KEFUROX IN PLASTIC CONTAINER
Clinical safety rating: caution
Comprehensive clinical and safety monograph for KEFUROX IN PLASTIC CONTAINER (KEFUROX IN PLASTIC CONTAINER).
Cefuroxime is a second-generation cephalosporin antibiotic that inhibits bacterial cell wall synthesis by binding to penicillin-binding proteins (PBPs), specifically PBP-3 and PBP-1a/1b, leading to inhibition of transpeptidase activity and autolysin-mediated cell death.
| Metabolism | Cefuroxime is not metabolized to a significant extent; it is primarily eliminated unchanged by the kidneys via glomerular filtration and tubular secretion. |
| Excretion | Renal: 80-90% unchanged by glomerular filtration and tubular secretion. Biliary: <2% excreted in bile. Fecal: <1%. |
| Half-life | 1.2-1.6 hours in adults with normal renal function. Extended to 15-22 hours in end-stage renal disease. |
| Protein binding | 33-50%; primarily to serum albumin. |
| Volume of Distribution | 0.13-0.23 L/kg; indicates distribution primarily into extracellular fluid. |
| Bioavailability | IM: 100% (well absorbed); Oral (cefuroxime axetil): 30-50% when taken with food. |
| Onset of Action | IV: Immediate; IM: 15-30 minutes for therapeutic serum levels. |
| Duration of Action | 6-8 hours after IV/IM administration; prolonged in renal impairment. |
| Molecular Weight | 424.38 |
750 mg to 1.5 g IV every 8 hours; for severe infections, up to 3 g IV every 8 hours.
| Dosage form | INJECTABLE |
| Renal impairment | CrCl 10-30 mL/min: 750 mg IV every 12 hours; CrCl <10 mL/min: 750 mg IV every 24 hours. |
| Liver impairment | No dose adjustment required for hepatic impairment as drug is primarily renally eliminated. |
| Pediatric use | Children >3 months: 50-100 mg/kg/day IV divided every 6-8 hours; maximum 3 g/day. |
| Geriatric use | Adjust dose based on renal function; no specific age-related dose changes beyond renal considerations. |
| 1st trimester | Cefuroxime is generally considered safe in the first trimester; however, it should be used only if clearly needed. Animal studies have not shown fetal harm, but adequate human studies are limited. |
| 2nd trimester | Safe for use in the second trimester; cefuroxime crosses the placenta but is not associated with teratogenic risk. |
| 3rd trimester | Safe for use in the third trimester; no known risk of harm to the fetus. Prolonged use may theoretically affect neonatal gut flora. |
Clinical note
Comprehensive clinical and safety monograph for KEFUROX IN PLASTIC CONTAINER (KEFUROX IN PLASTIC CONTAINER).
| Placental transfer | Cefuroxime crosses the placenta readily, achieving fetal serum concentrations of approximately 50-100% of maternal levels. The transfer is facilitated by passive diffusion and is increased during late pregnancy. |
| Breastfeeding | Cefuroxime is excreted into breast milk in small amounts. It is generally considered compatible with breastfeeding due to low oral bioavailability in infants. However, caution is advised in premature infants or those with renal impairment; monitor for diarrhea or rash. |
■ FDA Black Box Warning
None
| Serious Effects |
Known hypersensitivity to cefuroxime or any cephalosporin antibioticHistory of severe immediate hypersensitivity reaction (e.g., anaphylaxis) to penicillins or other beta-lactams
| Precautions | Serious hypersensitivity reactions (anaphylaxis) reported, especially in patients with a history of penicillin or other beta-lactam allergy; cross-sensitivity may occur, Clostridioides difficile-associated diarrhea (CDAD) can occur and may range from mild diarrhea to fatal colitis; evaluate if diarrhea occurs during or after treatment, Dosage adjustment required in patients with renal impairment (creatinine clearance <30 mL/min); prolonged half-life may lead to accumulation and increased toxicity, Cefuroxime may cause a false-positive direct Coombs test; monitor hematologic parameters during prolonged therapy, Increased risk of seizures in patients with renal impairment when high doses are used; reduce dose accordingly, Superinfection with non-susceptible organisms, including fungi, may occur with prolonged use, Drug-induced immune hemolytic anemia (rare) has been reported |
| Food/Dietary |
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| Lactation Rating | L2 (Probably Compatible) |
| Teratogenic Risk | Cefuroxime is a cephalosporin antibiotic classified as FDA Pregnancy Category B. Animal studies have not demonstrated teratogenic effects. There are no adequate and well-controlled studies in pregnant women. Cefuroxime crosses the placenta. First trimester: no known teratogenic risk. Second and third trimesters: considered safe when clinically indicated; no known fetal risk. |
| Fetal Monitoring | No specific monitoring required beyond routine prenatal care. Monitor for maternal allergic reactions (e.g., rash, anaphylaxis). Assess for diarrhea in mother indicating C. difficile colitis. No need for fetal monitoring specifically related to cefuroxime. |
| Fertility Effects | No known adverse effects on human fertility. Animal studies have not shown impaired fertility. |
| Avoid alcohol and alcohol-containing products during therapy and for 72 hours post-treatment due to risk of disulfiram-like reaction. No other food interactions reported. |
| Clinical Pearls | Kefurox (cefuroxime) in plastic container is a second-generation cephalosporin administered IV. Requires dose adjustment in renal impairment (CrCl <30 mL/min). Monitor for hypersensitivity reactions, especially in penicillin-allergic patients. Can cause a disulfiram-like reaction with alcohol; avoid concurrent use. May prolong PT in patients on warfarin. Use with caution in history of colitis. |
| Patient Advice | This medication is given intravenously; report any burning, pain, or redness at the injection site. · Avoid alcohol during treatment and for 72 hours after completion to prevent severe nausea, vomiting, and headache. · Take the full course as prescribed; do not stop even if you feel better. · Notify your doctor immediately if you develop rash, itching, difficulty breathing, or severe diarrhea. · This drug may increase the effect of blood thinners; inform your doctor if you take warfarin. |