Ciprofloxacin 0.3% Op Sol 10ml-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 that are 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 contact lenses 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 inner 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 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 unless specifically advised by your doctor. If you must wear them, remove them before instilling drops and wait at least 15 minutes before reinserting.
  • Wash your hands thoroughly before and after applying the eye drops.
  • Avoid touching the dropper tip to your eye, eyelid, or any other surface to prevent contamination.
  • Tilt your head back, pull down your lower eyelid to form a pouch, and instill the prescribed number of drops. Close your eye gently for a few moments.
  • If using other eye medications, wait at least 5-10 minutes between applications.
  • Complete the full course of treatment, even if your symptoms improve, to prevent recurrence and antibiotic resistance.

Dosing & Administration

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Adult Dosing

Standard Dose: For bacterial conjunctivitis: 1-2 drops into the conjunctival sac every 2 hours while awake for 2 days, then 1-2 drops every 4 hours while awake for 5 days. For corneal ulcers: Initial: 2 drops every 15 minutes for 6 hours, then 2 drops every 30 minutes for the remainder of the first day. Day 2: 2 drops every hour. Day 3-14: 2 drops every 4 hours. Treatment may extend beyond 14 days.

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 the first day. Day 2: 2 drops every hour. Day 3-14: 2 drops every 4 hours.
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Pediatric Dosing

Neonatal: Not established
Infant: For bacterial conjunctivitis and corneal ulcers: â‰Ĩ1 year old, same as adult dosing.
Child: For bacterial conjunctivitis and corneal ulcers: â‰Ĩ1 year old, same as adult dosing.
Adolescent: Same as adult dosing.
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Dose Adjustments

Renal Impairment:

Mild: No adjustment needed
Moderate: No adjustment needed
Severe: No adjustment needed
Dialysis: No specific considerations due to minimal systemic absorption.

Hepatic Impairment:

Mild: No adjustment needed
Moderate: No adjustment needed
Severe: No adjustment needed

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 ultimately bacterial cell death.
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Pharmacokinetics

Absorption:

Bioavailability: Minimal systemic absorption (typically below detectable limits)
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: Not applicable (minimal systemic absorption)
Unchanged: Not applicable (minimal systemic absorption)
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Pharmacodynamics

OnsetOfAction: Rapid antibacterial effect, clinical improvement typically within 1-2 days.
PeakEffect: Local concentration peaks shortly after administration.
DurationOfAction: Dependent on dosing frequency and local tissue retention.

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 is a harmless condition that does not affect vision 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 bother you or do not go away:

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

This is not an exhaustive list of possible 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, redness, or swelling
  • Increased or purulent discharge from the eye
  • Blurred vision or any changes in vision
  • Sensitivity to light (photophobia)
  • Signs of an allergic reaction, such as rash, itching, hives, swelling of the face/lips/tongue/throat, or difficulty breathing (seek immediate medical attention for severe allergic reactions).
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Before Using This Medicine

Before taking this medication, it is essential to inform your doctor about the following:

Any allergies you have, including allergies to this drug, any of its components, or other substances, such as foods or other medications. Be sure to describe the symptoms you experienced as a result of the allergy.
Potential interactions with other medications or health conditions, as this drug may affect or be affected by other drugs or health problems.
All medications you are currently taking, including prescription and over-the-counter (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 these may impact the safety and effectiveness of this medication.
* Do not initiate, discontinue, or modify the dosage of any medication without first consulting your doctor to confirm that it is safe to do so in conjunction with this drug.
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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 can help. Do not use this medication for a longer period than prescribed, as this can increase the risk of a secondary infection. Although rare, severe and potentially life-threatening allergic reactions have occurred with this 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, 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. If accidentally ingested, mild gastrointestinal upset may occur.

What to Do:

If accidental ingestion occurs, drink fluids. For significant ingestion or concerning symptoms, 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.

Timing: Prior to initiating treatment

Culture and sensitivity testing

Rationale: Recommended for severe infections (e.g., corneal ulcers) to identify causative organism and guide therapy.

Timing: Prior to initiating treatment

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Routine Monitoring

Clinical response (reduction in redness, discharge, pain)

Frequency: Daily

Target: Improvement of symptoms

Action Threshold: Lack of improvement or worsening symptoms after 2-3 days may indicate resistance or incorrect diagnosis.

Visual acuity

Frequency: Daily (especially for corneal ulcers)

Target: Stable or improving

Action Threshold: Decreased visual acuity may indicate worsening infection or complications.

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Symptom Monitoring

  • Worsening eye pain
  • Increased redness or swelling of the eye/eyelid
  • Increased or purulent discharge
  • Blurred vision or vision changes
  • Photophobia (light sensitivity)
  • Signs of allergic reaction (e.g., rash, itching, swelling of face/throat, difficulty breathing)

Special Patient Groups

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Pregnancy

Ciprofloxacin ophthalmic solution is classified as Pregnancy Category C. While systemic absorption is minimal, use during pregnancy should only be considered if the potential benefit justifies the potential risk to the fetus. Consult with a healthcare provider.

Trimester-Specific Risks:

First Trimester: Potential risk cannot be ruled out; use only if clearly needed.
Second Trimester: Potential risk cannot be ruled out; use only if clearly needed.
Third Trimester: Potential risk cannot be ruled out; use only if clearly needed.
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Lactation

Ciprofloxacin is excreted in human milk following systemic administration. However, systemic absorption from ophthalmic administration is minimal, and therefore, the risk to a breastfed infant is considered low. Caution is advised, and the infant should be monitored for gastrointestinal disturbances (e.g., diarrhea, candidiasis).

Infant Risk: L3 (Moderate risk, but low for ophthalmic use due to minimal absorption)
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Pediatric Use

Ciprofloxacin ophthalmic solution is safe and effective for use in pediatric patients aged 1 year and older for bacterial conjunctivitis and corneal ulcers. Safety and effectiveness in infants younger than 1 year have not been established.

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Geriatric Use

No overall differences in safety or effectiveness have been observed between elderly and younger patients. No specific dosage adjustments are needed for geriatric patients.

Clinical Information

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Clinical Pearls

  • Advise patients to remove contact lenses before instilling ciprofloxacin eye drops and to wait at least 15 minutes before reinserting them. Ideally, contact lens wear should be avoided during treatment for bacterial eye infections.
  • Emphasize the importance of completing the full prescribed course of therapy, even if symptoms improve, to prevent bacterial resistance and recurrence of infection.
  • Temporary blurred vision or mild stinging/burning may occur immediately after instillation; advise patients not to drive or operate machinery until vision clears.
  • Ciprofloxacin is effective against a broad spectrum of gram-positive and gram-negative bacteria commonly causing ocular infections, including Pseudomonas aeruginosa.
  • For severe infections like corneal ulcers, frequent dosing is critical in the initial phase to achieve adequate drug concentrations.
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Alternative Therapies

  • Moxifloxacin ophthalmic solution (e.g., Vigamox)
  • Gatifloxacin ophthalmic solution (e.g., Zymar, Zymaxid)
  • Levofloxacin ophthalmic solution (e.g., Quixin, Iquix)
  • Ofloxacin ophthalmic solution (e.g., Ocuflox)
  • Tobramycin ophthalmic solution (e.g., Tobrex)
  • Gentamicin ophthalmic solution
  • Polymyxin B/Trimethoprim ophthalmic solution (e.g., Polytrim)
  • Azithromycin ophthalmic solution (e.g., Azasite)
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Cost & Coverage

Average Cost: $15 - $50 per 10ml 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 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 for more information. If you have any questions or concerns about this 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 details about the medication, including the amount taken and the time it happened, to ensure you receive the best possible care.