Bacitracin Zinc Top Ointment 144gm

Manufacturer MAJOR PHARMACEUTICALS 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 ointment is a topical antibiotic used to 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 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 and areas exposed to heat. 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 continue with your regular application schedule. Do not apply two doses at once 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. If contact occurs, rinse thoroughly with water.
  • Do not use for more than 7 days unless directed by a doctor.
  • Keep the treated area clean and dry.

Dosing & Administration

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Adult Dosing

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

Condition-Specific Dosing:

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

Neonatal: Not established
Infant: Apply a thin layer to the affected area 1 to 3 times daily, after cleaning the area. Consult pediatrician for infants under 2 years.
Child: Apply a thin layer to the affected area 1 to 3 times daily, after cleaning the area.
Adolescent: Apply a thin layer to the affected area 1 to 3 times daily, after cleaning the area.
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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 for topical use (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: Local antibacterial effect begins shortly after application.
PeakEffect: Local antibacterial effect is sustained with repeated application.
DurationOfAction: Duration of effect is localized to the application site and requires reapplication.

Safety & Warnings

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Side Effects

Serious 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 any side effects that bother you or do not go away, contact your doctor or seek medical help.

Important Note

This list does not include all possible side effects. If you have questions or concerns about side effects, contact your doctor. For medical advice about side effects, consult your doctor.

Reporting Side Effects

You can 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 allergic reaction (rash, itching, hives, severe redness, swelling, blistering)
  • Worsening of the infection (increased redness, swelling, pain, pus)
  • No improvement in the infection after 7 days of use
  • Fever
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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.

This information is crucial because 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.
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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:

  • Unlikely with topical application due to minimal systemic absorption. Ingesting large amounts could potentially lead to gastrointestinal upset.

What to Do:

If ingested, seek medical attention. For topical overuse, discontinue use and wash the area. Call 1-800-222-1222 (Poison Control Center) for advice if concerns arise.

Drug Interactions

Monitoring

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Routine Monitoring

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

Frequency: Daily

Target: Improvement or resolution

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

Signs of allergic contact dermatitis

Frequency: Daily

Target: Absence of rash, itching, or increased redness

Action Threshold: Development of new rash, itching, or significant increase in redness/swelling at application site.

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Symptom Monitoring

  • Worsening redness
  • Increased swelling
  • Increased pain
  • Pus or discharge
  • Fever
  • New rash or itching at application site (signs of allergic reaction)
  • Lack of improvement after 7 days

Special Patient Groups

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Pregnancy

Topical bacitracin is generally considered safe during pregnancy due to minimal systemic absorption. However, use should be limited to small areas and for short durations. Consult a healthcare provider.

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

Topical bacitracin is considered compatible with breastfeeding due to minimal systemic absorption by the mother and negligible transfer into breast milk. Avoid applying to the nipple area to prevent direct infant ingestion.

Infant Risk: Low risk.
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Pediatric Use

Generally safe for use in children for minor skin infections. For infants under 2 years, consult a pediatrician. Avoid prolonged use or application to large areas.

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Geriatric Use

No specific dosage adjustments or precautions are generally necessary for geriatric patients, as systemic absorption is minimal. Use with caution if skin integrity is severely compromised.

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.
  • Allergic contact dermatitis to bacitracin is relatively common, presenting as a red, itchy rash, sometimes with vesicles, at the application site. Discontinue use if this occurs.
  • Not effective against fungal or viral infections.
  • Zinc is included in the formulation to enhance the stability of bacitracin.
  • For deep or puncture wounds, animal bites, or serious burns, medical consultation is necessary before use.
  • Overuse or use on large areas of broken skin could theoretically lead to systemic absorption, though this is rare with typical use.
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Alternative Therapies

  • Mupirocin (prescription topical antibiotic)
  • Retapamulin (prescription topical antibiotic)
  • Topical silver sulfadiazine (for burns)
  • Oral antibiotics (for more severe or widespread infections)
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Cost & Coverage

Average Cost: $5 - $20 per 144gm tube
Generic Available: Yes
Insurance Coverage: Often available over-the-counter (OTC) and may not be covered by prescription insurance unless prescribed.
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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 overdose, including the medication taken, the amount, and the time it occurred.