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. |
| Molecular Weight | 677.72 |
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 | No adequate studies in pregnant women; use only if potential benefit justifies potential risk to fetus. Animal studies have shown adverse effects. |
| 2nd trimester | Same as t1. |
| 3rd trimester | Same as t1. |
Clinical note
Comprehensive clinical and safety monograph for NEOBIOTIC (NEOBIOTIC).
| Placental transfer | Not established; likely crosses placenta based on molecular weight and animal data. |
| Breastfeeding | Not recommended during breastfeeding due to potential for serious adverse reactions in nursing infants. Excretion in milk is unknown. |
| Lactation Rating | Avoid |
■ FDA Black Box Warning
None
| Serious Effects |
Hypersensitivity to Neomycin or any componentIntestinal obstructionInflammatory bowel disease
| 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. |
| Food/Dietary | No significant food interactions reported for topical use. Avoid consuming spoiled or contaminated food as a general precaution, but no specific restrictions apply. |
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| 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. |
| Fertility Effects | No adverse effects on fertility reported in animal studies; insufficient human data. |
| Clinical Pearls |
| NEOBIOTIC is a combination product containing neomycin, polymyxin B, and bacitracin, used for topical infections. Avoid use on large areas of broken skin due to risk of systemic absorption, especially neomycin's nephrotoxicity and ototoxicity. Monitor for hypersensitivity reactions (e.g., contact dermatitis) with prolonged use. Do not apply to eyes or mucous membranes. |
| Patient Advice | Apply a thin layer to the affected area 1-3 times daily as directed. · Wash hands before and after application unless treating hands. · Avoid contact with eyes, mouth, or nose; if contact occurs, rinse with water. · Do not use on large areas of skin or for longer than 1 week unless directed by doctor. · Stop use and consult doctor if rash, swelling, or irritation develops. · Inform your doctor if you have kidney disease or hearing problems before use. |