Moxifloxacin 0.5% (bid) Oph Sol 3ml
It is used to treat eye infections.
Drug Class
Ophthalmic Anti-infective
Pharmacologic Class
Fluoroquinolone Antibiotic
Pregnancy Category
Category C
FDA Approved
Jun 2003
DEA Schedule
Not Controlled
Overview
What is this medicine?
Moxifloxacin eye drops are an antibiotic medication used to treat bacterial infections of the eye, such as pink eye (bacterial conjunctivitis). 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. Continue using the medication as directed, even if your symptoms improve. This medication is for eye use only.
Administration Instructions
1. Wash your hands before and after using the medication to prevent contamination.
2. Avoid touching the container tip to your eye, lid, or surrounding skin, as this can introduce bacteria into the medication and potentially cause severe eye problems or vision loss.
3. Tilt your head back and gently drop the medication into your eye.
4. After administering the medication, 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.
Storage and Disposal
Store the medication at room temperature or in the refrigerator. Do not freeze. Keep all medications in a secure location, 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. You may also want to check if there are drug take-back programs available in your area.
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 scheduled dose, skip the missed dose and resume your regular dosing 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. Continue using the medication as directed, even if your symptoms improve. This medication is for eye use only.
Administration Instructions
1. Wash your hands before and after using the medication to prevent contamination.
2. Avoid touching the container tip to your eye, lid, or surrounding skin, as this can introduce bacteria into the medication and potentially cause severe eye problems or vision loss.
3. Tilt your head back and gently drop the medication into your eye.
4. After administering the medication, 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.
Storage and Disposal
Store the medication at room temperature or in the refrigerator. Do not freeze. Keep all medications in a secure location, 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. You may also want to check if there are drug take-back programs available in your area.
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 scheduled dose, skip the missed dose and resume your regular dosing schedule. Do not use two doses at the same time or take extra doses.
Lifestyle & Tips
- Do not wear contact lenses while using this medication or if you have signs and symptoms of bacterial conjunctivitis.
- Avoid contaminating the dropper tip by not touching it to the eye or any other surface.
- Wash hands thoroughly before and after applying eye drops.
- Complete the full course of treatment, even if symptoms improve, to prevent recurrence and antibiotic resistance.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
1 drop in the affected eye(s) twice daily for 7 days
Condition-Specific Dosing:
bacterialConjunctivitis:
1 drop in the affected eye(s) twice daily for 7 days
Pediatric Dosing
Neonatal:
Not established (safety and efficacy not established in infants less than 1 year of age)
Infant:
1 drop in the affected eye(s) twice daily for 7 days (for infants 1 year of age and older)
Child:
1 drop in the affected eye(s) twice daily for 7 days
Adolescent:
1 drop in the affected eye(s) twice daily for 7 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
Moxifloxacin is a fluoroquinolone antibacterial agent that inhibits bacterial DNA gyrase (topoisomerase II) and topoisomerase IV. DNA gyrase is an essential enzyme that is involved in the replication, transcription, repair, and recombination of bacterial DNA. Topoisomerase IV is an enzyme known to play a primary role in the partitioning of the chromosomal DNA during bacterial cell division. The dual inhibition of DNA gyrase and topoisomerase IV results in bactericidal activity.
Pharmacokinetics
Absorption:
Bioavailability:
Minimal systemic absorption (peak plasma concentrations typically in the ng/mL range)
Tmax:
Not applicable (minimal systemic absorption)
FoodEffect:
Not applicable (ophthalmic administration)
Distribution:
Vd:
Not applicable (minimal systemic absorption)
ProteinBinding:
Approximately 50% (systemic)
CnssPenetration:
Limited (minimal systemic absorption)
Elimination:
HalfLife:
Not applicable (minimal systemic absorption)
Clearance:
Not applicable (minimal systemic absorption)
ExcretionRoute:
Primarily renal and fecal (systemic, but minimal for ophthalmic)
Unchanged:
Not applicable (minimal systemic absorption)
Pharmacodynamics
OnsetOfAction:
Rapid (bactericidal effect within hours)
PeakEffect:
Not precisely quantified for ophthalmic effect, but bacterial inhibition is rapid.
DurationOfAction:
Sustained antibacterial activity in ocular tissues for the dosing interval.
Note:
Pharmacodynamics are primarily local in the eye due to minimal systemic absorption.
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Attention Immediately
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 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, difficulty breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat
- Changes in vision, eye pain, or severe eye irritation
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 that bother you or do not go away, contact your doctor for advice:
- Eye irritation
- Short-term pain after using the medication
- Dry eyes
- Excessive tearing
Reporting Side Effects
This list does not include all possible side effects. If you have questions or concerns about side effects, consult your doctor. For medical advice about side effects, you can also contact your doctor. Additionally, you can 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 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, difficulty breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat
- Changes in vision, eye pain, or severe eye irritation
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 that bother you or do not go away, contact your doctor for advice:
- Eye irritation
- Short-term pain after using the medication
- Dry eyes
- Excessive tearing
Reporting Side Effects
This list does not include all possible side effects. If you have questions or concerns about side effects, consult your doctor. For medical advice about side effects, you can also contact your doctor. Additionally, you can 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 redness, pain, or discharge
- New or worsening blurred vision
- Signs of an allergic reaction (e.g., rash, itching, swelling of the face/tongue/throat, severe dizziness, trouble breathing)
- Any new or unusual eye symptoms
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 existing health problems, 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 and 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 existing health problems, 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 and 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 using this drug, avoid wearing contact lenses unless your doctor advises you to do so. If your eyes become irritated or infected, do not reinsert your contact lenses.
Exercise caution when driving or performing tasks that require clear vision to ensure your safety.
Do not use this medication for a longer period than prescribed by your doctor, as this may increase the risk of a second infection.
Although rare, severe and potentially life-threatening allergic reactions have occurred with this drug and similar medications. Discuss any concerns with your doctor.
If you are pregnant, planning to become pregnant, or are breastfeeding, consult your doctor to weigh the benefits and risks of this medication to both you and your baby.
When using this drug, avoid wearing contact lenses unless your doctor advises you to do so. If your eyes become irritated or infected, do not reinsert your contact lenses.
Exercise caution when driving or performing tasks that require clear vision to ensure your safety.
Do not use this medication for a longer period than prescribed by your doctor, as this may increase the risk of a second infection.
Although rare, severe and potentially life-threatening allergic reactions have occurred with this drug and similar medications. Discuss any concerns with your doctor.
If you are pregnant, planning to become pregnant, or are breastfeeding, consult your doctor to weigh the benefits and risks of this medication to both you and your baby.
Overdose Information
Overdose Symptoms:
- Unlikely with ophthalmic use due to minimal systemic absorption. If accidentally ingested, symptoms would likely be mild gastrointestinal upset.
What to Do:
If accidental ingestion occurs, drink fluids. If irritation or symptoms persist after ocular overdose, flush the eye with lukewarm water. For significant ingestion or severe symptoms, call a poison control center (1-800-222-1222) or seek emergency medical attention.
Drug Interactions
Monitoring
Baseline Monitoring
Ocular examination
Rationale: To confirm diagnosis of bacterial conjunctivitis and assess baseline ocular health.
Timing: Prior to initiation of therapy
Visual acuity
Rationale: To establish baseline vision.
Timing: Prior to initiation of therapy
Routine Monitoring
Resolution of symptoms (redness, discharge, irritation)
Frequency: Daily
Target: Improvement or resolution
Action Threshold: Lack of improvement or worsening of symptoms after 2-3 days; consider re-evaluation and alternative therapy.
Signs of adverse reactions (e.g., ocular irritation, allergic reactions)
Frequency: Daily
Target: Absence of significant adverse effects
Action Threshold: Development of severe irritation, pain, or signs of allergic reaction; discontinue use and seek medical attention.
Symptom Monitoring
- Ocular redness
- Ocular discharge
- Ocular irritation or discomfort
- Blurred vision (if new or worsening)
- Pain in the eye
- Swelling of eyelids
Special Patient Groups
Pregnancy
Category C. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Due to minimal systemic absorption from ophthalmic administration, systemic exposure to the fetus is expected to be low.
Trimester-Specific Risks:
First Trimester:
Potential risk cannot be ruled out, but systemic exposure is minimal.
Second Trimester:
Potential risk cannot be ruled out, but systemic exposure is minimal.
Third Trimester:
Potential risk cannot be ruled out, but systemic exposure is minimal.
Lactation
Considered low risk. It is not known whether ophthalmic moxifloxacin is excreted in human milk. However, due to minimal systemic absorption, excretion into breast milk is expected to be negligible. Benefits of breastfeeding should be weighed against potential risks.
Infant Risk:
Low risk of adverse effects to the breastfed infant due to minimal maternal systemic absorption.
Pediatric Use
Approved for use in pediatric patients 1 year of age and older. Safety and efficacy have not been established in infants less than 1 year of age.
Geriatric Use
No overall differences in safety or effectiveness have been observed between elderly and younger patients. No dosage adjustment is necessary.
Clinical Information
Clinical Pearls
- Moxifloxacin ophthalmic solution is generally well-tolerated with a low incidence of systemic side effects due to minimal absorption.
- Patients should be instructed on proper eye drop instillation technique to maximize efficacy and minimize contamination.
- Advise patients not to share eye drops to prevent spread of infection.
- If more than one topical ophthalmic medication is being used, they should be administered at least 5 minutes apart.
Alternative Therapies
- Gatifloxacin ophthalmic solution
- Levofloxacin ophthalmic solution
- Ciprofloxacin ophthalmic solution
- Ofloxacin ophthalmic solution
- Tobramycin ophthalmic solution/ointment
- Polymyxin B/Trimethoprim ophthalmic solution
Cost & Coverage
Average Cost:
$30 - $80 per 3ml bottle
Generic Available:
Yes
Insurance Coverage:
Tier 1 or 2 (often 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 your safety, 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. 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 medical attention. When seeking help, be prepared to provide detailed information about the overdose, including the medication taken, the amount, and the time it occurred.