Neo/poly/dex 0.1% Opth Oint 3.5gm
It is used to treat or prevent eye infections.
Drug Class
Ophthalmic Anti-infective and Anti-inflammatory
Pharmacologic Class
Aminoglycoside Antibiotic, Polypeptide Antibiotic, Corticosteroid
Pregnancy Category
Category C
FDA Approved
Jan 1970
DEA Schedule
Not Controlled
Overview
What is this medicine?
This eye ointment contains two antibiotics (neomycin and polymyxin B) to fight bacterial infections and a steroid (dexamethasone) to reduce swelling, redness, and irritation in the eye. It's used to treat eye infections that also have inflammation.
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. 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 prevent contamination.
3. Avoid touching the container tip to your eye, lid, or other 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. To administer the medication, tilt your head back and gently pull down your lower eyelid.
6. Squeeze in the amount of medication prescribed by your doctor.
7. Look down before closing your eye.
8. Release the lower eyelid and keep your eyes closed for 1 to 2 minutes.
Storage and Disposal
Store this medication at room temperature, keeping it in a safe place out of the reach of children and pets. Dispose of unused or expired medication properly. Do not flush it down the toilet or pour it down the drain unless instructed to do so. If you have questions about disposal, consult your pharmacist, who may be aware of drug take-back programs 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 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. 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 prevent contamination.
3. Avoid touching the container tip to your eye, lid, or other 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. To administer the medication, tilt your head back and gently pull down your lower eyelid.
6. Squeeze in the amount of medication prescribed by your doctor.
7. Look down before closing your eye.
8. Release the lower eyelid and keep your eyes closed for 1 to 2 minutes.
Storage and Disposal
Store this medication at room temperature, keeping it in a safe place out of the reach of children and pets. Dispose of unused or expired medication properly. Do not flush it down the toilet or pour it down the drain unless instructed to do so. If you have questions about disposal, consult your pharmacist, who may be aware of drug take-back programs 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 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
- Wash hands thoroughly before and after applying the ointment.
- Do not touch the tip of the ointment tube to your eye, eyelid, or any other surface to avoid contamination.
- Pull down your lower eyelid to create a small pocket, apply a small ribbon of ointment into the pocket, and then close your eye gently for 1-2 minutes.
- Do not wear contact lenses during treatment, especially if you have an eye infection. If you must wear them, remove them before applying the ointment and wait at least 15 minutes before reinserting them.
- Avoid sharing eye medications with others.
- Store at room temperature, away from moisture and heat.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
Apply a small amount (approximately 1/2 inch ribbon) into the conjunctival sac 3 to 4 times daily.
Dose Range:
3 - 4 mg
Condition-Specific Dosing:
severe_infection:
May apply more frequently initially, then reduce as infection improves.
Pediatric Dosing
Neonatal:
Not established (use with extreme caution, if at all, due to potential for systemic absorption in neonates and specific ophthalmic conditions)
Infant:
Not established (use with caution, consult ophthalmologist)
Child:
Apply a small amount (approximately 1/2 inch ribbon) into the conjunctival sac 3 to 4 times daily, similar to adults, but use with caution and under medical supervision.
Adolescent:
Apply a small amount (approximately 1/2 inch ribbon) into the conjunctival sac 3 to 4 times daily, similar to adults.
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed (minimal systemic absorption from ophthalmic use)
Moderate:
No adjustment needed (minimal systemic absorption from ophthalmic use)
Severe:
No adjustment needed (minimal systemic absorption from ophthalmic use)
Dialysis:
No adjustment needed (minimal systemic absorption from ophthalmic use)
Hepatic Impairment:
Mild:
No adjustment needed (minimal systemic absorption from ophthalmic use)
Moderate:
No adjustment needed (minimal systemic absorption from ophthalmic use)
Severe:
No adjustment needed (minimal systemic absorption from ophthalmic use)
Pharmacology
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 contents. Dexamethasone: A potent synthetic corticosteroid that suppresses inflammation by inhibiting the release of inflammatory mediators (e.g., prostaglandins, leukotrienes) and reducing capillary permeability and leukocyte migration.
Pharmacokinetics
Absorption:
Bioavailability:
Minimal systemic absorption (less than 1%) from topical ophthalmic administration.
Tmax:
Not applicable systemically for topical ophthalmic use.
FoodEffect:
Not applicable for topical ophthalmic use.
Distribution:
Vd:
Not clinically relevant for topical ophthalmic use.
ProteinBinding:
Not clinically relevant for topical ophthalmic use.
CnssPenetration:
Limited (not clinically relevant for topical ophthalmic use).
Elimination:
HalfLife:
Not clinically relevant for topical ophthalmic use.
Clearance:
Not clinically relevant for topical ophthalmic use.
ExcretionRoute:
Not clinically relevant for topical ophthalmic use.
Unchanged:
Not clinically relevant for topical ophthalmic use.
Pharmacodynamics
OnsetOfAction:
Anti-inflammatory effects (dexamethasone) may be observed within hours; full antibiotic effect (neomycin, polymyxin B) may take 24-48 hours.
PeakEffect:
Not precisely defined for topical ophthalmic use.
DurationOfAction:
Depends on frequency of application; typically 6-8 hours per application.
Safety & Warnings
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
Important Note
This list is not exhaustive, and you may experience other side effects not mentioned here. If you have questions or concerns about side effects, don't hesitate to reach out to your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
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
Important Note
This list is not exhaustive, and you may experience other side effects not mentioned here. If you have questions or concerns about side effects, don't hesitate to reach out to your doctor. You can also 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 pain, redness, or swelling
- Increased discharge from the eye
- New or worsening blurred vision
- Sensitivity to light
- Signs of a new infection (e.g., fungal infection, which may appear as white spots on the cornea)
- Any signs of allergic reaction (e.g., rash, severe itching, swelling of face/tongue/throat, severe dizziness, trouble breathing)
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 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 with your doctor.
Additionally, provide your doctor and pharmacist with a comprehensive list of all the medications you are taking, including:
Prescription medications
Over-the-counter (OTC) medications
Natural products
Vitamins
It is vital to verify that it is safe to take this medication with all your other medications and health conditions. Never start, stop, or change the dosage of any medication without first consulting your doctor.
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 with your doctor.
Additionally, provide your doctor and pharmacist with a comprehensive list of all the medications you are taking, including:
Prescription medications
Over-the-counter (OTC) medications
Natural products
Vitamins
It is vital to verify that it is safe to take this medication with all your other medications and health conditions. Never start, stop, or change the dosage of any medication without first consulting your doctor.
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. It is crucial to discuss this with your doctor to understand the potential risks.
If you are using this medication long-term, it is recommended that you have your eye pressure checked regularly. Consult with your doctor to schedule these checks and discuss any concerns.
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.
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. It is crucial to discuss this with your doctor to understand the potential risks.
If you are using this medication long-term, it is recommended that you have your eye pressure checked regularly. Consult with your doctor to schedule these checks and discuss any concerns.
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.
Overdose Information
Overdose Symptoms:
- Unlikely with topical ophthalmic use due to minimal systemic absorption. Local irritation or increased adverse effects (e.g., elevated IOP) might occur with excessive use.
What to Do:
If excessive amount is applied, wipe away excess. If swallowed, call a poison control center (1-800-222-1222) or seek medical attention, though systemic toxicity from accidental ingestion is unlikely due to poor absorption.
Drug Interactions
Contraindicated Interactions
- Epithelial herpes simplex keratitis (dendritic keratitis)
- Vaccinia, varicella, and most other viral diseases of the cornea and conjunctiva
- Mycobacterial infection of the eye
- Fungal diseases of ocular structures
- Hypersensitivity to any component of the medication (neomycin, polymyxin B, dexamethasone, or excipients)
Moderate Interactions
- Other topical ophthalmic medications: If multiple ophthalmic medications are used, administer them at least 5 minutes apart to prevent washout.
Monitoring
Baseline Monitoring
Ocular examination (visual acuity, slit lamp exam)
Rationale: To assess baseline ocular health and identify specific infection/inflammation.
Timing: Prior to initiation of therapy.
Intraocular pressure (IOP)
Rationale: To establish baseline, especially if prolonged corticosteroid use is anticipated, due to risk of steroid-induced glaucoma.
Timing: Prior to initiation of therapy.
Ocular culture and sensitivity (if indicated)
Rationale: To identify causative organism and guide appropriate antibiotic therapy, especially in severe or non-responsive cases.
Timing: Prior to initiation of therapy, if clinically warranted.
Routine Monitoring
Intraocular pressure (IOP)
Frequency: Periodically, especially with prolonged use (e.g., >10 days) or in patients predisposed to glaucoma.
Target: Normal range (typically 10-21 mmHg)
Action Threshold: Significant elevation above baseline or normal range; consider discontinuing or reducing steroid, or adding IOP-lowering medication.
Signs and symptoms of infection/inflammation
Frequency: Daily by patient, periodically by clinician.
Target: Resolution of redness, discharge, pain, swelling.
Action Threshold: Worsening symptoms, new symptoms, or lack of improvement after several days; consider re-evaluation, culture, or alternative therapy.
Corneal integrity (slit lamp exam)
Frequency: Periodically, especially with prolonged use.
Target: Intact cornea, no ulceration or thinning.
Action Threshold: Development of corneal thinning, ulceration, or perforation; discontinue use immediately.
Symptom Monitoring
- Eye pain or discomfort
- Redness or irritation of the eye
- Blurred vision or other visual disturbances
- Increased sensitivity to light (photophobia)
- Eye discharge (pus or excessive tearing)
- Itching or burning sensation in the eye
- Swelling of eyelids or around the eye
Special Patient Groups
Pregnancy
Category C. Use only if the potential benefit justifies the potential risk to the fetus. Animal studies have shown adverse effects with corticosteroids, and systemic absorption of neomycin/polymyxin B is minimal but not zero. Consult with a healthcare provider.
Trimester-Specific Risks:
First Trimester:
Potential for teratogenicity with systemic corticosteroids, though risk from topical ophthalmic is very low due to minimal absorption.
Second Trimester:
Minimal risk from topical ophthalmic use.
Third Trimester:
Minimal risk from topical ophthalmic use; however, prolonged or repeated corticosteroid use near term could theoretically affect fetal adrenal function.
Lactation
L3 (Moderately Safe). Dexamethasone is excreted in breast milk in small amounts, but systemic absorption from ophthalmic use is minimal, making infant exposure low. Neomycin and Polymyxin B are poorly absorbed orally by the infant. Use with caution; monitor infant for potential adverse effects (e.g., diarrhea, candidiasis).
Infant Risk:
Low risk of adverse effects to the infant due to minimal systemic absorption by the mother and poor oral absorption by the infant.
Pediatric Use
Use with caution, especially in infants and young children. Prolonged use of corticosteroids in pediatric patients may increase the risk of elevated IOP and cataract formation. Safety and efficacy in neonates and infants have not been fully established. Close monitoring by an ophthalmologist is recommended.
Geriatric Use
No specific dosage adjustments are typically required. Elderly patients may be more susceptible to steroid-induced IOP elevation or cataract formation, so regular monitoring is important.
Clinical Information
Clinical Pearls
- This combination is effective for bacterial conjunctivitis or blepharitis when inflammation is also present. It is not for viral or fungal infections.
- Prolonged use (typically >10 days) of the corticosteroid component (dexamethasone) can lead to increased intraocular pressure (IOP) and potentially glaucoma, as well as posterior subcapsular cataracts. Regular IOP monitoring is crucial.
- Superinfection with non-susceptible organisms, including fungi, can occur with prolonged antibiotic/corticosteroid use. If symptoms worsen or new symptoms appear, re-evaluate the patient.
- Neomycin can cause hypersensitivity reactions (e.g., itching, redness, swelling of the eyelid) in some patients. Discontinue if such reactions occur.
- Ophthalmic ointments can cause temporary blurred vision after application; advise patients not to drive or operate machinery until vision clears.
Alternative Therapies
- Topical ophthalmic antibiotics alone (e.g., Moxifloxacin, Gatifloxacin, Azithromycin, Erythromycin) for bacterial infections without significant inflammation.
- Topical ophthalmic corticosteroids alone (e.g., Prednisolone, Dexamethasone) for inflammatory conditions without infection.
- Oral antibiotics for severe or systemic infections affecting the eye.
Cost & Coverage
Average Cost:
$15 - $40 per 3.5gm tube
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 (for generic versions)
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 it's a good idea to check with your pharmacist. 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 information about the medication taken, the amount, and the time it happened.