VELOSEF '250'
Clinical safety rating: caution
Comprehensive clinical and safety monograph for VELOSEF '250' (VELOSEF '250').
Bactericidal antibiotic that inhibits cell wall synthesis by binding to penicillin-binding proteins (PBPs), specifically inhibiting transpeptidase activity, leading to cell lysis.
| Metabolism | Cephradine is predominantly eliminated unchanged by the kidneys via tubular secretion and glomerular filtration. Minimal hepatic metabolism occurs via hydrolysis and N-acetylation. |
| Excretion | Primarily renal (80-90% unchanged by glomerular filtration and tubular secretion); remainder biliary/fecal (<10%) |
| Half-life | 1.2-1.5 hours in normal renal function; prolonged in renal impairment (up to 10-20 hours in ESRD) |
| Protein binding | 20-30% bound to serum albumin |
| Volume of Distribution | 0.2-0.3 L/kg; limited to extracellular fluid; higher in neonates (0.4-0.5 L/kg) |
| Bioavailability | Oral: 80-90% (with food: slightly reduced); Intramuscular: ~100% |
| Onset of Action | Oral: 1-2 hours; Intramuscular: 0.5-1 hour |
| Duration of Action | 6-8 hours (dose-dependent); reduces in severe infection due to increased clearance |
250 mg orally every 6 hours for adults with normal renal function.
| Dosage form | CAPSULE |
| Renal impairment | CrCl 30-50 mL/min: 250 mg every 8 hours; CrCl 10-29 mL/min: 250 mg every 12 hours; CrCl <10 mL/min: 250 mg every 24 hours. |
| Liver impairment | No specific adjustment required; dose as in normal hepatic function. |
| Pediatric use | Children: 25-50 mg/kg/day in divided doses every 6 hours. |
| Geriatric use | Adjust dose based on renal function; monitor for adverse effects due to age-related decline in renal function. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for VELOSEF '250' (VELOSEF '250').
| Breastfeeding | Cephradine is excreted in human breast milk in small amounts. The milk-to-plasma ratio is approximately 0.2. It is generally considered compatible with breastfeeding, but caution is advised as it may cause alteration of infant gut flora or allergic sensitization. |
| Teratogenic Risk | VELOSEF (cephradine) is a first-generation cephalosporin. Animal studies have not shown teratogenic effects. There are no adequate and well-controlled studies in pregnant women. However, cephalosporins are generally considered low risk during pregnancy. No specific fetal risks have been identified in the first, second, or third trimester. FDA Pregnancy Category B. |
■ FDA Black Box Warning
None
| Serious Effects |
["Hypersensitivity to cephalosporins or any component of the formulation","Severe immediate hypersensitivity reaction to penicillins (cross-sensitivity)"]
| Precautions | ["Hypersensitivity reactions (including anaphylaxis, Stevens-Johnson syndrome)","Clostridium difficile-associated diarrhea (CDAD)","Renal impairment (dose adjustment required)","Prolonged use may lead to superinfection","Seizures (especially in patients with renal impairment)","Interference with Coombs test and urine glucose tests (false positives)"] |
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| Fetal Monitoring | Standard prenatal monitoring with no specific additional monitoring required. However, monitor for signs of allergic reactions or gastrointestinal disturbances in the mother. No specific fetal monitoring indicated. |
| Fertility Effects | No known adverse effects on fertility. Animal studies have not shown impaired fertility. |