Ofloxacin 0.3% Oph Sol 10ml (eye)
It is used to treat eye infections.
Drug Class
Ophthalmic Anti-infective
Pharmacologic Class
Fluoroquinolone Antibiotic
Pregnancy Category
Category C
FDA Approved
Jan 1993
DEA Schedule
Not Controlled
Overview
What is this medicine?
Ofloxacin ophthalmic solution is an antibiotic eye drop used to treat bacterial infections of the eye, such as pink eye (conjunctivitis) or more serious infections like corneal ulcers. It works by killing the bacteria that cause 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. Take the medication at the same time every day to establish a routine.
Administration Instructions
1. Use the medication only in your eye.
2. Wash your hands before and after using the medication to prevent contamination.
3. 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.
4. Tilt your head back and gently pull down your lower eyelid.
5. Squeeze in the prescribed amount of medication.
6. After administration, keep your eyes closed and apply gentle pressure to the inside corner of your eye for 1 to 2 minutes to help the medication stay in your eye.
Important Precautions
Do not wear contact lenses unless your doctor advises you to do so.
Use the medication as instructed, and do not stop using it without consulting your doctor.
Storage and Disposal
Store the medication at room temperature, away from freezing temperatures. Keep all medications in a safe place, out of the 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 disposing of medications, consult your pharmacist, who may be aware of drug take-back programs in your area.
Missed Dose Instructions
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 the same time or take 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 Instructions
1. Use the medication only in your eye.
2. Wash your hands before and after using the medication to prevent contamination.
3. 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.
4. Tilt your head back and gently pull down your lower eyelid.
5. Squeeze in the prescribed amount of medication.
6. After administration, keep your eyes closed and apply gentle pressure to the inside corner of your eye for 1 to 2 minutes to help the medication stay in your eye.
Important Precautions
Do not wear contact lenses unless your doctor advises you to do so.
Use the medication as instructed, and do not stop using it without consulting your doctor.
Storage and Disposal
Store the medication at room temperature, away from freezing temperatures. Keep all medications in a safe place, out of the 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 disposing of medications, consult your pharmacist, who may be aware of drug take-back programs in your area.
Missed Dose Instructions
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 the same time or take extra doses to make up for a missed dose.
Lifestyle & Tips
- Do not wear contact lenses during treatment for bacterial conjunctivitis or corneal ulcers, unless specifically advised by your doctor.
- Wash your hands thoroughly before and after applying eye drops.
- Avoid touching the dropper tip to your eye or any other surface to prevent contamination.
- If you are using other eye drops, wait at least 5 minutes between applications.
- Complete the full course of treatment, even if your symptoms improve, to prevent the infection from returning.
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: Instill 1-2 drops into the affected eye(s) every 2-4 hours for the first 2 days, then 4 times daily for up to 5 additional days. For corneal ulcers: Instill 1-2 drops into the affected eye(s) every 30 minutes to 1 hour while awake and 4-6 hours after retiring for the first 2 days, then 1-2 drops every hour while awake on days 3-7, then 1-2 drops 4 times daily through day 7-9.
Condition-Specific Dosing:
bacterialConjunctivitis:
1-2 drops every 2-4 hours for 2 days, then 4 times daily for 5 days.
cornealUlcers:
Initial: 1-2 drops every 30-60 min (awake) and 4-6 hours (asleep) for 2 days. Then: 1-2 drops every hour (awake) for days 3-7. Then: 1-2 drops 4 times daily for days 7-9.
Pediatric Dosing
Neonatal:
Not established (use with caution, consult specialist)
Infant:
For bacterial conjunctivitis (âĨ1 year): Same as adult dosing. For corneal ulcers (âĨ1 year): Same as adult dosing.
Child:
Same as adult dosing for bacterial conjunctivitis and corneal ulcers.
Adolescent:
Same as adult dosing for bacterial conjunctivitis and corneal ulcers.
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 specific considerations (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 disruption of bacterial DNA and cell death.
Pharmacokinetics
Absorption:
Bioavailability:
Minimal systemic absorption after ophthalmic administration. Plasma concentrations are typically below the limit of detection (0.005 mcg/mL).
Tmax:
Not applicable (minimal systemic absorption)
FoodEffect:
Not applicable (ophthalmic administration)
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:
Not applicable (minimal systemic absorption)
Unchanged:
Not applicable (minimal systemic absorption)
Pharmacodynamics
OnsetOfAction:
Rapid, typically within hours for symptomatic relief, but full eradication requires continued treatment.
PeakEffect:
Not precisely quantified for ophthalmic effect, but antibacterial activity is sustained with regular dosing.
DurationOfAction:
Dependent on dosing frequency; maintains therapeutic concentrations in ocular tissues for several hours after instillation.
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience 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
Changes in eyesight, eye pain, or severe eye irritation
Joint pain or swelling
A severe skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis), which can cause:
+ 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 have mild ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor:
Burning
Eye irritation
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns, 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, this medication can cause severe and potentially life-threatening side effects. If you experience 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
Changes in eyesight, eye pain, or severe eye irritation
Joint pain or swelling
A severe skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis), which can cause:
+ 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 have mild ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor:
Burning
Eye irritation
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns, 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 severe eye irritation, burning, or stinging
- Swelling around the eye
- Vision changes or decreased vision
- Signs of an allergic reaction (e.g., rash, itching, severe swelling of the face/throat, difficulty breathing - seek immediate medical attention)
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 and pharmacist identify potential interactions between this medication and other substances.
* Any existing health problems, as this medication may interact with certain conditions.
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 dose 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 information will help your doctor and pharmacist identify potential interactions between this medication and other substances.
* Any existing health problems, as this medication may interact with certain conditions.
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 dose 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 ensure the best outcome for you and your baby.
Overdose Information
Overdose Symptoms:
- Unlikely with ophthalmic use due to minimal systemic absorption. Local irritation may occur with excessive use.
What to Do:
If accidentally ingested, drink fluids. If eye irritation occurs, rinse eye with lukewarm water. For any concerning symptoms, call a poison control center (1-800-222-1222) or seek medical attention.
Drug Interactions
Monitoring
Baseline Monitoring
Ophthalmic examination (visual acuity, slit lamp, external exam)
Rationale: To assess the severity and nature of the infection and establish baseline ocular health.
Timing: Prior to initiating treatment
Culture and sensitivity testing (for severe or non-responsive cases)
Rationale: To identify the causative organism and confirm susceptibility to ofloxacin, guiding treatment decisions.
Timing: Prior to initiating treatment, if indicated
Routine Monitoring
Clinical response (reduction in redness, discharge, pain, foreign body sensation)
Frequency: Daily or at follow-up visits (e.g., 2-3 days after initiation)
Target: Improvement in symptoms and signs of infection
Action Threshold: Lack of improvement or worsening symptoms after 2-3 days of treatment warrants re-evaluation and potential change in therapy.
Adverse ocular effects (e.g., burning, stinging, itching, photophobia)
Frequency: Daily, patient self-monitoring
Target: Absence or mild, tolerable effects
Action Threshold: Severe or persistent adverse effects warrant discontinuation and re-evaluation.
Symptom Monitoring
- Eye redness
- Eye discharge (purulent, watery)
- Eye pain or discomfort
- Foreign body sensation
- Itching or burning sensation in the eye
- Photophobia (sensitivity to light)
- Blurred vision
- Swelling of eyelids
Special Patient Groups
Pregnancy
Ofloxacin ophthalmic solution is classified as Pregnancy Category C. While systemic fluoroquinolones have shown some effects in animal studies, systemic absorption from ophthalmic use is minimal. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Trimester-Specific Risks:
First Trimester:
Minimal systemic absorption suggests low risk, but caution is advised.
Second Trimester:
Minimal systemic absorption suggests low risk, but caution is advised.
Third Trimester:
Minimal systemic absorption suggests low risk, but caution is advised.
Lactation
Ofloxacin is excreted in human milk after systemic administration. However, due to minimal systemic absorption from ophthalmic use, the amount excreted into breast milk is expected to be negligible. It is generally considered compatible with breastfeeding, but caution is advised.
Infant Risk:
Low risk of adverse effects to the breastfed infant due to minimal maternal systemic absorption.
Pediatric Use
Ofloxacin ophthalmic solution is generally safe and effective for use in pediatric patients aged 1 year and older for bacterial conjunctivitis and corneal ulcers. Safety and efficacy in infants younger than 1 year have not been fully established, and use should be with caution and under specialist guidance.
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 ophthalmic solution is effective against a wide range of gram-positive and gram-negative bacteria commonly causing eye infections.
- Patients should be instructed on proper eye drop instillation technique to maximize efficacy and minimize contamination.
- Advise patients to remove contact lenses before instilling drops and to wait at least 15 minutes before reinserting them (or avoid during treatment if indicated).
- If symptoms do not improve within a few days, or worsen, re-evaluate the diagnosis and consider alternative treatments or cultures.
- While systemic fluoroquinolones have significant warnings, these are generally not relevant for ophthalmic use due to negligible systemic absorption.
Alternative Therapies
- Moxifloxacin ophthalmic solution (Vigamox)
- Gatifloxacin ophthalmic solution (Zymar, Zymaxid)
- Besifloxacin ophthalmic suspension (Besivance)
- Ciprofloxacin ophthalmic solution (Ciloxan)
- Tobramycin ophthalmic solution/ointment (Tobrex)
- Erythromycin ophthalmic ointment
- Polymyxin B/Trimethoprim ophthalmic solution (Polytrim)
Cost & Coverage
Average Cost:
$20 - $50 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 for further guidance. 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 happened.