Bacitracin Ophth Ointment 3.5gm

Manufacturer PERRIGO Active Ingredient Bacitracin (Ophthalmic)(bas i TRAY sin) Pronunciation bas i TRAY sin
It is used to treat eye infections.
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Drug Class
Ophthalmic Anti-infective
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Pharmacologic Class
Polypeptide Antibiotic
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Pregnancy Category
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?

Bacitracin ophthalmic ointment is an antibiotic medicine used to treat bacterial infections of the eye, such as pink eye (conjunctivitis) or eyelid infections. It works by stopping the growth of bacteria.
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How to Use This Medicine

Taking Your Medication Correctly

To use this medication safely and effectively, follow your doctor's instructions carefully. Read all the information provided to you and follow the instructions precisely. Continue using the medication as directed, even if your symptoms improve.

Administration

This medication is for ophthalmic use only.
Wash your hands thoroughly before and after using the medication.
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.
Gently pull down your lower eyelid and administer the prescribed amount of medication.
Release your lower eyelid and keep your eyes closed for 1 to 2 minutes.

Storage and Disposal

Store the medication at room temperature in a dry place, avoiding bathrooms.
Keep all medications in a secure location, out of the reach of children and pets.
Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so. Consult your pharmacist for guidance on the best disposal method. You may also want to explore drug take-back programs in your area.

Missing a Dose

If you miss a dose, take it as soon as you remember.
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 the same time or use extra doses to make up for a missed dose.
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Lifestyle & Tips

  • Wash hands thoroughly before and after applying the ointment.
  • Do not touch the tip of the ointment tube to the eye or any other surface to avoid contamination.
  • Do not share the ointment with others.
  • Remove contact lenses before applying the ointment and wait at least 15 minutes before reinserting them (unless advised otherwise by your doctor).
  • Complete the full course of treatment, even if symptoms improve, to prevent recurrence and antibiotic resistance.

Dosing & Administration

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Adult Dosing

Standard Dose: Apply a small amount (approximately 1/2 inch ribbon) into the conjunctival sac 1 to 3 times daily.
Dose Range: 1 - 3 mg

Condition-Specific Dosing:

bacterial_conjunctivitis: Apply 1 to 3 times daily for 7-10 days or as directed by physician.
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Pediatric Dosing

Neonatal: Not established (use with caution, consult pediatrician)
Infant: Apply a small amount into the conjunctival sac 1 to 3 times daily, similar to adult dosing, under medical supervision.
Child: Apply a small amount into the conjunctival sac 1 to 3 times daily, similar to adult dosing.
Adolescent: Apply a small amount into the conjunctival sac 1 to 3 times daily, 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

Bacitracin inhibits bacterial cell wall synthesis by interfering with the dephosphorylation of the lipid carrier molecule, undecaprenyl pyrophosphate, which is involved in the transport of peptidoglycan precursors across the bacterial cell membrane. This leads to the accumulation of cell wall precursors and ultimately cell lysis.
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Pharmacokinetics

Absorption:

Bioavailability: Negligible systemic absorption from ophthalmic application
Tmax: Not applicable (local action)
FoodEffect: Not applicable

Distribution:

Vd: Not applicable (localized to ocular surface)
ProteinBinding: Not applicable (localized to ocular surface)
CnssPenetration: No

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 local antibacterial effect
PeakEffect: Local, within hours of application
DurationOfAction: Several hours (requires multiple daily applications)

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, including:
+ 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

Other Possible Side Effects

Like all medications, this drug can cause side effects. However, many people do not experience any side effects or only have mild ones. If you have side effects that bother you or do not go away, contact your doctor for advice.

Reporting Side Effects

This list does not include all possible side effects. If you have questions or concerns about side effects, discuss them with your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch. Your doctor can provide medical advice on managing side effects.
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Seek Immediate Medical Attention If You Experience:

  • Worsening eye redness, pain, or discharge
  • New or increased swelling around the eye
  • Significant blurred vision that does not clear
  • Signs of an allergic reaction (e.g., rash, severe itching, swelling of the face/tongue/throat, severe dizziness, trouble breathing)
  • No improvement in symptoms after 2-3 days of use
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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 any allergies you have, including allergies to this medication, any of its components, or other substances, such as foods or drugs. Describe the allergic reaction you experienced, including any symptoms that occurred.

This medication may interact with other medications or health conditions. To ensure safe use, disclose all your medications (prescription, over-the-counter, natural products, and vitamins) and health problems to your doctor and pharmacist. Carefully review your medications and health conditions to confirm it is safe to take this medication. Never start, stop, or adjust the dosage of any medication without first consulting your doctor.
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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 when driving or performing tasks that require clear vision to ensure your safety. Do not exceed the prescribed duration of use, as this may increase the risk of a secondary infection. If you are pregnant, planning to become pregnant, or are breastfeeding, consult your doctor 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 application.

What to Do:

If excessive local irritation occurs, discontinue use and rinse eye with sterile water. For systemic ingestion (unlikely), contact a poison control center (1-800-222-1222) or seek emergency medical attention.

Drug Interactions

Monitoring

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Baseline Monitoring

Ocular examination (redness, discharge, swelling)

Rationale: To assess the severity and type of infection

Timing: Prior to initiation of therapy

Visual acuity

Rationale: To establish baseline and monitor for changes

Timing: Prior to initiation of therapy

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Routine Monitoring

Resolution of infection signs/symptoms

Frequency: Daily

Target: Improvement or resolution

Action Threshold: Lack of improvement or worsening symptoms after 2-3 days, consider re-evaluation and alternative therapy.

Adverse ocular reactions (e.g., irritation, itching, swelling)

Frequency: Daily

Target: Absence or mild, transient

Action Threshold: Persistent or severe irritation, discontinue use and consult physician.

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Symptom Monitoring

  • Decreased redness of the eye
  • Reduction in ocular discharge
  • Decreased itching or irritation
  • Improved comfort
  • Absence of new or worsening pain
  • No changes in vision (e.g., increased blurring)

Special Patient Groups

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Pregnancy

Bacitracin ophthalmic is generally considered low risk during pregnancy due to minimal systemic absorption. Use only if clearly needed and potential benefits outweigh potential risks.

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

Considered compatible with breastfeeding due to minimal systemic absorption by the mother and negligible exposure to the infant.

Infant Risk: Low risk
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Pediatric Use

Commonly used in pediatric patients for bacterial eye infections. Dosing is similar to adults. Safety and efficacy are generally established. Neonatal use should be under strict medical supervision.

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Geriatric Use

No specific dose adjustments are necessary for geriatric patients. Use with caution in patients with pre-existing ocular conditions or sensitivities.

Clinical Information

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Clinical Pearls

  • Bacitracin ophthalmic ointment is effective against many Gram-positive bacteria, including Staphylococcus aureus and Streptococcus species, which are common causes of bacterial conjunctivitis.
  • Ointments may cause temporary blurred vision; advise patients to apply at bedtime if possible or be cautious with activities requiring clear vision.
  • Ensure proper administration technique: pull down the lower eyelid, apply a thin ribbon into the conjunctival sac, and close the eye gently for a few seconds.
  • This product is for bacterial infections only; it is not effective against viral or fungal eye infections.
  • Patients should be advised to discard the tube after the treatment course is completed or within one month of opening to prevent contamination.
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Alternative Therapies

  • Erythromycin ophthalmic ointment
  • Tobramycin ophthalmic solution/ointment
  • Gentamicin ophthalmic solution/ointment
  • Fluoroquinolone ophthalmic solutions (e.g., Moxifloxacin, Gatifloxacin, Ciprofloxacin, Ofloxacin)
  • Sulfacetamide ophthalmic solution/ointment
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Cost & Coverage

Average Cost: $10 - $30 per 3.5gm tube
Generic Available: Yes
Insurance Coverage: Tier 1 (Generic)
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General Drug Facts

If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe and effective treatment, 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 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 emergency medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it occurred.