|
This information has been developed and provided by an independent third-party source. Merck & Co., Inc. does not endorse and is not responsible for the accuracy of the content, or for practices or
standards of non-Merck sources.
Pronunciation
(bas i TRAY sin)
Generic Available (U.S.)
Yes
Brand Names: U.S.
Brand Names: Canada
Pharmacologic Category
Pharmacologic Category Synonyms
Use: Labeled Indications
Treatment of susceptible bacterial infections mainly; has activity against gram-positive bacilli; due to toxicity risks, systemic and irrigant uses of bacitracin should be limited to situations where less toxic alternatives would not be effective
Use: Unlabeled
Oral administration: Successful in antibiotic-associated colitis; has been used for enteric eradication of vancomycin-resistant enterococci (VRE)
Pregnancy Risk Factor
C
Lactation
Excretion in breast milk unknown/use caution
Contraindications
Hypersensitivity to bacitracin or any component of the formulation; I.M. use is contraindicated in patients with renal impairment
Warnings/Precautions
Box warnings:
• Renal failure: See “Concerns related to adverse effects” below.
Concerns related to adverse effects:
• Renal failure: [U.S. Boxed Warning]: I.M. use may cause renal failure due to tubular and glomerular necrosis; monitor renal function daily. Avoid concurrent use with other nephrotoxic drugs; discontinue use if toxicity occurs.
• Superinfection: Prolonged use may result in fungal or bacterial superinfection, including C. difficile-associated diarrhea (CDAD) and pseudomembranous colitis; CDAD has been observed >2 months postantibiotic treatment..
Other warnings/precautions:
• Appropriate administration: Do not administer intravenously because severe thrombophlebitis occurs.
Adverse Reactions
1% to 10%:
Cardiovascular: Hypotension, edema of the face/lips, chest tightness
Central nervous system: Pain
Dermatologic: Rash, itching
Gastrointestinal: Anorexia, nausea, vomiting, diarrhea, rectal itching
Hematologic: Blood dyscrasias
Miscellaneous: Diaphoresis
<1%: Rare cases of anaphylaxis have been reported in association with topical and intraoperative exposures.
Drug Interactions
Increased toxicity: Nephrotoxic drugs, neuromuscular blocking agents, and anesthetics (increases neuromuscular blockade).
Reconstitution
For I.M. use only. Bacitracin sterile powder should be dissolved in 0.9% sodium chloride injection containing 2% procaine hydrochloride. Once reconstituted, bacitracin is stable for 1 week under refrigeration (2°C to 8°C). Sterile powder should be stored in the refrigerator. Do not use diluents containing parabens.
Mechanism of Action
Inhibits bacterial cell wall synthesis by preventing transfer of mucopeptides into the growing cell wall
Pharmacodynamics/Kinetics
Duration: 6-8 hours
Absorption: Poor from mucous membranes and intact or denuded skin; rapidly following I.M. administration; not absorbed by bladder irrigation, but absorption can occur from peritoneal or mediastinal lavage
Distribution: CSF: Nil even with inflammation
Protein binding, plasma: Minimal
Time to peak, serum: I.M.: 1-2 hours
Excretion: Urine (10% to 40%) within 24 hours
Dosage
Do not administer I.V.:
Infants: I.M.:
≤2.5 kg: 900 units/kg/day in 2-3 divided doses
>2.5 kg: 1000 units/kg/day in 2-3 divided doses
Children: I.M.: 800-1200 units/kg/day divided every 8 hours
Adults: Oral:
Antibiotic-associated colitis: 25,000 units 4 times/day for 7-10 days
VRE eradication (unlabeled use): 25,000 units 4 times/day for 7-10 days
Children and Adults:
Topical: Apply 1-5 times/day
Ophthalmic, ointment: Instill 1/4” to 1/2” ribbon every 3-4 hours into conjunctival sac for acute infections, or 2-3 times/day for mild-to-moderate infections for 7-10 days
Irrigation, solution: 50-100 units/mL in normal saline, lactated Ringer's, or sterile water for irrigation; soak sponges in solution for topical compresses 1-5 times/day or as needed during surgical procedures
Administration: Oral
The injection formulation is extemporaneously prepared and flavored to improve palatability.
Administration: I.M.
For I.M. administration only. pH of urine should be kept >6 by using sodium bicarbonate. Bacitracin sterile powder should be dissolved in 0.9% sodium chloride injection containing 2% procaine hydrochloride. Do not use diluents containing parabens.
Administration: I.V.
Not for I.V. administration.
Monitoring Parameters
I.M.: Urinalysis, renal function tests
Patient Education
Oral/I.M.: Maintain adequate hydration (2-3 L/day of fluids) unless instructed to restrict fluid intake. Report rash, redness, or itching; change in urinary pattern; acute dizziness; swelling of face or lips; chest pain or tightness; acute nausea or vomiting; or loss of appetite (small, frequent meals or frequent mouth care may help).
Ophthalmic: Instill as many times per day as directed. Wash hands before using. Gently pull lower eyelid forward, instill prescribed amount of ointment into lower eyelid. Close eye and roll eyeball in all directions. May cause blurred vision; use caution when driving or engaging in tasks that require clear vision. Report any adverse reactions such as rash or itching, swelling of face or lips, burning or pain in eye, worsening of condition, or if condition does not improve.
Topical: Apply a thin film as many times a day as prescribed to the affected area. May cover with porous sterile bandage (avoid occlusive dressings). Do not use longer than 1 week unless advised by prescriber. Pregnancy/breast-feeding precautions: Inform prescriber if you are or intend to become pregnant. Consult prescriber if breast-feeding.
Additional Information
1 unit is equivalent to 0.026 mg
Dental Health: Effects on Dental Treatment
No significant effects or complications reported
Dental Health: Vasoconstrictor/Local Anesthetic Precautions
No information available to require special precautions
Mental Health: Effects on Mental Status
None reported
Mental Health: Effects on Psychiatric Treatment
None reported
Nursing: Physical Assessment/Monitoring
Do not administer I.V. Assess potential for interactions with other pharmacological agents patient may be taking (eg, nephrotoxic drugs, neuromuscular blocking agents, and anesthetics). Assess laboratory results (urinalysis and renal function with I.M.), effectiveness of therapy, and adverse reactions. Teach patient proper use, possible side effects/appropriate interventions, and adverse symptoms to report.
Dosage Forms
Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product
Injection, powder for reconstitution (BaciiM®): 50,000 units
Ointment, ophthalmic (AK-Tracin® [DSC]): 500 units/g (3.5 g)
Ointment, topical: 500 units/g (0.9 g, 15 g, 30 g, 120 g, 454 g)
Baciguent®: 500 units/g (15 g, 30 g)
Pricing: U.S. (www.drugstore.com)
Ointment (Bacitracin)
500 units/g (3.5): $7.99
500 units/g (30): $6.99
Extemporaneously Prepared
In some institutions, oral formulations have been prepared either by preparation of capsules from powder or oral administration of I.V. solution.
References
Chia JK, Nakata MM, Park SS, et al, “Use of Bacitracin Therapy for Infection Due to Vancomycin-Resistant Enterococcus faecium,” Clin Infect Dis, 1995, 21(6):1520.
Katz BE and Fisher AA, “Bacitracin: A Unique Topical Antibiotic Sensitizer,” J Am Acad Dermatol, 1987, 17(6):1016-24.
Kelly CP, Pothoulakis C, and LaMont JT, “Clostridium difficile Colitis,” N Engl J Med, 1994, 330(4):257-62.
Mondy KE, Shannon W, and Mundy LM, “Evaluation of Zinc Bacitracin Capsules Versus Placebo for Enteric Eradication of Vancomycin-Resistant Enterococcus faecium,” Clin Infect Dis, 2001, 33(4):473-6.
O'Donovan CA, Fan-Havard P, Tecson-Tumang FT, et al, “Enteric Eradication of Vancomycin-Resistant Enterococcus faecium With Oral Bacitracin,” Diagn Microbiol Infect Dis, 1994, 18(2):105-9.
Vale MA, Connolly A, Epstein AM, et al, “Bacitracin-Induced Anaphylaxis,” Arch Dermatol, 1978, 114(5):800.
Westerman EL, “Toxicity of Mediastinal Irrigation With Bacitracin,” JAMA, 1983, 250(7):899.
Young GP, Ward PB, Bayley N, et al, “Antibiotic-Associated Colitis Due to Clostridium difficile: Double-Blind Comparison of Vancomycin With Bacitracin,” Gastroenterology, 1985, 89(5):1038-45.
International Brand Names
Lexi-Comp.com
Last full review/revision December 2007
|
