Ofloxacin 0.3% Otic Soln 10ml (ear)
It is used to treat ear infections.
Drug Class
Otic anti-infective
Pharmacologic Class
Fluoroquinolone antibiotic
Pregnancy Category
Category C
FDA Approved
Dec 1995
DEA Schedule
Not Controlled
Overview
What is this medicine?
Ofloxacin ear drops are an antibiotic medication used to treat bacterial infections in the ear. It works by stopping the growth of bacteria. It's important to use it exactly as prescribed to clear up 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 this medication only in the ear and avoid getting it in your eye. Before and after use, wash your hands thoroughly.
To administer the drops:
1. Warm the solution by holding the container in your hands for 1 to 2 minutes.
2. Lie on your side with the affected ear facing upwards.
3. For children under 3 years old, gently pull the outer ear outward and downward. For children 3 years and older, and adults, pull the outer ear outward and upward.
4. Place the drops in your ear without touching the dropper to the ear.
5. Remain on your side for 5 minutes after administering the drops.
Important Handling Instructions
Do not touch the container tip with your fingers or any other object.
Use this medication at the same time every day.
* Continue using the medication as directed, even if your symptoms improve.
Storage and Disposal
Store this medication at room temperature, protected from light. Keep all medications in a safe place, out of the reach of children and pets.
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 use this medication correctly, follow your doctor's instructions and read all the information provided. Use this medication only in the ear and avoid getting it in your eye. Before and after use, wash your hands thoroughly.
To administer the drops:
1. Warm the solution by holding the container in your hands for 1 to 2 minutes.
2. Lie on your side with the affected ear facing upwards.
3. For children under 3 years old, gently pull the outer ear outward and downward. For children 3 years and older, and adults, pull the outer ear outward and upward.
4. Place the drops in your ear without touching the dropper to the ear.
5. Remain on your side for 5 minutes after administering the drops.
Important Handling Instructions
Do not touch the container tip with your fingers or any other object.
Use this medication at the same time every day.
* Continue using the medication as directed, even if your symptoms improve.
Storage and Disposal
Store this medication at room temperature, protected from light. Keep all medications in a safe place, out of the reach of children and pets.
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.
Lifestyle & Tips
- Keep the ear clean and dry. Avoid getting water in the ear during treatment (e.g., use cotton ball with petroleum jelly when showering/bathing).
- Do not insert cotton swabs or other objects into the ear canal.
- Complete the full course of treatment, even if symptoms improve, to prevent recurrence and antibiotic resistance.
Available Forms & Alternatives
Available Strengths:
- Ofloxacin 0.3% Otic Soln 5ml (ear)
- Ofloxacin 0.3% Otic Soln 10ml (ear)
- Ofloxacin 0.3% Oph Soln 10ml (eye)
- Ofloxacin 0.3% Otic Soln 10ml (ear)
- Ofloxacin 0.3% Oph Sol 10ml (eye)
- Ofloxacin 0.3% Oph Soln 5ml (eye)
- Ofloxacin 400mg Tablets
- Ofloxacin 300mg Tablets
- Ofloxacin 300mg Tablets
- Ofloxacin 0.3% Oph Sol 10ml (eye)
- Ofloxacin 0.3% Oph Soln 5ml (eye)
Dosing & Administration
Adult Dosing
Standard Dose:
10 drops (0.5 mL) into the affected ear twice daily for 10 days (for otitis externa) or 5 drops (0.25 mL) into the affected ear twice daily for 10 days (for chronic suppurative otitis media with perforated tympanic membranes)
Dose Range:
0.25 - 0.5 mg
Condition-Specific Dosing:
otitisExterna:
10 drops (0.5 mL) twice daily for 10 days
chronicSuppurativeOtitisMedia:
5 drops (0.25 mL) twice daily for 10 days
Pediatric Dosing
Neonatal:
Not established (safety and efficacy not established in infants <6 months for otitis externa, or <1 year for AOM with tympanostomy tubes, or <12 years for CSOM)
Infant:
Acute Otitis Media with Tympanostomy Tubes (AOM with TT) (âĨ6 months): 5 drops (0.25 mL) into the affected ear twice daily for 10 days. Otitis Externa (âĨ6 months): 10 drops (0.5 mL) into the affected ear twice daily for 10 days.
Child:
Acute Otitis Media with Tympanostomy Tubes (AOM with TT) (âĨ6 months): 5 drops (0.25 mL) into the affected ear twice daily for 10 days. Otitis Externa (âĨ6 months): 10 drops (0.5 mL) into the affected ear twice daily for 10 days. Chronic Suppurative Otitis Media (CSOM) with perforated tympanic membranes (âĨ12 years): 5 drops (0.25 mL) into the affected ear twice daily for 10 days.
Adolescent:
Acute Otitis Media with Tympanostomy Tubes (AOM with TT) (âĨ6 months): 5 drops (0.25 mL) into the affected ear twice daily for 10 days. Otitis Externa (âĨ6 months): 10 drops (0.5 mL) into the affected ear twice daily for 10 days. Chronic Suppurative Otitis Media (CSOM) with perforated tympanic membranes (âĨ12 years): 5 drops (0.25 mL) into the affected ear twice daily for 10 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
Ofloxacin is a fluoroquinolone antibacterial agent. It exerts its antibacterial effect by inhibiting DNA gyrase (topoisomerase II) and topoisomerase IV, enzymes essential for bacterial DNA replication, transcription, repair, and recombination. This leads to DNA strand breaks and bacterial cell death.
Pharmacokinetics
Absorption:
Bioavailability:
Negligible systemic absorption from otic administration. Peak plasma concentrations are typically below the limit of quantification (0.004 mcg/mL).
Tmax:
Not applicable for systemic peak after otic administration due to negligible absorption.
FoodEffect:
Not applicable for otic administration.
Distribution:
Vd:
Not applicable for systemic distribution due to negligible absorption.
ProteinBinding:
Not applicable for systemic protein binding due to negligible absorption.
CnssPenetration:
Limited/Not applicable (minimal systemic absorption).
Elimination:
HalfLife:
Not applicable for systemic half-life due to negligible absorption.
Clearance:
Not applicable for systemic clearance due to negligible absorption.
ExcretionRoute:
Not applicable for systemic excretion due to negligible absorption.
Unchanged:
Not applicable for systemic unchanged excretion due to negligible absorption.
Pharmacodynamics
OnsetOfAction:
Clinical improvement typically seen within a few days of treatment.
PeakEffect:
Not precisely defined for local otic effect, but clinical resolution occurs over the 10-day treatment course.
DurationOfAction:
Duration of treatment is 10 days; local antibacterial effect persists during this period.
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. 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
Severe ear pain
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:
Ear irritation
Change in taste
Note: This is not an exhaustive list of potential 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
Severe ear pain
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:
Ear irritation
Change in taste
Note: This is not an exhaustive list of potential 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 or discharge
- New or worsening redness, swelling, or itching around the ear
- Rash or hives
- Difficulty breathing or swallowing (signs of severe allergic reaction - seek immediate medical attention)
- Dizziness or lightheadedness
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 as a result of the allergy.
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. This is crucial because this medication may interact with other drugs or exacerbate existing health problems.
* Any health issues you are experiencing, as they may affect the safety and efficacy of this medication.
To ensure your safety, it is vital to verify that it is safe to take this medication with all your current medications and health conditions. 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, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced as a result of the allergy.
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. This is crucial because this medication may interact with other drugs or exacerbate existing health problems.
* Any health issues you are experiencing, as they may affect the safety and efficacy of this medication.
To ensure your safety, it is vital to verify that it is safe to take this medication with all your current medications and health conditions. 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. Adhere to the prescribed duration of treatment, as using this drug for an extended period may increase the risk of a second infection.
Although rare, severe and potentially life-threatening allergic reactions have been associated with this medication and similar drugs. It is crucial to discuss any concerns with your doctor.
If this medication is accidentally ingested, it can cause harm. In the event of ingestion, immediately contact a doctor or a poison control center for assistance.
If you are pregnant, planning to become pregnant, or are breastfeeding, consult your doctor to discuss the potential benefits and risks of this medication to both you and your baby.
Although rare, severe and potentially life-threatening allergic reactions have been associated with this medication and similar drugs. It is crucial to discuss any concerns with your doctor.
If this medication is accidentally ingested, it can cause harm. In the event of ingestion, immediately contact a doctor or a poison control center for assistance.
If you are pregnant, planning to become pregnant, or are breastfeeding, consult your doctor to discuss the potential benefits and risks of this medication to both you and your baby.
Overdose Information
Overdose Symptoms:
- Unlikely with otic administration due to minimal systemic absorption. Local irritation may occur with excessive use.
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 signs and symptoms of ear infection (e.g., pain, discharge, redness)
Frequency: Daily by patient/caregiver, periodically by clinician
Target: Resolution or improvement of symptoms
Action Threshold: Worsening symptoms, no improvement after 3-5 days, or new symptoms (e.g., rash, severe irritation)
Local irritation or hypersensitivity reactions (e.g., itching, rash, swelling)
Frequency: Daily by patient/caregiver
Target: Absence of irritation
Action Threshold: Presence of significant irritation or allergic reaction
Symptom Monitoring
- Reduction in ear pain
- Decrease in ear discharge
- Resolution of ear redness or swelling
- Absence of itching or rash in or around the ear
- Improvement in hearing (if affected by infection)
Special Patient Groups
Pregnancy
Ofloxacin otic solution is generally considered low risk during pregnancy due to negligible systemic absorption. Use only if clearly needed and potential benefits outweigh potential risks.
Trimester-Specific Risks:
First Trimester:
Low risk due to minimal systemic absorption.
Second Trimester:
Low risk due to minimal systemic absorption.
Third Trimester:
Low risk due to minimal systemic absorption.
Lactation
Ofloxacin is excreted in breast milk after systemic administration. However, due to negligible systemic absorption from otic use, exposure to the infant is expected to be minimal. Generally considered compatible with breastfeeding, but caution is advised.
Infant Risk:
Low risk (L3 - moderate risk for systemic, but minimal for otic).
Pediatric Use
Approved for use in pediatric patients as young as 6 months for otitis externa and AOM with TT, and 12 years for CSOM. Safety and efficacy not established in younger age groups for specific indications. Dosing is age and indication specific.
Geriatric Use
No specific dosage adjustments are necessary for geriatric patients. Systemic absorption is minimal, so age-related changes in renal or hepatic function are not expected to significantly impact drug exposure.
Clinical Information
Clinical Pearls
- Warm the solution by holding the bottle in your hand for a few minutes before administration to avoid dizziness that can occur from cold drops.
- Lie on your side with the affected ear facing up for 5-10 minutes after instilling drops to allow the medication to penetrate.
- For patients with tympanostomy tubes or perforated eardrums, Ofloxacin otic is often preferred over aminoglycoside otic drops due to lower ototoxicity risk.
- Ensure the ear canal is clean before administration; cerumen or debris can reduce efficacy.
- Do not touch the dropper tip to the ear or any other surface to prevent contamination.
Alternative Therapies
- Ciprofloxacin otic solution
- Ciprofloxacin/dexamethasone otic suspension
- Neomycin/polymyxin B/hydrocortisone otic solution/suspension (contraindicated with perforated tympanic membrane due to ototoxicity risk)
- Acetic acid otic solution (for mild otitis externa)
Cost & Coverage
Average Cost:
$30 - $70 per 10mL bottle
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 (preferred generic)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe and effective treatment, 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 discuss them with 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 appropriate care.