Bacitracin

Bacitracin
Black Box Warning
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Alberto Plate [2]

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Black Box Warning

WARNING See full prescribing information for complete Boxed Warning. Nephrotoxicity: Bacitracin in parenteral (intramuscular) therapy may cause renal failure due to tubular and glomerular necrosis. Its use should be restricted to infants with staphylococcal pneumonia and empyema when due to organisms shown to be susceptible to bacitracin. It should be used only where adequate laboratory facilities are available and when constant supervision of the patient is possible. Renal function should be carefully determined prior to and daily during therapy. The recommended daily dose should not be exceeded and fluid intake and urinary output maintained at proper levels to avoid kidney toxicity. If renal toxicity occurs the drug should be discontinued. The concurrent use of other nephrotoxic drugs, particularly streptomycin, kanamycin, polymyxin B, polymyxin E (colistin), and neomycin should be avoided.

Overview

Bacitracin is an antibiotic that is FDA approved for the treatment of infants with pneumonia and empyema caused by staphylococci shown to be susceptible to the drug. There is a Black Box Warning for this drug as shown here. Common adverse reactions include injection site pain.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

There is limited information regarding Bacitracin FDA-Labeled Indications and Dosage (Adult) in the drug label.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Bacitracin in adult patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Bacitracin in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

bacitracin is limited to the treatment of infants with pneumonia and empyema caused by staphylococci shown to be susceptible to the drug.

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Bacitracin and other antibacterial drugs, Bacitracin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Bacitracin in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Bacitracin in pediatric patients.

Contraindications

This drug is contraindicated in those individuals with a history of previous hypersensitivity or toxic reaction to it.

Warnings

WARNING See full prescribing information for complete Boxed Warning. Nephrotoxicity: Bacitracin in parenteral (intramuscular) therapy may cause renal failure due to tubular and glomerular necrosis. Its use should be restricted to infants with staphylococcal pneumonia and empyema when due to organisms shown to be susceptible to bacitracin. It should be used only where adequate laboratory facilities are available and when constant supervision of the patient is possible. Renal function should be carefully determined prior to and daily during therapy. The recommended daily dose should not be exceeded and fluid intake and urinary output maintained at proper levels to avoid kidney toxicity. If renal toxicity occurs the drug should be discontinued. The concurrent use of other nephrotoxic drugs, particularly streptomycin, kanamycin, polymyxin B, polymyxin E (colistin), and neomycin should be avoided.

Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including Bacitracin for Injection and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile.

C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents.

If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated.

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Bacitracin Clinical Trials Experience in the drug label.

Postmarketing Experience

There is limited information regarding Bacitracin Postmarketing Experience in the drug label.

Drug Interactions

There is limited information regarding Bacitracin Drug Interactions in the drug label.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): There is no FDA guidance on usage of Bacitracin in women who are pregnant.
Pregnancy Category (AUS): There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Bacitracin in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Bacitracin during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Bacitracin in women who are nursing.

Pediatric Use

There is no FDA guidance on the use of Bacitracin in pediatric settings.

Geriatic Use

There is no FDA guidance on the use of Bacitracin in geriatric settings.

Gender

There is no FDA guidance on the use of Bacitracin with respect to specific gender populations.

Race

There is no FDA guidance on the use of Bacitracin with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Bacitracin in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Bacitracin in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Bacitracin in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Bacitracin in patients who are immunocompromised.

Administration and Monitoring

Administration

There is limited information regarding Bacitracin Administration in the drug label.

Monitoring

There is limited information regarding Bacitracin Monitoring in the drug label.

IV Compatibility

There is limited information regarding the compatibility of Bacitracin and IV administrations.

Overdosage

There is limited information regarding Bacitracin overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.

Pharmacology

There is limited information regarding Bacitracin Pharmacology in the drug label.

Mechanism of Action

There is limited information regarding Bacitracin Mechanism of Action in the drug label.

Structure

There is limited information regarding Bacitracin Structure in the drug label.

Pharmacodynamics

There is limited information regarding Bacitracin Pharmacodynamics in the drug label.

Pharmacokinetics

There is limited information regarding Bacitracin Pharmacokinetics in the drug label.

Nonclinical Toxicology

There is limited information regarding Bacitracin Nonclinical Toxicology in the drug label.

Clinical Studies

There is limited information regarding Bacitracin Clinical Studies in the drug label.

How Supplied

There is limited information regarding Bacitracin How Supplied in the drug label.

Storage

There is limited information regarding Bacitracin Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

There is limited information regarding Bacitracin Patient Counseling Information in the drug label.

Precautions with Alcohol

Alcohol-Bacitracin interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

There is limited information regarding Bacitracin Brand Names in the drug label.

Look-Alike Drug Names

There is limited information regarding Bacitracin Look-Alike Drug Names in the drug label.

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.