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). |
| Molecular Weight | 453.45 |
| 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 | Human data limited; animal studies show no evidence of teratogenicity. Generally considered safe if clearly needed. |
| 2nd trimester | No known risks; use if clearly indicated. |
| 3rd trimester | Considered safe; avoid near term due to theoretical risk of kernicterus (displaces bilirubin). |
Clinical note
Comprehensive clinical and safety monograph for SUPRAX (SUPRAX).
| Placental transfer | Cefixime crosses the placenta to a limited extent; fetal serum concentrations reach approximately 2-6% of maternal levels. |
| Breastfeeding | Cefixime is excreted into breast milk in low concentrations (estimated 1-3% of maternal dose). Not expected to cause adverse effects in infants; use with caution in infants with glucose-6-phosphate dehydrogenase deficiency or sulfonamide allergies (none applicable). |
■ FDA Black Box Warning
No FDA black box warning.
| Serious Effects |
Hypersensitivity to cefixime or any cephalosporinSevere hypersensitivity to penicillins (immediate-type reactions)
| 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. |
| Food/Dietary | Absorption of cefixime is slightly delayed but not significantly reduced when taken with food. Aluminum- or magnesium-containing antacids reduce absorption; avoid concurrent use. Dairy products and calcium supplements may chelate the drug; separate by at least 2 hours. Avoid alcohol for 72 hours after last dose to reduce risk of disulfiram-like reaction. |
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| Lactation Rating |
| L2 (Probably Compatible) |
| 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. |
| Fertility Effects | No data on fertility effects; animal studies show no impairment. |
| Clinical Pearls | Use SUPRAX (cefixime) for uncomplicated urinary tract infections, otitis media, pharyngitis/tonsillitis, and uncomplicated gonorrhea. It is a third-generation cephalosporin with good oral bioavailability. Avoid in patients with immediate hypersensitivity to penicillins (cross-reactivity ~10%). Monitor renal function in elderly; adjust dose in CrCl <30 mL/min. Consider for step-down therapy after IV ceftriaxone for susceptible infections. Not active against Staphylococcus aureus or anaerobes. |
| Patient Advice | Take exactly as prescribed, even if you feel better. Complete the full course. · You may take this medication with or without food. If stomach upset occurs, take with food. · Do not take with dairy products (milk, yogurt) or calcium-fortified juices within 2 hours, as they may reduce absorption. · Common side effects include diarrhea, nausea, and headache. Contact your doctor if you experience severe diarrhea, rash, or difficulty breathing. · If you have a penicillin allergy, inform your doctor before taking this medication. · Store at room temperature, away from moisture and heat. |