Dosing & Uses
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
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
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
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.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%
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)
