Cipro/fluocinolone Pf Otic Soln 14s
It is used to treat ear infections.
Drug Class
Otic anti-infective and anti-inflammatory
Pharmacologic Class
Fluoroquinolone antibiotic; Corticosteroid
Pregnancy Category
Category C
FDA Approved
Sep 2015
DEA Schedule
Not Controlled
Overview
What is this medicine?
This medicine is a combination of an antibiotic (ciprofloxacin) and a steroid (fluocinolone). It is used to treat ear infections, specifically in children who are getting ear tubes. The antibiotic helps kill bacteria, and the steroid helps reduce swelling and inflammation in the ear.
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
Use the medication only in your ear.
Wash your hands before administering the medication.
Warm the solution by holding the container in your hands for 1 to 2 minutes before putting drops in your ear.
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 adults, gently pull the outer ear outward and upward.
Place the drops in your ear without touching the dropper to your ear. Remain on your side for 1 minute after administration.
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 the foil pouch until use.
Missing a Dose
If you miss a dose, use it as soon as you remember.
If it is close to the time for your next dose, skip the missed dose and resume your regular schedule.
* Do not use 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. Continue using the medication as directed, even if your symptoms improve.
Administration Instructions
Use the medication only in your ear.
Wash your hands before administering the medication.
Warm the solution by holding the container in your hands for 1 to 2 minutes before putting drops in your ear.
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 adults, gently pull the outer ear outward and upward.
Place the drops in your ear without touching the dropper to your ear. Remain on your side for 1 minute after administration.
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 the foil pouch until use.
Missing a Dose
If you miss a dose, use it as soon as you remember.
If it is close to the time for your next dose, skip the missed dose and resume your regular schedule.
* Do not use two doses at the same time or take extra doses.
Lifestyle & Tips
- Keep the ear dry as instructed by your doctor.
- Avoid getting water in the ear, especially after ear tube placement.
- Follow up with your doctor as recommended to ensure the infection has cleared.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
Not indicated for adult use in this specific formulation (Otiprio).
Pediatric Dosing
Neonatal:
Not established (indicated for 6 months and older)
Infant:
For pediatric patients 6 months of age and older undergoing tympanostomy tube placement (TTP): 0.2 mL administered as a single intratympanic administration into each affected ear by a physician.
Child:
For pediatric patients 6 months of age and older undergoing tympanostomy tube placement (TTP): 0.2 mL administered as a single intratympanic administration into each affected ear by a physician.
Adolescent:
Not typically indicated for adolescents in this specific formulation (Otiprio), as it's for OME with TTP in younger children.
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 adjustment needed (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
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 inhibit the release of hydrolytic enzymes from leukocytes, suppress the proliferation of fibroblasts, deposition of collagen, and subsequent scar formation.
Pharmacokinetics
Absorption:
Bioavailability:
Minimal systemic absorption (plasma concentrations of ciprofloxacin and fluocinolone acetonide were below the limit of quantification in clinical studies after intratympanic administration)
Tmax:
Not applicable (for systemic absorption)
FoodEffect:
Not applicable (otic administration)
Distribution:
Vd:
Not applicable (for systemic absorption)
ProteinBinding:
Not applicable (for systemic absorption)
CnssPenetration:
No (minimal systemic absorption)
Elimination:
HalfLife:
Not applicable (for systemic absorption)
Clearance:
Not applicable (for systemic absorption)
ExcretionRoute:
Not applicable (for systemic absorption)
Unchanged:
Not applicable (for systemic absorption)
Pharmacodynamics
OnsetOfAction:
Rapid local anti-inflammatory and antibacterial effect (within hours to days)
PeakEffect:
Within days of administration
DurationOfAction:
Sustained release formulation designed for prolonged local effect (e.g., Otiprio provides sustained drug exposure for up to 14 days)
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. 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.
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. 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
- Increased ear discharge or new discharge
- Fever
- Signs of allergic reaction (e.g., rash, itching, swelling)
- 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 allergic reaction you experienced, including any symptoms that occurred.
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 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 with all your other medications and health conditions. Never start, stop, or change the dose 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
+ 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 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 with all your other medications and health conditions. Never start, stop, or change the dose 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.
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 this medication to both 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 this medication to both you and your baby.
Overdose Information
Overdose Symptoms:
- Overdose with otic solutions is highly unlikely due to the small volume administered and minimal systemic absorption. Local irritation might occur with excessive application.
What to Do:
If accidental ingestion occurs, contact a poison control center immediately. For local irritation, discontinue use and consult a healthcare professional. Call 1-800-222-1222 for poison control.
Drug Interactions
Monitoring
Baseline Monitoring
Diagnosis of otitis media with effusion (OME)
Rationale: To confirm appropriate indication for tympanostomy tube placement (TTP) and drug administration.
Timing: Prior to administration
Otoscopic examination
Rationale: To assess ear canal and tympanic membrane status.
Timing: Prior to administration
Routine Monitoring
Clinical signs and symptoms of ear infection (e.g., pain, discharge, fever)
Frequency: Daily or as clinically indicated
Target: Resolution or improvement of symptoms
Action Threshold: Worsening symptoms or lack of improvement may indicate treatment failure or need for alternative therapy.
Otoscopic examination
Frequency: As clinically indicated (e.g., follow-up visit)
Target: Resolution of inflammation and infection
Action Threshold: Persistent inflammation or signs of infection.
Symptom Monitoring
- Ear pain
- Ear discharge
- Fever
- Irritability (in infants/young children)
- Hearing changes
Special Patient Groups
Pregnancy
Pregnancy Category C. While animal studies have shown some adverse effects with systemic ciprofloxacin and corticosteroids, 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
Ciprofloxacin is excreted in human milk after systemic administration, but systemic levels are negligible after otic administration. Fluocinolone acetonide systemic absorption is also minimal. Therefore, risk to the breastfed infant is considered low. Use with caution.
Infant Risk:
Low risk due to minimal systemic absorption.
Pediatric Use
Indicated for pediatric patients 6 months of age and older undergoing tympanostomy tube placement. Safety and efficacy in pediatric patients younger than 6 months of age have not been established.
Geriatric Use
Not specifically studied in geriatric populations for this indication, but given minimal systemic absorption, no specific dose adjustments or precautions are expected to be necessary.
Clinical Information
Clinical Pearls
- This specific formulation (e.g., Otiprio) is a single-dose, physician-administered product, not intended for patient self-administration.
- It is designed for sustained release, providing prolonged local drug exposure.
- Primarily used in conjunction with tympanostomy tube placement for otitis media with effusion.
- Due to minimal systemic absorption, systemic side effects and drug interactions commonly associated with oral/IV ciprofloxacin or systemic corticosteroids are not expected.
- Ensure proper visualization of the tympanic membrane and middle ear space before administration.
Alternative Therapies
- Oral antibiotics (if systemic infection or severe local infection warrants)
- Topical otic antibiotics (e.g., Ofloxacin, Ciprofloxacin)
- Topical otic corticosteroids (e.g., Hydrocortisone otic)
Cost & Coverage
Average Cost:
$2000 - $2500 per single-use vial (e.g., Otiprio)
Insurance Coverage:
Specialty Tier / Medical Benefit (often administered in clinic)
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 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.