SUPRAX
Clinical safety rating: caution
Comprehensive clinical and safety monograph for SUPRAX (SUPRAX).
Cefixime is a third-generation cephalosporin antibiotic that inhibits bacterial cell wall synthesis by binding to penicillin-binding proteins (PBPs), thereby inhibiting peptidoglycan cross-linking. It has broad-spectrum activity against gram-positive and gram-negative bacteria.
| Metabolism | Cefixime is not significantly metabolized; it is primarily excreted unchanged in the urine via glomerular filtration and tubular secretion. Minimal hepatic metabolism occurs. |
| Excretion | Renal: 50-55% unchanged in urine; biliary/fecal: 10-20% (biliary excretion); remainder metabolized or excreted via feces. |
| Half-life | Terminal elimination half-life: 3-4 hours in normal renal function; prolonged to 11-15 hours in severe renal impairment (CrCl <20 mL/min). |
| Protein binding | 65-70% (primarily albumin). |
| Volume of Distribution | 0.2-0.3 L/kg (moderate tissue penetration; adequate for respiratory and urinary tract infections). |
| Bioavailability | Oral: 40-50% (cefixime); 90-100% (cefotaxime desacetyl metabolite). |
| Onset of Action | Oral: 1-2 hours (peak serum concentration); intravenous: immediate onset. |
| Duration of Action | 12-24 hours (concentration-dependent bactericidal activity; once-daily dosing for most infections). |
| Action Class | Cephalosporins: 3 generation |
| Brand Substitutes | Askacef 200mg Capsule, Aqcef 200mg Capsule, Secef 200mg Capsule, Mucifi 200mg Capsule, Safex 200mg Capsule, Askacef 100mg Capsule, Cefspan 100mg Capsule, Mucifi 100mg Capsule, Fixinic 100mg Capsule, Axime 100mg Capsule |
400 mg orally once daily or 200 mg orally every 12 hours.
| Dosage form | FOR SUSPENSION |
| Renal impairment | CrCl 30-60 mL/min: 300 mg once daily; CrCl 15-29 mL/min: 200 mg once daily; CrCl <15 mL/min or on hemodialysis: 200 mg once daily (administer after dialysis). |
| Liver impairment | No adjustment required for mild to moderate hepatic impairment (Child-Pugh A and B). Not studied in severe hepatic impairment (Child-Pugh C). |
| Pediatric use | Children >6 months: 8 mg/kg once daily or 4 mg/kg every 12 hours; maximum 400 mg/day. For otitis media: 8 mg/kg/day divided every 12-24 hours. |
| Geriatric use | No specific dose adjustment based solely on age; adjust dose based on renal function as per CrCl. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for SUPRAX (SUPRAX).
| Breastfeeding | Cefixime is excreted in human milk in low concentrations. M/P ratio not established. Caution advised; consider risk of infant diarrhea and sensitization. |
| Teratogenic Risk | Pregnancy Category B. No evidence of teratogenicity in animal studies. Inadequate human data; potential fetal risk cannot be ruled out. Use only if clearly needed. |
| Fetal Monitoring | No specific monitoring required beyond routine pregnancy care. Monitor for maternal adverse effects and infection resolution. |
■ FDA Black Box Warning
No FDA black box warning.
| Serious Effects |
["Hypersensitivity to cefixime, any cephalosporin, or any component of the formulation.","Previous immediate-type hypersensitivity reaction to penicillins (relative contraindication due to potential cross-reactivity)."]
| Precautions | ["Hypersensitivity reactions (including anaphylaxis) have been reported; use with caution in penicillin-allergic patients due to cross-sensitivity.","Clostridium difficile-associated diarrhea (CDAD) may occur; consider discontinuation if diarrhea persists.","Dosage adjustment required in patients with renal impairment (CrCl <60 mL/min).","Prolonged use may result in superinfection with nonsusceptible organisms.","Seizures have been reported with high doses or renal impairment."] |
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| Fertility Effects | No data on fertility effects; animal studies show no impairment. |