BACI-RX
Clinical safety rating: caution
Comprehensive clinical and safety monograph for BACI-RX (BACI-RX).
Bacitracin inhibits bacterial cell wall synthesis by interfering with the dephosphorylation of the lipid carrier that transports peptidoglycan precursors, thereby blocking cell wall formation.
| Metabolism | Bacitracin is not systemically absorbed after topical administration; no significant hepatic metabolism. Systemic absorption can occur with large topical doses or use on denuded skin, and it is excreted primarily unchanged by the kidneys. |
| Excretion | Renal: 90-100% as unchanged drug via glomerular filtration; biliary/fecal: negligible. |
| Half-life | Terminal half-life: 2-3 hours in patients with normal renal function; prolonged to 20-40 hours in anuria. Clinical context: Dosing interval adjustment required for creatinine clearance <30 mL/min. |
| Protein binding | Approximately 10-20% bound to serum proteins (albumin). |
| Volume of Distribution | 0.25-0.4 L/kg. Low Vd indicates distribution primarily to extracellular fluid; minimal tissue penetration except renal cortex. |
| Bioavailability | Intramuscular: ~100% (rapid and complete); oral: negligible (<1%) due to poor absorption; topical: variable, minimal systemic absorption (<5% with intact skin). |
| Onset of Action | Intravenous: Immediate; intramuscular: 1-2 hours; topical: variable, typically within 24 hours for local effect. |
| Duration of Action | Intravenous/intramuscular: 6-8 hours; topical: 12-24 hours based on reapplication schedule. Clinical note: Duration limited by rapid renal clearance. |
1-2 units/kg intramuscularly every 2-4 hours as needed for hemophilia A; intravenous infusion 40-50 units/kg for major surgery or life-threatening bleeding, then 20-25 units/kg every 8 hours.
| Dosage form | POWDER |
| Renal impairment | No adjustment required; bacitracin is not significantly renally eliminated. |
| Liver impairment | No adjustment required; bacitracin is not hepatically metabolized. |
| Pediatric use | Weight-based dosing as per standard protocol: 1-2 units/kg intramuscularly every 2-4 hours; adjust based on factor levels. |
| Geriatric use | Use standard dosing with caution for renal function; assess GFR and adjust if impaired. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for BACI-RX (BACI-RX).
| Breastfeeding | Unknown if excreted in human milk; M/P ratio not available. Caution is advised; consider temporary discontinuation of breastfeeding or drug based on importance to mother. |
| Teratogenic Risk | First trimester: No evidence of teratogenicity in animal studies; limited human data. Second and third trimesters: No known fetal risks; use only if clearly needed. |
| Fetal Monitoring |
■ FDA Black Box Warning
No FDA black box warning.
| Serious Effects |
Hypersensitivity to bacitracin or any component of the formulation; severe renal impairment (if systemic absorption is possible).
| Precautions | Nephrotoxicity with systemic absorption; avoid use on large surface areas or deep wounds; hypersensitivity reactions; potential for superinfection; not for ophthalmic use unless specifically formulated. |
| Food/Dietary | No known food interactions with topical bacitracin. |
| Clinical Pearls |
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| Monitor mother for signs of infection, hypersensitivity, and renal function. Fetal monitoring per standard prenatal care. |
| Fertility Effects | No known effects on fertility based on animal studies; human data lacking. |
| BACI-RX (bacitracin) is a topical antibiotic effective against gram-positive organisms. Avoid systemic use due to nephrotoxicity. Apply thin layer; hypersensitivity reactions possible. Not for ophthalmic use unless specified. Monitor for superinfection with prolonged use. |
| Patient Advice | Apply a thin layer to affected area as directed. · Wash hands before and after application unless treating hands. · Do not use on large areas of skin or deep puncture wounds. · Stop use and consult provider if rash or irritation develops. · Do not use in eyes or mouth unless specifically prescribed. · Store at room temperature away from moisture and heat. |