SPECTRACEF
Clinical safety rating: caution
Comprehensive clinical and safety monograph for SPECTRACEF (SPECTRACEF).
Cefditoren, a third-generation cephalosporin, inhibits bacterial cell wall synthesis by binding to penicillin-binding proteins (PBPs), leading to cell lysis and death.
| Metabolism | Cefditoren pivoxil (prodrug) is hydrolyzed to cefditoren by esterases; cefditoren is not significantly metabolized by the liver. Excretion is primarily renal via tubular secretion. |
| Excretion | Renal: 88% as unchanged drug, Fecal: negligible, Biliary: minimal |
| Half-life | Terminal elimination half-life: 2.5 hours (range 2.0-3.0 hours) in healthy adults; prolonged in renal impairment (up to 10 hours in severe impairment) |
| Protein binding | Protein binding: 65-75%, primarily to albumin |
| Volume of Distribution | Volume of distribution: 0.3-0.5 L/kg; indicates distribution primarily into extracellular fluid and tissues |
| Bioavailability | Oral bioavailability: 90-95% (tablet) and 80-90% (oral suspension) |
| Onset of Action | Oral: Rapid absorption; peak serum concentrations at 2-3 hours; clinical effect within 24-48 hours for most infections |
| Duration of Action | Duration: 12 hours (bactericidal levels persist); dosing every 12 hours for most indications |
400 mg orally twice daily for 10-14 days.
| Dosage form | TABLET |
| Renal impairment | CrCl 30-49 mL/min: 200 mg twice daily; CrCl 15-29 mL/min: 200 mg every 24 hours; CrCl <15 mL/min or hemodialysis: 200 mg every 24 hours. |
| Liver impairment | No specific adjustment recommended for mild to moderate hepatic impairment; contraindicated in severe hepatic impairment (Child-Pugh C) due to lack of data. |
| Pediatric use | For patients 12 years and older: 400 mg twice daily. Safety and efficacy in patients under 12 years not established. |
| Geriatric use | Adjust dose based on renal function; elderly patients are more likely to have decreased renal function, so monitor CrCl and adjust accordingly. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for SPECTRACEF (SPECTRACEF).
| Breastfeeding | Excreted in human milk in low amounts; M/P ratio unknown. Caution advised; use only if clearly needed. |
| Teratogenic Risk | Insufficient human data; animal studies show no evidence of fetal harm at clinically relevant doses. Generally considered low risk; avoid in first trimester unless necessary. |
| Fetal Monitoring | No specific monitoring required; standard prenatal care. |
■ FDA Black Box Warning
No FDA black box warning is present for this drug.
| Common Effects | Increased heart rate Blurred vision Constipation Difficulty in urination Dryness in mouth Orthostatic hypotension sudden lowering of blood pressure on standing Weight gain |
| Serious Effects |
["Hypersensitivity to cefditoren, other cephalosporins, or any component of the formulation","Patients with carnitine deficiency or inborn errors of metabolism that require carnitine supplementation (due to pivalic acid release leading to decreased carnitine levels)"]
| Precautions | ["Hypersensitivity reactions, including anaphylaxis, particularly in patients with penicillin allergy","Clostridium difficile-associated diarrhea (CDAD)","Risk of bleeding with vitamin K deficiency or anticoagulant use due to reduction of vitamin K-producing gut flora","Renal impairment: dose adjustment required for CrCl <50 mL/min","Potential for false-positive urinary glucose tests (Clinitest) and direct Coombs test"] |
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| Fertility Effects | No known adverse effects on fertility in animal studies. |