POLYMOX
Clinical safety rating: caution
Comprehensive clinical and safety monograph for POLYMOX (POLYMOX).
Amoxicillin is a bactericidal antibiotic that inhibits bacterial cell wall synthesis by binding to penicillin-binding proteins (PBPs) and inhibiting transpeptidase activity, leading to cell lysis.
| Metabolism | Amoxicillin is primarily metabolized by hydrolysis of the beta-lactam ring to inactive metabolites. It is partially metabolized by hepatic enzymes, but the exact pathways are not well defined. |
| Excretion | Renal (70-80% unchanged via tubular secretion and glomerular filtration); biliary/fecal (small amount, <5%) |
| Half-life | Terminal elimination half-life = 1-1.5 hours in adults; prolonged in renal impairment (up to 12-20 hours in anuria) |
| Protein binding | ~20% bound to serum albumin |
| Volume of Distribution | 0.3-0.4 L/kg; indicates distribution primarily into extracellular fluid |
| Bioavailability | Oral: 50-70% (decreased by food); IM: ~100% |
| Onset of Action | Oral: 30-60 minutes; IV/IM: immediate (within minutes) |
| Duration of Action | 6-8 hours (oral); 4-6 hours (IV/IM); short half-life necessitates frequent dosing |
| Brand Substitutes | Moxiken CL 250 mg/250 mg Capsule, Lariclox 250mg/250mg Capsule, Stamox 250 mg/250 mg Capsule, Kokkos 250mg/250mg Capsule, Nemoclox 250 mg/250 mg Capsule |
250-500 mg orally every 8 hours or 500-875 mg orally every 12 hours; maximum 4 g/day.
| Dosage form | FOR SUSPENSION |
| Renal impairment | CrCl >30 mL/min: no adjustment; CrCl 10-30 mL/min: 250-500 mg every 12 hours; CrCl <10 mL/min: 250-500 mg every 24 hours. |
| Liver impairment | No dose adjustment required for mild to moderate hepatic impairment; Child-Pugh C: consider dose reduction or increased dosing interval (specific recommendations not established). |
| Pediatric use | Neonates and infants <3 months: 30 mg/kg/day divided every 12 hours; Children ≥3 months and <40 kg: 25-50 mg/kg/day divided every 8 hours or 45-90 mg/kg/day divided every 12 hours; maximum 2-3 g/day. |
| Geriatric use | No specific dose adjustment; monitor renal function and adjust according to creatinine clearance; increased risk of adverse effects due to age-related renal decline. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for POLYMOX (POLYMOX).
| Breastfeeding | Amoxicillin is excreted into breast milk in low concentrations (M/P ratio approximately 0.01-0.04). Generally considered compatible with breastfeeding. Monitor infant for potential gastrointestinal disturbances (diarrhea, candidiasis) or rash. No known adverse effects from typical maternal doses. |
| Teratogenic Risk | Polymox (amoxicillin) is classified as FDA Pregnancy Category B. No evidence of teratogenicity in animal studies. Limited human data show no increased risk of major birth defects. First trimester: no documented risk; second and third trimesters: considered safe when indicated. However, theoretical risk of altered gut flora in neonate if administered near term. |
■ FDA Black Box Warning
No FDA black box warning.
| Serious Effects |
["Hypersensitivity to amoxicillin, penicillin, or any component of the formulation","Previous history of severe hypersensitivity reaction to any beta-lactam antibiotic"]
| Precautions | ["Serious hypersensitivity reactions (anaphylaxis) may occur","Clostridium difficile-associated diarrhea (CDAD) can occur","Development of drug-resistant bacteria","Use with caution in patients with mononucleosis due to high incidence of maculopapular rash","Renal impairment may require dose adjustment"] |
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| Fetal Monitoring | No specific fetal monitoring required. For prolonged therapy, consider maternal monitoring for signs of superinfection, gastrointestinal adverse effects, or allergic reactions. In neonates, observe for rash, diarrhea, or signs of hypersensitivity. |
| Fertility Effects | No known adverse effects on human fertility. In animal studies, no impairment of fertility or reproductive performance at therapeutic doses. |