bacitracin (Discontinued)

Brand and Other Names:BACiiM
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Dosing & Uses

AdultPediatric

Not indicated

Dosage Forms & Strengths

lyophilized powder for injection solution

  • 50,000 units/vial

Pneumonia or Empyema

Use is limited to neonates/infants with pneumonia or empyema caused by susceptible strains of staphylococci when less toxic antibiotics would not be effective

<2.5 kg: 900 units/kg/day IM divided q8-12hr

≥2.5 kg: 1,000 units/kg/day IM divided q8-12hr

Children: 800-1200 units/kg/day divided q8hr

Administer IM in upper outer quadrant of the buttocks, alternating right and left and avoid multiple injections in the same region

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Adverse Effects

Frequency Not Defined

Nephrotoxic reactions including albuminuria, cylindruria, and azotemia

Nausea and vomiting

Itching

Nausea/vomiting

Blood dyscrasias

Diaphoresis

Pain at injection site

Skin rashes

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Warnings

Black Box Warnings

Nephrotoxicity

  • Parenteral (ie, IM administration) may cause renal failure due to tubular and glomerular necrosis
  • Monitor renal function before initiating and daily during therapy
  • Do not exceed recommended daily dose
  • Maintain fluid intake and urinary output to avoid kidney toxicity
  • Discontinue if renal toxicity develops
  • Avoid concurrent use with other nephrotoxic drugs (eg, streptomycin, gentamicin, kanamycin, polymyxin B, colistin, neomycin, amphotericin B)

Contraindications

Hypersensitivity

Cautions

Do not administer IV; severe thrombophlebitis could occur

Prescribing in absence of proven or strongly suspected bacterial infection or prophylactic indication may not benefit patient and increases development of bacterial resistance

Maintain adequate fluid intake

Antibiotics may cause overgrowth of nonsusceptible organisms, including fungi

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Pregnancy & Lactation

Pregnancy Category: C

Lactation: Unknown whether distributed in breast milk

Pregnancy Categories

A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA: Information not available.

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Pharmacology

Mechanism of Action

Bacteriostatic; inhibits bacterial cell wall synthesis

Antibacterial action in vitro against a variety of gram-positive and a few gram-negative organisms

In vivo, only staphylococcal infections qualify for consideration of bacitracin therapy to treat

Absorption

Absorption following IM injection is rapid and complete

Peak Plasma Concentration: 0.2-2 mcg/mL

Peak Plasma Time: 1-2 hours

Duration: 6-8 hours

Distribution

Widely distributed in all body organs and is found in ascitic and pleural fluids

CSF: Negligible distribution in CSF, even with inflamed meninges Protein binding: Minimal

Elimination

Excretion: Urine 10-40%

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Administration

IM Preparation

Reconstitution for IM injection

  • Dissolve in 0.9% NaCl solution containing 2% procaine
  • Concentration in solution should range between 5,000-10,000 units/mL
  • Do not use diluents containing parabens (may cause cloudiness or precipitate)
  • Inspect visually for particulate matter and discoloration prior to administration

IM Administration

Administer IM in upper outer quadrant of the buttocks, alternating right and left and avoid multiple injections in the same region

Storage

Unreconstituted product: Store refrigerated at 2-8°C (36-46°F)

Reconstituted solution: Store for up to 1 week refrigerated at 2-8°C (36-46°F)

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Images

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Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.