Bacitracin Ointment 28.4gm

Manufacturer G & W LABS 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 ointment is an antibiotic medicine applied to the skin to help 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

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 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 area with a bandage or dressing if needed.

Storage and Disposal

Store this medication at room temperature in a dry location, avoiding bathrooms and areas exposed to heat. Keep all medications in a safe place, out of the reach of children and pets.

Missed 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 once or use extra doses to make up for a missed dose.
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Lifestyle & Tips

  • Clean the affected area gently with soap and water before applying the ointment.
  • Apply a thin layer of ointment to the affected 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 these areas, rinse thoroughly with water.
  • Do not use on deep wounds, animal bites, or serious burns without consulting a doctor.
  • Do not use for longer 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.
Dose Range: 1 - 3 mg

Condition-Specific Dosing:

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

Neonatal: Not established for routine use; consult pediatrician. Use with caution on large areas or broken skin.
Infant: Apply a thin layer to the affected area 1 to 3 times daily. Use with caution on large areas or broken skin.
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 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. It interferes with the dephosphorylation of the lipid carrier molecule, bactoprenol pyrophosphate, which is essential for the transport of peptidoglycan precursors across the bacterial cell membrane. 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 none systemically from intact skin.
Tmax: Not applicable for topical use.
FoodEffect: Not applicable for topical use.

Distribution:

Vd: Not applicable for topical use.
ProteinBinding: Not applicable for topical use.
CnssPenetration: No

Elimination:

HalfLife: Not applicable for topical use.
Clearance: Not applicable for topical use.
ExcretionRoute: Not applicable for topical use.
Unchanged: Not applicable for topical use.
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Pharmacodynamics

OnsetOfAction: Local antibacterial effect begins shortly after application.
PeakEffect: Local antibacterial effect.
DurationOfAction: Maintained as long as the product is on the skin and reapplied as directed.

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, 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 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 guidance on managing side effects.
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Seek Immediate Medical Attention If You Experience:

  • Increased redness, swelling, pain, or pus at the application site (signs of worsening infection)
  • Rash, itching, hives, or severe burning (signs of allergic reaction)
  • No improvement in symptoms 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 as a result of the allergy.
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 existing health problems you have.

This information will help your doctor determine if it is safe for you to take this medication, considering potential interactions with other drugs or health conditions. Never start, stop, or change the dose of any medication without first consulting 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, notify your doctor. You and your doctor will need 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. Excessive application may lead to skin irritation.

What to Do:

If swallowed, call a Poison Control Center immediately (1-800-222-1222). For skin irritation, discontinue use and wash the area. Seek medical attention if irritation persists or worsens.

Drug Interactions

Monitoring

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Symptom Monitoring

  • Resolution of infection symptoms (e.g., redness, swelling, pus, pain)
  • Signs of allergic reaction (e.g., rash, itching, hives, worsening redness, swelling)
  • Signs of superinfection (e.g., new or worsening symptoms, fungal growth)

Special Patient Groups

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Pregnancy

Generally considered safe for topical use during pregnancy due to minimal systemic absorption. However, use with caution, especially on large areas of broken skin.

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, as systemic absorption is minimal. Avoid applying to the breast or nipple area to prevent infant ingestion.

Infant Risk: Low risk if applied appropriately and not on areas where the infant may ingest it.
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Pediatric Use

Generally safe for use in children for minor skin infections. Use with caution on large areas of skin or broken skin, especially in infants and neonates, as increased absorption could theoretically occur, though rare.

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Geriatric Use

No specific dose adjustments or precautions are generally needed for elderly patients for topical use. Use with caution on large areas of broken skin.

Clinical Information

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Clinical Pearls

  • Bacitracin is effective against many Gram-positive bacteria, including Staphylococcus aureus and Streptococcus pyogenes.
  • It is a common ingredient in many over-the-counter triple antibiotic ointments (e.g., Neosporin, which also contains neomycin and polymyxin B).
  • Allergic contact dermatitis to bacitracin is relatively common, presenting as redness, itching, and swelling that may mimic a worsening infection.
  • Patients should be advised to discontinue use and consult a healthcare provider if signs of allergic reaction or worsening infection occur.
  • Not effective against fungal or viral infections.
  • For external use only. Do not use in the eyes or on mucous membranes.
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Alternative Therapies

  • Mupirocin ointment (prescription)
  • Retapamulin ointment (prescription)
  • Topical silver sulfadiazine (for burns)
  • Other topical antiseptics (e.g., povidone-iodine, chlorhexidine) for wound care.
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Cost & Coverage

Average Cost: $5 - $15 per 28.4gm tube
Generic Available: Yes
Insurance Coverage: Over-the-counter (OTC) product, generally not covered by prescription plans unless prescribed by a physician and covered under specific 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 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.