DISPERMOX
Clinical safety rating: caution
Comprehensive clinical and safety monograph for DISPERMOX (DISPERMOX).
Amoxicillin inhibits bacterial cell wall synthesis by binding to penicillin-binding proteins (PBPs), inhibiting transpeptidase activity and disrupting peptidoglycan cross-linking.
| Metabolism | Amoxicillin is primarily metabolized by hydrolysis to penicilloic acid, which is excreted renally. Minor hepatic metabolism occurs via glucuronidation. |
| Excretion | Renal excretion 80% as unchanged drug, biliary/fecal 10%. |
| Half-life | Terminal elimination half-life 1.5 hours; prolonged in renal impairment. |
| Protein binding | 15-30% bound to albumin. |
| Volume of Distribution | 0.3 L/kg; distributes primarily in extracellular fluid. |
| Bioavailability | Oral: 80-90%; IM: 95%. |
| Onset of Action | Oral: 1-2 hours; IV: immediate. |
| Duration of Action | 6-8 hours; increased in renal failure. |
Adults: 1 g (as amoxicillin 875 mg + clavulanate 125 mg) orally every 12 hours for 7-10 days.
| Dosage form | TABLET, FOR SUSPENSION |
| Renal impairment | For GFR 10-30 mL/min: 500 mg (amoxicillin 500 mg + clavulanate 125 mg) every 12 hours. For GFR <10 mL/min: 500 mg every 24 hours. Hemodialysis: 500 mg every 24 hours, supplement during and after dialysis. |
| Liver impairment | Contraindicated in Child-Pugh Class C. Child-Pugh A or B: Use with caution; no specific dose adjustment established. |
| Pediatric use | For children <40 kg: Based on amoxicillin component, using 45 mg/kg/day divided every 12 hours (e.g., 25 mg/kg/dose every 12 hours) for 10 days. Maximum 875 mg amoxicillin per dose. |
| Geriatric use | Renal function should be assessed. Dose adjustment follows renal impairment guidelines. No specific age-related dose recommendation. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for DISPERMOX (DISPERMOX).
| Breastfeeding | Amoxicillin is excreted into human breast milk in low concentrations (M/P ratio ~0.01-0.04). The American Academy of Pediatrics considers amoxicillin compatible with breastfeeding. Theoretical risks include alteration of infant gut flora and allergic sensitization, but adverse effects are rare. Monitor infant for diarrhea or rash. |
| Teratogenic Risk | DISPERMOX (amoxicillin) is classified as FDA Pregnancy Category B. Animal studies have not demonstrated fetal risk, and there are no adequate well-controlled studies in pregnant women. However, amoxicillin crosses the placenta. First trimester exposure is not associated with major congenital malformations. Second and third trimester use is considered low risk. Potential risks include alteration of neonatal gut flora, but no specific teratogenic effects are established. Caution in premature infants due to immature renal function. |
■ FDA Black Box Warning
No FDA black box warning.
| Serious Effects |
["Hypersensitivity to amoxicillin, any penicillin, or any component of the formulation.","History of immediate hypersensitivity reaction (e.g., anaphylaxis, Stevens-Johnson syndrome) to any beta-lactam antibiotic."]
| Precautions | ["Serious and occasionally fatal hypersensitivity reactions (anaphylaxis) have been reported.","Clostridium difficile-associated diarrhea (CDAD) may occur.","Hepatotoxicity, including hepatic dysfunction and cholestatic jaundice.","Renal impairment requires dose adjustment; monitor renal function.","Prolonged use may result in superinfection."] |
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| Fetal Monitoring | Monitor maternal renal function and signs of hypersensitivity. Fetal monitoring not routinely required, but assess for potential effects on fetal gut flora with prolonged use. In high-dose therapy, monitor for electrolyte imbalances. No specific fetal heart rate or growth monitoring indicated. |
| Fertility Effects | Amoxicillin has no direct effects on human fertility. Standard animal studies show no impairment of fertility. However, alteration of gut microbiota by antibiotics may indirectly affect reproductive health, but no specific data for amoxicillin. |