FORBAXIN
Clinical safety rating: caution
Comprehensive clinical and safety monograph for FORBAXIN (FORBAXIN).
FORBAXIN is a prodrug of the active moiety cefditoren, a cephalosporin antibiotic that inhibits bacterial cell wall synthesis by binding to penicillin-binding proteins (PBPs), leading to cell lysis and death.
| Metabolism | Cefditoren pivoxil is hydrolyzed by esterases to cefditoren, which is minimally metabolized. The prodrug is not significantly metabolized by CYP450 enzymes. |
| Excretion | Renal (60-70% unchanged), biliary/fecal (20-30%) |
| Half-life | 8-12 hours; prolonged in renal impairment (up to 24 hours in severe cases) |
| Protein binding | 30-40% bound to albumin |
| Volume of Distribution | 0.6-0.8 L/kg; indicates moderate tissue penetration |
| Bioavailability | Oral: 60-70%; Intravenous: 100% |
| Onset of Action | Intravenous: 15-30 minutes; Oral: 1-2 hours |
| Duration of Action | 12-24 hours; may be extended in hepatic impairment |
IV: 500 mg every 12 hours, infused over 30 minutes.
| Dosage form | TABLET |
| Renal impairment | CrCl 30-49 mL/min: 250 mg every 12 hours; CrCl 15-29 mL/min: 250 mg every 24 hours; CrCl <15 mL/min: 250 mg every 48 hours; hemodialysis: administer after dialysis. |
| Liver impairment | Child-Pugh A and B: no adjustment required; Child-Pugh C: not recommended, use alternative agent. |
| Pediatric use | Weight ≥40 kg: 500 mg IV every 12 hours; Weight <40 kg: 10 mg/kg IV every 12 hours, max 500 mg per dose. |
| Geriatric use | No specific dose adjustment based on age; adjust for renal function per renal_adjustment criteria. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for FORBAXIN (FORBAXIN).
| Breastfeeding | FORBAXIN is excreted in human breast milk. The milk-to-plasma ratio is approximately 0.8. Due to potential for serious adverse reactions in the breastfed infant, breastfeeding is not recommended during treatment and for 5 days after the last dose. |
| Teratogenic Risk | FORBAXIN is contraindicated in pregnancy. Teratogenic effects have been observed in animal studies, including skeletal and visceral malformations. First trimester exposure carries the highest risk for major congenital anomalies. Second and third trimester exposure may cause fetal renal impairment and oligohydramnios. |
■ FDA Black Box Warning
No FDA black box warning.
| Serious Effects |
["Hypersensitivity to cefditoren or any cephalosporin","Hypersensitivity to penicillins or other beta-lactams","Carnitine deficiency or inborn errors of metabolism affecting carnitine (e.g., primary carnitine deficiency)","Patients with milk protein hypersensitivity (not milk sugar)"]
| Precautions | ["Clostridium difficile-associated diarrhea","Hypersensitivity reactions including anaphylaxis","Seizures in patients with renal impairment","Potential for development of drug-resistant bacteria","Pseudomembranous colitis"] |
Loading safety data…
| Fetal Monitoring | Monitor maternal renal function and electrolytes. If inadvertent exposure occurs during pregnancy, perform detailed fetal ultrasound to assess for anomalies and monitor amniotic fluid volume. |
| Fertility Effects | FORBAXIN has been shown to impair fertility in animal studies with reduced implantation rates and sperm motility. In humans, reversible decreases in fertility may occur; consider fertility preservation prior to treatment. |