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Product Name
:
CEFUROX (tab)
Chemical Name
:
Cefuroxime (Axetil)
Therapeutic Category
:
Antimicrobial
Pharmacologic Category
:
Antibiotic, Cephalosporin (Second Generation)
Pharmaceutical Form
:
Tablets
Composition
:
Cefuroxime (Axetil) 250mg / 500mg
Monitoring Parameters
Dosing
 
Dosing: Adult
Bronchitis, acute (and exacerbations of chronic bronchitis):
Oral: 250-500 mg every 12 hours for 10 days
I.V.: 500-750 mg every 8 hours (complete therapy with oral dosing)
Gonorrhea:
Disseminated: I.M., I.V.: 750 mg every 8 hours
Uncomplicated:
Oral: 1 g as a single dose
I.M.: 1.5 g as single dose (administer in two different sites with probenecid)
Intra-abdominal infection, complicated, community-acquired, mild-to-moderate (in combination with metronidazole): 1.5 g every 8 hours for 4-7 days (provided source controlled)
Pharyngitis/tonsillitis and sinusitis: Oral: 250 mg twice daily for 10 days
Skin/skin structure infection, uncomplicated:
Oral: 250-500 mg every 12 hours for 10 days
I.M., I.V.: 750 mg every 8 hours
Pneumonia, uncomplicated: I.M., I.V.: 750 mg every 8 hours
Severe or complicated infections: I.M., I.V.: 1.5 g every 8 hours (up to 1.5 g every 6 hours in life-threatening infections)
Surgical prophylaxis: I.V.: 1.5 g 30 minutes to 1 hour prior to procedure (if procedure is prolonged can give 750 mg every 8 hours I.M.)
Cholecystectomy: I.V.: 1.5 g every 8 hours, discontinue within 24 hours unless infection outside gallbladder suspected
Open heart: I.V.: 1.5 g every 12 hours to a total of 6 g
Urinary tract infection, uncomplicated:
Oral: 125-250 mg twice daily for 7-10 days
I.V., I.M.: 750 mg every 8 hours

Dosing: Pediatric 
Children 3 months to 12 years:
Acute otitis media, impetigo:

Oral:
Suspension: 30 mg/kg/day (maximum: 1 g/day) in 2 divided doses for 10 days
Tablet: 250 mg every 12 hours for 10 days
I.M., I.V.: 75-150 mg/kg/day divided every 8 hours (maximum dose: 6 g/day)
Acute bacterial maxillary sinusitis: Oral:
Suspension: 30 mg/kg/day in 2 divided doses for 10 days (maximum dose: 1 g/day)
Tablet: 250 mg twice daily for 10 days
Meningitis: NOT recommended (doses of 200-240 mg/kg/day divided every 6-8 hours have been used) (maximum dose: 9 g/day)
Pharyngitis, tonsillitis:
Oral:
Suspension: 20 mg/kg/day (maximum: 500 mg/day) in 2 divided doses for 10 days
Tablet: 125 mg every 12 hours for 10 days
I.M., I.V.: 75-150 mg/kg/day divided every 8 hours; maximum dose: 6 g/day
Children ≥13 years: Refer to adult dosing.

Dosing: Renal Impairment
Clcr 10-20 mL/minute: Administer every 12 hours.
Clcr <10 mL/minute: Administer every 24 hours.
Use
 
Treatment of infections caused by staphylococci, group B streptococci, H. influenzae (type A and B), E. coli, Enterobacter, Salmonella, and Klebsiella; treatment of susceptible infections of the upper and lower respiratory tract, otitis media, urinary tract, uncomplicated skin and soft tissue, bone and joint, sepsis, uncomplicated gonorrhea, and early Lyme disease; surgical prophylaxis
Adverse Reactions
 
>10%: Gastrointestinal: Diarrhea (4% to 11%, duration-dependent)
1% to 10%:
Dermatologic: Diaper rash (3%)
Endocrine & metabolic: Alkaline phosphatase increased (2%), lactate dehydrogenase increased (1%)
Gastrointestinal: Nausea/vomiting (3% to 7%)
Genitourinary: Vaginitis (≤5%)
Hematologic: Eosinophilia (7%), hemoglobin and hematocrit decreased (10%)
Hepatic: Transaminases increased (2% to 4%)
Local: Thrombophlebitis (2%)
Reactions reported with other cephalosporins: Agranulocytosis, aplastic anemia, asterixis, colitis, encephalopathy, hemorrhage, neuromuscular excitability, serum-sickness reactions, superinfection, toxic nephropathy
Contraindications
 
Hypersensitivity to cefuroxime, any component of the formulation, or other cephalosporins
Warnings / Precautions Drug
 
Food: Bioavailability is increased with food; cefuroxime serum levels may be increased if taken with food or dairy products.
Interactions
 
Antacids: May decrease the serum concentration of Cefuroxime. Management: Consider administering antacids and cefuroxime at least 2 hours apart. Risk D: Consider therapy modification
BCG: Antibiotics may diminish the therapeutic effect of BCG. Risk X: Avoid combination
H2-Antagonists: May decrease the absorption of Cefuroxime. Separate oral doses by at least 2 hours. Risk C: Monitor therapy
Probenecid: May increase the serum concentration of Cephalosporins. Risk C: Monitor therapy
Typhoid Vaccine: Antibiotics may diminish the therapeutic effect of Typhoid Vaccine. Only the live attenuated Ty21a strain is affected. Management: Vaccination with live attenuated typhoid vaccine (Ty21a) should be avoided in patients being treated with systemic antibacterial agents. Use of this vaccine should be postponed until at least 24 hours after cessation of antibacterial agents. Risk D: Consider therapy modification
Pregnancy
 
B
Lactation
 
Enters breast milk/use caution
Mechanism of Action
 
Inhibits bacterial cell wall synthesis by binding to one or more of the penicillin-binding proteins (PBPs) which in turn inhibits the final transpeptidation step of peptidoglycan synthesis in bacterial cell walls, thus inhibiting cell wall biosynthesis. Bacteria eventually lyse due to ongoing activity of cell wall autolytic enzymes (autolysins and murein hydrolases) while cell wall assembly is arrested.
Pharmacodynamics / Kinetics
 
Absorption: Oral (cefuroxime axetil): Increases with food
Distribution: Widely to body tissues and fluids; crosses blood-brain barrier; therapeutic concentrations achieved in CSF even when meninges are not inflamed
Protein binding: 33% to 50%
Bioavailability: Tablet: Fasting: 37%; Following food: 52%
Half-life elimination: Children 1-2 hours; Adults: 1-2 hours; prolonged with renal impairment
Time to peak, serum: I.M.: ∼15-60 minutes; I.V.: 2-3 minutes; Oral: Children: 3-4 hours; Adults: 2-3 hours
Excretion: Urine (66% to 100% as unchanged drug)
 
   
 
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