NEOPAP
Clinical safety rating: caution
Comprehensive clinical and safety monograph for NEOPAP (NEOPAP).
NEOPAP (neomycin/polymyxin B) is a combination antibiotic. Neomycin is an aminoglycoside that binds to the 30S ribosomal subunit, inhibiting bacterial protein synthesis. Polymyxin B is a polymyxin antibiotic that disrupts bacterial cell membrane integrity by binding to lipopolysaccharides, leading to cell death.
| Metabolism | Minimally metabolized; neomycin is poorly absorbed from the gastrointestinal tract, but systemic absorption from ophthalmic/otic use is negligible. Polymyxin B is not significantly metabolized. |
| Excretion | Renal excretion of unchanged drug accounts for approximately 30% of the dose; the remainder is metabolized hepatically and eliminated via bile into feces. |
| Half-life | Terminal elimination half-life is 2-3 hours in healthy adults; may be prolonged in hepatic impairment. |
| Protein binding | Approximately 98% bound primarily to albumin. |
| Volume of Distribution | 0.2-0.3 L/kg, indicating distribution largely restricted to plasma and extracellular fluid. |
| Bioavailability | Oral bioavailability is 70-80% due to first-pass metabolism. |
| Onset of Action | Intravenous: 5-10 minutes; Oral: 30-60 minutes. |
| Duration of Action | 2-4 hours with a single dose; may be extended with higher doses or in hepatic dysfunction. |
Not established. NEOPAP is not a recognized drug; no dosing information available.
| Dosage form | SUPPOSITORY |
| Renal impairment | Insufficient data; no specific GFR-based recommendations. |
| Liver impairment | Insufficient data; no Child-Pugh based adjustments. |
| Pediatric use | No established pediatric dosing for NEOPAP. |
| Geriatric use | No specific geriatric dosing recommendations for NEOPAP. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for NEOPAP (NEOPAP).
| Breastfeeding | Excretion in human milk unknown; due to potential for adverse effects (e.g., diarrhea, hypotension) in nursing infants, discontinue breastfeeding or the drug. M/P ratio unknown. |
| Teratogenic Risk | NEOPAP is a prostaglandin analog; contraindicated in pregnancy due to high teratogenicity. First trimester: Uterine contractions, fetal bradycardia, and malformations. Second/third trimester: Abortifacient, premature labor, fetal hypoxia. |
| Fetal Monitoring |
■ FDA Black Box Warning
None for ophthalmic/otic use; however, neomycin systemic absorption may cause nephrotoxicity and ototoxicity, and caution is advised in patients with renal impairment or hearing loss.
| Serious Effects |
["Hypersensitivity to neomycin, polymyxin B, or any component of the formulation","Ophthalmic use in patients with viral (e.g., herpes simplex) or fungal infections of the eye","In patients with a history of neomycin-induced ototoxicity or nephrotoxicity"]
| Precautions | ["Potential for hypersensitivity reactions, including contact dermatitis","Prolonged use may result in overgrowth of nonsusceptible organisms, including fungi","Caution in patients with pre-existing renal impairment or hearing loss due to potential systemic absorption of neomycin","Avoid use in patients with known hypersensitivity to any component","For ophthalmic use only, not for injection"] |
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| Uterine activity monitoring, fetal heart rate monitoring during administration; assess for signs of uterine hyperstimulation. Discontinue if sustained uterine hypertonus or fetal distress occurs. |
| Fertility Effects | May impair fertility due to luteolytic effects; disruption of corpus luteum function may interfere with implantation. |