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Cefuroxime

Pronunciation

Pronunciation

(se fyoor OKS eem)

Index Terms

  • Cefuroxime Axetil
  • Cefuroxime Sodium

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Solution, Intravenous, as sodium [strength expressed as base]:

Zinacef in Sterile Water: 1.5 g (50 mL)

Solution Reconstituted, Injection, as sodium [strength expressed as base]:

Zinacef: 750 mg (1 ea); 1.5 g (1 ea); 7.5 g (1 ea)

Generic: 750 mg (1 ea); 1.5 g (1 ea); 7.5 g (1 ea); 75 g (1 ea); 225 g (1 ea)

Solution Reconstituted, Intravenous, as sodium [strength expressed as base]:

Zinacef: 750 mg (1 ea); 1.5 g (1 ea)

Generic: 750 mg (1 ea); 1.5 g (1 ea); 7.5 g (1 ea)

Suspension Reconstituted, Oral, as axetil [strength expressed as base]:

Ceftin: 125 mg/5 mL (100 mL); 250 mg/5 mL (50 mL, 100 mL) [contains aspartame; tutti-frutti flavor]

Generic: 125 mg/5 mL (100 mL [DSC])

Tablet, Oral, as axetil [strength expressed as base]:

Ceftin: 250 mg, 500 mg

Generic: 250 mg, 500 mg

Brand Names: U.S.

  • Ceftin
  • Zinacef
  • Zinacef in Sterile Water

Pharmacologic Category

  • Antibiotic, Cephalosporin (Second Generation)

Pharmacology

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.

Absorption

Oral tablet: Increases with food

Distribution

Widely to body tissues and fluids including bronchial secretions, synovial and pericardial fluid, kidneys, heart, liver, bone and bile; crosses blood-brain barrier; therapeutic concentrations achieved in CSF even when meninges are not inflamed

Metabolism

Cefuroxime axetil (oral) is hydrolyzed in the intestinal mucosa and blood to cefuroxime

Excretion

Urine (66% to 100% as unchanged drug)

Time to Peak

Serum: IM: ~15 to 60 minutes; IV: 2 to 3 minutes; Oral: Children: ~3 to 4 hours; Adults: ~2 to 3 hours

Half-Life Elimination

Premature neonates:

PNA ≤3 days: Median: 5.8 hours (de Louvois 1982)

PNA ≥8 days: Median: 1.6-3.8 hours (de Louvois 1982)

Children and Adolescents: 1.4-1.9 hours

Adults: ~1 to 2 hours; prolonged with renal impairment

Protein Binding

33% to 50%

Use: Labeled Indications

Acute bacterial maxillary sinusitis (tablets and oral suspension only): Treatment of mild-to-moderate acute bacterial maxillary sinusitis in infants≥3 months, children, adolescents, and adults caused by S. pneumoniae, H. influenzae (non-beta-lactamase producing strains).

Note: According to the IDSA guidelines for acute bacterial rhinosinusitis, cefuroxime is no longer recommended as monotherapy for initial empiric treatment (Chow 2012).

Acute otitis media (tablets and oral suspension only): Treatment of infants ≥3 months and children with acute bacterial otitis media caused by S. pneumoniae, H. influenzae (including beta-lactamase-producing strains), Moraxella catarrhalis (including beta-lactamase-producing strains), or S. pyogenes

Bone and joint infections (injection only): Treatment of bone and joint infections caused by Staphylococcus aureus (penicillinase- and non-penicillinase-producing strains).

Bronchitis (acute bacterial and secondary bacterial) (tablets only): Treatment of acute bacterial exacerbations of chronic bronchitis and secondary bacterial infections of acute bronchitis in adolescents and adults caused by Streptococcus pneumoniae, Haemophilus influenzae (beta-lactamase negative strains), or Haemophilus parainfluenzae (beta-lactamase negative strains).

Lower respiratory tract infections (injection only): Treatment of lower respiratory tract infections, including pneumonia, caused by S. pneumoniae, H. influenzae (including ampicillin-resistant strains), Klebsiella spp., S. aureus (penicillinase- and non-penicillinase-producing strains), Streptococcus pyogenes, and Escherichia coli.

Lyme disease (early) (tablets only): Treatment of patients ≥13 years with early Lyme disease caused by Borrelia burgdorferi.

Pharyngitis/tonsillitis (tablets and oral suspension only): Treatment of mild-to-moderate pharyngitis and tonsillitis caused by S. pyogenes

Septicemia (injection only): Treatment of septicemia caused by S. aureus (penicillinase- and non-penicillinase-producing strains), S. pneumoniae, E. coli, H. influenzae (including ampicillin-resistant strains), and Klebsiella spp.

Skin and skin structure infection (impetigo) (oral suspension only): Treatment of pediatric patients 3 months to 12 years of age with skin or skin structure infections (impetigo) caused by S. aureus (including beta-lactamase-producing strains) or S. pyogenes.

Skin and skin structure infection (uncomplicated) (tablets only): Treatment of skin and skin-structure infections (including impetigo) caused by S. aureus (penicillinase- and non-penicillinase-producing strains), S. pyogenes, E. coli, Klebsiella spp., and Enterobacter spp.

Surgical (perioperative) prophylaxis (injection only): Prophylaxis of infection in patients undergoing surgical procedures (eg, vaginal hysterectomy) that are classified as clean-contaminated or potentially contaminated procedures.

Urinary tract infections (tablets and injection only): Treatment of urinary tract infections caused by E. coli and Klebsiella spp.

Contraindications

Hypersensitivity to cefuroxime, any component of the formulation, or other beta-lactam antibacterial drugs (eg, penicillins and cephalosporins)

Dosing: Adult

Note: Cefuroxime axetil film-coated tablets and oral suspension are not bioequivalent and are not substitutable on a mg/mg basis. All oral doses listed are for tablet formulation:

Acute bacterial maxillary sinusitis: Oral: 250 mg twice daily for 10 days

Bronchitis, acute (and exacerbations of chronic bronchitis):

Oral: 250 to 500 mg every 12 hours for 10 days

IV: 500 to 750 mg every 8 hours (complete therapy with oral dosing)

Cholecystitis, mild-to-moderate: IV: 1.5 g every 8 hours for 4 to 7 days (provided source controlled) (Solomkin 2010)

Intra-abdominal infection, complicated, community-acquired, mild-to-moderate (in combination with metronidazole): IV: 1.5 g every 8 hours for 4 to 7 days (provided source controlled) (Solomkin 2010)

Lyme disease (early): Oral: 500 mg twice daily for 20 days

Pharyngitis/tonsillitis: Oral: 250 mg twice daily for 10 days

Pneumonia, uncomplicated: IM, IV: 750 mg every 8 hours. Note: Cefuroxime is considered an alternate therapy for lower respiratory tract infections in adults caused by Streptococcus pneumoniae (with MICs <2 mcg/mL for penicillin) (Mandell 2007).

Severe or complicated infections: IM, IV: 1.5 g every 8 hours (up to 1.5 g every 6 hours in life-threatening infections)

Skin/skin structure infection, uncomplicated:

Oral: 250 to 500 mg every 12 hours for 10 days

IM, IV: 750 mg every 8 hours

Surgical (perioperative) prophylaxis: IV:

Manufacturer's labeling: 1.5 g 30 minutes to 1 hour prior to procedure (if procedure is prolonged can give 750 mg every 8 hours IV or IM)

Open heart: IV: 1.5 g every 12 hours for a total of 4 doses starting at anesthesia induction

Alternative recommendation: 1.5 g within 60 minutes prior to surgical incision. Doses may be repeated in 4 hours if procedure is lengthy or if there is excessive blood loss (Bratzler 2013).

Urinary tract infection, uncomplicated:

Oral: 250 mg twice daily for 7 to 10 days

IV, IM: 750 mg every 8 hours

Bite wounds (animal) (off-label use) (IDSA [Stevens 2014]): Oral: 500 mg twice daily in combination with clindamycin or metronidazole for anaerobic coverage

Dosing: Geriatric

Refer to adult dosing.

Dosing: Pediatric

Note: Cefuroxime axetil film-coated tablets and oral suspension are not bioequivalent and are not substitutable on a mg/mg basis.

Children ≥1 year:

Surgical (perioperative) prophylaxis: IV: 50 mg/kg within 60 minutes prior to surgical incision (maximum dose: 1,500 mg). Doses may be repeated in 4 hours if procedure is lengthy or if there is excessive blood loss (Bratzler 2013).

Infants and Children ≥3 months and ≤12 years:

Acute bacterial maxillary sinusitis, acute otitis media:

Oral: Suspension: 30 mg/kg/day in 2 divided doses for 10 days (maximum dose: 1,000 mg/day); tablet: 250 mg twice daily for 10 days

IM, IV: 75 to 150 mg/kg/day divided every 8 hours (maximum dose: 6 g/day)

Pharyngitis/tonsillitis:

Oral: Suspension: 20 mg/kg/day (maximum: 500 mg/day) in 2 divided doses for 10 days

IM, IV: 75 to 150 mg/kg day divided every 8 hours (maximum: 6 g/day)

Skin and skin structure infection (impetigo): Oral: Suspension: 30 mg/kg/day in 2 divided doses for 10 days (maximum dose: 1,000 mg/day)

Urinary tract infection, uncomplicated (off-label dosing):

Infants and Children ≥2 months to 2 years: Oral: 20 to 30 mg/kg/day divided twice daily for 7 to 14 days (AAP 2011)

Children ≥2 years: Moderate to severe disease (possible pyelonephritis): Oral: 20 to 30 mg/kg/day divided twice daily (maximum dose: 1,000 mg/day) (Bradley 2012; Red Book [AAP 2012])

Children >12 years and Adolescents: Refer to adult dosing.

Dosing: Renal Impairment

Oral:

Manufacturer’s labeling:

Adults:

CrCl ≥30 mL/minute: No dosage adjustment necessary

CrCl 10 to <30 mL/minute: Administer recommended dose based on indication every 24 hours

CrCl <10 mL/minute: Administer recommended dose based on indication every 48 hours

ESRD requiring intermittent hemodialysis (IHD): Additional recommended dose based on indication should be given at the end of each dialysis session.

Pediatric: There are no dosage adjustments provided in the manufacturer’s labeling; however, the following adjustments have been reported in the literature (Aronoff 2007): Note: Renally adjusted dose recommendations are based on doses of 30 mg/kg/day divided every 12 hours:

CrCl ≥30 mL/minute/1.73 m2: No dosage adjustment necessary.

CrCl 10 to 29 mL/minute/1.73 m2: 15 mg/kg/dose every 12 hours.

CrCl <10 mL/minute/1.73 m2: 15 mg/kg/dose every 24 hours.

Hemodialysis: Dialyzable: 15 mg/kg/dose every 24 hours

Peritoneal dialysis: 15 mg/kg/dose every 24 hours

IV: Children and Adults:

Manufacturer’s labeling:

CrCl >20 mL/minute: No dosage adjustment necessary

CrCl 10 to 20 mL/minute: Administer recommended dose based on indication every 12 hours

CrCl <10 mL/minute: Administer recommended dose based on indication every 24 hours

Hemodialysis: Administer additional recommended dose based on indication at the end of dialysis

Alternate dosing (Aronoff 2007):

Peritoneal dialysis:

Adults: Administer full dose every 24 hours

Children: 25 to 50 mg/kg dose every 24 hours

Continuous renal replacement therapy (CRRT):

Adults: 1 g every 12 hours

Children: 25 to 50 mg/kg every 8 hours

Dosing: Hepatic Impairment

There are no dosage adjustments provided in the manufacturer’s labeling.

Reconstitution

Oral suspension: Refer to manufacturer’s product labeling for reconstitution instructions.

Duplex container: Unlatch side tab, unfold, and remove foil strip from drug chamber. Point set port in downward direction, fold container just below the diluent meniscus, and squeeze the diluent chamber until the seal between the diluent and drug powder opens. Shake until dissolved.

Administration

Oral suspension: Administer with food. Shake well before use.

Oral tablet: May administer with or without food. Swallow tablet whole (crushed tablet has strong, persistent, bitter taste).

IM: Inject deep IM into large muscle mass.

IV: Inject direct IV over 3 to 5 minutes. Infuse intermittent infusion over 15 to 30 minutes.

Dietary Considerations

Some products may contain phenylalanine and/or sodium.

Oral suspension: Should be taken with food.

Compatibility

Stable in D51/4NS, D51/2NS, D5NS, D5W, D10W, LR, NS.

Y-site administration: Incompatible with azithromycin, filgrastim, fluconazole, midazolam, pantoprazole, vinorelbine.

Storage

Injection: Store intact vials at 15°C to 30°C (59°F to 86°F); protect from light. Reconstituted solution is stable for 24 hours at room temperature and 48 hours when refrigerated. IV infusion in NS or D5W solution is stable for 24 hours at room temperature, 7 days when refrigerated, or 26 weeks when frozen. After freezing, thawed solution is stable for 24 hours at room temperature or 21 days when refrigerated.

Duplex container: Store unactivated units at 20°C to 25°C (68°F to 77°F). Unactivated units with foil strip removed from the drug chamber must be protected from light and used within 7 days. Once activated, may be stored for up to 24 hours at room temperature or for 7 days under refrigeration. Do not freeze.

ADD-Vantage vials: Joined, but not activated, vials are stable for 14 days. Once activated, stable for 24 hours at room temperature and 7 days refrigerated. Do not freeze.

Premix Galaxy plastic containers: Store frozen at -20°C. Thaw container at room temperature or under refrigeration; do not force thaw. Thawed solution is stable for 24 hours at room temperature and 28 days refrigerated; do not refreeze.

Oral suspension: Prior to reconstitution, store at 2°C to 30°C (36°F to 86°F). Reconstituted suspension is stable for 10 days at 2°C to 8°C (36°F to 46°F).

Tablet: Store at 15°C to 30°C (59°F to 86°F).

Drug Interactions

Aminoglycosides: Cephalosporins (2nd Generation) may enhance the nephrotoxic effect of Aminoglycosides. Monitor therapy

Antacids: May decrease the serum concentration of Cefuroxime. Management: Consider administering antacids and cefuroxime at least 2 hours apart. Consider therapy modification

BCG (Intravesical): Antibiotics may diminish the therapeutic effect of BCG (Intravesical). Avoid combination

BCG Vaccine (Immunization): Antibiotics may diminish the therapeutic effect of BCG Vaccine (Immunization). Monitor therapy

H2-Antagonists: May decrease the absorption of Cefuroxime. Separate oral doses by at least 2 hours. Monitor therapy

Probenecid: May increase the serum concentration of Cephalosporins. Monitor therapy

Sodium Picosulfate: Antibiotics may diminish the therapeutic effect of Sodium Picosulfate. Management: Consider using an alternative product for bowel cleansing prior to a colonoscopy in patients who have recently used or are concurrently using an antibiotic. Consider therapy modification

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 3 days after cessation of antibacterial agents. Consider therapy modification

Vitamin K Antagonists (eg, warfarin): Cephalosporins may enhance the anticoagulant effect of Vitamin K Antagonists. Monitor therapy

Test Interactions

Positive direct Coombs', false-positive urinary glucose test using cupric sulfate (Benedict's solution, Clinitest®, Fehling's solution); false-negative may occur with ferricyanide test. Glucose oxidase or hexokinase-based methods should be used.

Adverse Reactions

>10%: Gastrointestinal: Diarrhea (4% to 11%, duration dependent)

1% to 10%:

Cardiovascular: Local thrombophlebitis (2%)

Dermatologic: Diaper rash (children 3%)

Endocrine & metabolic: Increased lactate dehydrogenase (1%)

Gastrointestinal: Nausea and vomiting (3% to 7%), unpleasant taste (children 5%)

Genitourinary: Vaginitis (≤5%)

Hematologic & oncologic: Decreased hematocrit (≤10%), decreased hemoglobin (≤10%), eosinophilia (1% to 7%)

Hepatic: Increased serum transaminases (2% to 4%), increased serum alkaline phosphatase (2%)

Immunologic: Jarisch-Herxheimer reaction (6%)

<1% (Limited to important or life-threatening): Anaphylaxis, angioedema, anorexia, brain disease, candidiasis, chest tightness, cholestasis, Clostridium difficile associated diarrhea, colitis, decreased creatinine clearance, drug fever, dyspepsia, dysuria, erythema, erythema multiforme, gastrointestinal hemorrhage, gastrointestinal infection, glossitis, headache, hearing loss, hemolytic anemia, hepatitis, hyperactivity, hyperbilirubinemia, hypersensitivity, hypersensitivity angiitis, increased blood urea nitrogen, increased liver enzymes, increased serum creatinine, increased thirst, interstitial nephritis, irritability, joint swelling, leukopenia, muscle cramps, muscle rigidity, muscle spasm (neck), neutropenia, oral mucosa ulcer, pancytopenia, positive direct Coombs test, prolonged prothrombin time, pseudomembranous colitis, renal insufficiency, renal pain, seizure, serum sickness-like reaction, sialorrhea, sinusitis, Stevens-Johnson syndrome, swollen tongue, tachycardia, thrombocytopenia (rare), toxic epidermal necrolysis, trismus, upper respiratory tract infection, urethral bleeding, urethral pain, urinary tract infection, vaginal discharge, vaginal irritation, viral infection, vulvovaginal candidiasis, vulvovaginal pruritus

Warnings/Precautions

Concerns related to adverse effects:

• Elevated INR: May be associated with increased INR, especially in nutritionally-deficient patients, prolonged treatment, hepatic or renal disease.

• Hypersensitivity reactions: Serious and occasionally severe or fatal hypersensitivity (anaphylactic) reactions have been reported in patients receiving beta-lactam drugs. Before initiating therapy, carefully investigate previous penicillin, cephalosporin, or other allergen hypersensitivity. Use caution if given to a patient with a penicillin or other beta-lactam allergy because cross sensitivity among beta-lactam antibacterial drugs has been established. If an allergic reaction occurs, discontinue and institute appropriate therapy.

• Superinfection: Prolonged use may result in fungal or bacterial superinfection, including C. difficile-associated diarrhea (CDAD) and pseudomembranous colitis; CDAD has been observed >2 months postantibiotic treatment.

Disease-related concerns:

• Gastrointestinal disease: Use with caution in patients with a history of colitis.

• Renal impairment: Use with caution in patients with renal impairment; modify dosage in severe impairment.

• Seizure disorders: Use with caution in patients with a history of seizure disorder; cephalosporins have been associated with seizure activity, particularly in patients with renal impairment not receiving dose adjustments. Discontinue if seizures occur.

Concurrent drug therapy issues:

• Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information.

Dosage form specific issues:

• Benzyl alcohol and derivatives: Some dosage forms may contain sodium benzoate/benzoic acid; benzoic acid (benzoate) is a metabolite of benzyl alcohol; large amounts of benzyl alcohol (≥99 mg/kg/day) have been associated with a potentially fatal toxicity (“gasping syndrome”) in neonates; the “gasping syndrome” consists of metabolic acidosis, respiratory distress, gasping respirations, CNS dysfunction (including convulsions, intracranial hemorrhage), hypotension, and cardiovascular collapse (AAP ["Inactive" 1997]; CDC 1982); some data suggests that benzoate displaces bilirubin from protein binding sites (Ahlfors 2001); avoid or use dosage forms containing benzyl alcohol derivative with caution in neonates. See manufacturer’s labeling.

• Phenylalanine: Some products may contain phenylalanine.

• Suspension/tablet bioequivalence: Tablets and oral suspension are not bioequivalent; do not substitute on a mg-per-mg basis.

• Tablets: Should not be crushed or chewed due to a strong, persistent bitter taste. Patients unable to swallow whole tablets should be prescribed the oral suspension.

Monitoring Parameters

Monitor renal, hepatic, and hematologic function periodically with prolonged therapy. Monitor prothrombin time in patients at risk of prolongation during cephalosporin therapy (nutritionally-deficient, prolonged treatment, renal or hepatic disease). Observe for signs and symptoms of anaphylaxis during first dose.

Pregnancy Risk Factor

B

Pregnancy Considerations

Adverse events were not observed in animal reproduction studies. Cefuroxime crosses the placenta and reaches the cord serum and amniotic fluid. Placental transfer is decreased in the presence of oligohydramnios. Several studies have failed to identify an increased teratogenic risk to the fetus following maternal cefuroxime use.

During pregnancy, mean plasma concentrations of cefuroxime are 50% lower, the AUC is 25% lower, and the plasma half-life is shorter than nonpregnant values. At term, plasma half-life is similar to nonpregnant values and peak maternal concentrations after IM administration are slightly decreased. Pregnancy does not alter the volume of distribution. Cefuroxime is one of the antibiotics recommended for prophylactic use prior to cesarean delivery.

Patient Education

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience diarrhea. Have patient report immediately to prescriber severe injection site irritation, severe nausea, severe vomiting, bruising, bleeding, urinary retention, change in amount of urine passed, severe loss of strength and energy, chills, pharyngitis, vaginitis, hearing impairment, or signs of Clostridium difficile (C. diff)-associated diarrhea (stomach pain or cramps, very loose or watery stools, or bloody stools) (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for healthcare professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience and judgment in diagnosing, treating and advising patients.

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