Bacitracin Zinc Topical Oint 28.4gm

Manufacturer TARO Active Ingredient Bacitracin (Topical)(bas i TRAY sin) Pronunciation bas i TRAY sin
It is used to avoid or treat skin infections.
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Drug Class
Topical Antibiotic
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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 zinc topical ointment is an antibiotic medicine applied to the skin to help prevent minor skin infections from small cuts, scrapes, or burns. It works by stopping the growth of certain bacteria.
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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.

Application Instructions

This medication is for topical use only, meaning it should be applied directly to the affected area of your skin. Avoid getting the medication in your mouth, nose, or eyes, as it may cause irritation or burning.

Before applying the medication, wash your hands thoroughly. If the affected area is on your hand, you do not need to wash that hand after application. Clean the affected area before use and make sure it is completely dry. Then, apply a thin layer of the medication to the affected area and gently rub it in. You may cover the area with a bandage or dressing if needed.

Storage and Disposal

To maintain the medication's effectiveness, store it at room temperature in a dry location, avoiding bathrooms and areas exposed to heat. Keep all medications in a secure place, out of the reach of children and pets.

Missed Dose Instructions

If you miss a dose, apply 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 application schedule. Do not apply two doses at the same time or use extra doses to make up for a missed dose.
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Lifestyle & Tips

  • Clean the affected area thoroughly before applying the ointment.
  • Apply a small amount of ointment (about the size of a fingertip) to the area.
  • You may cover the treated area with a sterile bandage if desired.
  • Wash your hands before and after applying the ointment.
  • Avoid getting the ointment in your eyes, nose, or mouth. If it gets into your eyes, rinse thoroughly with water.
  • Do not use on deep wounds, animal bites, or serious burns without consulting a doctor.

Dosing & Administration

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Adult Dosing

Standard Dose: Apply a thin layer to the affected area 1 to 3 times daily.

Condition-Specific Dosing:

minor_cuts_scrapes_burns: Apply a thin layer to the affected area 1 to 3 times daily after cleaning the wound.
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Pediatric Dosing

Neonatal: Not established (consult pediatrician)
Infant: Apply a thin layer to the affected area 1 to 3 times daily (consult pediatrician)
Child: Apply a thin layer to the affected area 1 to 3 times daily
Adolescent: Apply a thin layer to the affected area 1 to 3 times daily
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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 is a polypeptide antibiotic that inhibits bacterial cell wall synthesis by interfering with the dephosphorylation of the lipid carrier molecule, undecaprenyl pyrophosphate. This prevents the regeneration of the lipid carrier, which is essential for the transport of peptidoglycan precursors across the bacterial cell membrane.
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Pharmacokinetics

Absorption:

Bioavailability: Minimal systemic absorption from intact skin
Tmax: Not applicable (minimal systemic absorption)
FoodEffect: Not applicable (topical administration)

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: Within hours to days (clinical effect)
PeakEffect: Not precisely defined for topical use
DurationOfAction: Depends on application frequency (typically 8-24 hours per application)

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

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, 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.
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Seek Immediate Medical Attention If You Experience:

  • Signs of worsening infection (increased redness, swelling, pain, pus)
  • No improvement in the wound after 7 days of use
  • Signs of an allergic reaction (rash, itching, hives, severe burning, stinging, or irritation at the application site)
  • Fever or chills (may indicate a spreading infection)
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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 symptoms you experienced as a result of the allergy.
If a large area of your body needs to be treated with this medication.

Additionally, this medication may interact with other medications or health conditions. To ensure your safety, it is crucial to:

Inform your doctor and pharmacist about all the medications you are taking, including prescription and over-the-counter drugs, natural products, and vitamins.
Disclose any health problems you have, as they may affect the safety of taking this medication.
Verify that it is safe to take this medication with all your other medications and health conditions before starting treatment.
Do not start, stop, or change the dose 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. Adhere to the prescribed duration of use, as prolonged use beyond the recommended period may increase the risk of a second infection.

In case of accidental ingestion, this medication can be harmful. If swallowed, immediately contact a doctor or a poison control center for assistance.

If you are pregnant, planning to become pregnant, or are currently breast-feeding, notify your doctor. You and your doctor will need to discuss the potential benefits and risks of using this medication to ensure the best outcome for both you and your baby.
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Overdose Information

Overdose Symptoms:

  • Unlikely with topical use due to minimal systemic absorption. Ingesting large amounts could potentially cause stomach upset.

What to Do:

If ingested, seek medical attention. For topical overdose, simply wipe off excess. For any concerning symptoms, call Poison Control at 1-800-222-1222.

Drug Interactions

Monitoring

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Routine Monitoring

Signs of infection improvement (e.g., decreased redness, swelling, pus)

Frequency: Daily

Target: Resolution of symptoms

Action Threshold: Worsening symptoms or no improvement after 7 days

Signs of allergic reaction (e.g., rash, itching, swelling, hives)

Frequency: Daily

Target: Absence of allergic symptoms

Action Threshold: Appearance of new or worsening skin irritation

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Symptom Monitoring

  • Redness
  • Swelling
  • Pain
  • Pus or discharge
  • Fever (if infection spreads)
  • Rash
  • Itching
  • Hives

Special Patient Groups

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Pregnancy

Generally considered safe for topical use during pregnancy due to minimal systemic absorption. However, use only if clearly needed and after consulting a healthcare provider.

Trimester-Specific Risks:

First Trimester: Low risk (minimal systemic absorption)
Second Trimester: Low risk (minimal systemic absorption)
Third Trimester: Low risk (minimal systemic absorption)
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Lactation

Considered safe for use during breastfeeding. Minimal systemic absorption means negligible amounts are expected to pass into breast milk. Avoid applying to the breast area to prevent infant ingestion.

Infant Risk: Low risk
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Pediatric Use

Generally safe for use in children for minor cuts and scrapes. For infants, consult a pediatrician. Avoid prolonged use or application over large areas.

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Geriatric Use

No specific dose adjustments or precautions are generally needed for elderly patients, as systemic absorption is minimal.

Clinical Information

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Clinical Pearls

  • Bacitracin is effective against many Gram-positive bacteria, including Staphylococcus aureus and Streptococcus pyogenes, which are common causes of skin infections.
  • While generally well-tolerated, bacitracin is known to cause allergic contact dermatitis in a small percentage of individuals. If a rash or increased irritation occurs, discontinue use.
  • Often combined with other antibiotics (e.g., neomycin, polymyxin B) in OTC products for broader spectrum coverage.
  • Not intended for deep or puncture wounds, animal bites, or serious burns; these require medical evaluation.
  • Regular cleaning of the wound before application is crucial for efficacy.
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Alternative Therapies

  • Mupirocin (prescription topical antibiotic for impetigo and other skin infections)
  • Topical antiseptics (e.g., povidone-iodine, chlorhexidine, hydrogen peroxide - for cleaning, not typically for leaving on the wound)
  • Silver sulfadiazine (for burns)
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Cost & Coverage

Average Cost: $5 - $15 per 28.4gm tube
Generic Available: Yes
Insurance Coverage: Generally not covered by insurance as it is an over-the-counter (OTC) product, unless specifically prescribed and covered by certain plans.
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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. 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 detailed information about the overdose, including the medication taken, the amount, and the time it occurred.