Ciprofloxacin 0.2% Pf Earsol 14 Sgl
It is used to treat ear infections.
Drug Class
Otic anti-infective
Pharmacologic Class
Fluoroquinolone antibiotic
Pregnancy Category
Category C
FDA Approved
Mar 1998
DEA Schedule
Not Controlled
Overview
What is this medicine?
Ciprofloxacin ear drops are an antibiotic medication used to treat bacterial infections in the ear canal, such as swimmer's ear (otitis externa). It works by killing the bacteria causing the infection.
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. Use the medication as directed, even if your symptoms improve.
Administration Instructions
1. Use this medication for your ear only.
2. Wash your hands before and after using the medication.
3. Warm the solution by holding the container in your hands for 1 to 2 minutes before putting drops in your ear.
4. Lie on your side with the affected ear facing up.
5. 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.
6. Put the drops in your ear without touching the dropper to your ear. Remain on your side for 1 minute.
7. Avoid touching the container tip to your skin.
Storage and Disposal
Store this medication at room temperature. Keep unused containers in the foil pouch until you are ready to use them. Protect the medication from light.
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 continue with your regular 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. Use the medication as directed, even if your symptoms improve.
Administration Instructions
1. Use this medication for your ear only.
2. Wash your hands before and after using the medication.
3. Warm the solution by holding the container in your hands for 1 to 2 minutes before putting drops in your ear.
4. Lie on your side with the affected ear facing up.
5. 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.
6. Put the drops in your ear without touching the dropper to your ear. Remain on your side for 1 minute.
7. Avoid touching the container tip to your skin.
Storage and Disposal
Store this medication at room temperature. Keep unused containers in the foil pouch until you are ready to use them. Protect the medication from light.
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 continue with your regular schedule. Do not use two doses at the same time or take extra doses.
Lifestyle & Tips
- Clean the ear canal gently before applying drops, if advised by your doctor.
- Warm the bottle by holding it in your hand for a few minutes before use to prevent dizziness.
- Lie down with the affected ear facing up for 5-10 minutes after applying drops to allow the medication to penetrate.
- Do not touch the dropper tip to the ear or any other surface to prevent contamination.
- Complete the full course of treatment, even if symptoms improve, to prevent recurrence and antibiotic resistance.
- Avoid swimming or getting water in the ear during treatment unless advised otherwise by your doctor.
Available Forms & Alternatives
Available Strengths:
- Ciprofloxacin 0.3% Op Sol 5ml-Eye
- Ciprofloxacin 0.3% Op Sol 2.5ml-Eye
- Ciprofloxacin 100mg Pack
- Ciprofloxacin 250mg Tablets
- Ciprofloxacin 0.3% Op Sol 10ml-Eye
- Ciprofloxacin 500mg Tablets
- Ciprofloxacin 250mg Tablets
- Ciprofloxacin 750mg Tablets
- Ciprofloxacin 0.2% Pf Earsol 14 Sgl
- Ciprofloxacin 500mg Tablets
- Ciprofloxacin 250mg Tablets
- Ciprofloxacin 750mg Tablets
- Ciprofloxacin I.V. 400mg Sol, 200ml
- Ciprofloxacin 250mg Tablets
- Ciprofloxacin 750mg Tablets
Dosing & Administration
Adult Dosing
Standard Dose:
4 drops into the affected ear(s) twice daily for 7 days.
Condition-Specific Dosing:
acuteotitisexterna:
4 drops into the affected ear(s) twice daily for 7 days.
Pediatric Dosing
Neonatal:
Not established (generally not recommended for infants under 1 year unless specifically indicated and supervised)
Infant:
Not established (generally not recommended for infants under 1 year unless specifically indicated and supervised)
Child:
1 year and older: 4 drops into the affected ear(s) twice daily for 7 days.
Adolescent:
4 drops into the affected ear(s) twice daily for 7 days.
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed due to minimal systemic absorption.
Moderate:
No adjustment needed due to minimal systemic absorption.
Severe:
No adjustment needed due to minimal systemic absorption.
Dialysis:
No adjustment needed due to minimal systemic absorption.
Hepatic Impairment:
Mild:
No adjustment needed due to minimal systemic absorption.
Moderate:
No adjustment needed due to minimal systemic absorption.
Severe:
No adjustment needed due to minimal systemic absorption.
Pharmacology
Mechanism of Action
Ciprofloxacin is a fluoroquinolone antibiotic. It exerts its bactericidal effect by inhibiting bacterial DNA gyrase (topoisomerase II) and topoisomerase IV, enzymes essential for bacterial DNA replication, transcription, repair, and recombination. This leads to inhibition of bacterial growth and cell death.
Pharmacokinetics
Absorption:
Bioavailability:
Negligible systemic absorption from otic administration.
Tmax:
Not applicable for systemic effects; local concentration peaks rapidly.
FoodEffect:
Not applicable (otic administration).
Distribution:
Vd:
Not applicable (minimal systemic distribution).
ProteinBinding:
Not applicable (minimal systemic distribution).
CnssPenetration:
No (minimal systemic absorption).
Elimination:
HalfLife:
Not applicable (minimal systemic elimination).
Clearance:
Not applicable (minimal systemic elimination).
ExcretionRoute:
Not applicable (minimal systemic excretion).
Unchanged:
Not applicable (minimal systemic excretion).
Pharmacodynamics
OnsetOfAction:
Local antibacterial effect begins rapidly, typically within hours.
PeakEffect:
Clinical improvement usually seen within 2-3 days.
DurationOfAction:
Local effect persists as long as drug is present in the ear canal; dosing twice daily maintains therapeutic levels.
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
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 immediately or seek emergency medical attention:
Signs of an allergic reaction, which may include:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing
+ Tightness in the chest or throat
+ Difficulty breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Severe ear irritation
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 that bother you or persist, contact your doctor for advice:
Headache
Itching
* Short-term pain after use
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.
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 immediately or seek emergency medical attention:
Signs of an allergic reaction, which may include:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing
+ Tightness in the chest or throat
+ Difficulty breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Severe ear irritation
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 that bother you or persist, contact your doctor for advice:
Headache
Itching
* Short-term pain after use
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.
Seek Immediate Medical Attention If You Experience:
- Increased ear pain or swelling
- New or worsening ear discharge
- Rash or hives
- Severe dizziness
- Hearing loss
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, any of its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced as a result of the allergy.
Potential interactions with other medications or health conditions. This medication may interact with other drugs or exacerbate existing health problems.
To ensure safe use, provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter (OTC) medications you are currently taking
Any natural products or vitamins you are using
* Existing health problems or conditions
Carefully review your medications and health conditions to confirm that it is safe to take this medication in conjunction with them. Never start, stop, or adjust the dosage 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, any of its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced as a result of the allergy.
Potential interactions with other medications or health conditions. This medication may interact with other drugs or exacerbate existing health problems.
To ensure safe use, provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter (OTC) medications you are currently taking
Any natural products or vitamins you are using
* Existing health problems or conditions
Carefully review your medications and health conditions to confirm that it is safe to take this medication in conjunction with them. Never start, stop, or adjust the dosage 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. To minimize the risk of a second infection, do not use this drug for a longer period than prescribed. If you are pregnant, planning to become pregnant, or are breastfeeding, notify your doctor immediately. Your doctor will discuss the potential benefits and risks of this medication with you, considering both your health and the health of your baby, to determine the best course of action.
Overdose Information
Overdose Symptoms:
- Systemic overdose is highly unlikely due to minimal absorption from otic administration. Local irritation may occur with excessive application.
What to Do:
If accidental ingestion occurs, contact a poison control center (1-800-222-1222) or seek medical attention. For local irritation, discontinue use and rinse ear if possible.
Drug Interactions
Monitoring
Routine Monitoring
Clinical response (reduction in ear pain, discharge, inflammation)
Frequency: Daily
Target: Improvement of symptoms
Action Threshold: Lack of improvement or worsening symptoms after 2-3 days; consider re-evaluation and alternative therapy.
Local adverse reactions (e.g., ear discomfort, pruritus)
Frequency: Daily
Target: Absence or mild, tolerable reactions
Action Threshold: Severe or persistent local reactions; discontinue use and consult healthcare provider.
Symptom Monitoring
- Ear pain
- Ear discharge
- Itching in the ear
- Redness or swelling of the ear canal
- Hearing changes
Special Patient Groups
Pregnancy
Ciprofloxacin is Pregnancy Category C. While systemic ciprofloxacin has shown some risk in animal studies, otic absorption is minimal. Use during pregnancy should only be considered if the potential benefit justifies the potential risk to the fetus.
Trimester-Specific Risks:
First Trimester:
Minimal systemic exposure, but caution advised.
Second Trimester:
Minimal systemic exposure, but caution advised.
Third Trimester:
Minimal systemic exposure, but caution advised.
Lactation
Ciprofloxacin is excreted in human milk after systemic administration (L3). However, due to negligible systemic absorption from otic administration, significant exposure to the infant is unlikely. Use with caution, or consult a healthcare provider.
Infant Risk:
Low risk due to minimal maternal systemic absorption.
Pediatric Use
Approved for use in pediatric patients 1 year of age and older for acute otitis externa. Safety and efficacy in infants younger than 1 year 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 and dry before administration for optimal efficacy.
- Warm the solution to body temperature before instillation to prevent caloric reaction (dizziness).
- Instruct patients to lie on their side for several minutes after instillation to allow the drops to penetrate.
- Emphasize the importance of completing the full 7-day course of therapy, even if symptoms improve, to prevent relapse and resistance.
- Advise patients to avoid getting water in the ear during treatment (e.g., using earplugs during bathing/showering).
Alternative Therapies
- Ofloxacin otic solution
- Polymyxin B/neomycin/hydrocortisone otic solution
- Acetic acid otic solution
Cost & Coverage
Average Cost:
$30 - $70 per 10 mL bottle
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 (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 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 medication, including the amount taken and the time it happened, to facilitate prompt and effective treatment.