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. |
| Molecular Weight | 327.39 |
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 | Avoid due to potential teratogenicity in animal studies. |
| 2nd trimester | Use only if clearly needed, no well-controlled human studies. |
| 3rd trimester | Avoid during labor as may cause neonatal respiratory depression. |
Clinical note
Comprehensive clinical and safety monograph for DISPERMOX (DISPERMOX).
| Placental transfer | Crosses placenta readily, achieving fetal serum levels similar to maternal. |
| Breastfeeding | Excreted in breast milk in small amounts; monitor infant for drowsiness or breathing difficulty. |
| Lactation Rating | L4 (Possibly Hazardous) |
■ FDA Black Box Warning
No FDA black box warning.
| Serious Effects |
Known hypersensitivity to drugSevere respiratory depressionAcute or severe bronchial asthma
| 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. |
| Food/Dietary | May be taken with food to reduce gastrointestinal upset. Avoid alcohol as it may increase risk of liver toxicity. No significant drug-food interactions beyond GI tolerability. |
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| 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. |
| 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. |
| Clinical Pearls |
| DISPERMOX (amoxicillin/clavulanate) should be taken with food to reduce gastrointestinal upset. Adjust dose for renal impairment (CrCl <30 mL/min). Not effective against MRSA. Use with caution in patients with hepatic impairment or mononucleosis due to increased rash risk. |
| Patient Advice | Take exactly as prescribed; complete the full course even if you feel better. · Take with food or milk to prevent stomach upset. · Shake oral suspension well before each use; measure dose carefully. · Report any skin rash, severe diarrhea, or signs of liver problems (jaundice, dark urine) immediately. · May reduce effectiveness of oral contraceptives; use backup birth control. |