Bacitracin/polymyx Ophthoint 3.5gm
It is used to treat eye infections.
Drug Class
Ophthalmic Antibiotic
Pharmacologic Class
Polypeptide Antibiotic (Bacitracin), Cyclic Polypeptide Antibiotic (Polymyxin B)
Pregnancy Category
Category C
FDA Approved
Jan 1970
DEA Schedule
Not Controlled
Overview
What is this medicine?
This medication is an antibiotic ointment used to treat bacterial eye infections. It contains two different antibiotics, bacitracin and polymyxin B, which work together to kill bacteria causing the infection.
How to Use This Medicine
Taking Your Medication Correctly
To use this medication safely and effectively, follow your doctor's instructions and the information provided with your prescription. Use the medication as directed, even if your symptoms improve.
Administration Instructions
1. For ophthalmic use only.
2. Wash your hands before and after applying the medication to prevent contamination.
3. Avoid touching the container tip to your eye, eyelid, or surrounding skin, as this can introduce bacteria into the medication and potentially cause severe eye problems or vision loss.
4. To apply the ointment:
Pull down the lower eyelid of the affected eye(s).
Place a thin film of ointment into the lower eye.
* Close your eye and gently roll your eyeball around for 1 to 2 minutes.
Storage and Disposal
Store the medication at room temperature, away from children and pets. Properly dispose of unused or expired medication. Do not flush it down the toilet or pour it down the drain unless instructed to do so by your pharmacist. If you have questions about disposal, consult your pharmacist, who can provide information about potential 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 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 to make up for a missed dose.
To use this medication safely and effectively, follow your doctor's instructions and the information provided with your prescription. Use the medication as directed, even if your symptoms improve.
Administration Instructions
1. For ophthalmic use only.
2. Wash your hands before and after applying the medication to prevent contamination.
3. Avoid touching the container tip to your eye, eyelid, or surrounding skin, as this can introduce bacteria into the medication and potentially cause severe eye problems or vision loss.
4. To apply the ointment:
Pull down the lower eyelid of the affected eye(s).
Place a thin film of ointment into the lower eye.
* Close your eye and gently roll your eyeball around for 1 to 2 minutes.
Storage and Disposal
Store the medication at room temperature, away from children and pets. Properly dispose of unused or expired medication. Do not flush it down the toilet or pour it down the drain unless instructed to do so by your pharmacist. If you have questions about disposal, consult your pharmacist, who can provide information about potential 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 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 to make up for a missed dose.
Lifestyle & Tips
- Wash hands thoroughly before and after applying the ointment.
- Do not touch the tip of the ointment tube to your eye or any other surface to prevent contamination.
- Do not share this medication with others.
- Remove contact lenses before applying the ointment and wait at least 15 minutes before reinserting them, or as advised by your doctor.
- Complete the full course of treatment, even if symptoms improve, to prevent recurrence and antibiotic resistance.
- Avoid rubbing your eyes.
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 a day.
Condition-Specific Dosing:
bacterial_conjunctivitis:
Apply 3-4 times daily for 7-10 days or as directed by physician.
Pediatric Dosing
Neonatal:
Apply a small amount (approximately 1/2 inch ribbon) into the conjunctival sac 3 to 4 times a day.
Infant:
Apply a small amount (approximately 1/2 inch ribbon) into the conjunctival sac 3 to 4 times a day.
Child:
Apply a small amount (approximately 1/2 inch ribbon) into the conjunctival sac 3 to 4 times a day.
Adolescent:
Apply a small amount (approximately 1/2 inch ribbon) into the conjunctival sac 3 to 4 times a day.
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 adjustment needed (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
Mechanism of Action
Bacitracin interferes with bacterial cell wall synthesis by inhibiting the dephosphorylation of the lipid carrier molecule, undecaprenyl pyrophosphate. Polymyxin B acts as a cationic detergent, disrupting the integrity of the bacterial cell membrane, leading to leakage of intracellular components and cell death. The combination provides broad-spectrum antibacterial activity against susceptible organisms.
Pharmacokinetics
Absorption:
Bioavailability:
Negligible systemic absorption from ophthalmic administration
Tmax:
Not applicable (local action)
FoodEffect:
Not applicable
Distribution:
Vd:
Not applicable (minimal systemic distribution)
ProteinBinding:
Not applicable (minimal systemic distribution)
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)
Pharmacodynamics
OnsetOfAction:
Rapid (local antibacterial effect)
PeakEffect:
Not precisely quantifiable (local effect)
DurationOfAction:
Several hours (local effect)
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Attention Immediately
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 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
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 does not include all possible side effects. If you have questions or concerns about side effects, consult your doctor. For medical advice about side effects, contact 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 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
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 does not include all possible side effects. If you have questions or concerns about side effects, consult your doctor. For medical advice about side effects, contact 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:
- Severe eye pain or discomfort
- Sudden vision changes
- Increased redness, swelling, or itching of the eye or eyelid (signs of allergic reaction)
- Pus or excessive discharge from the eye
- No improvement in symptoms after 3-4 days of use
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 drugs, 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 with all your other medications and health conditions.
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 drugs, 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 with all your other medications and health conditions.
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 when driving or performing tasks that require clear vision, as it may affect your eyesight. If you are using this medication for an extended period, consult with your doctor about scheduling a comprehensive eye exam to monitor your eye health. Do not exceed the recommended duration of use, as this may increase the risk of developing a secondary infection. If you are pregnant, planning to become pregnant, or breastfeeding, discuss the potential benefits and risks of this medication with your doctor to determine the best course of treatment for you and your baby.
Overdose Information
Overdose Symptoms:
- Unlikely with ophthalmic use due to minimal systemic absorption. Local irritation may occur with excessive application.
What to Do:
If excessive amount is applied, wipe away excess. If swallowed, contact a poison control center (Call 1-800-222-1222) or seek medical attention, though systemic toxicity from accidental ingestion is unlikely due to poor absorption.
Drug Interactions
Monitoring
Routine Monitoring
Clinical signs and symptoms of infection (e.g., redness, discharge, pain)
Frequency: Daily
Target: Improvement or resolution of symptoms
Action Threshold: Worsening symptoms, no improvement after 3-4 days, or signs of allergic reaction
Signs of local irritation or allergic reaction (e.g., itching, swelling, increased redness)
Frequency: Daily
Target: Absence of irritation
Action Threshold: Presence of irritation or allergic reaction
Symptom Monitoring
- Worsening eye redness
- Increased eye discharge
- Increased eye pain or discomfort
- Swelling around the eye
- Itching or rash around the eye
- Blurred vision (if new or worsening)
Special Patient Groups
Pregnancy
Use during pregnancy should be considered only if the potential benefit justifies the potential risk to the fetus. Systemic absorption from ophthalmic administration is minimal, reducing systemic exposure.
Trimester-Specific Risks:
First Trimester:
Low risk due to minimal systemic absorption, but caution advised.
Second Trimester:
Low risk due to minimal systemic absorption.
Third Trimester:
Low risk due to minimal systemic absorption.
Lactation
Considered low risk during breastfeeding due to minimal systemic absorption of the active ingredients. It is unlikely to be excreted in breast milk in clinically significant amounts.
Infant Risk:
Low risk
Pediatric Use
Generally considered safe and effective for use in pediatric patients, including neonates, for appropriate indications. Dosing is similar to adults.
Geriatric Use
No specific dosage adjustments are necessary for geriatric patients. The safety and efficacy profile is similar to that in younger adults.
Clinical Information
Clinical Pearls
- Ophthalmic ointments can cause temporary blurred vision; advise patients not to drive or operate machinery until vision clears.
- Ensure patients understand proper application technique to maximize efficacy and minimize contamination.
- This combination is effective against many common Gram-positive (Bacitracin) and Gram-negative (Polymyxin B) bacteria, making it a good empirical choice for many superficial eye infections.
- Advise patients to avoid wearing contact lenses during treatment for bacterial conjunctivitis.
- If symptoms do not improve within a few days, or worsen, re-evaluation by a healthcare professional is necessary to rule out resistant organisms or other causes.
Alternative Therapies
- Erythromycin Ophthalmic Ointment
- Tobramycin Ophthalmic Solution/Ointment
- Ciprofloxacin Ophthalmic Solution/Ointment
- Ofloxacin Ophthalmic Solution
- Moxifloxacin Ophthalmic Solution
Cost & Coverage
Average Cost:
$15 - $40 per 3.5gm tube
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 (Generic)
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 is a good idea to check with your pharmacist for more information. If you have any questions or concerns about your medication, do not 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 emergency medical attention. When seeking help, be prepared to provide details about the overdose, including the medication taken, the amount, and the time it occurred.