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. |
| Molecular Weight | 365.4 |
| 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 | Amoxicillin crosses the placenta; generally considered safe but use only if clearly needed. No evidence of teratogenicity. |
| 2nd trimester | Safe; commonly used for infections during pregnancy. |
| 3rd trimester | Safe; no known adverse effects on fetus or neonate. |
Clinical note
Comprehensive clinical and safety monograph for WYMOX (WYMOX).
| Placental transfer | Amoxicillin crosses the placenta; achieves therapeutic levels in fetal circulation. |
| Breastfeeding | Amoxicillin is excreted into breast milk in small amounts; unlikely to cause adverse effects in infants. Use with caution in infants with history of allergy or diarrhea. |
| Lactation Rating |
■ FDA Black Box Warning
No FDA black box warnings.
| Serious Effects |
Hypersensitivity to amoxicillin or any penicillinHistory of anaphylactic reaction to beta-lactam antibiotics
| 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 |
| Food/Dietary | Take with or without food; food may reduce gastrointestinal upset. Avoid alcohol as it may increase risk of side effects. No significant food-drug interactions beyond potential for reduced absorption with high-fiber foods. |
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| L1 (Safe) |
| 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 | 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. |
| Clinical Pearls |
| WYMOX (amoxicillin) is a penicillin-class antibiotic. Use with caution in patients with mononucleosis due to high risk of maculopapular rash. Ensure complete course despite symptom improvement. Allergic cross-reactivity with cephalosporins occurs in ~1% of cases. |
| Patient Advice | Take exactly as prescribed; complete the full course even if you feel better. · If you miss a dose, take it as soon as possible unless it is almost time for the next dose; do not double doses. · Common side effects include diarrhea, nausea, and skin rash. Contact your doctor if severe diarrhea or rash occurs. · Do not take WYMOX if you are allergic to penicillins or cephalosporins. · Use effective contraception if you are of childbearing age; inform your doctor if you become pregnant. |