Neo/poly/dex Ophth Susp 5ml

Manufacturer BAUSCH HEALTH Active Ingredient Neomycin, Polymyxin B, and Dexamethasone Eye Drops(nee oh MYE sin, pol i MIKS in bee, & deks a METH a sone) Pronunciation nee oh MYE sin, pol i MIKS in bee, & deks a METH a sone
It is used to treat or prevent eye infections.
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Drug Class
Ophthalmic Anti-infective and Anti-inflammatory
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Pharmacologic Class
Aminoglycoside Antibiotic, Polypeptide Antibiotic, Corticosteroid
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Pregnancy Category
C
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FDA Approved
Jan 1970
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

This eye drop is a combination medicine that contains two antibiotics (neomycin and polymyxin B) to treat bacterial eye infections and a steroid (dexamethasone) to reduce inflammation, redness, and discomfort in the eye. It helps to clear up the infection and soothe your eye.
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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 accompanying information carefully. Use the medication as directed, even if your symptoms improve.

Administration Instructions

1. Use this medication for the eye only.
2. Wash your hands before and after use to maintain cleanliness.
3. Avoid touching the container tip to your eye, eyelid, or surrounding skin, as this can introduce bacteria into the medication, potentially leading to severe eye problems or vision loss.
4. Do not wear contact lenses while using this medication.
5. Shake the container well before each use.
6. Tilt your head back and gently drop the medication into your eye.
7. 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 this medication at room temperature, in a secure location that is inaccessible to children and pets. Dispose of unused or expired medication according to the following guidelines:
- Do not flush medication down the toilet or pour it down the drain unless instructed to do so.
- Consult your pharmacist for guidance on proper disposal methods.
- Check if there are drug take-back programs available 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 once or use extra doses to compensate for a missed dose.
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Lifestyle & Tips

  • Shake the bottle well before each use.
  • Wash your hands thoroughly before and after applying the eye drops.
  • Do not touch the dropper tip to your eye or any other surface to prevent contamination.
  • Remove contact lenses before applying the drops and wait at least 15 minutes before reinserting them (or avoid wearing them during treatment if advised by your doctor).
  • Do not share your eye drops with anyone else.
  • Store at room temperature, away from light and moisture.
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Available Forms & Alternatives

Dosing & Administration

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Adult Dosing

Standard Dose: 1 to 2 drops into the conjunctival sac every 3 to 4 hours initially, then tapered as inflammation subsides.
Dose Range: 1 - 2 mg

Condition-Specific Dosing:

severe_inflammation: 1 to 2 drops every hour, tapering to less frequent administration as inflammation subsides.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established (generally not recommended for infants due to risk of systemic absorption and specific eye conditions)
Child: Generally similar to adult dosing for children 2 years and older, under ophthalmologist supervision.
Adolescent: Similar to adult dosing.
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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 (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

Neomycin: An aminoglycoside antibiotic that inhibits bacterial protein synthesis by binding to the 30S ribosomal subunit. Polymyxin B: A polypeptide antibiotic that disrupts the bacterial cell membrane, leading to leakage of intracellular components. Dexamethasone: A potent synthetic corticosteroid that suppresses inflammation by inhibiting phospholipase A2, thereby reducing the synthesis of prostaglandins and leukotrienes. It also stabilizes lysosomal membranes and reduces capillary permeability and leukocyte migration.
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Pharmacokinetics

Absorption:

Bioavailability: <1% (systemic from ophthalmic route)
Tmax: Not clinically relevant for ophthalmic use
FoodEffect: Not applicable for ophthalmic use

Distribution:

Vd: Not clinically relevant for ophthalmic use
ProteinBinding: Not clinically relevant for ophthalmic use
CnssPenetration: Limited (not clinically relevant for ophthalmic use)

Elimination:

HalfLife: Not clinically relevant for ophthalmic use
Clearance: Not clinically relevant for ophthalmic use
ExcretionRoute: Not clinically relevant for ophthalmic use
Unchanged: Not clinically relevant for ophthalmic use
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Pharmacodynamics

OnsetOfAction: Rapid anti-inflammatory effect (within hours); antibacterial effect within hours to days.
PeakEffect: Within hours
DurationOfAction: Several hours per dose (requires frequent dosing)

Safety & Warnings

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Side Effects

Urgent Side Effects: Seek Medical Help Right Away

While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. If you notice 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

Other Possible Side Effects

Like all medications, this drug can cause side effects. Although 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

Reporting Side Effects

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:

  • Increased eye pain or discomfort
  • Worsening redness or swelling of the eye/eyelid
  • Increased discharge or pus from the eye
  • New or worsening blurred vision
  • Sensitivity to light
  • Any signs of an allergic reaction (e.g., itching, rash, severe swelling of the eyelids)
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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 allergic reaction you experienced, including any symptoms that occurred.
Certain health conditions, including:
+ Fungal infections of the eye
+ Tuberculosis (TB) infections of the eye
+ Viral infections of the eye

This list is not exhaustive, and it is crucial to discuss all your health problems and medications with your doctor.

To ensure your safety, provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter (OTC) medications you are taking
Natural products and vitamins you are using
* Any health problems you have

Before starting, stopping, or changing the dose of any medication, including this one, consult with your doctor to confirm it is safe for you to do so.
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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.

After administering this drug to your eye, you may experience blurred vision. To ensure your safety, avoid driving and other activities that require clear vision until your vision clears.

Do not use this medication for an extended period beyond the duration prescribed by your doctor. Prolonged use may increase the risk of developing cataracts or glaucoma. Discuss this potential risk with your doctor.

If you are using this medication long-term, it is crucial to have your eye pressure checked regularly. Consult with your doctor to schedule these check-ups.

If you are pregnant, planning to become pregnant, or are breastfeeding, inform your doctor. You and your doctor will need to discuss the potential 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 may occur with excessive use.

What to Do:

If swallowed, drink fluids. If excessive topical application causes irritation, rinse eye with lukewarm water. Contact a poison control center (1-800-222-1222) or seek medical attention if symptoms are severe or concerning.

Drug Interactions

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Contraindicated Interactions

  • Epithelial herpes simplex keratitis (dendritic keratitis)
  • Vaccinia
  • Varicella
  • Many other viral diseases of the cornea and conjunctiva
  • Mycobacterial infection of the eye
  • Fungal diseases of ocular structures
  • Uncomplicated purulent ocular infections (steroids can mask or enhance infection)
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Minor Interactions

  • Other topical ophthalmic agents (administer at least 5 minutes apart to avoid washout)

Monitoring

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Baseline Monitoring

Ocular examination (visual acuity, slit lamp)

Rationale: To assess baseline ocular health and severity of infection/inflammation.

Timing: Prior to initiation of therapy

Intraocular Pressure (IOP)

Rationale: To establish baseline, especially if prolonged use (>10 days) is anticipated due to risk of steroid-induced glaucoma.

Timing: Prior to initiation of therapy (if prolonged use)

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Routine Monitoring

Ocular examination (visual acuity, slit lamp)

Frequency: Regularly, as clinically indicated (e.g., daily to weekly depending on severity)

Target: Improvement in signs and symptoms of infection/inflammation

Action Threshold: Worsening symptoms, signs of secondary infection, or lack of improvement after appropriate duration

Intraocular Pressure (IOP)

Frequency: Weekly or bi-weekly for prolonged use (>10 days)

Target: Normal range (typically 10-21 mmHg)

Action Threshold: Sustained elevation above normal range; consider discontinuation or switch to non-steroid therapy

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Symptom Monitoring

  • Increased eye pain
  • Worsening redness
  • Increased swelling of the eyelid or eye
  • Increased discharge from the eye
  • New or worsening sensitivity to light (photophobia)
  • Changes in vision (e.g., blurred vision, halos around lights)

Special Patient Groups

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Pregnancy

Pregnancy Category C. Use only if the potential benefit justifies the potential risk to the fetus. While systemic absorption from ophthalmic use is minimal, corticosteroids have been shown to be teratogenic in animal studies when administered systemically at relatively low doses.

Trimester-Specific Risks:

First Trimester: Potential for teratogenicity, though risk is low with minimal systemic absorption.
Second Trimester: Risk considered low due to minimal systemic absorption.
Third Trimester: Risk considered low due to minimal systemic absorption.
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Lactation

Dexamethasone is excreted in breast milk following systemic administration. However, due to minimal systemic absorption from ophthalmic use, infant exposure is expected to be negligible. Use with caution and weigh potential benefits against risks.

Infant Risk: Low risk of adverse effects to the infant due to minimal systemic absorption.
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Pediatric Use

Safety and efficacy generally established for children 2 years of age and older. Dosing is typically similar to adults. Caution is advised in infants and young children due to potential for greater systemic absorption and specific ocular conditions.

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Geriatric Use

No specific dosage adjustments are needed for geriatric patients. The safety and efficacy profile is similar to that in younger adults.

Clinical Information

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Clinical Pearls

  • Shake the suspension well before each use to ensure uniform distribution of ingredients.
  • This medication is for ophthalmic use only; do not inject or ingest.
  • Prolonged use (typically beyond 10 days) of corticosteroid-containing eye drops can lead to increased intraocular pressure (IOP) and potentially glaucoma, as well as posterior subcapsular cataracts. Regular IOP monitoring is crucial for long-term therapy.
  • The steroid component can mask signs of infection or enhance existing fungal or viral infections. Do not use if a viral (e.g., herpes simplex) or fungal eye infection is suspected.
  • Hypersensitivity reactions (e.g., itching, redness, swelling of the eyelid) to the neomycin component are common. Discontinue use if these occur.
  • Risk of secondary ocular infections (fungal, viral) is increased with prolonged use of corticosteroids.
  • If improvement is not seen after 7-10 days, re-evaluate the diagnosis and treatment plan.
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Alternative Therapies

  • Topical ophthalmic antibiotics (e.g., Moxifloxacin, Gatifloxacin, Azithromycin) for bacterial infections alone.
  • Topical ophthalmic corticosteroids (e.g., Prednisolone acetate, Loteprednol etabonate, Fluorometholone) for inflammation alone.
  • Non-steroidal anti-inflammatory drugs (NSAIDs) for ocular inflammation (e.g., Ketorolac, Bromfenac).
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Cost & Coverage

Average Cost: $15 - $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'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 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 details about the medication taken, the amount, and the time it happened.