VELOSEF '125'
Clinical safety rating: caution
Comprehensive clinical and safety monograph for VELOSEF '125' (VELOSEF '125').
Cephalexin is a first-generation cephalosporin antibiotic that inhibits bacterial cell wall synthesis by binding to penicillin-binding proteins (PBPs), inhibiting peptidoglycan cross-linking, leading to cell lysis.
| Metabolism | Primarily excreted unchanged in urine via glomerular filtration and tubular secretion; minor hepatic metabolism (less than 10%) via deacetylation. |
| Excretion | Renal: 80-90% unchanged via glomerular filtration and tubular secretion; biliary/fecal: <5% |
| Half-life | Terminal elimination half-life: 0.5-1.0 hour (normal renal function); prolonged to 10-20 hours in severe renal impairment (CrCl <10 mL/min) |
| Protein binding | 10-15% bound to serum albumin |
| Volume of Distribution | 0.2-0.4 L/kg (indicates distribution primarily in extracellular fluid) |
| Bioavailability | Oral: 90-95% (capsule); IM: 80-90% (relative to IV) |
| Onset of Action | Oral: 30-60 minutes; Intramuscular: 15-30 minutes; Intravenous: immediate |
| Duration of Action | 6-8 hours (dose-dependent; extended with probenecid co-administration) |
500 mg orally every 6 hours for uncomplicated infections; 1 g orally every 6 hours for more severe infections.
| Dosage form | FOR SUSPENSION |
| Renal impairment | CrCl 50-80 mL/min: 500 mg every 8 hours; CrCl 10-49 mL/min: 500 mg every 12 hours; CrCl <10 mL/min: 500 mg every 24 hours. |
| Liver impairment | No clinically significant adjustment required; no Child-Pugh based modifications established. |
| Pediatric use | 25-50 mg/kg/day in 4 divided doses every 6 hours; maximum 1 g/day. |
| Geriatric use | No specific adjustment based on age alone; adjust dose for renal function per CrCl. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for VELOSEF '125' (VELOSEF '125').
| Breastfeeding | Cefradine (Velosef) is excreted into breast milk in low concentrations (M/P ratio approximately 0.1). Generally considered compatible with breastfeeding; observe infant for diarrhea or rash. |
| Teratogenic Risk | Cephalosporins (FDA category B). No fetal risk observed in animal studies; no adequate human studies. Use only if clearly needed. No known teratogenicity in any trimester. |
| Fetal Monitoring |
■ FDA Black Box Warning
No FDA boxed warning.
| Serious Effects |
["Known hypersensitivity to cephalexin or other cephalosporins","Hypersensitivity to penicillins (cross-sensitivity)"]
| Precautions | ["Serious hypersensitivity reactions (anaphylaxis) possible, especially in penicillin-allergic patients","Clostridioides difficile-associated diarrhea (CDAD) may occur","Renal impairment requires dose adjustment (creatinine clearance <30 mL/min)","Prolonged use may result in overgrowth of nonsusceptible organisms","Positive direct Coombs' test may develop"] |
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| Monitor maternal renal function, CBC, and stool for signs of superinfection or C. difficile colitis. No specific fetal monitoring beyond routine antenatal care. |
| Fertility Effects | No known adverse effects on human fertility based on animal data and limited human experience; no specific fertility studies. |