NEOSPORIN G.U. IRRIGANT
Clinical safety rating: caution
Comprehensive clinical and safety monograph for NEOSPORIN G.U. IRRIGANT (NEOSPORIN G.U. IRRIGANT).
Neosporin G.U. Irrigant is a combination of neomycin and polymyxin B. Neomycin is an aminoglycoside antibiotic that binds to the 30S ribosomal subunit, inhibiting bacterial protein synthesis. Polymyxin B is a polymyxin antibiotic that disrupts bacterial cell membrane permeability by binding to lipopolysaccharides, leading to cell death.
| Metabolism | Neomycin is minimally absorbed when applied topically as an irrigant; systemic absorption is negligible. Polymyxin B is not absorbed to a significant extent via irrigation. Metabolism is not well characterized due to minimal systemic exposure. |
| Excretion | Renal excretion of intact drug: ~80–90% for neomycin, ~1–3% for polymyxin B; negligible fecal elimination. |
| Half-life | Neomycin: 2–3 hours (normal renal function); prolonged in renal impairment. Polymyxin B: 4–6 hours (normal renal function); 2–3 days in anuria. |
| Protein binding | Neomycin: 0–30% bound to plasma proteins. Polymyxin B: ~50–60% bound to plasma proteins. |
| Volume of Distribution | Neomycin: 0.1–0.3 L/kg (extracellular fluid). Polymyxin B: 0.5–0.6 L/kg (largely extracellular). |
| Bioavailability | Oral: <3% for neomycin; negligible for polymyxin B. Topical (bladder): minimally absorbed; bioavailability considered negligible (<1%). |
| Onset of Action | Topical (bladder irrigation): immediate upon contact through direct antibacterial action. |
| Duration of Action | Duration: 6–8 hours after single irrigation; clinical effect persists while drug remains in contact with mucosa. |
1 mL of Neosporin G.U. Irrigant (containing 40 mg neomycin sulfate and 200,000 units polymyxin B sulfate) per 1 L sterile isotonic saline solution, used for continuous bladder irrigation. Typical adult dose: 1 L of this solution per 24 hours via continuous irrigation.
| Dosage form | SOLUTION |
| Renal impairment | Contraindicated in patients with renal impairment (eGFR < 30 mL/min/1.73 m²) due to risk of systemic absorption and nephrotoxicity. For GFR 30-50 mL/min/1.73 m², use with extreme caution and monitor serum neomycin levels and renal function; consider reducing irrigation rate or frequency. For GFR > 50 mL/min/1.73 m², no adjustment specified, but monitor renal function. |
| Liver impairment | No specific hepatic adjustments; not hepatically metabolized. Use caution in severe hepatic disease due to potential for systemic absorption and additive toxicity. |
| Pediatric use | Safety and effectiveness in pediatric patients have not been established. Not recommended for use in children. |
| Geriatric use | Elderly patients are more susceptible to nephrotoxicity and ototoxicity from aminoglycosides; use only if clearly needed and monitor renal function and drug levels closely. Adjust irrigation rate based on renal function per renal adjustment guidelines. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for NEOSPORIN G.U. IRRIGANT (NEOSPORIN G.U. IRRIGANT).
| Breastfeeding | Unknown excretion in breast milk; minimal systemic absorption. M/P ratio not determined. Use with caution. |
| Teratogenic Risk | First trimester: Aminoglycosides (neomycin, polymyxin B) are not associated with major congenital malformations. Second and third trimesters: Theoretical risk of fetal nephrotoxicity and ototoxicity if significant systemic absorption occurs, but negligible with irrigation. Fetal risk not established. |
| Fetal Monitoring |
■ FDA Black Box Warning
Irreversible bilateral cochlear ototoxicity and nephrotoxicity may occur if absorbed systemically. Prolonged use may result in overgrowth of nonsusceptible organisms including fungi. Not for injection; for irrigation use only.
| Serious Effects |
["Hypersensitivity to neomycin, polymyxin B, or any component of the formulation","Systemic use (for injection) is contraindicated","Pre-existing cochlear damage or renal impairment (relative)"]
| Precautions | ["Risk of ototoxicity and nephrotoxicity if absorbed systemically","Caution in patients with renal impairment","Monitor for signs of systemic absorption","Prolonged use may lead to superinfection","Do not use for irrigation in patients with known hypersensitivity to any component","Aminoglycoside-induced neuromuscular blockade risk"] |
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| Monitor serum neomycin/polymyxin B levels if large volumes or impaired renal function. Assess renal function and hearing in mother and neonate if prolonged use. |
| Fertility Effects | No known adverse effects on fertility from topical irrigation. |