Cefuroxime

Pharmacologic Category

Antibiotic, Cephalosporin (Second Generation)

Dosing: Adult

Note: Ceftin oral suspension has been discontinued in the US for more than 1 year.

Bite wound, prophylaxis or treatment (animal or human bite) (alternative agent) (off-label use): Oral: 500 mg twice daily, in combination with an agent appropriate for anaerobes (Baddour 2019a; IDSA [Stevens 2014]). Duration of prophylaxis is 3 to 5 days (IDSA [Stevens 2014]). Duration of treatment for established infection typically ranges from 5 to 14 days and varies based on clinical response and patient-specific factors (Baddour 2019a; Baddour 2019b).

Chronic obstructive pulmonary disease, acute exacerbation: Note: Some experts reserve cefuroxime for patients without risk factors for poor outcomes (eg, <65 years of age without major comorbidities, FEV₁ >50% predicted, infrequent exacerbations) or Pseudomonas infection (Sethi 2020).

Oral: 250 to 500 mg twice daily for 3 to 7 days (GOLD 2020; Sethi 2020; Yoon 2013; manufacturer’s labeling).

Intraabdominal infection, community-acquired (mild to moderate infection in low-risk patients) (off-label use):

Cholecystitis, acute: IV: 1.5 g every 8 hours; continue for 1 day after gallbladder removal or until clinical resolution in patients managed nonoperatively (SIS/IAI [Mazuski 2017]; SIS/IDSA [Solomkin 2010]; Vollmer 2019). Note: The addition of anaerobic therapy (eg, metronidazole) is recommended if biliary-enteric anastomosis is present (SIS/IDSA [Solomkin 2010]).

Other intraabdominal infections (eg, perforated appendix, diverticulitis, intraabdominal abscess): IV: 1.5 g every 8 hours in combination with metronidazole. May switch to an oral regimen when clinically improved and able to tolerate an oral diet. Total duration of therapy is for 4 to 7 days following adequate source control (SIS/IAI [Mazuski 2017]; SIS/IDSA [Solomkin 2010]); for infections managed without surgical or percutaneous intervention, a longer duration may be necessary (Barshak 2019; Pemberton 2019).

Lyme disease (Borrelia spp. infection):

Early localized (eg, erythema migrans): Oral: 500 mg twice daily for 14 to 21 days (IDSA [Wormser 2006])

Early disseminated, carditis (initial therapy for mild disease [first-degree atrioventricular block with PR interval <300 msec] or step-down therapy after initial parenteral treatment for more severe disease once PR interval <300 msec) (off-label use): Oral: 500 mg twice daily for 14 to 21 days (Hu 2019; IDSA [Wormser 2006]); for step-down therapy, some experts prefer a total duration of 21 to 28 days (Hu 2019).

Early disseminated, mild neurologic involvement (isolated facial nerve palsy [no evidence of meningitis]) (alternative agent) (off-label use): Oral: 500 mg twice daily for 14 to 21 days (IDSA [Wormser 2006])

Late disease, arthritis without neurologic involvement (off-label use): Oral: 500 mg twice daily for 28 days (IDSA [Wormser 2006]). Some experts reserve cefuroxime for patients who cannot take doxycycline or amoxicillin (Hu 2019).

Otitis media, acute (alternative agent for mild [nonanaphylactic] penicillin allergy) (off-label): Oral: 500 mg twice daily; duration of therapy is 5 to 7 days (mild to moderate infection) or 10 days (severe infection) (Limb 2019).

Pneumonia, community-acquired, outpatient empiric therapy (patients with comorbidities): Oral: 500 mg twice daily as part of an appropriate combination regimen. Duration is for a minimum of 5 days; patients should be clinically stable with normal vital signs before discontinuing therapy (ATS/IDSA [Metlay 2019]).

Streptococcal pharyngitis (group A) (alternative agent for mild [nonanaphylactic] penicillin allergy): Oral: 250 mg twice daily for 10 days (Pichichero 2020; manufacturer's labeling)

Surgical prophylaxis (eg, cardiac surgery, head and neck surgery) (alternative agent): IV: 1.5 g within 60 minutes prior to surgical incision; use in combination with metronidazole for select head and neck procedures. Cefuroxime dose may be repeated intraoperatively in 4 hours if procedure is lengthy or if there is excessive blood loss (ASHP/IDSA/SIS/SHEA [Bratzler 2013]). In cases where an extension of prophylaxis is warranted postoperatively, total duration should be ≤24 hours (Anderson 2014; ASHP/IDSA/SIS/SHEA [Bratzler 2013]). Postoperative prophylaxis is not recommended in clean and clean-contaminated surgeries (CDC [Berríos-Torres 2017]).

Urinary tract infection (alternative agent): Acute uncomplicated cystitis or acute simple cystitis (infection limited to bladder and no signs/symptoms of upper tract or systemic infection): Oral: 250 mg twice daily for 5 to 7 days (Hooton 2019a; Hooton 2019b; manufacturer's labeling). Note: Although evidence is limited, some experts recommend the use of beta-lactams, such as cefuroxime, when first-line agents cannot be used (efficacy of oral beta-lactams in this setting is decreased compared to other agents) (Hooton 2019a; Hooton 2019b; IDSA/ESCMID [Gupta 2011]).

* See Dosage and Administration in AHFS Essentials for additional information.

Dosing: Geriatric

Refer to adult dosing.

Dosing: Renal Impairment: Adult

Oral:

Manufacturer’s labeling:

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.

IV:

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.

Alternative dosing (Aronoff 2007):

Peritoneal dialysis: Administer full dose every 24 hours.

Continuous renal replacement therapy (CRRT): 1 g every 12 hours

Dosing: Hepatic Impairment: Adult

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

Dosing: Pediatric

Note: Ceftin oral suspension has been discontinued in the US for >1 year.

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

General dosing, susceptible infection (Red Book [AAP 2015]): Infants, Children, and Adolescents:

Mild to moderate infection:

Oral: 20 to 30 mg/kg/day divided twice daily; maximum dose: 500 mg/dose

IM, IV: 75 to 100 mg/kg/day divided in 3 doses; maximum dose: 1,500 mg/dose

Severe infection: IM, IV: 100 to 200 mg/kg/day divided in 3 to 4 doses; maximum dose: 1,500 mg/dose

Bone and joint infection: Infants ≥3 months, Children, and Adolescents: IM, IV: 50 mg/kg/dose every 8 hours; maximum dose: 1,500 mg/dose. Note: Upon completion of parenteral therapy follow with oral antibiotic therapy if indicated.

Bronchitis, chronic; acute exacerbations: Adolescents: Oral tablets: 250 to 500 mg every 12 hours for 10 days

Impetigo: Infants ≥3 months and Children: Oral suspension: 15 mg/kg/dose twice daily for 10 days; maximum dose: 500 mg/dose

Intra-abdominal infection complicated, community-acquired: Infants, Children, and Adolescents: IV: 150 mg/kg/day in divided doses every 6 to 8 hours; maximum dose: 1,500 mg/dose (IDSA [Solomkin 2010])

Lyme disease: Infants, Children, and Adolescents:

Acrodermatitis chronica atrophicans: Oral: 15 mg/kg/dose every 12 hours for 21 days; maximum dose: 500 mg/dose (Wormser 2006)

Early localized disease: Oral: 15 mg/kg/dose every 12 hours for 14 days; maximum dose: 500 mg/dose (Red Book [AAP 2015]; Wormser 2006)

Late disease (arthritis): Oral: 15 mg/kg/dose every 12 hours for 28 days; maximum dose: 500 mg/dose (Wormser 2006)

Otitis media, acute: Infants ≥3 months and Children:

Oral suspension: 15 mg/kg/dose twice daily for 10 days; maximum dose: 500 mg/dose

Oral tablet (patients able to swallow tablet whole): 250 mg twice daily for 10 days

Note: AAP recommends variable duration of therapy depending on age: If 6 months to 2 years of age or severe symptoms (any age): 10-day course; if 2 to 5 years of age with mild to moderate symptoms: 7-day course; if ≥6 years of age with mild to moderate symptoms: 5- to 7-day course (AAP [Lieberthal 2013])

Pharyngitis/tonsillitis:

Infants ≥3 months and Children: Oral suspension: 10 mg/kg/dose twice daily for 10 days; maximum dose: 250 mg/dose

Adolescents: Oral tablets: 250 mg twice daily for 10 days

Pneumonia, bacterial (HIV-exposed/-positive): Infants and Children: IV: 35 to 50 mg/kg/dose 3 times daily; maximum dose: 2,000 mg/dose (HHS [OI pediatric 2016])

Sinusitis:

Infants ≥3 months and Children:

Oral suspension: 15 mg/kg/dose twice daily for 10 days; maximum dose: 500 mg/dose

Oral tablet (for patients able to swallow tablet whole): 250 mg twice daily for 10 days

Adolescents: Oral tablet: 250 mg twice daily for 10 days

Skin and skin structure infections, uncomplicated: Adolescents: Oral tablet: 250 to 500 mg twice daily for 10 days

Surgical prophylaxis: Children and Adolescents: IV: 50 mg/kg within 60 minutes prior to procedure; may repeat dose in 4 hours if procedure is lengthy or if there is excessive blood loss; maximum dose: 1,500 mg/dose (Bratzler 2013)

Urinary tract infection, uncomplicated:

Infants and Children 2 to 24 months: Oral suspension: 10 to 15 mg/kg/dose twice daily (AAP 2011)

Children >24 months: Moderate to severe disease (possible pyelonephritis): Oral suspension: 20 to 30 mg/kg/day divided twice daily; maximum dose: 500 mg/dose (Bradley 2017)

Adolescents: Oral tablet: 250 mg twice daily for 7 to 10 days

Dosing: Renal Impairment: Pediatric

Infants, Children, and Adolescents:

Oral: 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:

GFR ≥30 mL/minute/1.73 m²: No adjustment required

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

GFR <10 mL/minute/1.73 m²: Administer 15 mg/kg/dose every 24 hours

Intermittent hemodialysis: Administer 15 mg/kg/dose every 24 hours

Peritoneal dialysis (PD): Administer 15 mg/kg/dose every 24 hours

IV: The manufacturer's labeling recommends decreasing the frequency similar to adult recommendations. The following guidelines have been used by some clinicians (Aronoff 2007). Note: Renally adjusted dose recommendations are based on doses of 75 to 150 mg/kg/day divided every 8 hours.

GFR ≥30 mL/minute/1.73 m²: No adjustment required

GFR 10 to 29 mL/minute/1.73 m²: Administer 25 to 50 mg/kg/dose every 12 hours

GFR <10 mL/minute/1.73 m²: Administer 25 to 50 mg/kg/dose every 24 hours

Intermittent hemodialysis: Administer 25 to 50 mg/kg/dose every 24 hours

Peritoneal dialysis (PD): Administer 25 to 50 mg/kg/dose every 24 hours

Continuous renal replacement therapy (CRRT): Administer 25 to 50 mg/kg/dose every 8 hours

Dosing: Hepatic Impairment: Pediatric

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

Calculations

• Creatinine Clearance by Cockcroft-Gault
• Creatinine Clearance by Cockcroft-Gault (SI units)
• Creatinine Clearance by Cockcroft-Gault with IBW
• Creatinine Clearance by Cockcroft-Gault with IBW (SI units)

Use: Labeled Indications

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

Chronic obstructive pulmonary disease, acute exacerbation (tablets only): Treatment of mild to moderate acute bacterial exacerbations of chronic bronchitis in adults and adolescents ≥13 years of age 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 adults and adolescents ≥13 years of age with early Lyme disease caused by Borrelia burgdorferi.

Otitis media, acute (tablets and oral suspension only): Treatment of pediatric patients ≥3 months of age 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.

Pharyngitis/tonsillitis (tablets and oral suspension only): Treatment of mild to moderate pharyngitis/tonsillitis caused by S. pyogenes in adults and pediatric patients ≥3 months of age.

Limitations of use: Efficacy in the prevention of rheumatic fever has not been established in clinical trials. Efficacy in the treatment of penicillin-resistant strains of S. pyogenes has not been demonstrated.

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.

Sinusitis, acute bacterial (tablets and oral suspension only): Treatment of mild to moderate acute bacterial maxillary sinusitis caused by S. pneumoniae or H. influenzae (non-beta-lactamase-producing strains only).

Limitations of use: Effectiveness for sinus infections caused by beta-lactamase-producing H. influenzae or M. catarrhalis in patients with acute bacterial maxillary sinusitis has not been established. Note: According to the IDSA guidelines for acute bacterial rhinosinusitis, cefuroxime is no longer recommended as monotherapy for initial empiric treatment (IDSA [Chow 2012]).

Skin and skin-structure infections (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 infections (injection; tablets [uncomplicated infections only]): Treatment of adults and pediatric patients >3 months of age with 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 prophylaxis (injection only): Prophylaxis of infection in patients undergoing surgical procedures that are classified as clean-contaminated or potentially contaminated procedures.

Urinary tract infections (tablets and injection only): Treatment of adults and pediatric patients >3 months of age with urinary tract infections caused by E. coli and Klebsiella spp.

* See Uses in AHFS Essentials for additional information.

Use: Off-Label: Adult

Bite wound, prophylaxis or treatment (animal or human bite)Level of Evidence [C, G]

Based on the Infectious Diseases Society of America (IDSA) guidelines for the diagnosis and management of skin and soft tissue infections (SSTIs), cefuroxime, in combination with an agent appropriate for anaerobes, is an effective and recommended alternative option for prophylaxis and treatment of animal bite wounds.

Clinical experience also suggests the utility of cefuroxime as an alternative agent for prophylaxis and treatment of human bite wounds ^Ref.

Intraabdominal infection, community-acquired (mild to moderate infection in low-risk patients)Level of Evidence [G]

Based on the Surgical Infection Society/IDSA guidelines for the diagnosis and management of complicated intraabdominal infection in adults and children, cefuroxime, in combination with metronidazole, is an effective and recommended empiric treatment option for the management of community-acquired intraabdominal infection, and, as monotherapy, for the management of mild to moderate acute cholecystitis.

Lyme disease (Borrelia spp. infection), early disseminated or late diseaseLevel of Evidence [G]

Based on the IDSA guidelines for the clinical assessment, treatment, and prevention of Lyme disease, human granulocytic anaplasmosis, and babesiosis, cefuroxime is effective and recommended for the treatment of early disseminated Lyme disease (isolated facial nerve palsy [alternative agent] or mild carditis) or late Lyme disease (arthritis without neurologic involvement).

Level of Evidence Definitions

Level of Evidence Scale

Use: Unsupported: Adult

Gonococcal infections

Although included as an FDA-approved use in the manufacturer's prescribing information for the treatment of uncomplicated and disseminated gonococcal infections, clinical practice guidelines do not recommend cefuroxime for the treatment of gonorrhea because of widespread resistance (CDC [Workowski 2015]).

Meningitis

In pediatric clinical trials, the use of cefuroxime has been found to be inferior to third-generation cephalosporins (eg, ceftriaxone) in the treatment of bacterial meningitis. Therefore, cefuroxime is NOT recommended for the treatment of bacterial meningitis (IDSA [Tunkel 2004]).

Class and Related Monographs

Cephalosporins

Clinical Practice Guidelines

Chronic Obstructive Pulmonary Disease:

GOLD, “Global Strategy for Diagnosis, Management, and Prevention of Chronic Obstructive Pulmonary Disease”, 2019

Intraabdominal Infection:

Infectious Diseases Society of America (IDSA), “Diagnosis and Management of Complicated Intra-Abdominal Infections in Adults and Children,” January 2010

Lyme Disease:

American Academy of Neurology (AAN), “Practice Parameter: Treatment of Nervous System Lyme Disease (an evidence-based review),” July 2007

Pneumonia, Community-Acquired:

ATS/IDSA, "Diagnosis and Treatment of Adults With Community-Acquired Pneumonia," October 2019

IDSA/PIDS, "The Management of Community-Acquired Pneumonia in Infants and Children Older Than 3 Months of Age," 2011

Skin and Soft-tissue Infection:

IDSA, “Practice Guidelines for the Diagnosis and Management of Skin and Soft Tissue Infections,” June 2014

Surgical Prophylaxis:

ASHP, “Clinical Practice Guidelines for Antimicrobial Prophylaxis in Surgery,” February 2013

Administration: IM

Inject deep IM into large muscle mass.

Administration: IV

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

Administration: Injectable Detail

pH: 6 to 8.5 (reconstituted solution in vial); 5 to 7.5 (frozen premixed solution)

Administration: Oral

Suspension: Administer with food. Shake well before use.

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

Administration: Pediatric

Oral: Cefuroxime axetil suspension must be administered with food; shake suspension well before use; tablets may be administered with or without food; administer with food to decrease GI upset; avoid crushing the tablet due to its bitter taste

Parenteral:

IM: Inject deep IM into large muscle mass, such as gluteus or lateral part of thigh

Intermittent IV infusion: Administer over 15 to 30 minutes

IV Push: Administer over 3 to 5 minutes

Dietary Considerations

Some products may contain phenylalanine and/or sodium.

Oral suspension: Should be taken with food.

Storage/Stability

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.

TwistVial 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).

Preparation for Administration: Adult

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.

Preparation for Administration: Pediatric

Oral suspension: Reconstitute powder for oral suspension with appropriate amount of water as specified on the bottle. Shake vigorously until suspended.

Parenteral:

IM: Dilute 750 mg vial with 3 mL SWFI; resultant suspension with a concentration of 225 mg/mL

Intermittent IV infusion: Further dilute reconstituted solution to a final concentration ≤30 mg/mL; in fluid restricted patients, dilution with SWFI to a concentration of 137 mg/mL results in a maximum recommended osmolality for peripheral infusion (Robinson 1987)

IV Push: Reconstitute vial to a final concentration of 90 or 95 mg/mL (per manufacturer), some centers have used a final concentration of 100 mg/mL.

Compatibility

See Trissel’s IV Compatibility Database

Open Trissel's IV Compatibility

Medication Patient Education with HCAHPS Considerations

What is this drug used for?

• It is used to treat or prevent bacterial infections.

Frequently reported side effects of this drug

• Nausea

• Vomiting

• Bad taste

• Injection site irritation

• Diarrhea

Other side effects of this drug: Talk with your doctor right away if you have any of these signs of:

• Bruising

• Bleeding

• Unable to pass urine

• Change in amount of urine passed

• Severe loss of strength and energy

• Seizure

• Vaginal pain, itching, and discharge

• Hearing loss

• Clostridioides (formerly Clostridium) difficile-associated diarrhea like abdominal pain or cramps, severe diarrhea or watery stools, or bloody stools.

• Signs of a significant reaction like 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. Talk to your doctor if you have questions.

Consumer Information Use and Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.

Medication Safety Issues

Sound-alike/look-alike issues:

International issues:

Contraindications

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

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.

* See Cautions in AHFS Essentials for additional information.

Geriatric Considerations

Adjust dose for renal function. Considered one of the drugs of choice for outpatient treatment of community-acquired pneumonia in the elderly.

Pregnancy Considerations

Cefuroxime crosses the placenta (Dallmann 2017; Lalic-Popovic 2016).

An increased risk of major birth defects or other adverse fetal or maternal outcomes has generally not been observed following maternal use of cephalosporin antibiotics, including cefuroxime.

Due to pregnancy-induced physiologic changes, some pharmacokinetic properties of cefuroxime may be altered (Dallmann 2017; Lalic-Popovic 2016).

Cefuroxime is one of the antibiotics effective for prophylactic use prior to cesarean delivery (ACOG 199 2018).

Breast-Feeding Considerations

Cefuroxime is present in breast milk.

The relative infant dose (RID) of cefuroxime is 0.5% when calculated using the highest breast milk concentration located and compared to an oral infant therapeutic dose of 30 mg/kg/day.

In general, breastfeeding is considered acceptable when the RID is <10% (Anderson 2016; Ito 2000).

The RID of cefuroxime was calculated using the highest milk concentration located (1.05 mcg/mL), providing an estimated daily infant dose via breast milk of 0.158 mg/kg/day. This milk concentration was obtained 0.5 to 1.5 hours following maternal administration of oral cefuroxime axetil 500 mg (Vree 1990).

Diarrhea has been reported in breastfeeding infants exposed to cefuroxime (Benyami 2005). In general, antibiotics that are present in breast milk may cause non-dose-related modification of bowel flora. Monitor infants for GI disturbances, such as thrush and diarrhea (WHO 2002).

According to the manufacturer, the decision to breastfeed during therapy should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and benefits of treatment to the mother. Beta-lactam antibiotics are generally considered compatible with breastfeeding when used in usual recommended doses; cefuroxime was not specifically included within this report (WHO 2002).

Lexicomp Pregnancy & Lactation, In-Depth

• Cefuroxime

Briggs' Drugs in Pregnancy & Lactation

• Cefuroxime

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%, postmarketing, and/or case reports (Limited to important or life-threatening): Abdominal pain, anaphylaxis, angioedema, anorexia, arthralgia, brain disease, candidiasis, chest pain, chest tightness, chills, cholestasis, Clostridioides (formerly Clostridium) difficile-associated diarrhea, colitis, cough, decreased creatinine clearance, dizziness, drowsiness, drug fever, dyspepsia, dyspnea, dysuria, erythema, erythema multiforme, fever, flatulence, 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, jaundice, joint swelling, leukopenia, muscle cramps, muscle rigidity, muscle spasm (neck), neutropenia, oral mucosa ulcer, pancytopenia, positive direct Coombs test, prolonged prothrombin time, pruritus, pseudomembranous colitis, renal insufficiency, renal pain, seizure, serum sickness-like reaction, sialorrhea, sinusitis, skin rash, Stevens-Johnson syndrome, stomach cramps, tachycardia, thrombocytopenia (rare), toxic epidermal necrolysis, trismus, upper respiratory tract infection, urethral bleeding, urethral pain, urinary tract infection, urticaria, vaginal discharge, vaginal irritation, viral infection, vulvovaginal candidiasis, vulvovaginal pruritus

* See Cautions in AHFS Essentials for additional information.

Allergy and Idiosyncratic Reactions

• Cephalosporin Allergy

Metabolism/Transport Effects

None known.

Drug Interactions Open Interactions

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

Antacids: May decrease the serum concentration of Cefuroxime. Management: Administer cefuroxime axetil at least 1 hour before or 2 hours after the administration of short-acting antacids. Risk D: Consider therapy modification

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

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

Cholera Vaccine: Antibiotics may diminish the therapeutic effect of Cholera Vaccine. Management: Avoid cholera vaccine in patients receiving systemic antibiotics, and within 14 days following the use of oral or parenteral antibiotics. Risk X: Avoid combination

Histamine H2 Receptor Antagonists: May decrease the absorption of Cefuroxime. Separate oral doses by at least 2 hours. Risk X: Avoid combination

Lactobacillus and Estriol: Antibiotics may diminish the therapeutic effect of Lactobacillus and Estriol. Risk C: Monitor therapy

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

Proton Pump Inhibitors: May decrease the absorption of Cefuroxime. Risk X: Avoid combination

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. Risk D: 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. Risk D: Consider therapy modification

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

Food Interactions

Bioavailability is increased with food; cefuroxime serum levels may be increased if taken with food or dairy products. Clinical and bacteriologic responses were independent of food intake in clinical trials. Management: Administer tablet without regard to meals; suspension must be administered with food.

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.

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.

Advanced Practitioners Physical Assessment/Monitoring

Assess results of culture/sensitivity tests and patient's allergy history prior to therapy. Monitor for nephrotoxicity. Assess prothrombin times. Monitor for hemolytic anemia, hypoprothrombinemia, and bleeding. Advise patients with diabetes about use of Clinitest® (may cause false-positive test). Teach patient to report opportunistic infection and hypersensitivity reaction.

Nursing Physical Assessment/Monitoring

Results of culture/sensitivity tests and patient's allergy history should be assessed prior to therapy. Monitor for nephrotoxicity. Assess prothrombin times. Monitor for hemolytic anemia, hypoprothrombinemia, and bleeding. Advise patients with diabetes about use of Clinitest® (may cause false-positive test). Teach patient to report opportunistic infection and hypersensitivity reaction.

Product Availability

Ceftin oral suspension has been discontinued in the US for more than 1 year.

Dosage Forms: US

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

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

Zinacef in Sterile Water: 1.5 g (50 mL [DSC])

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

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

Generic: 750 mg (1 ea [DSC])

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

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

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

Zinacef: 750 mg (1 ea [DSC]); 1.5 g (1 ea [DSC])

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

Generic: 1.5 g (1 ea)

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

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

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

Ceftin: 250 mg [DSC], 500 mg [DSC]

Generic: 250 mg, 500 mg

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

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

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 (70 mL, 100 mL) [contains aspartame]

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

Ceftin: 250 mg, 500 mg [contains methylparaben, propylparaben, sodium benzoate]

Generic: 250 mg, 500 mg

Anatomic Therapeutic Chemical (ATC) Classification

• J01DC02
• S01AA27

Generic Available (US)

May be product dependent

Pricing: US

Solution (reconstituted) (Cefuroxime Sodium Injection)

7.5 g (per each): $24.00 - $65.95

750 mg (per each): $2.70 - $3.67

Solution (reconstituted) (Cefuroxime Sodium Intravenous)

1.5 g (per each): $5.40 - $7.01

Tablets (Cefuroxime Axetil Oral)

250 mg (per each): $4.39 - $5.66

500 mg (per each): $8.02 - $11.11

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

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 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

Protein binding: 33% to 50%

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

Bioavailability: Tablet: Fasting: 37%; Following food: 52%; Cefuroxime axetil suspension is less bioavailable than the tablet (91% of the AUC for tablets).

Half-life elimination:

Premature neonates:

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

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

Children and Adolescents: 1.4 to 1.9 hours

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

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

Excretion: Urine (66% to 100% as unchanged drug)

Local Anesthetic/Vasoconstrictor Precautions

No information available to require special precautions

Effects on Dental Treatment

Rare occurrence of candidiasis, glossitis, oral mucosal ulcers and trismus.

Effects on Bleeding

No information available to require special precautions

Related Information

• Oral Medications That Should Not Be Crushed or Altered
• Relative Infant Dose

Index Terms

Cefuroxime Axetil; Cefuroxime Sodium

FDA Approval Date

October 19, 1983

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Brand Names: International

Actixim (VN); Adrox (BD); Aksef (UA); Alporin (KR); Altacef (PH); Altamax (PH); Anbacim (ID); Aprok (IE); Aprokam (BE, GB); Axet (PH); Axetine (BH, CN, NZ, PH, SG); Axim (BD, HK); Axurocef (TW); Bacticef (IN); C-Tri T (TH); Carvixime (PH); Cef2 (TZ); Cefabiot (MX); Cefasun (IN); Cefero (LK); Cefmono (PH); Cefora (LB); Cefosan (PH); Ceftil (KR); Cefudura (DE); Cefuhexal (DE); Cefumax (EG, LB, PH); Cefuracet (MX); Cefurax (DE); Cefuro-Puren (DE); Cefurocos (ZW); Cefurox (TH); Cefurox-wolff (DE); Cefutil (AE, CY, ET, IQ, IR, JO, KW, LY, OM, SA, SY, YE); Cefutin (KR); Cefuxime (HK, KR); Cefuzime (BH); Cefxin (SG); Cefzime (PH); Celocid (ID); Ceprosim (KR); Cerox A (BD); Ceroxim (ZA, ZW); Cethixim (ID); Cetil (ET, IN, PE); Cetoxil (MX); Cexil (KR); Cexim (HU); CMaxid (HK); Cortum (PH); Curocef (AT, CL); Curoxime (PT); Daliroxim (LK); Daroxime (LB, QA); Daroxine (BH); Deltrox (AR); Efox (HR); Efurox (MY); Elobact (DE); Eroxmit (PH); Famicef (BD); Farmacef (TH); Fornax (PE); Froxime (AE, CY, IQ, IR, JO, KW, LY, OM, SA, SY, YE); Furacam (EC); Furobioxin (MX); Furoxim (PH); Furoxime (TH); Glanax (VN); Gomcef (KR); Jectocef (PH); Keef-250 (PH); Kefezy (PH); Kefloxa (ZW); Kefrox (LK); Kefstar (PH); Kefurox (LU); Ketocef (HR); Kimatcef (UA); Magnaspor (TH); Maxil (BH, JO, QA); Medaxetine (VN); Medxime (PH); Milcef (LK); Neurox-250 (TH); Novador (MX); Novocef (HR); Olcef (KR); Oratil (ZW); Oraxim (AE, CY, IQ, IR, JO, KW, LY, OM, SA, SY, YE); Oxtercid (ID); Profurex (PH); Rucef (PH); Sefuxim (HK); Sharox-500 (ID); Shincef (KR); Situroxime (ID); Teikeden (HK); Theoroxime (PH); U-Cef (BH); Unoximed (PH); Vekfazolin (GR); Vexuro (LK); Xorim (QA); Xorimax (HK, MY, PH, QA, SG, VN); Xorufec (MX); Zamur (QA, TT); Zefu (MY); Zegen (PH); Zenon (BH, QA); Zicef (PH); Zilisten (MT); Zinacef (AE, BB, BE, BG, CH, CN, CO, CY, CZ, DK, EE, EG, ES, ET, FI, GB, GR, HU, IE, IS, JO, KW, LB, LK, LT, LU, MT, NL, NO, NZ, PH, PL, PT, QA, RU, SA, SE, SK, TR, UA, VN, ZW); Zinat (CH); Zincef (KR); Zinnat (AE, AT, AU, BB, BE, BF, BG, BH, BJ, BM, BR, BS, BZ, CH, CI, CL, CO, CR, CY, CZ, DE, DK, DO, EC, EE, EG, ES, ET, FI, FR, GB, GH, GM, GN, GT, GY, HK, HN, HR, HU, ID, IE, IL, IQ, IR, IS, IT, JM, JO, KE, KR, KW, LB, LK, LR, LT, LU, LV, LY, MA, ML, MR, MT, MU, MW, MX, MY, NE, NG, NI, NL, NZ, OM, PA, PE, PH, PK, PL, PR, PY, QA, RO, SA, SC, SD, SG, SK, SL, SN, SR, SV, SY, TH, TN, TR, TW, TZ, UG, UY, VE, VN, YE, ZA, ZM, ZW); Zinoximor (BH); Zocef (TH, TZ); Zoref (PT)

Last Updated 3/11/20