Bacitracin Zinc Topical Oint 28gm

Manufacturer RUGBY LABORATORIES 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 is an antibiotic ointment used on the skin to prevent or treat minor skin infections, such as cuts, scrapes, and burns. It works by stopping the growth of certain 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.

Applying the Medication

This medication is for topical use only, meaning it should be applied directly to the affected area of your skin. Do not take it by mouth. Avoid getting the medication in your mouth, nose, or eyes, as it may cause burning.

Before applying the medication, wash your hands thoroughly. If the affected area is on your hand, you do not need to wash your hand after applying the medication. Clean the affected area before applying the medication and make sure it is completely dry. 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.

Storing and Disposing of Your Medication

Store the medication at room temperature in a dry place, away from bathrooms and heat sources. Keep all medications in a safe and secure location, out of the reach of children and pets.

Missing a Dose

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 continue with your regular dosing 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.
  • Wash hands before and after applying the ointment.
  • Do not use on deep wounds, animal bites, or serious burns without consulting a doctor.
  • Avoid contact with eyes, nose, and mouth. If contact occurs, rinse thoroughly with water.
  • Do not use for more than 7 days unless directed by 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:

minorSkinInfections: Apply a thin layer to the affected area 1 to 3 times daily, typically for 7-10 days or until infection clears.
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Pediatric Dosing

Neonatal: Not established
Infant: Apply a thin layer to the affected area 1 to 3 times daily. Consult pediatrician for infants under 2 years.
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: Negligible (systemic from intact skin)
Tmax: Not applicable (topical)
FoodEffect: Not applicable (topical)

Distribution:

Vd: Not significant (topical)
ProteinBinding: Not significant (topical)
CnssPenetration: No

Elimination:

HalfLife: Not significant (topical)
Clearance: Not significant (topical)
ExcretionRoute: Not significant (topical)
Unchanged: Not significant (topical)
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Pharmacodynamics

OnsetOfAction: Local antibacterial effect begins shortly after application.
PeakEffect: Local antibacterial effect sustained with regular application.
DurationOfAction: Duration of effect is localized to the application site and requires reapplication.

Safety & Warnings

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Side Effects

Urgent Side Effects: Seek Medical Help Right Away

Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor immediately or seek emergency 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
+ Difficulty 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 any 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.
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Seek Immediate Medical Attention If You Experience:

  • Rash, itching, or hives (signs of allergic reaction)
  • Increased redness, swelling, pain, or pus (signs of worsening infection)
  • Fever
  • No improvement in symptoms after 7 days
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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.
If a large area of your body needs to be treated with this medication.

To ensure safe use, it is crucial to discuss the following with your doctor and pharmacist:

All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins.
Any health problems you have, as this medication may interact with other drugs or health conditions.

Before making any changes to your medication regimen, consult with your doctor to confirm that it is safe to:

Start taking this medication
Stop taking this medication
* Change the dose of this medication or any other medication you are taking
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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 taking it for longer than recommended may increase the risk of a second infection.

In the event that this medication is accidentally swallowed, seek immediate medical attention by calling a doctor or contacting a poison control center.

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 possible outcome for both you and your baby.
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Overdose Information

Overdose Symptoms:

  • Unlikely with topical use due to minimal systemic absorption. Ingestion of large amounts may cause gastrointestinal upset.

What to Do:

For accidental ingestion, contact a poison control center immediately (e.g., 1-800-222-1222). For topical overuse, discontinue use and wash the area.

Drug Interactions

Monitoring

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Routine Monitoring

Resolution of infection symptoms (e.g., redness, swelling, pus)

Frequency: Daily

Target: Improvement within 7 days

Action Threshold: No improvement or worsening of symptoms after 7 days; signs of allergic reaction (rash, itching, swelling).

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Symptom Monitoring

  • Signs of allergic reaction (rash, itching, hives, swelling)
  • Worsening of infection (increased redness, pain, swelling, pus, fever)
  • Development of new skin irritation at application site

Special Patient Groups

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Pregnancy

Generally considered safe for topical use during pregnancy due to minimal systemic absorption. Use only if clearly needed and under medical supervision.

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 when applied topically. Minimal systemic absorption is expected, making infant exposure unlikely. Avoid applying to the breast area if breastfeeding.

Infant Risk: Low risk
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Pediatric Use

Generally safe for use in children for minor skin infections. Consult a healthcare professional for infants under 2 years of age or for extensive use.

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Geriatric Use

No specific dosage adjustments or precautions are generally needed for geriatric patients for topical use, as systemic absorption is minimal.

Clinical Information

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Clinical Pearls

  • Bacitracin is effective against many Gram-positive bacteria, including Staphylococcus and Streptococcus species.
  • Often used for minor cuts, scrapes, and burns to prevent infection.
  • Not effective against fungal or viral infections.
  • Discontinue use if signs of allergic reaction (e.g., rash, itching) or worsening infection occur.
  • Resistance to bacitracin is rare but can occur.
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Alternative Therapies

  • Mupirocin (prescription topical antibiotic)
  • Neomycin (topical antibiotic)
  • Polymyxin B (topical antibiotic)
  • Silver sulfadiazine (for burns)
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Cost & Coverage

Average Cost: $5 - $15 per 28gm tube
Generic Available: Yes
Insurance Coverage: Often Over-The-Counter (OTC), may not be covered by prescription plans unless prescribed.
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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 this 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 emergency medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.