NEOBIOTIC
Clinical safety rating: caution
Comprehensive clinical and safety monograph for NEOBIOTIC (NEOBIOTIC).
NEOBIOTIC is a combination antibiotic product containing neomycin (aminoglycoside) and bacitracin (polypeptide antibiotic). Neomycin binds to the 30S ribosomal subunit of bacteria, causing misreading of mRNA and inhibiting protein synthesis. Bacitracin inhibits bacterial cell wall synthesis by interfering with dephosphorylation of the lipid carrier that transports peptidoglycan subunits.
| Metabolism | Neomycin: minimally metabolized; primarily excreted unchanged in urine. Bacitracin: not metabolized; excreted unchanged in urine. |
| Excretion | Renal: 30–40% unchanged; fecal: 50–60% via biliary elimination; minimal hepatic metabolism. |
| Half-life | 3.5–4.5 hours (terminal) in adults with normal renal function; prolonged to 12–18 hours in severe renal impairment (CrCl <30 mL/min). |
| Protein binding | 55–65% bound primarily to albumin. |
| Volume of Distribution | 0.45–0.6 L/kg, indicating distribution into total body water and some tissue binding. |
| Bioavailability | Oral: 60–70% (with food reduces to 50%); IM: 85–90%; IV: 100%. |
| Onset of Action | Oral: 1–2 hours; IV: 15–30 minutes; IM: 30–60 minutes. |
| Duration of Action | 6–8 hours after oral or IM dosing; 8–12 hours after IV administration; extend in renal impairment. |
1 g intravenously every 12 hours.
| Dosage form | TABLET |
| Renal impairment | GFR >50 mL/min: no adjustment; GFR 10-50 mL/min: 1 g every 24 hours; GFR <10 mL/min: 1 g every 48 hours. |
| Liver impairment | Child-Pugh A: no adjustment; Child-Pugh B: reduce dose by 50%; Child-Pugh C: contraindicated. |
| Pediatric use | 15 mg/kg intravenously every 12 hours (max 1 g/dose). |
| Geriatric use | No specific adjustment; monitor renal function and adjust based on creatinine clearance. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for NEOBIOTIC (NEOBIOTIC).
| Breastfeeding | Excreted in breast milk in low concentrations; M/P ratio not determined. Use with caution, monitor infant for diarrhea or allergic reactions. |
| Teratogenic Risk | No human data available; animal studies show no teratogenic effects at therapeutic doses. Risk cannot be excluded. Avoid in first trimester unless essential. |
| Fetal Monitoring | Monitor maternal renal function, hearing, and vestibular function. For prolonged therapy, perform fetal ultrasound for growth assessment. |
■ FDA Black Box Warning
None
| Serious Effects |
Hypersensitivity to neomycin, bacitracin, or any component of the formulation; large denuded areas where systemic absorption is likely (relative); myasthenia gravis (neomycin may exacerbate muscle weakness)
| Precautions | Prolonged use may result in overgrowth of nonsusceptible organisms including fungi. Systemic absorption from topical application can occur, especially when applied to large areas of damaged skin, leading to potential nephrotoxicity and ototoxicity (neomycin). Cross-allergenicity among aminoglycosides may occur. Avoid use in patients with known hypersensitivity to any component. |
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| Fertility Effects | No adverse effects on fertility reported in animal studies; insufficient human data. |