Ofloxacin 0.3% Otic Soln 5ml (ear)
It is used to treat ear infections.
Drug Class
Anti-infective, Otic
Pharmacologic Class
Fluoroquinolone Antibiotic
Pregnancy Category
C
FDA Approved
Jan 1997
DEA Schedule
Not Controlled
Overview
What is this medicine?
Ofloxacin otic solution is an antibiotic ear drop used to treat bacterial infections of the ear, such as swimmer's ear (otitis externa) or certain middle ear infections (otitis media) in patients with ear tubes or a perforated eardrum. It works by stopping the growth of bacteria.
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 up.
3. For children under 3 years old, gently pull the outer ear downward and outward. For children 3 years old and above, and for adults, pull the outer ear upward and outward.
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 up.
3. For children under 3 years old, gently pull the outer ear downward and outward. For children 3 years old and above, and for adults, pull the outer ear upward and outward.
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
- Complete the full course of treatment, even if symptoms improve.
- Do not touch the dropper tip to the ear or any other surface to prevent contamination.
- Warm the solution by holding the bottle in your hand for a few minutes before use to prevent dizziness.
- Lie on your side with the affected ear facing up for 5-10 minutes after instilling drops to allow the medication to penetrate.
- Avoid getting water in the ear during treatment (e.g., use earplugs when showering or swimming).
- Keep the ear clean and dry.
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(s) twice daily for 10 days
Condition-Specific Dosing:
acuteotitisexterna:
10 drops (0.5 mL) into the affected ear(s) twice daily for 10 days
chronicsuppurativeotitismedia:
10 drops (0.5 mL) into the affected ear(s) twice daily for 14 days (with perforated tympanic membrane)
Pediatric Dosing
Neonatal:
Not established (safety and efficacy not established in infants < 6 months)
Infant:
6 months to 12 years: 5 drops (0.25 mL) into the affected ear(s) twice daily for 10 days (for acute otitis externa or acute otitis media with tympanostomy tubes)
Child:
6 months to 12 years: 5 drops (0.25 mL) into the affected ear(s) twice daily for 10 days (for acute otitis externa or acute otitis media with tympanostomy tubes)
Adolescent:
12 years and older: 10 drops (0.5 mL) into the affected ear(s) 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 broad-spectrum fluoroquinolone antibiotic. It exerts its antibacterial effect by inhibiting bacterial DNA gyrase (topoisomerase II) and topoisomerase IV, enzymes essential for DNA replication, transcription, repair, and recombination. This leads to inhibition of bacterial cell growth and death.
Pharmacokinetics
Absorption:
Bioavailability:
Negligible (systemic absorption after otic administration is minimal)
Tmax:
Not applicable (minimal systemic absorption)
FoodEffect:
Not applicable
Distribution:
Vd:
Not applicable (minimal systemic absorption)
ProteinBinding:
Not applicable (minimal systemic absorption)
CnssPenetration:
Limited (negligible 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 antibacterial effect)
PeakEffect:
Within days (resolution of infection symptoms)
DurationOfAction:
Dependent on treatment course (typically 10-14 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. 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
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
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
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 or discharge
- New or worsening itching, rash, or swelling around the ear
- Dizziness or vertigo
- Hearing loss
- Signs of a new infection
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 information will help your doctor identify potential interactions between this medication and other substances.
Any health problems you have, as they may affect the safety and efficacy of this medication.
To ensure your safety, it is crucial to:
Discuss all your medications and health problems with your doctor and pharmacist to verify that it is safe to take this medication in conjunction with your other treatments.
* Avoid starting, stopping, or changing the dose of any medication without first consulting your doctor. This precaution will help prevent potential interactions or adverse effects.
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 information will help your doctor identify potential interactions between this medication and other substances.
Any health problems you have, as they may affect the safety and efficacy of this medication.
To ensure your safety, it is crucial to:
Discuss all your medications and health problems with your doctor and pharmacist to verify that it is safe to take this medication in conjunction with your other treatments.
* Avoid starting, stopping, or changing the dose of any medication without first consulting your doctor. This precaution will help prevent potential interactions or adverse effects.
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 prolonged use may increase the risk of a secondary infection.
Although rare, severe and potentially life-threatening allergic reactions have been associated with this drug and similar medications. It is crucial to discuss any concerns with your doctor.
If this medication is ingested, it can cause harm. In the event of accidental ingestion, immediately contact a doctor or a poison control center for assistance.
If you are pregnant, planning to become pregnant, or are breastfeeding, notify your doctor. You and your doctor will need to weigh the 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 drug and similar medications. It is crucial to discuss any concerns with your doctor.
If this medication is ingested, it can cause harm. In the event of accidental ingestion, immediately contact a doctor or a poison control center for assistance.
If you are pregnant, planning to become pregnant, or are breastfeeding, notify your doctor. You and your doctor will need to weigh the benefits and risks of this medication to both you and your baby.
Overdose Information
Overdose Symptoms:
- Local irritation (e.g., burning, stinging, itching) if excessive amounts are applied
- Systemic effects are highly unlikely due to minimal absorption
What to Do:
If local irritation occurs, discontinue use and rinse the ear with water. If swallowed, systemic toxicity is unlikely due to poor oral absorption; however, contact a poison control center (Call 1-800-222-1222) or seek medical attention if concerns arise.
Drug Interactions
Monitoring
Baseline Monitoring
Clinical assessment of ear infection (e.g., otoscopy, symptoms)
Rationale: To establish diagnosis and severity of infection
Timing: Prior to initiation of therapy
Routine Monitoring
Resolution of symptoms (e.g., pain, discharge, redness)
Frequency: Daily
Target: Improvement leading to resolution
Action Threshold: Lack of improvement or worsening symptoms after 3-5 days; consider re-evaluation and alternative therapy
Signs of local irritation or hypersensitivity (e.g., itching, rash, swelling)
Frequency: Daily
Target: Absence of irritation
Action Threshold: Presence of significant irritation; discontinue use and seek medical advice
Symptom Monitoring
- Ear pain
- Ear discharge
- Redness or swelling of the ear canal
- Itching in or around the ear
- Fever (if associated with ear infection)
- Hearing changes
Special Patient Groups
Pregnancy
Ofloxacin is Pregnancy Category C. While systemic fluoroquinolones are generally avoided in pregnancy due to potential risks, the systemic absorption of otic ofloxacin 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, theoretical risk of cartilage damage (based on animal studies with systemic exposure) is low.
Second Trimester:
Minimal systemic exposure, theoretical risk of cartilage damage is low.
Third Trimester:
Minimal systemic exposure, theoretical risk of cartilage damage is low.
Lactation
Ofloxacin is Lactation Risk L3 (moderately safe) for systemic use. Due to minimal systemic absorption from otic administration, the amount of drug excreted into breast milk is expected to be negligible. It is generally considered compatible with breastfeeding when used topically.
Infant Risk:
Low risk of adverse effects to the infant due to minimal systemic exposure.
Pediatric Use
Safe and effective for use in pediatric patients 6 months of age and older for specific indications (acute otitis externa, acute otitis media with tympanostomy tubes). Safety and efficacy in infants 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, given the minimal systemic absorption.
Clinical Information
Clinical Pearls
- Ofloxacin otic is one of the few otic antibiotics approved for use in patients with a perforated tympanic membrane or tympanostomy tubes.
- Ensure the ear canal is clean and free of excessive cerumen or debris before instilling drops for optimal efficacy.
- Patients should be instructed on proper administration technique to maximize drug delivery to the site of infection.
- Resistance can develop with prolonged or inappropriate use; use only for bacterial infections.
- Dizziness may occur if the solution is instilled cold; warming the bottle in hand for a few minutes can prevent this.
Alternative Therapies
- Ciprofloxacin otic (e.g., Cetraxal, Otiprio)
- Ciprofloxacin/dexamethasone otic (e.g., Ciprodex)
- Neomycin/polymyxin B/hydrocortisone otic (e.g., Cortisporin Otic)
- Acetic acid otic (for mild otitis externa)
Cost & Coverage
Average Cost:
$20 - $60 per 5mL bottle
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 (for 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 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 emergency medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it occurred.