Ciprodex Otic Suspension (ear)
It is used to treat ear infections.
Drug Class
Otic antibiotic and corticosteroid combination
Pharmacologic Class
Fluoroquinolone antibiotic; Corticosteroid
Pregnancy Category
Category C
FDA Approved
Mar 2003
DEA Schedule
Not Controlled
Overview
What is this medicine?
Ciprodex Otic is an ear drop medication that contains two active ingredients: ciprofloxacin, an antibiotic that kills bacteria causing ear infections, and dexamethasone, a steroid that reduces swelling and inflammation in the ear. It is used to treat certain ear infections.
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 use in the ear only.
Preparation and Administration
1. Wash your hands before and after handling the medication.
2. Warm the liquid by holding the bottle in your hands for 1 to 2 minutes before use.
3. Shake the bottle well before administering the medication.
4. Lie on your side with the affected ear facing upwards.
5. For children 3 years of age and older, and adults, gently pull the outer ear outward and upward. For children younger than 3 years of age, pull the outer ear outward and downward.
6. Place the drops in the ear without touching the dropper to the ear. Remain on your side for 1 minute after administration.
7. Avoid touching the container tip to the skin to prevent contamination.
Storage and Disposal
Store the medication at room temperature, away from light and freezing temperatures. Discard any unused portion after completing the treatment course.
Missed Dose Instructions
If you miss a dose, use 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 use two doses at the same time 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. Continue using the medication as directed, even if your symptoms improve. This medication is for use in the ear only.
Preparation and Administration
1. Wash your hands before and after handling the medication.
2. Warm the liquid by holding the bottle in your hands for 1 to 2 minutes before use.
3. Shake the bottle well before administering the medication.
4. Lie on your side with the affected ear facing upwards.
5. For children 3 years of age and older, and adults, gently pull the outer ear outward and upward. For children younger than 3 years of age, pull the outer ear outward and downward.
6. Place the drops in the ear without touching the dropper to the ear. Remain on your side for 1 minute after administration.
7. Avoid touching the container tip to the skin to prevent contamination.
Storage and Disposal
Store the medication at room temperature, away from light and freezing temperatures. Discard any unused portion after completing the treatment course.
Missed Dose Instructions
If you miss a dose, use 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 use two doses at the same time or take extra doses to make up for a missed dose.
Lifestyle & Tips
- Shake the bottle well before each use.
- Warm the bottle by holding it in your hand for 1-2 minutes before use to avoid dizziness that may result from instilling a cold solution into the ear canal.
- Lie with the affected ear upward and instill the drops. Remain in this position for at least 30-60 seconds to allow the drops to penetrate the ear canal.
- Do not touch the dropper tip to the ear or any other surface to prevent contamination.
- Keep the ear dry during treatment. Avoid swimming or submerging the head in water.
- Complete the full course of treatment, even if symptoms improve, to prevent recurrence and antibiotic resistance.
Available Forms & Alternatives
Available Strengths:
Generic Alternatives:
Dosing & Administration
Adult Dosing
Standard Dose:
4 drops into the affected ear(s) twice daily
Dose Range:
4 - 4 mg
Condition-Specific Dosing:
acuteOtitisExterna:
4 drops into the affected ear(s) twice daily for 7 days
acuteOtitisMediaWithTympanostomyTubes:
4 drops into the affected ear(s) twice daily for 7 days
Pediatric Dosing
Neonatal:
Not established (safety and efficacy not established in patients younger than 6 months of age)
Infant:
6 months to <1 year: 4 drops into the affected ear(s) twice daily for 7 days
Child:
1 year to <12 years: 4 drops into the affected ear(s) twice daily for 7 days
Adolescent:
12 years to 17 years: 4 drops into the affected ear(s) twice daily for 7 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: A fluoroquinolone antibiotic that inhibits bacterial DNA gyrase and topoisomerase IV, enzymes essential for bacterial DNA replication, transcription, repair, and recombination. Dexamethasone: A potent synthetic corticosteroid that suppresses inflammation by inhibiting the migration of leukocytes and fibroblasts, reversing increased capillary permeability, and lysosomal stabilization.
Pharmacokinetics
Absorption:
Bioavailability:
Minimal systemic absorption (less than 1% of the administered dose)
Tmax:
Not applicable (minimal systemic absorption)
FoodEffect:
Not applicable (otic administration)
Distribution:
Vd:
Not applicable (primarily local action)
ProteinBinding:
Not applicable (minimal systemic absorption)
CnssPenetration:
No (minimal systemic absorption)
Elimination:
HalfLife:
Not applicable (minimal systemic absorption)
Clearance:
Not applicable (minimal systemic absorption)
ExcretionRoute:
Not applicable (minimal systemic absorption)
Unchanged:
Not applicable (minimal systemic absorption)
Pharmacodynamics
OnsetOfAction:
Within hours to days (local anti-inflammatory and antibacterial effects)
PeakEffect:
Within days (resolution of symptoms)
DurationOfAction:
Dependent on treatment duration (7 days)
Confidence:
Medium
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. Immediately contact your doctor or seek medical attention if you experience any of the following symptoms:
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
Severe ear irritation
Dizziness
Fast or abnormal heartbeat
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. Contact your doctor or seek medical help if you experience any of the following side effects or if they bother you or persist:
Ear discomfort
Itching
* Ear pain
Note: This is not an exhaustive list of possible 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. Your doctor can provide medical advice about side effects.
While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. Immediately contact your doctor or seek medical attention if you experience any of the following symptoms:
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
Severe ear irritation
Dizziness
Fast or abnormal heartbeat
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. Contact your doctor or seek medical help if you experience any of the following side effects or if they bother you or persist:
Ear discomfort
Itching
* Ear pain
Note: This is not an exhaustive list of possible 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. Your doctor can provide medical advice about side effects.
Seek Immediate Medical Attention If You Experience:
- Worsening ear pain or discharge
- New or worsening itching, rash, or hives around the ear
- Signs of a severe allergic reaction (e.g., swelling of face/tongue, difficulty breathing)
- Development of new symptoms or lack of improvement after a few days of treatment
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. Adhere to the prescribed duration of treatment, as using it for an extended period may increase the risk of a secondary infection. Although rare, this drug and similar medications have been associated with severe and potentially life-threatening allergic reactions. It is crucial to discuss this risk with your doctor. If you are pregnant, planning to become pregnant, or are breastfeeding, consult your doctor to weigh the benefits and risks of treatment to both you and your baby.
Overdose Information
Overdose Symptoms:
- Overdose with otic administration is unlikely due to minimal systemic absorption. If accidentally ingested, symptoms may include nausea, vomiting, diarrhea, or dizziness.
What to Do:
If accidental ingestion occurs, contact a poison control center or emergency medical services immediately. Call 1-800-222-1222.
Drug Interactions
Monitoring
Baseline Monitoring
Clinical assessment of ear infection (e.g., otoscopy, symptoms)
Rationale: To confirm diagnosis and establish baseline severity
Timing: Prior to initiation of therapy
Routine Monitoring
Clinical response (e.g., reduction in pain, discharge, inflammation)
Frequency: Daily or as needed
Target: Resolution of symptoms
Action Threshold: Lack of improvement or worsening symptoms after 2-3 days of treatment
Signs of local irritation or hypersensitivity
Frequency: Daily
Target: Absence of redness, itching, rash
Action Threshold: Development of new or worsening local symptoms
Symptom Monitoring
- Ear pain
- Ear discharge
- Itching in the ear
- Redness or swelling around the ear
- Fever (if present at baseline)
- Hearing changes
Special Patient Groups
Pregnancy
Ciprodex Otic is Pregnancy Category C. While animal studies have shown adverse effects with systemic ciprofloxacin and dexamethasone, 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:
Potential risk based on systemic data, but minimal absorption from otic route.
Second Trimester:
Potential risk based on systemic data, but minimal absorption from otic route.
Third Trimester:
Potential risk based on systemic data, but minimal absorption from otic route.
Lactation
Ciprofloxacin and dexamethasone are excreted in human milk after systemic administration. However, due to minimal systemic absorption from otic administration, significant exposure to the infant is unlikely. Caution should be exercised when administering to a nursing mother.
Infant Risk:
Low risk due to minimal systemic absorption.
Pediatric Use
Approved for use in pediatric patients 6 months of age and older for acute otitis externa and acute otitis media with tympanostomy tubes. Safety and efficacy not established in patients younger than 6 months of age.
Geriatric Use
No overall differences in safety or effectiveness have been observed between elderly and younger patients. Dosage adjustment is not typically required.
Clinical Information
Clinical Pearls
- Ensure the ear canal is clean and dry before instilling drops.
- Instruct patients to warm the bottle in their hands for a minute or two before use to prevent dizziness.
- Emphasize the importance of completing the full 7-day course of treatment, even if symptoms improve earlier, to prevent relapse and antibiotic resistance.
- Advise patients to avoid getting water in the ear during treatment (e.g., use earplugs when showering or bathing).
- If symptoms do not improve after 2-3 days, or worsen, advise the patient to contact their healthcare provider.
Alternative Therapies
- Ofloxacin otic solution (Floxin Otic)
- Acetic acid/hydrocortisone otic solution
- Topical antibiotics alone (e.g., polymyxin B/neomycin/bacitracin)
- Oral antibiotics (for more severe or systemic infections, or if topical treatment fails)
Cost & Coverage
Average Cost:
Variable, typically $150-$250 per 7.5 mL bottle
Generic Available:
Yes
Insurance Coverage:
Tier 2 or 3 (may require prior authorization for brand, generic often preferred)
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 medical attention. When seeking help, be prepared to provide details about the medication, including the amount taken and the time it happened, to facilitate prompt and effective treatment.