Ciprofloxacin 0.3% Op Sol 5ml-Eye

Manufacturer SANDOZ Active Ingredient Ciprofloxacin Eye Drops(sip roe FLOKS a sin) Pronunciation sip roe FLOKS a sin
It is used to treat eye infections.
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Drug Class
Ophthalmic anti-infective
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Pharmacologic Class
Fluoroquinolone antibiotic
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Pregnancy Category
Category C
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FDA Approved
Mar 1991
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Ciprofloxacin eye drops are an antibiotic medication used to treat bacterial infections of the eye, such as bacterial conjunctivitis (pink eye) and corneal ulcers. It works by killing the bacteria causing the infection.
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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 and lead to severe eye problems or vision loss.
3. Remove contact lenses before using the medication. Consult your doctor to determine if you can reinsert your contact lenses after use. Do not put your contacts back in if your eyes are irritated or infected.
4. Tilt your head back and gently drop the medication into your eye.
5. 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, away from light and freezing temperatures. Keep all medications in a safe location, 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 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.
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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 avoid contamination.
  • Remove contact lenses before applying the drops and wait at least 15 minutes before reinserting them, unless advised otherwise by your doctor.
  • Do not share your eye drops with others.
  • Complete the full course of treatment as prescribed, even if symptoms improve, to prevent recurrence and antibiotic resistance.
  • Avoid rubbing your eyes.

Dosing & Administration

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Adult Dosing

Standard Dose: For bacterial conjunctivitis: 1-2 drops into the affected eye(s) every 2 hours while awake for 2 days, then 1-2 drops every 4 hours while awake for the next 5 days. For corneal ulcers: 2 drops into the affected eye(s) every 15 minutes for the first 6 hours, then 2 drops every 30 minutes for the remainder of the first day. On day 2, 2 drops every hour. Days 3-14, 2 drops every 4 hours. Treatment may continue after 14 days.

Condition-Specific Dosing:

bacterial_conjunctivitis: 1-2 drops every 2 hours (awake) for 2 days, then 1-2 drops every 4 hours (awake) for 5 days.
corneal_ulcers: Initial: 2 drops every 15 min for 6 hours, then 2 drops every 30 min for rest of day 1. Day 2: 2 drops every hour. Days 3-14: 2 drops every 4 hours.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established for infants less than 1 year of age.
Child: For children 1 year of age and older: Dosing similar to adults for bacterial conjunctivitis and corneal ulcers.
Adolescent: Dosing similar to adults.
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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 due to 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

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Mechanism of Action

Ciprofloxacin is a fluoroquinolone antibacterial. It exerts its bactericidal effect by inhibiting bacterial DNA gyrase (topoisomerase II) and topoisomerase IV, enzymes essential for bacterial DNA replication, transcription, repair, and recombination. This leads to DNA strand breaks and bacterial cell death.
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Pharmacokinetics

Absorption:

Bioavailability: Minimal systemic absorption (ophthalmic route).
Tmax: Not applicable for systemic Tmax; local concentrations peak rapidly.
FoodEffect: Not applicable (ophthalmic route).

Distribution:

Vd: Not applicable (minimal systemic distribution).
ProteinBinding: Not applicable (minimal systemic absorption).
CnssPenetration: Limited (minimal systemic absorption).

Elimination:

HalfLife: Not applicable systemically; primarily local elimination from ocular surface.
Clearance: Not applicable systemically.
ExcretionRoute: Primarily local clearance from the eye; minimal systemic excretion.
Unchanged: Not applicable systemically.
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Pharmacodynamics

OnsetOfAction: Rapid, typically within hours for symptomatic relief.
PeakEffect: Within 1-2 days of consistent dosing.
DurationOfAction: Dependent on dosing frequency; maintains therapeutic concentrations in ocular tissues with regular application.

Safety & Warnings

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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
+ 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
Eye or eyelid swelling
Joint pain or swelling

Note: In some cases, this medication may cause white crystals to form in the eye. This condition is harmless and does not affect eyesight or the medication's effectiveness. If you notice this, inform your doctor.

Other Possible Side Effects

Like all medications, this drug can cause side effects. While many people do not experience any side effects or only have mild ones, it is 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:

Blurred eyesight
Eye irritation
Bloodshot eyes
Eyelid crusting
Feeling of something in the eye
Bad taste in your mouth

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.
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Seek Immediate Medical Attention If You Experience:

  • Worsening eye pain or discomfort
  • Increased redness or swelling
  • New or worsening discharge
  • Significant vision changes
  • Signs of allergic reaction (e.g., rash, itching, severe swelling of face/throat, difficulty breathing - seek immediate medical attention)
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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, any of 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 this medication can be taken safely with all your other medications and health conditions. Never start, stop, or adjust the dose of any medication without first consulting your doctor.
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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 while 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 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; therefore, it is crucial to discuss any concerns with your doctor. If you are pregnant, planning to become pregnant, or are breastfeeding, you must consult your doctor to weigh the benefits and risks of this medication to both you and your baby.
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Overdose Information

Overdose Symptoms:

  • Unlikely with ophthalmic use due to minimal systemic absorption. Local irritation, redness, or tearing may occur with excessive application.

What to Do:

If accidentally ingested, drink fluids. For ocular irritation, rinse eye with lukewarm water. If symptoms persist or are severe, contact a poison control center (e.g., 1-800-222-1222) or seek medical attention.

Drug Interactions

Monitoring

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Baseline Monitoring

Ocular examination

Rationale: To assess the extent and nature of the infection (e.g., conjunctivitis, corneal ulcer) and establish baseline symptoms.

Timing: Prior to initiating treatment.

Bacterial culture and susceptibility testing

Rationale: Recommended for severe or non-responsive infections to identify the causative organism and guide therapy.

Timing: Prior to initiating treatment, especially for corneal ulcers or severe conjunctivitis.

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Routine Monitoring

Clinical response (e.g., reduction in redness, discharge, pain, photophobia)

Frequency: Daily or as clinically indicated.

Target: Progressive improvement in symptoms.

Action Threshold: Lack of improvement or worsening symptoms after 2-3 days may indicate resistant organism or alternative diagnosis; re-evaluate treatment.

Ocular examination (e.g., slit lamp for corneal ulcers)

Frequency: As clinically indicated, especially for corneal ulcers (daily initially).

Target: Resolution of signs of infection.

Action Threshold: Persistent or worsening signs of infection.

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Symptom Monitoring

  • Eye redness
  • Eye discharge (purulent, watery)
  • Eye pain or discomfort
  • Foreign body sensation
  • Photophobia (light sensitivity)
  • Blurred vision
  • Swelling of eyelids or conjunctiva

Special Patient Groups

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Pregnancy

Ciprofloxacin ophthalmic solution is classified as Pregnancy Category C. While systemic ciprofloxacin has shown adverse 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 exposure, but caution advised.
Second Trimester: Minimal systemic exposure, but caution advised.
Third Trimester: Minimal systemic exposure, but caution advised.
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Lactation

Ciprofloxacin is excreted in human milk after systemic administration. However, due to minimal systemic absorption of ophthalmic ciprofloxacin, the amount excreted in breast milk is expected to be negligible. Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for the drug and any potential adverse effects on the breastfed infant from the drug or from the underlying maternal condition.

Infant Risk: Low risk due to minimal systemic absorption.
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Pediatric Use

Safety and effectiveness in pediatric patients less than 1 year of age have not been established. For children 1 year of age and older, dosing is similar to adults. Fluoroquinolones have been associated with arthropathy in juvenile animals, but this risk is considered negligible with ophthalmic use due to minimal systemic exposure.

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Geriatric Use

No overall differences in safety or effectiveness have been observed between elderly and younger patients. No dosage adjustment is necessary.

Clinical Information

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Clinical Pearls

  • Ciprofloxacin ophthalmic solution is highly effective against a broad spectrum of gram-positive and gram-negative bacteria commonly causing eye infections.
  • It is particularly useful for severe infections like corneal ulcers due to its potent bactericidal action and ability to achieve high local concentrations.
  • Patients should be instructed on proper instillation technique to maximize efficacy and minimize contamination.
  • Advise patients to avoid wearing contact lenses during treatment for bacterial eye infections.
  • Superinfection with non-susceptible organisms, including fungi, can occur with prolonged use. Monitor for new infections.
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Alternative Therapies

  • Moxifloxacin ophthalmic solution (e.g., Vigamox)
  • Gatifloxacin ophthalmic solution (e.g., Zymar)
  • Ofloxacin ophthalmic solution (e.g., Ocuflox)
  • Levofloxacin ophthalmic solution (e.g., Quixin)
  • Tobramycin ophthalmic solution
  • Erythromycin ophthalmic ointment
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Cost & Coverage

Average Cost: $20 - $50 per 5ml bottle
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 2 (preferred generic)
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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 medication taken, the amount, and the time it happened.