Otovel Otic Soln S/u Drops 14s
It is used to treat ear infections.
Drug Class
Otic anti-infective and corticosteroid
Pharmacologic Class
Fluoroquinolone antibiotic; Topical corticosteroid
Pregnancy Category
C
FDA Approved
Dec 2016
DEA Schedule
Not Controlled
Overview
What is this medicine?
Otovel is an ear drop medication that contains two medicines: an antibiotic (ciprofloxacin) to kill bacteria causing ear infections, and a steroid (fluocinolone) to reduce swelling and inflammation. It's used to treat ear infections in children with ear tubes.
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.
Administration Instructions
1. Wash your hands before using the medication.
2. Warm the solution by holding the container in your hands for 1 to 2 minutes before administering the drops.
3. Lie on your side with the affected ear facing upwards.
- For children under 3 years old, gently pull the outer ear outward and downward.
- For children 3 years old and above, and for adults, gently pull the outer ear outward and upward.
4. Place the drops in your ear without touching the dropper to the ear. Remain on your side for 1 minute after administration.
5. Each vial is for single use only. Discard any unused portion after administering the dose.
Storage and Disposal
Store the medication at room temperature, protected from light. Keep unused containers in their foil pouches until use.
Missed Dose
If you miss a dose, use it as soon as you remember. However, if it's close to the time for your next dose, skip the missed dose and resume your regular schedule. Do not use two doses at once 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.
Administration Instructions
1. Wash your hands before using the medication.
2. Warm the solution by holding the container in your hands for 1 to 2 minutes before administering the drops.
3. Lie on your side with the affected ear facing upwards.
- For children under 3 years old, gently pull the outer ear outward and downward.
- For children 3 years old and above, and for adults, gently pull the outer ear outward and upward.
4. Place the drops in your ear without touching the dropper to the ear. Remain on your side for 1 minute after administration.
5. Each vial is for single use only. Discard any unused portion after administering the dose.
Storage and Disposal
Store the medication at room temperature, protected from light. Keep unused containers in their foil pouches until use.
Missed Dose
If you miss a dose, use it as soon as you remember. However, if it's close to the time for your next dose, skip the missed dose and resume your regular schedule. Do not use two doses at once or take extra doses.
Lifestyle & Tips
- Shake the single-use container well before use.
- Warm the container by holding it in your hand for 1 minute before use to avoid dizziness.
- Lie on your side with the affected ear facing up.
- Instill the prescribed number of drops into the ear canal.
- Remain in the lying position for at least 1 minute to allow the drops to penetrate.
- Do not touch the tip of the container to the ear or any other surface to prevent contamination.
- Discard the single-use container after use, even if there is solution remaining.
- Complete the full 10-day course of treatment, even if symptoms improve, to prevent recurrence and antibiotic resistance.
- Avoid getting water in the ear during treatment (e.g., use earplugs when bathing or swimming).
Available Forms & Alternatives
Available Strengths:
Generic Alternatives:
Dosing & Administration
Adult Dosing
Standard Dose:
6 drops into the affected ear canal twice daily
Dose Range:
6 - 6 mg
Condition-Specific Dosing:
acuteOtitisMediaWithTympanostomyTubes:
6 drops into the affected ear canal twice daily for 10 days
Pediatric Dosing
Neonatal:
Not established
Infant:
6 drops into the affected ear canal twice daily for 10 days (for infants 6 months and older)
Child:
6 drops into the affected ear canal twice daily for 10 days
Adolescent:
6 drops into the affected ear canal twice daily for 10 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
Ciprofloxacin is a fluoroquinolone antibacterial that inhibits bacterial DNA gyrase and topoisomerase IV, essential enzymes for DNA replication, transcription, repair, and recombination. Fluocinolone acetonide is a corticosteroid that exerts anti-inflammatory, antipruritic, and vasoconstrictive actions. Corticosteroids are thought to act by the induction of phospholipase A2 inhibitory proteins, lipocortins, which control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of their common precursor, arachidonic acid.
Pharmacokinetics
Absorption:
Bioavailability:
Minimal systemic absorption (less than 1% for both components)
Tmax:
Not applicable for local otic effect; systemic Tmax not clinically relevant
FoodEffect:
Not applicable for otic administration
Distribution:
Vd:
Not clinically relevant due to local administration
ProteinBinding:
Not clinically relevant due to local administration
CnssPenetration:
No (minimal systemic absorption)
Elimination:
HalfLife:
Not clinically relevant due to local administration
Clearance:
Not clinically relevant due to local administration
ExcretionRoute:
Not clinically relevant due to local administration
Unchanged:
Not clinically relevant due to local administration
Pharmacodynamics
OnsetOfAction:
Within hours to days for symptom improvement
PeakEffect:
Within several days of treatment
DurationOfAction:
Duration of treatment (10 days) for resolution of infection and inflammation
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. 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
Dizziness or fainting
Fast or abnormal heartbeat
Change in balance
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. If you experience any of the following side effects or any other unusual symptoms that bother you or persist, contact your doctor for advice:
Fluid draining from the ear
Ear irritation
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects not mentioned here. If you have questions or concerns about side effects, don't hesitate to reach out to your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
While rare, some people may experience severe and potentially life-threatening side effects when 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
Dizziness or fainting
Fast or abnormal heartbeat
Change in balance
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. If you experience any of the following side effects or any other unusual symptoms that bother you or persist, contact your doctor for advice:
Fluid draining from the ear
Ear irritation
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects not mentioned here. If you have questions or concerns about side effects, don't hesitate to reach out to 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
- New or worsening fever
- Rash, itching, or swelling around the ear or face (signs of allergic reaction)
- Any new or unusual symptoms
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.
Certain health conditions, including:
+ Chickenpox
+ Herpes infection
+ Other viral infections of the ear
+ Fungal infections of the ear
This list is not exhaustive, and it is crucial to discuss all your health problems and medications with your doctor.
To ensure safe treatment, provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter (OTC) medications you are taking
Natural products and vitamins you are using
* Any health problems you have
Before making any changes to your medication regimen, including starting, stopping, or adjusting the dose of any drug, consult with your doctor to confirm it is safe to do so.
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.
Certain health conditions, including:
+ Chickenpox
+ Herpes infection
+ Other viral infections of the ear
+ Fungal infections of the ear
This list is not exhaustive, and it is crucial to discuss all your health problems and medications with your doctor.
To ensure safe treatment, provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter (OTC) medications you are taking
Natural products and vitamins you are using
* Any health problems you have
Before making any changes to your medication regimen, including starting, stopping, or adjusting the dose of any drug, consult with your doctor to confirm it is safe to do so.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
Rarely, severe and potentially life-threatening allergic reactions have occurred with this drug and similar medications. Be sure to discuss this risk with your doctor.
Do not take this medication for a longer period than prescribed, as this may increase the risk of developing a secondary infection.
If you are pregnant, planning to become pregnant, or are breastfeeding, notify your doctor. You and your doctor will need to carefully weigh the benefits and risks of taking this medication to ensure the best possible outcome for you and your baby.
Rarely, severe and potentially life-threatening allergic reactions have occurred with this drug and similar medications. Be sure to discuss this risk with your doctor.
Do not take this medication for a longer period than prescribed, as this may increase the risk of developing a secondary infection.
If you are pregnant, planning to become pregnant, or are breastfeeding, notify your doctor. You and your doctor will need to carefully weigh the benefits and risks of taking this medication to ensure the best possible outcome for you and your baby.
Overdose Information
Overdose Symptoms:
- Overdose with otic administration is unlikely due to minimal systemic absorption. Local irritation may occur with excessive use.
What to Do:
If accidental ingestion occurs, contact a poison control center or seek medical attention. For local irritation, discontinue use and consult a healthcare provider. Call 1-800-222-1222 for poison control.
Drug Interactions
Monitoring
Baseline Monitoring
Clinical assessment of ear infection (e.g., otoscopy)
Rationale: To confirm diagnosis and assess severity of acute otitis media with tympanostomy tubes (AOMT)
Timing: Prior to initiation of therapy
Routine Monitoring
Resolution of symptoms (e.g., ear pain, discharge)
Frequency: Daily by patient/caregiver; clinical re-evaluation as needed
Target: Complete resolution or significant improvement
Action Threshold: Lack of improvement or worsening symptoms after 3-5 days of treatment warrants re-evaluation by a healthcare provider.
Adherence to treatment regimen
Frequency: Throughout treatment course
Target: Consistent twice-daily administration for 10 days
Action Threshold: Missed doses or early discontinuation may lead to treatment failure or recurrence.
Symptom Monitoring
- Ear pain
- Ear discharge (otorrhea)
- Redness or swelling around the ear
- Fever
- Hearing changes
- Signs of allergic reaction (e.g., rash, itching, swelling)
Special Patient Groups
Pregnancy
Pregnancy Category C. While systemic ciprofloxacin and fluocinolone have risks, systemic absorption from otic administration is minimal. Use only if the potential benefit justifies the potential risk to the fetus.
Trimester-Specific Risks:
First Trimester:
Minimal systemic absorption suggests low risk, but caution advised.
Second Trimester:
Minimal systemic absorption suggests low risk, but caution advised.
Third Trimester:
Minimal systemic absorption suggests low risk, but caution advised.
Lactation
Lactation Risk L3. It is not known whether ciprofloxacin or fluocinolone acetonide are excreted in human milk following otic administration. However, due to minimal systemic absorption, excretion into breast milk is expected to be very low. Caution should be exercised, but generally considered compatible with breastfeeding.
Infant Risk:
Low risk to breastfed infant due to minimal maternal systemic absorption.
Pediatric Use
Approved for use in pediatric patients 6 months of age and older. Safety and efficacy have been established in this population. No dosage adjustment is needed based on age within the approved range.
Geriatric Use
No specific dosage adjustments are necessary for geriatric patients. Systemic exposure is minimal, so age-related changes in renal or hepatic function are not expected to significantly impact drug levels.
Clinical Information
Clinical Pearls
- Otovel is specifically indicated for acute otitis media with tympanostomy tubes (AOMT) in pediatric patients 6 months and older, and adults.
- Emphasize proper administration technique: warming the drops, lying down, and discarding single-use containers after each use.
- Stress the importance of completing the full 10-day course of therapy to ensure eradication of the infection and prevent resistance, even if symptoms improve quickly.
- Advise patients to avoid getting water in the ear during treatment to prevent re-infection or washing out the medication.
- If symptoms do not improve after 3-5 days, or worsen, re-evaluate the patient for alternative diagnoses or resistant organisms.
Alternative Therapies
- Ofloxacin otic solution (e.g., Floxin Otic)
- Ciprofloxacin otic solution (e.g., Cetraxal)
- Topical corticosteroids alone (e.g., hydrocortisone otic) for inflammation without infection
- Oral antibiotics (e.g., amoxicillin, augmentin) for systemic infection or when topical treatment is insufficient
Cost & Coverage
Average Cost:
$200 - $300 per 14 single-use drops
Insurance Coverage:
Tier 2 or Tier 3 (Specialty)
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 for more information. If you have any questions or concerns about this 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 details about the overdose, including the medication taken, the amount, and the time it occurred.