Ciprofloxacin 0.3% Op Sol 2.5ml-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) or corneal ulcers. It works by stopping the growth of bacteria that cause 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 freezing temperatures and light. Keep all medications in a secure 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

  • Do not wear contact lenses during treatment for bacterial eye infections, as they can worsen the infection or interfere with treatment.
  • Wash your hands thoroughly before and after administering the eye drops.
  • Avoid touching the dropper tip to your eye, eyelid, or any other surface to prevent contamination of the solution.
  • Do not share your eye drops with anyone else.
  • Complete the full course of treatment as prescribed by your doctor, even if your symptoms improve, to ensure the infection is fully cleared and to prevent antibiotic resistance.
  • If you are using other eye medications, wait at least 5 minutes between applications.

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 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. On days 3-14, 2 drops every 4 hours.

Condition-Specific Dosing:

bacterialConjunctivitis: 1-2 drops every 2 hours while awake for 2 days, then 1-2 drops every 4 hours while awake for 5 days.
cornealUlcers: Initial: 2 drops every 15 minutes for 6 hours, then 2 drops every 30 minutes for the remainder 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 under 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 for ophthalmic use 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 antibiotic that inhibits 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.
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Pharmacokinetics

Absorption:

Bioavailability: Not applicable (minimal systemic absorption from ophthalmic use). Local ocular concentrations are high.
Tmax: Not applicable (minimal systemic absorption).
FoodEffect: Not applicable.

Distribution:

Vd: Not applicable (minimal systemic absorption). Primarily distributed locally within ocular tissues (cornea, conjunctiva, aqueous humor).
ProteinBinding: Not significant for ophthalmic use.
CnssPenetration: Limited (no significant CNS penetration from ophthalmic use).

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).
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Pharmacodynamics

OnsetOfAction: Rapid, typically within hours for symptomatic improvement.
PeakEffect: Within hours of initial dosing.
DurationOfAction: Maintained by frequent application according to dosing regimen.

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:

  • Severe or worsening eye pain
  • Increased redness or swelling of the eye
  • Increased discharge or pus from the eye
  • Significant changes in vision
  • Signs of an allergic reaction (e.g., rash, itching, severe swelling of the face/throat, difficulty breathing)
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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, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced as a result of the allergy.
Potential interactions with other medications or health conditions. This drug may interact with other prescription or over-the-counter (OTC) medications, natural products, or vitamins, which could affect its safety and efficacy.
All medications you are currently taking, including prescription and OTC medications, natural products, and vitamins. This information will help your doctor and pharmacist assess potential interactions and ensure safe use.
Any existing health problems, as they may impact the safety and effectiveness of this medication.

To ensure your safety, do not start, stop, or change the dose of any medication without first consulting your doctor. It is crucial to verify that it is safe to take this medication in combination with your other medications and health conditions.
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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 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 are breastfeeding, discuss the potential benefits and risks of this medication with your doctor to ensure the best outcome for you and your baby.
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Overdose Information

Overdose Symptoms:

  • Excessive tearing
  • Increased redness or irritation of the eye

What to Do:

If an overdose occurs in the eye, rinse the eye with lukewarm water. Systemic overdose from ophthalmic use is highly unlikely due to minimal absorption. If accidentally ingested, contact a poison control center immediately. Call 1-800-222-1222 (Poison Control).

Drug Interactions

Monitoring

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Baseline Monitoring

Ocular examination (visual acuity, slit lamp examination)

Rationale: To assess the severity and nature of the infection, and to rule out other ocular conditions.

Timing: Prior to initiation of treatment.

Bacterial culture and susceptibility testing (if indicated)

Rationale: To identify the causative organism and confirm its susceptibility to ciprofloxacin, especially in severe or non-responsive cases.

Timing: Prior to initiation of treatment.

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Routine Monitoring

Clinical response (reduction in ocular redness, discharge, pain, foreign body sensation)

Frequency: Daily or as per physician's instruction.

Target: Progressive improvement in symptoms and signs of infection.

Action Threshold: Worsening symptoms, no improvement after 2-3 days of treatment, or development of new symptoms.

Adverse ocular reactions (e.g., burning, stinging, itching, lid edema, photophobia)

Frequency: Daily.

Target: Absence or mild, transient nature of reactions.

Action Threshold: Severe or persistent ocular discomfort, allergic reactions.

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Symptom Monitoring

  • Ocular irritation
  • Burning or stinging sensation
  • Itching
  • Foreign body sensation
  • Blurred vision
  • Photophobia
  • Lid edema
  • Tearing
  • Crusting of eyelids
  • Conjunctival hyperemia (redness)

Special Patient Groups

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Pregnancy

Ciprofloxacin ophthalmic solution is classified as Pregnancy Category C. While animal studies have shown some adverse effects with systemic ciprofloxacin, minimal systemic absorption occurs with ophthalmic use. It should be used during pregnancy 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.
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Lactation

Ciprofloxacin 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. The risk to the breastfed infant is considered low (L3). Use with caution.

Infant Risk: Low risk. Monitor infant for potential gastrointestinal disturbances (e.g., diarrhea) or candidiasis (thrush), though these are highly unlikely with ophthalmic use.
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Pediatric Use

Safe and effective for children 1 year of age and older. Safety and efficacy in infants younger than 1 year of age have not been established.

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Geriatric Use

No specific dose adjustments are needed for geriatric patients. Similar safety and efficacy profiles are observed compared to younger adults.

Clinical Information

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Clinical Pearls

  • Ciprofloxacin ophthalmic solution is a broad-spectrum fluoroquinolone effective against many Gram-positive and Gram-negative bacteria commonly causing ocular infections.
  • Patient adherence to the frequent dosing schedule, especially for corneal ulcers, is crucial for treatment success.
  • Emphasize proper eye drop administration technique to patients to maximize efficacy and prevent contamination.
  • Advise patients to avoid wearing contact lenses during the entire course of treatment for bacterial eye infections.
  • If symptoms do not improve within a few days or worsen, re-evaluation by an ophthalmologist is necessary.
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Alternative Therapies

  • Moxifloxacin ophthalmic solution
  • Gatifloxacin ophthalmic solution
  • Tobramycin ophthalmic solution
  • Azithromycin ophthalmic solution
  • Polymyxin B/Trimethoprim ophthalmic solution
  • Ofloxacin ophthalmic solution
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Cost & Coverage

Average Cost: Price range varies, typically $15-$50 per 2.5ml bottle
Generic Available: Yes
Insurance Coverage: Tier 1 or 2 (Generic)
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General Drug Facts

If your symptoms or health issues persist or worsen, it's 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 be sure 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 medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it occurred.