Bacitracin Zinc Topical Oint 425gm

Manufacturer DYNAREX Active Ingredient Bacitracin (Topical)(bas i TRAY sin) Pronunciation bas-i-TRAY-sin ZINK
It is used to avoid or treat skin infections.
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Drug Class
Antibiotic
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Pharmacologic Class
Polypeptide antibiotic
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Pregnancy 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 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. Apply a thin layer of the medication to the affected area and gently rub it in. You may cover the treated 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 place, avoiding bathrooms. Protect the medication from heat sources. Keep all medications in a safe location, 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.
  • Wash hands before and after applying the ointment.
  • Avoid touching the tip of the ointment tube to the skin or other surfaces to prevent contamination.
  • 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.

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: Clean the affected area. Apply a small amount (an amount equal to the surface area of the fingertip) to the area 1 to 3 times daily. May be covered with a sterile bandage.
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Pediatric Dosing

Neonatal: Not established (consult pediatrician)
Infant: Not established (consult pediatrician)
Child: Apply a thin layer to the affected area 1 to 3 times daily (similar to adult, but consult pediatrician for infants/very young children or extensive use).
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 for topical use due to minimal systemic absorption.
Moderate: No adjustment needed for topical use due to minimal systemic absorption.
Severe: No adjustment needed for topical use due to minimal systemic absorption.
Dialysis: No specific considerations for topical use due to minimal systemic absorption.

Hepatic Impairment:

Mild: No adjustment needed for topical use due to minimal systemic absorption.
Moderate: No adjustment needed for topical use due to minimal systemic absorption.
Severe: No adjustment needed for topical use due to 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, which is essential for peptidoglycan synthesis. This leads to the accumulation of undecaprenyl pyrophosphate and inhibition of cell wall formation, resulting in bactericidal activity.
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Pharmacokinetics

Absorption:

Bioavailability: Minimal to negligible systemic absorption from intact skin.
Tmax: Not applicable for topical use due to minimal systemic absorption.
FoodEffect: Not applicable for topical use.

Distribution:

Vd: Not clinically significant due to minimal systemic absorption.
ProteinBinding: Not clinically significant due to minimal systemic absorption.
CnssPenetration: Limited (not clinically significant for topical use).

Elimination:

HalfLife: Not clinically significant due to minimal systemic absorption.
Clearance: Not clinically significant due to minimal systemic absorption.
ExcretionRoute: Not clinically significant due to minimal systemic absorption.
Unchanged: Not clinically significant due to minimal systemic absorption.
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Pharmacodynamics

OnsetOfAction: Local antibacterial effect begins upon application.
PeakEffect: Local antibacterial effect is sustained with regular application.
DurationOfAction: Duration of local effect until washed off or reapplication.

Safety & Warnings

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Side Effects

Urgent Side Effects: Seek Medical Attention Immediately
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 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 or seek medical help.

Reporting Side Effects
This list does not include all possible side effects. If you have questions or concerns about side effects, contact your doctor for advice. 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:

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

To ensure safe use, tell your doctor and pharmacist about:

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 starting, stopping, or changing the dose of any medication, including this one, consult with your doctor to confirm it is safe to do so. This will help prevent potential interactions and ensure your safety while taking this medication.
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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 treatment, as using it for an extended 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 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:

  • Topical overdose is unlikely to cause systemic toxicity due to minimal absorption. Ingestion of large amounts may cause gastrointestinal upset.

What to Do:

If ingested, seek medical attention or call a poison control center. For topical overuse, wash off excess ointment. Call 1-800-222-1222 (Poison Control).

Drug Interactions

Monitoring

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Routine Monitoring

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

Frequency: Daily

Target: Improvement or resolution of symptoms

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

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

Frequency: Daily

Target: Absence of allergic reaction

Action Threshold: Presence of any allergic reaction symptoms.

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Symptom Monitoring

  • Redness
  • Swelling
  • Pain
  • Pus or discharge
  • Itching
  • Rash
  • Hives
  • Signs of worsening infection (e.g., fever, spreading redness)

Special Patient Groups

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Pregnancy

Bacitracin topical is generally considered low risk during pregnancy due to minimal systemic absorption. Use only if clearly needed and under medical advice.

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

Minimal systemic absorption of bacitracin from topical application suggests low risk to the nursing infant. Use on intact skin and avoid application to the breast area to prevent direct infant exposure.

Infant Risk: Low risk
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Pediatric Use

Generally safe for use in children for minor skin infections. However, for infants and very young children, or for use on large areas of skin, consult a pediatrician. Avoid prolonged use.

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Geriatric Use

No specific dosage adjustments or precautions are generally necessary for geriatric patients using topical bacitracin, given its minimal systemic absorption.

Clinical Information

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Clinical Pearls

  • Bacitracin is effective against many Gram-positive bacteria, including Staphylococcus aureus and Streptococcus pyogenes.
  • It is commonly used for minor cuts, scrapes, and burns to prevent infection.
  • Allergic contact dermatitis to bacitracin is relatively common, presenting as redness, itching, and swelling at the application site. Discontinue use if this occurs.
  • Not effective against fungal or viral infections.
  • Avoid using on large areas of broken skin or deep wounds, as systemic absorption could potentially occur, leading to nephrotoxicity (though rare with topical use).
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Alternative Therapies

  • Mupirocin (prescription topical antibiotic)
  • Polymyxin B (often in combination products)
  • Silver sulfadiazine (for burns)
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Cost & Coverage

Average Cost: $5 - $20 per 425gm ointment
Generic Available: Yes
Insurance Coverage: Often OTC, may not be covered by prescription plans unless prescribed for specific conditions. Generally inexpensive.
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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 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 emergency 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.