetration:
Limited (minimal systemic absorption).
Elimination:
HalfLife:
Not well-defined for otic topical application (systemic half-life not clinically relevant).
Clearance:
Not well-defined for otic topical application.
ExcretionRoute:
If absorbed systemically, primarily excreted renally.
Unchanged:
Not available
Pharmacodynamics
OnsetOfAction:
Within a few days of treatment initiation (local anti-inflammatory effect).
PeakEffect:
Within 1-2 weeks of treatment.
DurationOfAction:
Varies; effects persist as long as treatment continues.
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 or seek immediate 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
Signs of a weak adrenal gland, including:
+ Severe upset stomach or vomiting
+ Severe dizziness or fainting
+ Muscle weakness
+ Feeling extremely tired
+ Mood changes
+ Decreased appetite
+ Weight loss
Signs of Cushing's syndrome, such as:
+ Weight gain in the upper back or belly
+ Moon face
+ Severe headache
+ Slow healing
Signs of high blood sugar, including:
+ Confusion
+ Feeling sleepy
+ Unusual thirst or hunger
+ Passing urine more often
+ Flushing
+ Fast breathing
+ Breath that smells like fruit
Skin changes, such as:
+ Pimples
+ Stretch marks
+ Slow healing
+ Hair growth
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 contact your doctor or seek medical help if you notice any of the following:
Burning, itching, dryness, or other irritation at the application site
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns about 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.
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 or seek immediate 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
Signs of a weak adrenal gland, including:
+ Severe upset stomach or vomiting
+ Severe dizziness or fainting
+ Muscle weakness
+ Feeling extremely tired
+ Mood changes
+ Decreased appetite
+ Weight loss
Signs of Cushing's syndrome, such as:
+ Weight gain in the upper back or belly
+ Moon face
+ Severe headache
+ Slow healing
Signs of high blood sugar, including:
+ Confusion
+ Feeling sleepy
+ Unusual thirst or hunger
+ Passing urine more often
+ Flushing
+ Fast breathing
+ Breath that smells like fruit
Skin changes, such as:
+ Pimples
+ Stretch marks
+ Slow healing
+ Hair growth
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 contact your doctor or seek medical help if you notice any of the following:
Burning, itching, dryness, or other irritation at the application site
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns about 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.
Seek Immediate Medical Attention If You Experience:
- Worsening of ear pain, redness, or swelling
- New or increased ear discharge, especially if it's pus-like
- Fever or chills
- Hearing changes or dizziness
- Severe burning, itching, or irritation in the ear after applying the drops
- Signs of allergic reaction (e.g., rash, hives, severe itching, swelling of face/tongue/throat, difficulty 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 symptoms you experienced as a result of the allergy.
The presence of an infection at the site where this medication will be administered, as this may affect its use.
Potential interactions with other medications or health conditions. To ensure safe use, disclose all your medications, including:
+ Prescription and over-the-counter (OTC) drugs
+ Natural products
+ Vitamins
Any existing health problems, as these may influence the safety and efficacy of this medication.
Remember, it is crucial to verify the safety of taking this medication 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.
The presence of an infection at the site where this medication will be administered, as this may affect its use.
Potential interactions with other medications or health conditions. To ensure safe use, disclose all your medications, including:
+ Prescription and over-the-counter (OTC) drugs
+ Natural products
+ Vitamins
Any existing health problems, as these may influence the safety and efficacy of this medication.
Remember, it is crucial to verify the safety of taking this medication 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. Certain brands of this drug may contain peanut oil, so if you have a peanut allergy, consult your pharmacist to determine if your specific brand contains peanut oil.
Do not take this medication for a longer duration than prescribed by your doctor. When administering this drug to a child, exercise caution, as children may be at a higher risk of experiencing certain side effects. If you are pregnant, planning to become pregnant, or are breastfeeding, discuss the potential benefits and risks with your doctor to ensure the best decision for both you and your baby.
Do not take this medication for a longer duration than prescribed by your doctor. When administering this drug to a child, exercise caution, as children may be at a higher risk of experiencing certain side effects. If you are pregnant, planning to become pregnant, or are breastfeeding, discuss the potential benefits and risks with your doctor to ensure the best decision for both you and your baby.
Overdose Information
Overdose Symptoms:
- Local irritation (burning, itching, dryness)
- Skin atrophy (thinning of skin) with prolonged or excessive use
- Potential for systemic effects (e.g., Cushing's syndrome, adrenal suppression) with very prolonged, high-dose use over large surface areas, especially in children, though highly unlikely with proper otic use.
What to Do:
Discontinue use. For local irritation, symptomatic treatment. For suspected systemic effects, medical evaluation is needed. Call 1-800-222-1222 (Poison Control Center) for advice.
Drug Interactions
Monitoring
Baseline Monitoring
Clinical assessment of ear canal
Rationale: To establish baseline severity of eczematous external otitis and rule out acute infection.
Timing: Prior to initiation of therapy
Routine Monitoring
Clinical response (reduction in inflammation, itching, pain)
Frequency: Daily by patient, periodically by clinician
Target: Improvement of symptoms
Action Threshold: Lack of improvement or worsening of symptoms after 7 days, or signs of infection, warrants re-evaluation.
Local adverse reactions (e.g., burning, itching, irritation, dryness)
Frequency: Daily by patient
Target: Absence or mildness of reactions
Action Threshold: Severe or persistent local reactions warrant discontinuation.
Signs of secondary infection
Frequency: Daily by patient, periodically by clinician
Target: Absence of purulent discharge, increased pain, fever
Action Threshold: Presence of infection requires appropriate antimicrobial therapy.
Symptom Monitoring
- Reduction in ear itching
- Decrease in ear redness and inflammation
- Reduction in ear discharge (if present due to eczema)
- Absence of new or worsening ear pain
- Absence of signs of secondary infection (e.g., fever, purulent discharge)
Special Patient Groups
Pregnancy
Category C. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. While systemic absorption from otic use is minimal, corticosteroids have shown teratogenic effects in animal studies when administered systemically at high doses.
Trimester-Specific Risks:
First Trimester:
Potential for teratogenic effects, though risk is low with minimal systemic absorption.
Second Trimester:
Generally considered safer than first trimester, but still use with caution.
Third Trimester:
No specific risks identified beyond general corticosteroid effects; potential for HPA axis suppression in neonate is theoretical with high systemic exposure, but unlikely with otic use.
Lactation
L3 (Moderately safe). It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk. Caution should be exercised when fluocinolone acetonide otic oil is administered to a nursing woman. Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for the drug and any potential adverse effects on the breastfed infant from the drug or from the underlying maternal condition.
Infant Risk:
Low risk due to minimal systemic absorption. Monitor infant for signs of systemic corticosteroid effects (e.g., growth suppression) if mother uses large amounts or for prolonged periods, though highly unlikely with otic use.
Pediatric Use
Safety and effectiveness in pediatric patients below the age of 2 years have not been established. Children may absorb proportionally larger amounts of topical corticosteroids and thus be more susceptible to systemic adverse effects, including HPA axis suppression and Cushing's syndrome. Use the smallest effective dose for the shortest duration possible. Monitor for signs of systemic effects (e.g., growth retardation, delayed weight gain).
Geriatric Use
No overall differences in safety or effectiveness have been observed between elderly and younger patients. Dosage adjustment is generally not required.
Clinical Information
Clinical Pearls
- This formulation is an oil, which can help with dry, flaky skin often associated with chronic eczematous external otitis.
- Ensure the patient understands the correct instillation technique to maximize efficacy and minimize waste.
- Warn patients about potential transient dizziness if the drops are cold when instilled.
- Emphasize that this product is for external otitis and should not be used if a perforated eardrum is suspected or confirmed, unless specifically advised by an ENT specialist.
- If no improvement is seen after 7 days, or if symptoms worsen, re-evaluate the diagnosis to rule out bacterial or fungal infection, or other ear conditions.
Alternative Therapies
- Other topical corticosteroids (e.g., hydrocortisone otic, betamethasone otic)
- Topical calcineurin inhibitors (e.g., tacrolimus, pimecrolimus) for off-label use in severe cases resistant to steroids
- Antifungal or antibacterial ear drops if secondary infection is present
Cost & Coverage
Average Cost:
$100 - $200 per 20 mL bottle
Generic Available:
Yes
Insurance Coverage:
Tier 2 or 3 (often covered by most plans)
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 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.