WYMOX
Clinical safety rating: caution
Comprehensive clinical and safety monograph for WYMOX (WYMOX).
Amoxicillin is a semisynthetic penicillin antibiotic that inhibits bacterial cell wall synthesis by binding to penicillin-binding proteins (PBPs), leading to cell lysis and death.
| Metabolism | Amoxicillin is primarily metabolized by hydrolysis to inactive penicilloic acid via hepatic and renal pathways. Renal excretion of unchanged drug accounts for 60-80% of elimination. |
| Excretion | Renal: 60-70% unchanged via glomerular filtration and tubular secretion; biliary: <5%; fecal: <5%. |
| Half-life | 0.7-1.4 hours (mean ~1 hour) in adults with normal renal function; prolonged to 2-6 hours in anuria. |
| Protein binding | 17-20% bound to serum albumin. |
| Volume of Distribution | 0.26-0.42 L/kg; approximates extracellular fluid volume; higher in neonates (0.6-0.8 L/kg). |
| Bioavailability | Oral: 50-70% (decreased by food); IM: 100% (complete absorption from depot site). |
| Onset of Action | Oral: 0.5-1 hour; IV: immediate; IM: 15-30 minutes. |
| Duration of Action | Oral: 6-8 hours; IV/IM: 4-6 hours; clinical effect corresponds to serum levels above MIC. |
| Action Class | Cell wall active agent -Extended spectrum Penicillin |
| Brand Substitutes | Cipmox 500 Capsule, Tidoxyl 500mg Capsule, Actimox 500mg Capsule, SB Mox 500mg Capsule, Lizamox 500mg Capsule, Amoxipen 250mg Capsule, Hipen A 250mg Capsule, Moxipal 250mg Capsule, Amoxil 250mg Capsule, Moxikem 250mg Capsule, Amox C 500mg Injection, Amoxil 500mg Injection, Optimox 500mg Injection, Mox 500mg Injection, Vexicin 500mg Injection, Amox C 250mg Injection, Optimox 250mg Injection, Mox 250mg Injection |
250-500 mg orally every 8 hours or 500-875 mg orally every 12 hours for 7-14 days; maximum 4 g/day.
| Dosage form | CAPSULE |
| Renal impairment | GFR 10-50 mL/min: 250-500 mg every 12-24 hours; GFR <10 mL/min: 250-500 mg every 24-48 hours; hemodialysis: dose after dialysis. |
| Liver impairment | No adjustment required for mild to moderate impairment; use caution in severe impairment. |
| Pediatric use | Children weighing <40 kg: 20-40 mg/kg/day in divided doses every 8 hours or 25-45 mg/kg/day in divided doses every 12 hours; maximum 3 g/day. |
| Geriatric use | No specific adjustment needed; monitor renal function and adjust based on creatinine clearance; use lowest effective dose. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for WYMOX (WYMOX).
| Breastfeeding | Amoxicillin is excreted into breast milk in low concentrations. M/P ratio approximately 0.014–0.04. Considered compatible with breastfeeding; monitor infant for rash, diarrhea, or thrush. |
| Teratogenic Risk | WYMOX (amoxicillin) is classified as FDA Pregnancy Category B. No evidence of teratogenicity in animal studies. Avoid use in first trimester unless clearly needed; potential for altered gut flora and diarrhea in neonates if used near term. No known major malformations risk. |
| Fetal Monitoring |
■ FDA Black Box Warning
No FDA black box warnings.
| Serious Effects |
["Known hypersensitivity to penicillins or cephalosporins","History of anaphylactic reaction to penicillins"]
| Precautions | ["Serious hypersensitivity reactions (anaphylaxis) may occur","Clostridioides difficile-associated diarrhea (CDAD)","Skin rash (especially in patients with mononucleosis)","Prolonged therapy may cause superinfection","Renal impairment requires dose adjustment"] |
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| Monitor for maternal hypersensitivity reactions (rash, anaphylaxis). No specific fetal monitoring required unless signs of infection or maternal compromise. |
| Fertility Effects | No adverse effects on fertility reported in animal or human studies. |