Cipro/dexameth 0.3-0.1% Otic Susp
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
Jul 2003
DEA Schedule
Not Controlled
Overview
What is this medicine?
This medicine is an ear drop that contains two active ingredients: an antibiotic (ciprofloxacin) to kill bacteria causing ear infections, and a steroid (dexamethasone) to reduce swelling and redness in the ear. It's used to treat certain ear infections.
How to Use This Medicine
Proper Use of This Medication
To use this medication correctly, 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.
Administration Instructions
1. Wash your hands before and after using the medication.
2. Warm the liquid by holding the bottle in your hands for 1 to 2 minutes before putting drops in the ear.
3. Shake the bottle well before use.
4. Lie on your side with the affected ear facing up.
5. For children 3 years of age and older, and adults, gently pull the outer ear outward and upward.
6. For children younger than 3 years of age, gently pull the outer ear outward and downward.
7. Put the drops in the ear without touching the dropper to the ear.
8. Remain on your side for 1 minute after administering the drops.
9. Avoid touching the container tip to the skin.
Storage and Disposal
Store this medication at room temperature, away from light, and do not freeze. Discard any unused portion after completing the treatment course.
Missed 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 dosing schedule. Do not use two doses at the same time or take extra doses.
To use this medication correctly, 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.
Administration Instructions
1. Wash your hands before and after using the medication.
2. Warm the liquid by holding the bottle in your hands for 1 to 2 minutes before putting drops in the ear.
3. Shake the bottle well before use.
4. Lie on your side with the affected ear facing up.
5. For children 3 years of age and older, and adults, gently pull the outer ear outward and upward.
6. For children younger than 3 years of age, gently pull the outer ear outward and downward.
7. Put the drops in the ear without touching the dropper to the ear.
8. Remain on your side for 1 minute after administering the drops.
9. Avoid touching the container tip to the skin.
Storage and Disposal
Store this medication at room temperature, away from light, and do not freeze. Discard any unused portion after completing the treatment course.
Missed 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 dosing schedule. Do not use two doses at the same time or take extra doses.
Lifestyle & Tips
- Shake the bottle well before each use.
- Lie down with the affected ear facing upwards for 1-2 minutes after instilling drops to allow the medicine to penetrate.
- Avoid touching the dropper tip to the ear or any other surface to prevent contamination.
- Do not rinse the dropper.
- Complete the full course of treatment, even if symptoms improve, to prevent recurrence and antibiotic resistance.
- Keep the ear dry during treatment; avoid swimming or submerging the head in water.
- Use cotton balls or earplugs when showering or bathing to prevent water from entering the ear.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
4 drops instilled into the affected ear(s) twice daily for 7 days.
Condition-Specific Dosing:
acute_otitis_externa:
4 drops instilled into the affected ear(s) twice daily for 7 days.
acute_otitis_media_with_tympanostomy_tubes:
4 drops instilled into the affected ear(s) twice daily for 7 days.
Pediatric Dosing
Neonatal:
Not established (safety and efficacy in patients younger than 6 months of age have not been established).
Infant:
6 months to <2 years: 4 drops instilled into the affected ear(s) twice daily for 7 days.
Child:
2 to 12 years: 4 drops instilled into the affected ear(s) twice daily for 7 days.
Adolescent:
12 to 18 years: 4 drops instilled into the affected ear(s) twice daily for 7 days.
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: 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 (for otic use).
Tmax:
Not applicable (minimal systemic absorption).
FoodEffect:
Not applicable (otic administration).
Distribution:
Vd:
Not applicable (minimal systemic absorption).
ProteinBinding:
Not applicable (minimal systemic absorption).
CnssPenetration:
Limited (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 days for symptom improvement.
PeakEffect:
Within days for symptom improvement.
DurationOfAction:
Duration of treatment (7 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. Immediately contact your doctor or seek medical attention if you experience any of the following symptoms:
Signs of an allergic reaction, including:
+ 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 persist or bother you:
Ear discomfort
Itching
* Ear pain
Note: This list is not exhaustive, and you may experience other side effects not mentioned here. 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. Immediately contact your doctor or seek medical attention if you experience any of the following symptoms:
Signs of an allergic reaction, including:
+ 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 persist or bother you:
Ear discomfort
Itching
* Ear pain
Note: This list is not exhaustive, and you may experience other side effects not mentioned here. 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 or discharge
- New or worsening hearing loss
- Dizziness or vertigo
- Rash or severe itching around the ear
- Signs of a new infection (e.g., fever, chills)
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 and its symptoms.
Certain health conditions, including:
+ Chickenpox or a history of chickenpox
+ Herpes infection or other viral infections affecting 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
Do not start, stop, or change the dosage of any medication without first consulting your doctor to confirm that it is safe to do so in conjunction with this medication.
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 and its symptoms.
Certain health conditions, including:
+ Chickenpox or a history of chickenpox
+ Herpes infection or other viral infections affecting 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
Do not start, stop, or change the dosage of any medication without first consulting your doctor to confirm that it is safe to do so in conjunction with this medication.
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 this medication to both you and your baby.
Overdose Information
Overdose Symptoms:
- Unlikely with topical otic administration due to minimal systemic absorption. Local irritation may occur with excessive use.
What to Do:
Discontinue use and consult a healthcare professional. For accidental ingestion, call a poison control center (1-800-222-1222) or seek medical attention, though systemic toxicity is unlikely.
Drug Interactions
Monitoring
Baseline Monitoring
Otoscopic examination
Rationale: To assess the extent of infection/inflammation and rule out tympanic membrane perforation.
Timing: Prior to initiation of therapy
Routine Monitoring
Clinical signs and symptoms (e.g., pain, discharge, redness)
Frequency: Daily by patient, periodically by clinician
Target: Resolution or improvement
Action Threshold: Worsening symptoms or lack of improvement after 3-5 days may indicate treatment failure or resistant infection, requiring re-evaluation.
Otoscopic examination
Frequency: At follow-up visit (if needed)
Target: Resolution of inflammation and infection
Action Threshold: Persistent signs of infection/inflammation.
Symptom Monitoring
- Ear pain
- Ear discharge
- Redness or swelling of the ear canal
- Itching
- Hearing changes
Special Patient Groups
Pregnancy
Category C. While systemic absorption is minimal with otic use, animal studies with ciprofloxacin have shown some evidence of developmental toxicity. Dexamethasone is also Category C. Use only if the potential benefit justifies the potential risk to the fetus.
Trimester-Specific Risks:
First Trimester:
Low risk due to minimal systemic absorption, but caution advised.
Second Trimester:
Low risk due to minimal systemic absorption, but caution advised.
Third Trimester:
Low risk due to minimal systemic absorption, but caution advised.
Lactation
L3 (Moderately Safe). Ciprofloxacin and dexamethasone are excreted in breast milk following systemic administration. However, systemic absorption from otic administration is minimal, making infant exposure unlikely to be significant. Caution is advised, and benefits should outweigh potential risks.
Infant Risk:
Low risk due to minimal systemic absorption in the mother.
Pediatric Use
Approved for use in pediatric patients 6 months of age and older. Safety and efficacy in patients younger than 6 months have not been established.
Geriatric Use
No specific dosage adjustments are necessary for geriatric patients. The safety and efficacy profile is similar to that in younger adults.
Clinical Information
Clinical Pearls
- Ensure the ear canal is clean before administration for optimal drug penetration.
- Warm the bottle by holding it in your hand for a few minutes before use to prevent dizziness that can occur from cold drops.
- This medication is for ear use only; do not use in the eyes or inject.
- If a tympanic membrane perforation is known or suspected, use with caution and consult an ENT specialist, although this combination is generally considered safe for use with tympanostomy tubes.
- Prolonged use of corticosteroids may result in overgrowth of non-susceptible organisms, including fungi.
Alternative Therapies
- Oral antibiotics (e.g., amoxicillin, cephalexin) for systemic infections or when topical treatment is insufficient.
- Other topical otic antibiotics (e.g., acetic acid, polymyxin B/neomycin/hydrocortisone).
- Topical otic corticosteroids alone (e.g., hydrocortisone otic).
Cost & Coverage
Average Cost:
$100 - $250 per 7.5 mL bottle
Generic Available:
Yes
Insurance Coverage:
Tier 2 or Tier 3 (often preferred 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.