NEO-FRADIN
Clinical safety rating: caution
Comprehensive clinical and safety monograph for NEO-FRADIN (NEO-FRADIN).
Neomycin is an aminoglycoside antibiotic that binds to the 30S ribosomal subunit, causing misreading of mRNA and inhibiting bacterial protein synthesis. It also disrupts bacterial cell membrane integrity.
| Metabolism | Neomycin is minimally absorbed after oral administration; it is primarily excreted unchanged in feces. Any absorbed fraction is metabolized to a limited extent but specific pathways are not well defined; renal excretion accounts for elimination of absorbed drug. |
| Excretion | Renal: >90% unchanged drug via glomerular filtration, with small amount reabsorbed; biliary/fecal: <2%. |
| Half-life | 2-3 hours in normal renal function; prolonged to 24-30 hours in anuria or severe renal impairment; no significant change in hepatic disease. |
| Protein binding | 0-30% bound, primarily to albumin; binding is minimal and not clinically significant. |
| Volume of Distribution | 0.25-0.40 L/kg; indicates distribution primarily into extracellular fluid (ECF); low Vd due to water solubility and poor tissue penetration. |
| Bioavailability | Oral: <3% due to poor GI absorption; IM: 100% (administered as sulfate salt). |
| Onset of Action | Oral: not absorbed; IM: 1 hour for peak serum levels; topical: 2-4 hours for local effect. |
| Duration of Action | IM: 8-12 hours for antibacterial effect; topical: variable, typically 6-8 hours; oral: not applicable due to lack of absorption. |
50-100 mg/kg/day orally in 3-4 divided doses. Maximum 3 g/day.
| Dosage form | SOLUTION |
| Renal impairment | GFR >50 mL/min: no adjustment; GFR 10-50 mL/min: 50-75% of normal dose every 8-12 hours; GFR <10 mL/min: 25% of normal dose every 12 hours or 50% every 24 hours. Adjust based on serum levels. |
| Liver impairment | No specific adjustment required. Use with caution in severe hepatic impairment. |
| Pediatric use | Infants and children: 50-100 mg/kg/day orally in 3-4 divided doses. Neonates: 0-7 days: 25 mg/kg every 12 hours; >7 days: 25 mg/kg every 6-8 hours. |
| Geriatric use | Consider age-related renal impairment; adjust dose based on creatinine clearance. Monitor renal function and hearing. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for NEO-FRADIN (NEO-FRADIN).
| Breastfeeding | Minimal excretion into breast milk due to poor oral absorption. M/P ratio not established. Considered compatible with breastfeeding by AAP and WHO, but monitor infant for diarrhea or changes in gut flora. Use topical forms with caution on large areas or broken skin. |
| Teratogenic Risk | Neomycin (NEO-FRADIN) is an aminoglycoside antibiotic. It is poorly absorbed orally (<3%) but can accumulate with renal impairment. Systemic exposure during pregnancy may be associated with fetal ototoxicity and nephrotoxicity (8th cranial nerve damage) due to aminoglycoside class effects. Limited human data; animal studies show no consistent teratogenicity. Use only if clearly needed, with caution in all trimesters. Risk minimal if administered topically due to negligible absorption. |
■ FDA Black Box Warning
Aminoglycosides are associated with nephrotoxicity and ototoxicity (vestibular and auditory). Risk increases with high doses, prolonged use, renal impairment, and concurrent use of other ototoxic/nephrotoxic drugs. Neuromuscular blockade and respiratory paralysis have been reported, especially in patients with neuromuscular disorders or receiving anesthetics.
| Serious Effects |
["Hypersensitivity to neomycin or any aminoglycoside","Intestinal obstruction (for oral use)","Inflammatory bowel disease (risk of systemic absorption)","Concurrent use with other ototoxic or nephrotoxic drugs","Myasthenia gravis or other neuromuscular disorders (risk of neuromuscular blockade)"]
| Precautions | ["Monitor renal function and auditory function during therapy.","Use with caution in patients with pre-existing renal impairment, hearing loss, or neuromuscular disorders such as myasthenia gravis.","Avoid prolonged use due to risk of superinfection and malabsorption.","May cause Clostridium difficile-associated diarrhea.","Hypersensitivity reactions can occur."] |
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| Fetal Monitoring | Monitor maternal renal function (BUN, serum creatinine) and auditory function if prolonged use or high systemic absorption. In neonates exposed in utero, monitor for signs of ototoxicity (hearing tests) and nephrotoxicity (renal function). |
| Fertility Effects | No known direct effects on fertility. Animal studies show no impairment of fertility at therapeutic doses. Systemic aminoglycosides may cause male reproductive toxicity at high doses, but neomycin has minimal absorption. |