Ofloxacin 0.3% Oph Soln 5ml (eye)
It is used to treat eye infections.
Drug Class
Anti-infective, Ophthalmic
Pharmacologic Class
Fluoroquinolone Antibiotic
Pregnancy Category
Category C
FDA Approved
Jan 1993
DEA Schedule
Not Controlled
Overview
What is this medicine?
Ofloxacin eye drops are an antibiotic medication used to treat bacterial infections of the eye, such as pink eye (conjunctivitis) or more serious infections like corneal ulcers. 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 the medication as directed, even if your symptoms improve. Take the medication at the same time every day to establish a routine.
Administration
This medication is for eye use only. Before and after use, wash your hands thoroughly to prevent contamination. Avoid touching the container tip to your eye, lid, or surrounding skin, as this can introduce bacteria and lead to severe eye problems or vision loss.
To administer the medication:
1. Tilt your head back and gently pull down your lower eyelid.
2. Squeeze in the prescribed amount of medication.
3. After administration, keep your eyes closed and apply gentle pressure to the inside corner of your eye for 1 to 2 minutes. This helps retain the medication in your eye.
Important Precautions
Unless instructed otherwise by your doctor, avoid wearing contact lenses while using this medication.
Storage and Disposal
Store the medication at room temperature, away from freezing temperatures. Keep all medications in a secure location, out of reach of children and pets. Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so by your pharmacist. Check with your pharmacist for guidance on the best disposal method or to see if there are any drug take-back programs in your area.
Missed Dose
If you miss a dose, take it as soon as you remember. However, if it is close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule. Do not take two doses at once or use extra doses to make up for a missed dose.
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. Take the medication at the same time every day to establish a routine.
Administration
This medication is for eye use only. Before and after use, wash your hands thoroughly to prevent contamination. Avoid touching the container tip to your eye, lid, or surrounding skin, as this can introduce bacteria and lead to severe eye problems or vision loss.
To administer the medication:
1. Tilt your head back and gently pull down your lower eyelid.
2. Squeeze in the prescribed amount of medication.
3. After administration, keep your eyes closed and apply gentle pressure to the inside corner of your eye for 1 to 2 minutes. This helps retain the medication in your eye.
Important Precautions
Unless instructed otherwise by your doctor, avoid wearing contact lenses while using this medication.
Storage and Disposal
Store the medication at room temperature, away from freezing temperatures. Keep all medications in a secure location, out of reach of children and pets. Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so by your pharmacist. Check with your pharmacist for guidance on the best disposal method or to see if there are any drug take-back programs in your area.
Missed Dose
If you miss a dose, take it as soon as you remember. However, if it is close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule. Do not take two doses at once or use extra doses to make up for a missed dose.
Lifestyle & Tips
- Wash hands thoroughly before and after applying eye drops.
- Do not touch the dropper tip to your eye or any other surface to prevent contamination.
- Remove contact lenses before applying drops and wait at least 15 minutes before reinserting them, unless otherwise directed by your doctor.
- Do not share your eye drops with anyone else.
- Complete the full course of treatment, even if your symptoms improve, to prevent the infection from returning and to reduce the risk of antibiotic resistance.
- Store at room temperature, away from light and moisture.
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:
For bacterial conjunctivitis: 1-2 drops into the affected eye(s) every 2-4 hours for the first 2 days, then 1-2 drops four times daily for up to 5 additional days. For bacterial corneal ulcers: 1-2 drops into the affected eye(s) every 30 minutes for the first 2 days during waking hours, then 1-2 drops every hour for 5-7 days, then 1-2 drops four times daily for up to 3 additional days.
Condition-Specific Dosing:
bacterialConjunctivitis:
1-2 drops Q2-4H for 2 days, then QID for 5 days.
bacterialCornealUlcer:
1-2 drops Q30min (waking hours) for 2 days, then Q1H for 5-7 days, then QID for 3 days.
Pediatric Dosing
Neonatal:
Not established (use with caution, consult specialist)
Infant:
Not established (use with caution, consult specialist)
Child:
For bacterial conjunctivitis (>=1 year of age): 1-2 drops into the affected eye(s) every 2-4 hours for the first 2 days, then 1-2 drops four times daily for up to 5 additional days. For bacterial corneal ulcers (>=1 year of age): 1-2 drops into the affected eye(s) every 30 minutes for the first 2 days during waking hours, then 1-2 drops every hour for 5-7 days, then 1-2 drops four times daily for up to 3 additional days.
Adolescent:
Same as adult dosing.
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
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 bacterial DNA replication, transcription, repair, and recombination. This leads to inhibition of bacterial cell growth and death.
Pharmacokinetics
Absorption:
Bioavailability:
Minimal systemic absorption (less than 1% of a single dose)
Tmax:
Ocular tissue concentrations peak within 1-2 hours after topical administration.
FoodEffect:
Not applicable for ophthalmic solution.
Distribution:
Vd:
Not applicable for ophthalmic solution (minimal systemic distribution)
ProteinBinding:
Not applicable for ophthalmic solution (minimal systemic protein binding)
CnssPenetration:
Limited (negligible systemic absorption)
Elimination:
HalfLife:
Systemic half-life is 4-6 hours, but this is not clinically relevant for ophthalmic use due to minimal absorption. Ocular elimination is primarily via tears and ocular surface turnover.
Clearance:
Not applicable for ophthalmic solution (minimal systemic clearance)
ExcretionRoute:
Primarily via tears and ocular surface; minimal systemic excretion via urine.
Unchanged:
Not applicable for ophthalmic solution (minimal systemic absorption)
Pharmacodynamics
OnsetOfAction:
Rapid, typically within hours of first dose.
PeakEffect:
Within 1-2 days of consistent dosing for clinical improvement.
DurationOfAction:
Dependent on dosing frequency, maintains therapeutic concentrations in ocular tissues for several hours after each dose.
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Attention Immediately
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 or seek medical help right away:
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
Changes in eyesight, eye pain, or severe eye irritation
Joint pain or swelling
Symptoms of a severe skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis), including:
+ Red, swollen, blistered, or peeling skin (with or without fever)
+ Red or irritated eyes
+ Sores in your mouth, throat, nose, or eyes
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, contact your doctor for advice:
Burning
Eye irritation
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns, don't hesitate to contact 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 or seek medical help right away:
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
Changes in eyesight, eye pain, or severe eye irritation
Joint pain or swelling
Symptoms of a severe skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis), including:
+ Red, swollen, blistered, or peeling skin (with or without fever)
+ Red or irritated eyes
+ Sores in your mouth, throat, nose, or eyes
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, contact your doctor for advice:
Burning
Eye irritation
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns, don't hesitate to contact 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 eye pain, redness, or discharge
- New or worsening vision changes
- Swelling of the eyelids or around the eye
- Severe itching or rash (signs of allergic reaction)
- Any new or unusual symptoms
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about any allergies you have, including:
Allergies to this medication or any of its components
Allergies to other medications, foods, or substances
The specific symptoms you experienced as a result of the allergy
Additionally, this medication may interact with other medications or health conditions. To ensure safe use, please discuss the following with your doctor and pharmacist:
All prescription and over-the-counter medications you are currently taking
Any natural products or vitamins you are using
Any existing health problems or conditions
Before starting, stopping, or changing the dose of any medication, including this one, it is crucial to consult with your doctor to confirm that it is safe to do so. This will help prevent potential interactions or adverse effects.
It is essential to inform your doctor about any allergies you have, including:
Allergies to this medication or any of its components
Allergies to other medications, foods, or substances
The specific symptoms you experienced as a result of the allergy
Additionally, this medication may interact with other medications or health conditions. To ensure safe use, please discuss the following with your doctor and pharmacist:
All prescription and over-the-counter medications you are currently taking
Any natural products or vitamins you are using
Any existing health problems or conditions
Before starting, stopping, or changing the dose of any medication, including this one, it is crucial to consult with your doctor to confirm that it is safe to do so. This 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. When taking this drug, exercise caution when driving or performing tasks that require clear vision, as it may affect your eyesight. You may find that bright lights are bothersome, so wearing sunglasses can help. Do not use this medication for a longer period than prescribed, as this can increase the risk of a secondary infection. Although rare, severe and potentially life-threatening allergic reactions have occurred with this drug and similar medications. If you experience any symptoms of an allergic reaction, consult your doctor immediately. If you are pregnant, planning to become pregnant, or breastfeeding, discuss the potential benefits and risks of this medication with your doctor to determine the best course of action for you and your baby.
Overdose Information
Overdose Symptoms:
- Unlikely with ophthalmic use due to minimal systemic absorption. If accidentally ingested, symptoms might include nausea, vomiting, dizziness, or headache, but severe toxicity is rare.
What to Do:
If accidental ingestion occurs, drink fluids. If irritation or symptoms persist after ocular overdose, flush eye with lukewarm water. For significant ingestion or concerning symptoms, call a poison control center (1-800-222-1222) or seek immediate medical attention.
Drug Interactions
Monitoring
Baseline Monitoring
Ocular examination (visual acuity, slit lamp exam)
Rationale: To assess baseline severity of infection and rule out other ocular conditions.
Timing: Prior to initiation of therapy.
Bacterial culture and susceptibility testing (if indicated)
Rationale: To identify causative organism and guide therapy, especially in severe or non-responsive cases.
Timing: Prior to initiation of therapy, if clinically warranted.
Routine Monitoring
Clinical signs and symptoms of infection (e.g., redness, discharge, pain, swelling)
Frequency: Daily or as clinically indicated.
Target: Improvement or resolution of symptoms.
Action Threshold: Worsening symptoms, lack of improvement after 2-3 days, or new symptoms warrant re-evaluation and potential change in therapy.
Visual acuity
Frequency: Daily or as clinically indicated.
Target: Stable or improving.
Action Threshold: Decreased visual acuity warrants immediate re-evaluation.
Symptom Monitoring
- Decreased eye pain or discomfort
- Reduction in eye redness
- Decrease in eye discharge
- Reduced swelling of eyelids
- Improved vision (if affected)
Special Patient Groups
Pregnancy
Ofloxacin ophthalmic is classified as Pregnancy Category C. While systemic fluoroquinolones are generally avoided in pregnancy due to potential effects on cartilage development, the systemic absorption of ophthalmic ofloxacin is minimal. Therefore, the risk to the fetus is considered low. 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.
Second Trimester:
Low risk due to minimal systemic absorption.
Third Trimester:
Low risk due to minimal systemic absorption.
Lactation
Ofloxacin is excreted in human milk after systemic administration. However, due to the minimal systemic absorption of ophthalmic ofloxacin, the amount excreted into breast milk is expected to be negligible. Therefore, it is generally considered compatible with breastfeeding, but caution is advised. Monitor the infant for potential gastrointestinal disturbances (e.g., diarrhea, candidiasis) or rash.
Infant Risk:
Low risk (L3 - Moderately safe, but monitor infant)
Pediatric Use
Ofloxacin ophthalmic solution is approved for use in pediatric patients 1 year of age and older. Safety and effectiveness in infants younger than 1 year have not been established. Dosing is similar to adults for children 1 year and older.
Geriatric Use
No specific dosage adjustment is required for geriatric patients. The safety and efficacy profile is similar to that in younger adults. Minimal systemic absorption reduces concerns about age-related changes in renal or hepatic function.
Clinical Information
Clinical Pearls
- Ofloxacin ophthalmic is a common first-line treatment for bacterial conjunctivitis and corneal ulcers due to its broad spectrum and good ocular penetration.
- Emphasize proper instillation technique to patients to maximize efficacy and minimize contamination.
- Advise patients to avoid wearing contact lenses during treatment for bacterial eye infections.
- If multiple ophthalmic medications are prescribed, advise patients to wait at least 5 minutes between drops to prevent washout.
- While generally well-tolerated, transient burning or stinging upon instillation is common.
Alternative Therapies
- Moxifloxacin ophthalmic (e.g., Vigamox)
- Gatifloxacin ophthalmic (e.g., Zymar, Zymaxid)
- Besifloxacin ophthalmic (e.g., Besivance)
- Levofloxacin ophthalmic (e.g., Quixin, Iquix)
- Tobramycin ophthalmic (e.g., Tobrex)
- Gentamicin ophthalmic
- Polymyxin B/Trimethoprim ophthalmic (e.g., Polytrim)
- Erythromycin ophthalmic ointment
Cost & Coverage
Average Cost:
$15 - $40 per 5ml 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 is a good idea to check with your pharmacist for more information. If you have any questions or concerns about this medication, consult 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 reporting the overdose, be prepared to provide details about the medication taken, the amount, and the time it occurred.