Bacitracin

MEDICATION SAFETY ISSUES
Sound-alike/look-alike issues:
Bacitracin may be confused with Bactrim®, Bactroban®

U.S. BRAND NAMES — Baci-Rx; Baciguent® [OTC]; BaciiM®

PHARMACOLOGIC CATEGORY
Antibiotic, Miscellaneous
Antibiotic, Ophthalmic
Antibiotic, Topical

DOSING: ADULTS — Do not administer I.V.:

Antibiotic-associated colitis: Oral: 25,000 units 4 times/day for 7-10 days

VRE eradication (unlabeled use): Oral: 25,000 units 4 times/day for 7-10 days

Superficial dermal infection: Topical: Apply 1-5 times/day.

Ophthalmic infection: 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.

Local 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.

DOSING: PEDIATRIC — Do not administer I.V.

(For additional information see "Bacitracin: Pediatric drug information")

Treatment of infection:
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

Superficial dermal infection: Topical: Refer to adult dosing.

Ophthalmic infection: Ophthalmic (ointment): Refer to adult dosing.

Local irrigation: Solution: Refer to adult dosing.

DOSING: ELDERLY — Refer to adult dosing.

DOSAGE FORMS — Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Injection, powder for reconstitution: 50,000 units
BaciiM®: 50,000 units

Ointment, ophthalmic: 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)

Powder, for prescription compounding [micronized]:
Baci-Rx: 5 million units

DOSAGE FORMS: CONCISE
Injection, powder for reconstitution: 50,000 units
BaciiM®: 50,000 units

Ointment, ophthalmic: 500 units/g (3.5 g)

Ointment, topical: 500 units/g (0.9 g, 15 g, 30 g, 120 g, 454 g)
Baciguent® [OTC]: 500 units/g (15 g, 30 g)

Powder, for prescription compounding [micronized]:
Baci-Rx: 5 million units

GENERIC EQUIVALENT AVAILABLE — Yes

ADMINISTRATION — For I.M. administration only, do not administer I.V. Confirm any orders for parenteral use. 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.

USE — 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 / INVESTIGATIONAL — Oral administration: Successful in antibiotic-associated colitis; has been used for enteric eradication of vancomycin-resistant enterococci (VRE)

ADVERSE REACTIONS SIGNIFICANT
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.

CONTRAINDICATIONS — Hypersensitivity to bacitracin or any component of the formulation; I.M. use is contraindicated in patients with renal impairment

WARNINGS / PRECAUTIONS
Boxed 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.

DRUG INTERACTIONS — There are no known significant interactions.

PREGNANCY IMPLICATIONS — It is unknown if bacitracin crosses the placenta. The minimal absorption after topical use should limit the amount of medication available for transfer to the fetus.

LACTATION — Excretion in breast milk unknown/use caution

BREAST-FEEDING CONSIDERATIONS — It is unknown if bacitracin is distributed in human milk. The minimal absorption after topical use should limit the amount of medication available for transfer.

PRICING — (data from drugstore.com)
Ointment (Bacitracin)
500 units/g (3.5): $15.99
500 units/g (28.4): $12.99

MONITORING PARAMETERS — I.M.: Urinalysis, renal function tests

CANADIAN BRAND NAMES — Baciguent®; Baciject®

INTERNATIONAL BRAND NAMES — Glubacida (MX); Nebacetina (MX); Neosporin Dermico (MX); Polixin Ungena (MX); Tribiot (MX)

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

PATIENT INFORMATION

(For additional information see "Bacitracin: Patient drug information")
Ophthalmic: Tilt head back, place medication in conjunctival sac and close eyes; apply light finger pressure on lacrimal sac for 1 minute following instillation. Ophthalmic ointment may cause blurred vision; do not share eye medications with others.

Topical: Do not be use for longer than 1 week unless directed by prescriber.