Bacitracin

Nephrotoxic reactions—Albuminuria, cylindruria, azotemia. Rising blood levels without any increase in dosage.

Other reactions—Nausea and vomiting. Pain at site of injection. Skin rashes.

Included as part of the PRECAUTIONS section.

Patients should be counseled that antibacterial drugs, including Bacitracin, should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When Bacitracin is prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by Bacitracin or other antibacterial drugs in the future.

Diarrhea is a common problem caused by antibiotics which usually ends when the antibiotic is discontinued. Sometimes after starting treatment with antibiotics, patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as two or more months after having taken the last dose of the antibiotic. If this occurs, patients should contact their physician as soon as possible.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Bacitracin falls into category C:

In animal studies, pregnant animals were given this medication and had some babies born with problems. No well-controlled studies have been done in humans, though. Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child.

OR

There are no well-controlled studies that have been done in pregnant women. Bacitracin should be used during pregnancy only if the possible benefit outweighs the possible risk to the unborn baby.

OR

No studies have been done in animals, and no well-controlled studies have been done in pregnant women. Bacitracin should be given to a pregnant woman only if clearly needed.

Contraindications

• History of hypersensitivity or toxic reactions to bacitracin.100 104

Warnings/Precautions

Warnings

IM bacitracin may cause renal failure due to tubular and glomerular necrosis.100 104 Albuminuria,100 104 hematuria,a cylindruria,100 104 and rising blood concentrations of the drug100 104 may occur initially followed eventually by oliguria,a azotemia,100 104 and renal failure.100 104

Infants less prone to bacitracin nephrotoxicity than older children and adults.a Toxicity is related to total daily dosage and duration of therapy.a

Assess renal function prior to and daily during therapy.100 104 Discontinue drug if renal toxicity occurs.100 104

Keep patient well hydrated using oral or, if necessary, parenteral fluids.100 104 Maintain urine output at proper levels to avoid renal toxicity.100 104 Some suggest using sodium bicarbonate or another alkali to keep urine at pH 6 or greater to avoid renal irritation.a

Avoid concomitant use with other nephrotoxic drugs.100 104 (See Specific Drugs under Interactions.)

Because of the risk of nephrotoxicity, manufacturers state restrict use of IM bacitracin only to the treatment of staphylococcal pneumonia and empyema in infants when the causative organism has been shown to be susceptible to the drug.100 104 In addition, use the drug only if adequate laboratory facilities are available and constant supervision of the patient is possible.100 104

Sensitivity Reactions

Anaphylaxis and/or allergic contact dermatitis reported when bacitracin used for non-FDA-labeled indications.100 104

Rash100 104 and pruritusa also reported.

General Precautions

Possible emergence and overgrowth of nonsusceptible bacteria or fungi may occur.100 104 Institute appropriate therapy if superinfection occurs.100 104

Treatment with anti-infectives alters normal colon flora and may permit overgrowth of Clostridium difficile.100 104 110 111 112 C. difficile infection (CDI) and CDAD (also known as antibiotic-associated diarrhea and colitis or pseudomembranous colitis) reported with nearly all anti-infectives and may range in severity from mild diarrhea to fatal colitis.100 104 110 111 112 C. difficile produces toxins A and B which contribute to development of CDAD;100 104 110 hypertoxin-producing strains of C. difficile are associated with increased morbidity and mortality since they may be refractory to anti-infectives and colectomy may be required.100 104

Consider CDAD if diarrhea develops during or after therapy and manage accordingly.100 104 110 111 112 Obtain careful medical history since CDAD may occur as late as ≥2 months after anti-infective therapy is discontinued.100 104

If CDAD suspected or confirmed, discontinue anti-infectives not directed against C. difficile whenever possible.100 104 110 Initiate appropriate supportive therapy (e.g., fluid and electrolyte management, protein supplementation), anti-infective therapy directed against C. difficile (e.g., metronidazole, vancomycin), and surgical evaluation as clinically indicated.100 104 110 111 112

To reduce development of drug-resistant bacteria and maintain effectiveness of bacitracin and other antibacterials, use only for treatment or prevention of infections proven or strongly suspected to be caused by susceptible bacteria.100 104

When selecting or modifying anti-infective therapy, use results of culture and in vitro susceptibility testing.100 104 In the absence of such data, consider local epidemiology and susceptibility patterns when selecting anti-infectives for empiric therapy.100 104

Specific Populations

Category C.145

Not labeled for use in adults, including pregnant women.100 104

Not known whether bacitracin is distributed into milk.145

Not labeled for use in adults, including nursing women.100 104

Common Adverse Effects

Nephrotoxicity (albuminuria, cylindruria, azotemia, rising blood concentrations of the drug);100 104 GI effects (nausea, vomiting);100 104 pain at injection site;100 104 hypersensitivity reactions (rash).100 104

Bacitracin injection is an antibiotic that treats staph infection caused by a bacteria called staphylococcus (STAF-il-oh-KOK-us).

Bacitracin injection is used in infants to treat pneumonia. It is also used to treat an infection that causes pus to build up between the lungs and the membrane that covers them.

Bacitracin injection may also be used for purposes other than those listed in this medication guide.

Before your child receives bacitracin injection, tell the doctor if the child has a history of kidney disease.

Many other drugs can damage the kidneys and should not be used together with bacitracin. Tell your doctor if your child is receiving chemotherapy, medicines used to treat a bowel disorder, medications to prevent organ transplant rejection, antiviral medications, or any other injected antibiotics.

Get emergency medical help if your child has any of these signs of an allergic reaction: hives; difficulty breathing; swelling of the face, lips, tongue, or throat.

Serious side effects of bacitracin injection include urinating less than usual or not at all, blood in the urine, lower back pain, or painful urination.

Make sure your child receives this medication for the entire length of time prescribed by the doctor. Your child's symptoms may get better before the infection is completely treated. Bacitracin injection will not treat a viral infection such as the common cold or flu.

Follow your doctor's instructions about any restrictions on food, beverages, or activity while your child is receiving bacitracin injection.

Your pharmacist can provide more information about bacitracin injection.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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