Dermotic 0.01% Oil Ear Drops 20ml
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
Sep 1990
DEA Schedule
Not Controlled
Overview
What is this medicine?
Dermotic is an ear drop that contains a medicine called fluocinolone. It's a type of steroid that helps reduce swelling, redness, and itching in the ear canal, often used for conditions like ear eczema or 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. Use the medication as directed, even if your symptoms improve.
Apply the medication only to your ear. Avoid getting it 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 for 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.
What to Do If You Miss a Dose
If you miss a dose, use it as soon as you remember.
If it's close to the time for your next dose, skip the missed dose and resume your regular dosing schedule.
* Do not use two doses at once or take extra doses to make up for a missed dose.
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 your ear. Avoid getting it 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 for 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.
What to Do If You Miss a Dose
If you miss a dose, use it as soon as you remember.
If it's close to the time for your next dose, skip the missed dose and resume your regular dosing schedule.
* Do not use two doses at once or take extra doses to make up for a missed dose.
Lifestyle & Tips
- Shake the bottle well before each use.
- Lie down with the affected ear facing upwards. Gently pull the earlobe up and back to straighten the ear canal.
- Instill the prescribed number of drops into the ear canal.
- Remain in this position for a few minutes to allow the drops to penetrate.
- Do not touch the dropper tip to the ear or any other surface to prevent contamination.
- Do not rinse the dropper.
- Wash hands before and after use.
- Do not use for longer than prescribed by your doctor, typically no more than 14 days.
Available Forms & Alternatives
Available Strengths:
Generic Alternatives:
Dosing & Administration
Adult Dosing
Standard Dose:
5 drops into the affected ear canal twice daily
Condition-Specific Dosing:
otitis externa:
Apply 5 drops into the affected ear canal twice daily for up to 14 days.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
5 drops into the affected ear canal twice daily for up to 14 days (for children 2 years and older). Use with caution and for shortest duration possible.
Adolescent:
5 drops into the affected ear canal twice daily for up to 14 days.
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
Fluocinolone acetonide is a corticosteroid that exerts anti-inflammatory, antipruritic, and vasoconstrictive actions. It inhibits the migration of macrophages and leukocytes to the area, reverses capillary permeability and vasodilation, and reduces the release of inflammatory mediators. This leads to a reduction in edema, fibrin deposition, capillary leakage, and phagocytic activity.
Pharmacokinetics
Absorption:
Bioavailability:
Minimal systemic absorption from otic application
Tmax:
Not applicable (local action)
FoodEffect:
Not applicable
Distribution:
Vd:
Not significant systemically
ProteinBinding:
Not significant systemically
CnssPenetration:
Limited
Elimination:
HalfLife:
Not significant for otic use (systemic half-life not clinically relevant)
Clearance:
Not significant for otic use
ExcretionRoute:
Renal (if systemically absorbed)
Unchanged:
Not significant for otic use
Pharmacodynamics
OnsetOfAction:
Within hours to days (local anti-inflammatory effect)
PeakEffect:
Within days of consistent use
DurationOfAction:
Varies; local effect persists for several hours after application
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Attention Immediately
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 medical help right away:
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 discuss any concerns with your doctor. If you experience any of the following side effects or any other unusual symptoms, contact your doctor or seek medical help:
Burning, itching, dryness, or other irritation where the medication was applied
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 medical help right away:
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 discuss any concerns with your doctor. If you experience any of the following side effects or any other unusual symptoms, contact your doctor or seek medical help:
Burning, itching, dryness, or other irritation where the medication was applied
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 ear pain or itching
- New or increased ear discharge (especially if pus-like)
- Fever
- Signs of allergic reaction (rash, severe itching, swelling)
- Persistent burning or stinging after application
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.
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 to consult with your doctor before making any changes to your medication regimen, including starting, stopping, or adjusting the dose of any drug. This will help ensure your safety and the effectiveness of your treatment.
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.
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 to consult with your doctor before making any changes to your medication regimen, including starting, stopping, or adjusting the dose of any drug. This will help ensure your safety and the effectiveness of your treatment.
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 exceed the prescribed duration of treatment, as directed by your doctor. When administering this drug to children, exercise caution, as they may be at a higher risk of experiencing certain side effects.
If you are pregnant, planning to become pregnant, or are breastfeeding, notify your doctor. You and your doctor will need to discuss the potential benefits and risks of this medication to both you and your baby.
Do not exceed the prescribed duration of treatment, as directed by your doctor. When administering this drug to children, exercise caution, as they may be at a higher risk of experiencing certain side effects.
If you are pregnant, planning to become pregnant, or are breastfeeding, notify your doctor. You and your doctor will need to discuss the potential benefits and risks of this medication to both you and your baby.
Overdose Information
Overdose Symptoms:
- Systemic effects are unlikely with otic overdose due to minimal absorption.
- Local irritation or burning may occur with excessive application.
What to Do:
Discontinue use. If systemic effects are suspected (extremely rare), supportive care. For local irritation, rinse ear with warm water. Call 1-800-222-1222 (Poison Control) for advice if concerned.
Drug Interactions
Contraindicated Interactions
- None known due to minimal systemic absorption
Major Interactions
- None known due to minimal systemic absorption
Moderate Interactions
- None known due to minimal systemic absorption
Minor Interactions
- None known due to minimal systemic absorption
Monitoring
Baseline Monitoring
Assessment of ear canal inflammation/eczema
Rationale: To establish baseline severity and confirm diagnosis.
Timing: Prior to initiation of therapy
Routine Monitoring
Resolution of symptoms (itching, redness, swelling)
Frequency: Daily by patient, weekly by clinician if prolonged use
Target: Improvement or resolution of symptoms
Action Threshold: Lack of improvement or worsening of symptoms after 7 days, or signs of infection
Local adverse reactions (burning, stinging, irritation)
Frequency: Daily by patient
Target: Absence or mild, transient reactions
Action Threshold: Persistent or severe local irritation
Signs of secondary infection
Frequency: Periodically during treatment
Target: Absence of purulent discharge, increased pain, fever
Action Threshold: Development of new or worsening signs of infection
Symptom Monitoring
- Ear pain
- Itching
- Redness
- Swelling
- Discharge
- Hearing changes
- Burning or stinging sensation in the ear
Special Patient Groups
Pregnancy
Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. While systemic absorption from otic use is minimal, corticosteroids are generally Category C.
Trimester-Specific Risks:
First Trimester:
Potential for teratogenicity with high systemic doses; minimal risk with otic use.
Second Trimester:
Minimal risk with otic use.
Third Trimester:
Minimal risk with otic use.
Lactation
Caution should be exercised when administered to a nursing woman. It is not known whether topically administered corticosteroids are excreted in human milk. However, systemic absorption is minimal, making infant exposure unlikely to be significant.
Infant Risk:
Low risk due to minimal maternal systemic absorption.
Pediatric Use
Safety and effectiveness in pediatric patients under 2 years of age have not been established. In children 2 years and older, use with caution and for the shortest duration possible. Prolonged use of corticosteroids in children may interfere with growth and development, and may cause HPA axis suppression, although this is rare with otic preparations.
Geriatric Use
No specific dosage adjustments are necessary for geriatric patients. Systemic absorption is minimal, so age-related changes in renal or hepatic function are not expected to significantly impact drug exposure.
Clinical Information
Clinical Pearls
- Dermotic is an oil-based formulation, which may help with dry, flaky skin conditions in the ear canal.
- Ensure the ear canal is clean and dry before application for optimal efficacy.
- Avoid prolonged use (beyond 14 days) without re-evaluation by a healthcare professional to minimize potential for local side effects or masking of infection.
- If symptoms do not improve within 7 days, or worsen, re-evaluate the diagnosis as a fungal or bacterial infection may be present.
Alternative Therapies
- Other topical corticosteroids (e.g., hydrocortisone otic)
- Topical calcineurin inhibitors (e.g., tacrolimus, pimecrolimus) for chronic inflammatory conditions (off-label for ear)
- Antifungal ear drops (if fungal infection suspected)
- Antibiotic ear drops (if bacterial infection suspected)
Cost & Coverage
Average Cost:
Not readily available for specific brand/concentration, typically low for generic per 20ml bottle
Generic Available:
Yes
Insurance Coverage:
Tier 1-2 (for generic)
General Drug Facts
If your symptoms or health issues persist or worsen, it's 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 be sure to check with your pharmacist for more information. 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 medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.