Ofloxacin 0.3% Oph Soln 10ml (eye)
It is used to treat eye infections.
Drug Class
Anti-infective
Pharmacologic Class
Fluoroquinolone Antibiotic (Ophthalmic)
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 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
For eye use only. Wash your hands before and after handling the container to prevent contamination. Avoid touching the container tip to your eye, lid, or surrounding skin, as this can introduce bacteria and potentially cause severe eye problems or vision loss.
To administer the medication:
1. Tilt your head back.
2. Gently pull down your lower eyelid.
3. Squeeze in the prescribed amount of medication.
4. 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.
Contact Lens Use
Do not wear contact lenses unless your doctor advises you to do so.
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. If you have questions about disposal, consult your pharmacist. You may also have access to 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
For eye use only. Wash your hands before and after handling the container to prevent contamination. Avoid touching the container tip to your eye, lid, or surrounding skin, as this can introduce bacteria and potentially cause severe eye problems or vision loss.
To administer the medication:
1. Tilt your head back.
2. Gently pull down your lower eyelid.
3. Squeeze in the prescribed amount of medication.
4. 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.
Contact Lens Use
Do not wear contact lenses unless your doctor advises you to do so.
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. If you have questions about disposal, consult your pharmacist. You may also have access to 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 eye drops with others.
- Complete the full course of treatment, even if symptoms improve, to prevent recurrence and antibiotic resistance.
- Avoid rubbing your eyes.
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:
Bacterial Conjunctivitis: 1-2 drops into affected eye(s) every 2-4 hours for 2 days, then 1-2 drops 4 times daily for up to 5 additional days. Bacterial Corneal Ulcers: 1-2 drops into affected eye(s) every 30 minutes while awake for 2 days, then 1-2 drops every hour while awake for 4-6 days, then 1-2 drops 4 times daily until clinical cure.
Condition-Specific Dosing:
bacterialConjunctivitis:
1-2 drops into affected eye(s) every 2-4 hours for 2 days, then 1-2 drops 4 times daily for up to 5 additional days.
bacterialCornealUlcers:
1-2 drops into affected eye(s) every 30 minutes while awake for 2 days, then 1-2 drops every hour while awake for 4-6 days, then 1-2 drops 4 times daily until clinical cure.
Pediatric Dosing
Neonatal:
Not established (safety and efficacy in infants <1 year of age not established for conjunctivitis; for corneal ulcers, safety and efficacy in infants <6 months of age not established).
Infant:
Not established (see neonatal).
Child:
Bacterial Conjunctivitis (âĨ1 year): Same as adult dosing. Bacterial Corneal Ulcers (âĨ6 months): Same as adult dosing.
Adolescent:
Same as adult dosing.
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed (minimal systemic absorption with ophthalmic use).
Moderate:
No adjustment needed (minimal systemic absorption with ophthalmic use).
Severe:
No adjustment needed (minimal systemic absorption with ophthalmic use).
Dialysis:
No specific considerations (minimal systemic absorption with ophthalmic use).
Hepatic Impairment:
Mild:
No adjustment needed (minimal systemic absorption with ophthalmic use).
Moderate:
No adjustment needed (minimal systemic absorption with ophthalmic use).
Severe:
No adjustment needed (minimal systemic absorption with ophthalmic use).
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 division and cell death.
Pharmacokinetics
Absorption:
Bioavailability:
Minimal systemic absorption (less than 1 ng/mL plasma concentration after topical ophthalmic administration).
Tmax:
Not applicable (minimal systemic absorption).
FoodEffect:
Not applicable (topical ophthalmic).
Distribution:
Vd:
Not applicable (minimal systemic absorption).
ProteinBinding:
Not applicable (minimal systemic absorption).
CnssPenetration:
No (minimal systemic absorption).
Elimination:
HalfLife:
Not applicable (minimal systemic absorption).
Clearance:
Not applicable (minimal systemic absorption).
ExcretionRoute:
Primarily renal if systemically absorbed, but minimal systemic absorption with ophthalmic use.
Unchanged:
Not applicable (minimal systemic absorption).
Pharmacodynamics
OnsetOfAction:
Rapid (antibacterial effect begins shortly after administration).
PeakEffect:
Not precisely quantified for ophthalmic effect, but bacterial inhibition occurs within hours.
DurationOfAction:
Maintained by frequent dosing as per regimen.
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, which could indicate a serious reaction:
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. 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:
Burning
Eye irritation
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. Immediately contact your doctor or seek medical attention if you experience any of the following symptoms, which could indicate a serious reaction:
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. 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:
Burning
Eye irritation
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 eye pain, redness, or discharge.
- New or severe eye irritation, burning, or stinging.
- Swelling of the eyelids or face.
- Rash or hives.
- Sudden changes in vision.
- Signs of allergic reaction (e.g., difficulty breathing, severe swelling).
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 you experienced, including any symptoms that occurred.
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. This information will help your doctor and pharmacist assess potential interactions between this medication and other substances you are taking.
* Any existing health problems, as this medication may interact with certain conditions or exacerbate underlying health issues.
To ensure your safety, it is crucial to verify that it is safe to take this medication with all your current medications and health conditions. Never start, stop, or change 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 allergic reaction you experienced, including any symptoms that occurred.
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. This information will help your doctor and pharmacist assess potential interactions between this medication and other substances you are taking.
* Any existing health problems, as this medication may interact with certain conditions or exacerbate underlying health issues.
To ensure your safety, it is crucial to verify that it is safe to take this medication with all your current medications and health conditions. Never start, stop, or change 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. When taking this drug, exercise caution when driving or performing tasks that require clear vision, as it may affect your eyesight. You may be sensitive to bright lights, so wearing sunglasses is recommended. Do not use this medication for a longer period than prescribed, as this may increase the risk of a secondary infection. Although rare, severe and potentially life-threatening allergic reactions have been reported 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 treatment for you and your baby.
Overdose Information
Overdose Symptoms:
- Unlikely with ophthalmic use due to minimal systemic absorption. Local irritation may occur with excessive application.
What to Do:
If accidentally ingested, drink fluids. If local irritation occurs, rinse eye with lukewarm water. For any concerning symptoms, contact a poison control center (1-800-222-1222) or seek medical attention.
Drug Interactions
Monitoring
Baseline Monitoring
Ophthalmic examination
Rationale: To assess the extent and nature of the infection (e.g., conjunctivitis, corneal ulcer) and establish baseline visual acuity.
Timing: Prior to initiation of therapy.
Culture and sensitivity testing (if indicated)
Rationale: To identify the causative organism and determine its susceptibility to ofloxacin, especially in severe or non-responsive cases.
Timing: Prior to initiation of therapy, if clinically warranted.
Routine Monitoring
Clinical response (e.g., reduction in redness, discharge, pain, improvement in corneal clarity)
Frequency: Daily or as clinically indicated.
Target: Progressive improvement in signs and symptoms of infection.
Action Threshold: Lack of improvement or worsening symptoms may indicate resistant organism or alternative diagnosis, requiring re-evaluation.
Adverse reactions (e.g., ocular irritation, burning, stinging, itching)
Frequency: Daily, or with each dose.
Target: Absence or mild, tolerable reactions.
Action Threshold: Severe or persistent irritation, allergic reactions, or new symptoms warrant discontinuation and re-evaluation.
Symptom Monitoring
- Ocular redness
- Ocular discharge (amount, color, consistency)
- Ocular pain or discomfort
- Foreign body sensation
- Photophobia (light sensitivity)
- Blurred vision
- Itching or burning sensation in the eye
Special Patient Groups
Pregnancy
Category C. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Systemic absorption is minimal with ophthalmic use, reducing systemic exposure.
Trimester-Specific Risks:
First Trimester:
Limited data, but systemic exposure is minimal. Risk considered low.
Second Trimester:
Limited data, but systemic exposure is minimal. Risk considered low.
Third Trimester:
Limited data, but systemic exposure is minimal. Risk considered low.
Lactation
L3 (Moderate risk). Ofloxacin is excreted in human milk after systemic administration. However, systemic absorption after ophthalmic administration is minimal, making infant exposure via breast milk unlikely to be clinically significant. Use with caution; monitor infant for gastrointestinal disturbances (e.g., diarrhea, candidiasis).
Infant Risk:
Low risk due to minimal maternal systemic absorption.
Pediatric Use
Safety and efficacy established for bacterial conjunctivitis in patients âĨ1 year of age and for bacterial corneal ulcers in patients âĨ6 months of age. Dosing is similar to adults. Use in younger infants is not established.
Geriatric Use
No specific dosage adjustment is necessary. 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 solution is effective against a wide range of gram-positive and gram-negative bacteria commonly causing eye infections.
- Adherence to the prescribed dosing frequency, especially for corneal ulcers, is crucial for effective treatment and preventing resistance.
- Patients should be advised that temporary blurred vision or mild stinging may occur immediately after instillation.
- If more than one ophthalmic medication is being used, administer them at least 5 minutes apart to prevent washout.
- Discontinue use and consult a physician if symptoms worsen or persist after a few days of treatment, or if new signs of irritation or hypersensitivity appear.
Alternative Therapies
- Moxifloxacin ophthalmic solution
- Gatifloxacin ophthalmic solution
- Besifloxacin ophthalmic suspension
- Tobramycin ophthalmic solution/ointment
- Gentamicin ophthalmic solution/ointment
- Erythromycin ophthalmic ointment
- Polymyxin B/Trimethoprim ophthalmic solution
Cost & Coverage
Average Cost:
$20 - $60 per 10ml bottle
Generic Available:
Yes
Insurance Coverage:
Tier 1 or 2 (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 overdose, including the medication taken, the amount, and the time it occurred.