ULTRACEF
Clinical safety rating: caution
Comprehensive clinical and safety monograph for ULTRACEF (ULTRACEF).
Cefadroxil, a first-generation cephalosporin, inhibits bacterial cell wall synthesis by binding to penicillin-binding proteins (PBPs), inhibiting transpeptidation and disrupting peptidoglycan cross-linking, leading to cell lysis. It is bactericidal against susceptible organisms.
| Metabolism | Cefadroxil is not significantly metabolized; it is primarily excreted unchanged in urine via glomerular filtration and tubular secretion. |
| Excretion | Approximately 90% of an oral dose is excreted unchanged in urine via glomerular filtration and tubular secretion; less than 1% is excreted in feces via biliary elimination. |
| Half-life | 0.5–1.2 hours in normal renal function; prolonged to 2–4 hours in severe renal impairment (CrCl <10 mL/min). |
| Protein binding | ~25% bound to plasma proteins (primarily albumin). |
| Volume of Distribution | 0.2–0.3 L/kg, indicating distribution primarily in extracellular fluid. |
| Bioavailability | Oral: approximately 90% (capsule and suspension). |
| Onset of Action | Oral: 0.5–1 hour; intramuscular: 15–30 minutes. |
| Duration of Action | 4–6 hours or longer with probenecid; clinically, dosing every 6–12 hours depending on infection severity. |
| Action Class | Cephalosporins: 3 generation |
| Brand Substitutes | Emrocef 250mg Injection, Solfix-O 250mg Injection, Deczone 250mg Injection, Accuzon 250 Injection, Zikit 250mg Injection, Xone Hospital 1000mg Injection, Ritecef 1000mg Injection, Cefaxone 1gm Injection, Trixon 1000mg Injection, Ceftrax 1000mg Injection |
250 mg orally every 6 hours or 500 mg orally every 12 hours for uncomplicated urinary tract infections; 1 g orally every 12 hours for complicated urinary tract infections.
| Dosage form | TABLET |
| Renal impairment | CrCl 30-50 mL/min: 250 mg every 8 hours; CrCl 15-29 mL/min: 250 mg every 12 hours; CrCl 5-14 mL/min: 250 mg every 24 hours; CrCl <5 mL/min: 250 mg every 48 hours. |
| Liver impairment | No dose adjustment required for mild to moderate hepatic impairment; not studied in severe impairment. |
| Pediatric use | Children >1 month: 25-50 mg/kg/day orally divided every 6-8 hours for urinary tract infections; maximum 1 g/day. |
| Geriatric use | Start at lower end of dosing range due to age-related renal decline; adjust dose based on creatinine clearance. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for ULTRACEF (ULTRACEF).
| Breastfeeding | Excreted in breast milk in small amounts (M/P ratio ~0.08). Considered compatible with breastfeeding; monitor infant for diarrhea, rash, or sensitization. |
| Teratogenic Risk | FDA Category B. No evidence of teratogenicity in animal studies. Inadequate human data; however, penicillins are generally considered low risk. First trimester: insufficient data; second and third trimesters: no known fetal harm. |
| Fetal Monitoring |
■ FDA Black Box Warning
None.
| Serious Effects |
["Hypersensitivity to cefadroxil, other cephalosporins, or any component of the formulation","Contraindicated in patients with known severe immediate-type hypersensitivity to penicillins (cross-sensitivity and anaphylaxis risk)"]
| Precautions | ["Serious hypersensitivity reactions (anaphylaxis) may occur, especially in penicillin-allergic patients.","Clostridium difficile-associated diarrhea (CDAD) ranging from mild diarrhea to fatal colitis.","Dosage adjustment required in renal impairment (CrCl <30 mL/min) to avoid accumulation.","Prolonged use may result in overgrowth of non-susceptible organisms including fungi.","Cefadroxil may cause false-positive direct Coombs test and false-positive urine glucose tests with non-enzymatic methods."] |
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| Monitor for signs of hypersensitivity, diarrhea, and superinfection. In pregnancy, assess renal function and complete blood count periodically. |
| Fertility Effects | No adverse effects on fertility reported in animal studies. Human data lacking. |