Cefotaxime

Pharmacologic Category

Antibiotic, Cephalosporin (Third Generation)

Dosing: Adult

Acute bacterial rhinosinusitis, severe infection requiring hospitalization (off-label use): IV: 2 g every 4 to 6 hours for 5 to 7 days (IDSA [Chow 2012])

Bite wound (animal) (off-label use): IV: 1 to 2 g every 6 to 8 hours in combination with clindamycin or metronidazole for anaerobic coverage (IDSA [Stevens 2014])

Brain abscess (empiric treatment): IV: 2 g every 4 to 6 hours in combination with other antimicrobial therapy as warranted (eg, metronidazole) (Arlotti 2010; Brouwer 2014; Kowlessar 2006)

Cesarean section: IM, IV: 1 g IV as soon as the umbilical cord is clamped, then 1 g IV or IM at 6 and 12 hours after the first dose

Gonorrhea, disseminated infections (arthritis and arthritis-dermatitis syndrome) (alternative agent) (off-label use): IV: 1 g every 8 hours in combination with azithromycin. Continue for 24 to 48 hours after improvement begins, then switch to oral therapy guided by antimicrobial susceptibility testing. Total duration of therapy at least 7 days (CDC [Workowski 2015])

Intraabdominal infection (eg, perforated appendix, diverticulitis, intraabdominal abscess), community-acquired (mild to moderate infection in low-risk patients): IV: 2 g every 8 hours in combination with metronidazole (Barshak 2019). 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 (alternative agent) (off-label use):

Cardiac manifestations: IV: 2 g every 8 hours for 14 to 21 days (IDSA [Wormser 2006])

Neurologic manifestations (eg, meningitis, radiculopathy): IV: 2 g every 8 hours for 10 to 28 days (AAN [Halperin 2007]; IDSA [Wormser 2006])

Meningitis, bacterial: As a component of empiric therapy (community-acquired infections) or pathogen-specific therapy (eg, Cutibacterium acnes, H. influenzae, N. meningitidis, S. agalactiae, S. pneumoniae, and susceptible gram-negative bacilli; alternative agent for certain pathogens): IV: 2 g every 4 to 6 hours; for empiric therapy, use in combination with other appropriate agents (IDSA [Tunkel 2004]; IDSA [Tunkel 2017])

Pneumonia, community-acquired: Inpatients without risk factors for Pseudomonas aeruginosa:

IV: 1 to 2 g every 8 hours as part of an appropriate combination regimen. Duration of therapy is for a minimum of 5 days; patients should be clinically stable with normal vital signs before therapy is discontinued (ATS/IDSA [Metlay 2019]).

Sepsis: IV: 2 g every 6 to 8 hours

Septic arthritis:

Neisseria gonorrhoeae (alternative agent): IV: 1 g every 8 hours in combination with a single dose of azithromycin. Duration of cefotaxime is 7 to 14 days, depending on clinical status and response to therapy (CDC [Workowski 2015]; Klausner 2019).

Susceptible gram-negative bacilli: IV: 2 g every 8 hours; duration of therapy is 3 to 4 weeks (in the absence of osteomyelitis), including oral step-down therapy (Goldenberg 2019)

Skin and soft tissue necrotizing infections (off-label use):

Polymicrobial infection: IV: 2 g every 6 hours, in combination with metronidazole or clindamycin for empiric therapy of polymicrobial infections. Continue until further debridement is not necessary, patient has clinically improved, and patient is afebrile for 48 to 72 hours (IDSA [Stevens 2014]).

Necrotizing infection due to Vibrio vulnificus: IV: 2 g every 8 hours, in combination with doxycycline. Continue until further debridement is not necessary, patient has clinically improved, and patient is afebrile for 48 to 72 hours (IDSA [Stevens 2014]).

Spontaneous bacterial peritonitis (off-label dose): IV: 2 g every 8 hours (AASLD [Runyon 2012])

Surgical prophylaxis (off-label use): IV: 1 g within 60 minutes prior to surgical incision. Doses may be repeated in 3 hours if procedure is lengthy or if there is excessive blood loss (Bratzler 2013).

Obesity: The ASHP/IDSA/SIS/SHEA guidelines recommend that for patients weighing ≥120 kg (or alternatively defined as BMI >30 kg/m²), a dose of 2 g within 60 minutes prior to surgical incision should be administered (Bratzler 2013).

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

Dosing: Geriatric

Refer to adult dosing.

Dosing: Renal Impairment: Adult

Manufacturer’s labeling: Note: Renal function may be estimated using Cockcroft-Gault formula for dosage adjustment purposes.

CrCl <20 mL/minute/1.73 m²: Dose should be decreased by 50%.

Dialysis: Moderately dialyzable (20% to 50%)

Alternate recommendations:

The following dosage adjustments have been used by some clinicians (Aronoff 2007; Heintz 2009; Trotman 2005):

GFR >50 mL/minute: Administer every 6 hours (Aronoff 2007)

GFR 10 to 50 mL/minute: Administer every 6 to 12 hours (Aronoff 2007)

GFR <10 mL/minute: Administer every 24 hours or decrease the dose by 50% (and administer at usual intervals) (Aronoff 2007)

Intermittent hemodialysis (IHD): Administer 1 to 2 g every 24 hours (on dialysis days, administer after hemodialysis). Note: Dosing dependent on the assumption of 3 times/week, complete IHD sessions (Heintz 2009).

Peritoneal dialysis (PD): 1 g every 24 hours (Aronoff 2007)

Continuous renal replacement therapy (CRRT) (Heintz 2009; Trotman 2005): Drug clearance is highly dependent on the method of renal replacement, filter type, and flow rate. Appropriate dosing requires close monitoring of pharmacologic response, signs of adverse reactions due to drug accumulation, as well as drug concentrations in relation to target trough (if appropriate). The following are general recommendations only (based on dialysate flow/ultrafiltration rates of 1 to 2 L/hour and minimal residual renal function) and should not supersede clinical judgment:

CVVH: 1 to 2 g every 8 to 12 hours

CVVHD: 1 to 2 g every 8 hours

CVVHDF: 1 to 2 g every 6 to 8 hours

Dosing: Hepatic Impairment: Adult

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

Dosing: Obesity: Adult

Refer to indication-specific dosing for obesity-related information (may not be available for all indications).

Dosing: Pediatric

General dosing, susceptible infection: Infants, Children, and Adolescents: IM, IV: 150 to 180 mg/kg/day in divided doses every 8 hours; maximum daily dose: 8 g/day; higher doses necessary for treatment of meningitis (Bradley 2018; Red Book [AAP 2018])

Acute bacterial rhinosinusitis, severe infection requiring hospitalization: Children and Adolescents: IV: 100 to 200 mg/kg/day divided every 6 hours for 10 to 14 days; maximum dose: 2,000 mg (IDSA [Chow 2012])

Endocarditis, treatment: Children and Adolescents: IV: 200 mg/kg/day in divided doses every 6 hours; maximum daily dose: 12 g/day; treat for at least 4 to 6 weeks; longer durations may be necessary; may use in combination with gentamicin for some organisms (AHA [Baltimore 2015])

Enteric bacterial infections, empiric treatment (HIV-exposed/-positive): Adolescents: IV: 1,000 mg every 8 hours (HHS [OI adult 2018])

Gonorrhea, disseminated infections (including arthritis and arthritis-dermatitis syndrome) (as an alternative to ceftriaxone) (CDC [Workowski 2015]): Adolescents: IV: 1,000 mg every 8 hours in combination with azithromycin for a total duration of at least 7 days.

Intra-abdominal infection, complicated: Infants, Children, and Adolescents: IV: 150 to 200 mg/kg/day divided every 6 to 8 hours; maximum dose: 2,000 mg; use in combination with metronidazole (IDSA [Solomkin 2010])

Lyme disease, cardiac or CNS manifestations or recurrent arthritis: Infants, Children, and Adolescents: IV: 150 to 200 mg/kg/day in divided doses every 6 to 8 hours for 14 to 28 days; maximum daily dose: 6 g/day (AAN [Halperin 2007]; IDSA [Wormser 2006])

Meningitis: Infants, Children, and Adolescents: IV: 225 to 300 mg/kg/day divided every 6 to 8 hours; maximum dose: 2,000 mg/dose; use in combination with vancomycin for empiric coverage (IDSA [Tunkel 2004]; IDSA [Tunkel 2017]); some experts recommend 300 mg/kg/day divided every 4 to 6 hours with a maximum daily dose of 12 g/day (Red Book [AAP 2018])

Peritonitis (peritoneal dialysis) (ISPD [Warady 2012]): Infants, Children, and Adolescents: Intraperitoneal:

Intermittent: 30 mg/kg/dose every 24 hours in the long dwell

Continuous: Loading dose: 500 mg per liter of dialysate; maintenance dose: 250 mg per liter; Note: 125 mg/liter has also been recommended as a maintenance dose (Aronoff 2007)

Pneumonia:

Bacterial pneumonia (HIV-exposed/-positive): Infants, Children, and Adolescents: IV: 150 to 200 mg/kg/day divided every 6 to 8 hours; maximum dose: 2,000 mg/dose (HHS [OI adult 2018]; HHS [OI pediatric 2016])

Community-acquired pneumonia (CAP): Infants >3 months, Children, and Adolescents: IV: 50 mg/kg/dose every 8 hours; maximum dose: 2,000 mg; Note: May consider addition of vancomycin or clindamycin to empiric therapy if community-acquired MRSA suspected. In children ≥5 years, a macrolide antibiotic should be added if atypical pneumonia cannot be ruled out (IDSA/PIDS [Bradley 2011]).

Salmonellosis (HIV-exposed/-positive): Adolescents: IV: 1,000 mg every 8 hours (HHS [OI adult 2018])

Skin and soft tissue infections, necrotizing: Infants, Children, and Adolescents: IV: 50 mg/kg/dose every 6 hours in combination with metronidazole or clindamycin; maximum dose: 2,000 mg/dose. Continue until further debridement is not necessary, patient has clinically improved, and patient is afebrile for 48 to 72 hours (IDSA [Stevens 2014]).

Surgical prophylaxis: Children and Adolescents: IV: 50 mg/kg within 60 minutes prior to the procedure; may repeat in 3 hours if procedure is lengthy or if there is excessive blood loss; maximum dose: 1,000 mg; a larger maximum dose (2,000 mg) is recommended for obese patients (ASHP/IDSA [Bratzler 2013])

Urinary tract infection: Infants and Children 2 to 24 months: IM, IV: 150 mg/kg/day divided every 6 to 8 hours (AAP 2011)

Dosing: Renal Impairment: Pediatric

Infants, Children, and Adolescents: The following adjustments have been recommended (Aronoff 2007). Note: Renally adjusted dose recommendations are based on doses of 100 to 200 mg/kg/day divided every 8 hours.

GFR 30 to 50 mL/minute/1.73 m²: 35 to 70 mg/kg/dose every 8 to 12 hours

GFR 10 to 29 mL/minute/1.73 m²: 35 to 70 mg/kg/dose every 12 hours

GFR <10 mL/minute/1.73 m²: 35 to 70 mg/kg/dose every 24 hours

Intermittent hemodialysis: 35 to 70 mg/kg/dose every 24 hours

Peritoneal dialysis (PD): 35 to 70 mg/kg/dose every 24 hours

Continuous renal replacement therapy (CRRT): 35 to 70 mg/kg/dose every 12 hours

Dosing: Hepatic Impairment: Pediatric

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

Calculations

Use: Labeled Indications

Bacteremia/Septicemia: Treatment of bacteremia/septicemia caused by Escherichia coli, Klebsiella species, and Serratia marcescens, Staphylococcus aureus and Streptococcus species (including Streptococcus pneumoniae).

Bone or joint infections: Treatment of bone or joint infections caused by S. aureus (penicillinase and nonpenicillinase producing strains), Streptococcus species (including Streptococcus pyogenes), and Proteus mirabilis.

CNS infections: Treatment of CNS infections (eg, meningitis, ventriculitis) caused by Neisseria meningitidis, Haemophilus influenzae, S. pneumoniae, Klebsiella pneumoniae, and E. coli.

Genitourinary infections: Treatment of genitourinary infections, including urinary tract infections (UTIs), caused by Staphylococcus epidermidis, S. aureus (penicillinase and nonpenicillinase producing), Citrobacter species, Enterobacter species, E. coli, Klebsiella species, P. mirabilis, Proteus vulgaris, Providencia stuartii, Morganella morganii, Providencia rettgeri, and S. marcescens

Gynecologic infections: Treatment of gynecologic infections, including pelvic inflammatory disease, endometritis, and pelvic cellulitis, caused by S. epidermidis, Streptococcus species, Enterobacter species, Klebsiella species, E. coli, P. mirabilis, Bacteroides species (including Bacteroides fragilis), Clostridium species, and anaerobic cocci (including Peptostreptococcus and Peptococcus species) and Fusobacterium species (including Fusobacterium nucleatum).

Intraabdominal infections: Treatment of intraabdominal infections, including peritonitis caused by Streptococcus species, E. coli, Klebsiella species, Bacteroides species, and anaerobic cocci (including Peptostreptococcus species and Peptococcus species), P. mirabilis, and Clostridium species.

Lower respiratory tract infections: Treatment of lower respiratory tract infections, including pneumonia, caused by S. pneumoniae, S. pyogenes (group A streptococci) and other streptococci (excluding enterococci, [eg, Enterococcus faecalis]), S. aureus (penicillinase and nonpenicillinase producing), E. coli, Klebsiella species, H. influenzae (including ampicillin-resistant strains), H. parainfluenzae, P. mirabilis, S. marcescens, Enterobacter species, and indole-positive Proteus

Skin and skin structure infections: Treatment of skin and skin structure infections caused by S. aureus (penicillinase and nonpenicillinase producing), S. epidermidis, S. pyogenes (group A streptococci) and other streptococci, Acinetobacter species, E. coli, Citrobacter species (including Citrobacter freundii), Enterobacter species, Klebsiella species, P. mirabilis, P. vulgaris, M. morganii, P. rettgeri, S. marcescens, Bacteroides species, and anaerobic cocci (including Peptostreptococcus species and Peptococcus species).

Surgical prophylaxis: Reduce the incidence of certain infections in patients undergoing surgical procedures (eg, abdominal or vaginal hysterectomy, GI and GU tract surgery) that may be classified as contaminated or potentially contaminated; reduce the incidence of certain postoperative infections in patients undergoing cesarean section.

* See Uses in AHFS Essentials for additional information.

Use: Off-Label: Adult

Acute bacterial rhinosinusitisLevel of Evidence [G]

Based on the Infectious Diseases Society of America (IDSA) guidelines for acute bacterial rhinosinusitis (ABRS) in children and adults, cefotaxime (among other cephalosporins) is effective and recommended (in combination with clindamycin) for the treatment of ABRS.

Bite wound (animal)Level of Evidence [G]

Gonococcal, disseminated infection (arthritis and arthritis-dermatitis syndrome)Level of Evidence [G]

Based on Centers for Disease Control and Prevention (CDC) sexually transmitted diseases treatment guidelines, cefotaxime plus azithromycin is considered an alternative regimen for the treatment of arthritis and arthritis-dermatitis syndrome associated with disseminated gonococcal infection. Ceftriaxone plus azithromycin is the preferred regimen. Cefotaxime should not be used for the treatment of gonococcal meningitis and endocarditis due to disseminated gonococcal infection.

Lyme diseaseLevel of Evidence [G]

Based on the Infectious Diseases Society of America (IDSA) guidelines for the clinical assessment, treatment, and prevention of Lyme disease, cefotaxime is an effective and recommended alternative agent for the treatment of acute and late neurologic disease, carditis, and arthritis ^Ref.

Skin and soft tissue necrotizing infectionsLevel of Evidence [G]

Based on the Infectious Diseases Society of America (IDSA) guidelines for the diagnosis and management of skin and soft tissue infections (SSTI), cefotaxime, in combination with metronidazole or clindamycin, is an effective and recommended alternative for empiric treatment of mixed (polymicrobial) necrotizing infections of the skin, fascia, and muscle; in combination with doxycycline, cefotaxime is effective and recommended for treatment of necrotizing infections of the skin, fascia, and muscle due to Vibrio vulnificus.

Level of Evidence Definitions

Level of Evidence Scale

Use: Unsupported: Adult

Gonorrhea, uncomplicated (cervical/urethral and rectal)

Although included as an FDA-approved use in the manufacturer's prescribing information for the treatment of uncomplicated cervical/urethral and rectal gonorrhea, Centers for Disease Control and Prevention (CDC) STD guidelines do not recommend cefotaxime as a treatment option for uncomplicated gonorrhea (CDC [Workowski 2015]).

Class and Related Monographs

Cephalosporins

Clinical Practice Guidelines

Ascites:

AASLD Practice Guidelines: “Management of Adult Patients with Ascites Due to Cirrhosis: Update 2012,” 2012

Endocarditis:

AHA, Infective Endocarditis in Childhood, October 2015

Intra-abdominal 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

IDSA, “The Clinical Assessment, Treatment, and Prevention of Lyme Disease, Human Granulocytic Anaplasmosis, and Babesiosis,” November 2006

Meningitis, Bacterial:

IDSA, “Practice Guidelines for the Management of Bacterial Meningitis,” November 2004

Meningitis and Ventriculitis, Healthcare-Associated:

IDSA, "Clinical Practice Guidelines for Healthcare-Associated Ventriculitis and Meningitis," February 2017

Opportunistic Infections:

HHS, Guidelines for the Prevention and Treatment of Opportunistic Infections Among HIV-Exposed and HIV-Infected Children, November 2013. Note: Information contained within this monograph is pending revision based on these more recent guidelines.

HHS, Guidelines for the Prevention and Treatment of Opportunistic Infections in HIV-Infected Adults and Adolescents, April September 2015.

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

Rhinosinusitis:

IDSA, “Clinical Practice Guideline for Acute Bacterial Rhinosinusitis in Children and Adults,” 2012

Sexually-Transmitted Disease:

CDC, “Sexually Transmitted Diseases Treatment Guidelines,” June 2015.

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. Individual doses of 2 g may be given if the dose is divided and administered in different IM sites.

Administration: IV

Inject directly IV as a bolus over at least 3 to 5 minutes. Infuse intermittent infusion over 15 to 30 minutes.

Administration: Injectable Detail

pH: 5 to 7.5 (injectable solution)

Administration: Pediatric

Parenteral:

IM: Administer by deep IM injection into a large muscle mass such as the upper outer quadrant of the gluteus maximus. Doses of 2,000 mg should be divided and administered at two different sites.

IV:

IV Push: May be administered over 3 to 5 minutes; avoid rapid injection (<1 minute) due to association with arrhythmias

Intermittent infusion: Infuse over 15 to 30 minutes.

Dietary Considerations

Some products may contain sodium.

Storage/Stability

Store intact vials below 30°C (86°F). Protect from light. Reconstituted solution is stable for 12 to 24 hours at room temperature, 7 to 10 days when refrigerated, for 13 weeks when frozen. For IV infusion in NS or D₅W, solution is stable for 24 hours at room temperature, 5 days when refrigerated, or 13 weeks when frozen in Viaflex plastic containers. Thawed solutions of frozen premixed bags are stable for 24 hours at room temperature or 10 days when refrigerated.

Preparation for Administration: Adult

IM: Reconstitute vials with SWFI or bacteriostatic water for injection; dilute with 2 mL for the 500 mg vial (resulting concentration ~230 mg/mL), 3 mL for the 1 g vial (resulting concentration ~300 mg/mL), and 5 mL for the 2 g vial (resulting concentration 330 mg/mL). Shake to dissolve.

IV: Reconstitute vials with ≥10 mL SWFI; resulting concentration: 50 mg/mL (500 mg vial), 95 mg/mL (1 g vial), or 180 mg/mL (2 g vial). Shake to dissolve. May be further diluted up to 1000 mL with NS, D₅W, D₁₀W, D₅NS, D₅¹/₂NS, D₅¹/₄NS, or LR.

Preparation for Administration: Pediatric

Parenteral:

IM: Reconstitute powder for injection with SWFI to a final concentration between 230 to 330 mg/mL (see manufacturer's labeling for specific details). Shake to dissolve.

IV:

IV Push: Reconstitute vials with at least 10 mL SWFI to a maximum concentration of 200 mg/mL.

Intermittent infusion: Reconstitute powder for injection with SWFI, resultant concentration dependent upon product (single dose vials or Pharmacy Bulk vial; see manufacturer's labeling for specific details). Dilute dose to a final concentration of 10 to 40 mg/mL with NS, D5W, D10W, D5NS, D5¹/₂NS, D5¹/₄NS, or LR; some centers have used concentrations up to 60 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

• Diarrhea

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

• Liver problems like dark urine, fatigue, lack of appetite, nausea, abdominal pain, light-colored stools, vomiting, or yellow skin

• Bruising

• Bleeding

• Chills

• Sore throat

• Seizures

• Severe loss of strength and energy

• Severe injection site pain like redness, burning, swelling, or irritation.

• 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 cefotaxime, any component of the formulation, or other cephalosporins

Warnings/Precautions

Concerns related to adverse effects:

• Arrhythmia: A potentially life-threatening arrhythmia has been reported in patients who received a rapid (<1 minute) bolus injection via central venous catheter.

• Granulocytopenia: Granulocytopenia and more rarely agranulocytosis may develop during prolonged treatment (>10 days).

• Penicillin allergy: Use with caution in patients with a history of penicillin allergy, especially IgE-mediated reactions (eg, anaphylaxis, angioedema, urticaria).

• 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.

• Tissue inflammation: Minimize tissue inflammation by changing infusion sites when needed.

Disease-related concerns:

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

• Renal impairment: Use with caution in patients with renal impairment; dosage adjustment may be required.

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.

* See Cautions in AHFS Essentials for additional information.

Geriatric Considerations

Adjust dose for renal function.

Pregnancy Risk Factor

Pregnancy Considerations

Adverse events have not been observed in animal reproduction studies. Cefotaxime crosses the human placenta and can be found in fetal tissue. An increase in most types of birth defects was not found following first trimester exposure to cephalosporins. During pregnancy, peak cefotaxime serum concentrations are decreased and the serum half-life is shorter. Cefotaxime is approved for use in women undergoing cesarean section (consult current guidelines for appropriate use).

Breast-Feeding Considerations

Low concentrations of cefotaxime are found in breast milk. The manufacturer recommends that caution be exercised when administering cefotaxime to nursing women. Nondose-related effects could include modification of bowel flora. The pregnancy-related changes in cefotaxime pharmacokinetics continue into the early postpartum period.

Lexicomp Pregnancy & Lactation, In-Depth

Cefotaxime

Briggs' Drugs in Pregnancy & Lactation

Cefotaxime

Adverse Reactions

1% to 10%:

Dermatologic: Pruritus (≤2%), skin rash (≤2%)

Gastrointestinal: Colitis (≤1%), diarrhea (≤1%), nausea (≤1%), vomiting (≤1%)

Hematologic & oncologic: Eosinophilia (≤2%)

Local: Induration at injection site (IM ≤4%), inflammation at injection site (IV ≤4%), pain at injection site (IM ≤4%), tenderness at injection site (IM ≤4%)

Miscellaneous: Fever (≤2%)

<1%, postmarketing and/or case reports: Acute generalized exanthematous pustulosis, acute renal failure, agranulocytosis, anaphylaxis, bone marrow failure, brain disease, candidiasis, cardiac arrhythmia (after rapid IV injection via central catheter), cholestasis, Clostridioides (formerly Clostridium) difficile-associated diarrhea, dizziness, erythema multiforme, granulocytopenia, headache, hemolytic anemia, hepatitis, increased blood urea nitrogen, increased gamma-glutamyl transferase, increased lactate dehydrogenase, increased serum alkaline phosphatase, increased serum ALT, increased serum AST, increased serum bilirubin, increased serum creatinine, injection site phlebitis, interstitial nephritis, jaundice, leukopenia, local irritation, neutropenia, pancytopenia, positive direct Coombs test, pseudomembranous colitis, Stevens-Johnson syndrome, thrombocytopenia, toxic epidermal necrolysis, urticaria, vaginitis

* 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 (3rd Generation) may enhance the nephrotoxic effect of Aminoglycosides. Risk C: Monitor therapy

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

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

Probenecid: May increase the serum concentration of Cefotaxime. Management: Avoid cefotaxime doses greater than 6 g/day with concurrent probenecid. Any patients receiving this combination should be monitored closely for evidence of cefotaxime toxicity. Risk D: Consider therapy modification

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

Test Interactions

Positive direct Coombs', false-positive urinary glucose test using cupric sulfate (Benedict's solution, Clinitest®, Fehling's solution), false-positive serum or urine creatinine with Jaffé reaction

Monitoring Parameters

Observe for signs and symptoms of anaphylaxis during first dose; CBC with differential (especially with long courses [>10 days]); renal function

Advanced Practitioners Physical Assessment/Monitoring

Assess results of culture/sensitivity tests and patient's allergy history prior to therapy. Obtain CBC and renal function tests periodically with prolonged therapy. Monitor for signs of anaphylaxis during first dose. Assess for effectiveness of treatment. Test for C.difficile if patient develops diarrhea.

Nursing Physical Assessment/Monitoring

Check ordered labs and report abnormalities. Monitor closely for signs of hypersensitivity (shortness-of-breath, dyspnea, chest pain, complaints of difficulty swallowing or throat tightness, or change in vital signs). Monitor for severe or bloody diarrhea and send a specimen to the lab for C.difficile. Monitor for improvement with infection.

Dosage Forms: US

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

Solution Reconstituted, Injection:

Claforan: 500 mg (1 ea [DSC]); 2 g (1 ea [DSC]); 10 g (1 ea [DSC])

Generic: 1 g (1 ea); 2 g (1 ea)

Solution Reconstituted, Injection [preservative free]:

Generic: 500 mg (1 ea); 1 g (1 ea); 2 g (1 ea [DSC]); 10 g (1 ea [DSC])

Solution Reconstituted, Intravenous:

Claforan: 1 g (1 ea [DSC]); 2 g (1 ea [DSC])

Dosage Forms: Canada

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

Solution Reconstituted, Injection:

Claforan: 1 g ([DSC]); 2 g ([DSC])

Generic: 500 mg ([DSC]); 1 g (1 ea); 2 g (1 ea)

Anatomic Therapeutic Chemical (ATC) Classification

J01DD01

Generic Available (US)

Yes

Pricing: US

Solution (reconstituted) (Cefotaxime Sodium Injection)

1 g (per each): $2.64 - $11.76

2 g (per each): $23.56

500 mg (per each): $1.80

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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. Cefotaxime has activity in the presence of some beta-lactamases, both penicillinases and cephalosporinases, of gram-negative and gram-positive bacteria. Enterococcus species may be intrinsically resistant to cefotaxime. Most extended-spectrum beta-lactamase (ESBL)-producing and carbapenemase-producing isolates are resistant to cefotaxime.

Pharmacodynamics/Kinetics

Distribution: Widely to body tissues and fluids including aqueous humor, ascitic and prostatic fluids, bone; penetrates CSF best when meninges are inflamed

Protein binding: 31% to 50%

Metabolism: Partially hepatic to active metabolite, desacetylcefotaxime

Half-life elimination:

Cefotaxime: Infants ≤1500 g: 4.6 hours; Infants >1500 g: 3.4 hours; Children: 1.5 hours; Adults: 1 to 1.5 hours; prolonged with renal and/or hepatic impairment

Desacetylcefotaxime: 1.3 to 1.9 hours; prolonged with renal impairment (Ings 1982)

Time to peak, serum: IM: Within 30 minutes

Excretion: Urine (~60% as unchanged drug and metabolites)

Local Anesthetic/Vasoconstrictor Precautions

No information available to require special precautions

Effects on Dental Treatment

No significant effects or complications reported

Effects on Bleeding

No information available to require special precautions

Index Terms

Cefotaxime Sodium

FDA Approval Date

December 29, 1983

References

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Brand Names: International

Benaxima (MX); Biosint (MX); Biotax (IN); Cefacolin (AR); Cefalekol (HU); Cefirad (KR); Cefocam (PY); Ceforan (EG); Cefot (BD); Cefotaksim (HR); Cefotax (AE, BH, CY, IQ, IR, JO, JP, KW, LY, OM, RO, SA, SY, YE); Cefotaxim (DE, NO); Cefotrial (PE); Cefox (PH); Cefoxim (KR); Cefpiran (KR); Ceftax (AE, JO, QA, SA); Cetax (TW); Clacef (ID); Cladex (PH); Clafocare (LB); Claforan (AE, AT, AU, BB, BE, BF, BG, BH, BJ, BM, BR, BS, BZ, CH, CI, CR, CY, DK, DO, EC, EE, EG, ET, FI, FR, GB, GH, GM, GN, GR, GT, GY, HK, HN, HR, HU, ID, IE, IL, IN, IQ, IR, IT, JM, JO, KE, KR, KW, LB, LR, LU, LY, MA, ML, MR, MU, MW, MY, NE, NG, NI, NL, NZ, OM, PA, PH, PK, PY, QA, RU, SA, SC, SD, SE, SG, SI, SK, SL, SN, SR, SV, SY, TH, TN, TR, TT, TW, TZ, UG, VE, VN, YE, ZA, ZM, ZW); Clafotax (BH, JO, KW, SA); Claraxim (TH); Clatacef-3 (TH); Clatax (ID); Clavox (TW); Diabec (BD); Efotax (ID); Fot-Amsa (MX); Fotax (BD); Fotexina (CO, CR, DO, EC, GT, HN, MX, NI, PA, SV); Foxime (EG); Glocef (ID); Gloryfen (MT); Grifotaxima (CL); Haxim (PH); Kalfoxim (ID); Lapixime (ID); Letynol (MT); Loraxime (UA); Lyforan (IN); Makrocef (HR); Molelant (GR); Newtaxime (KR); Novatax (LK); Omnatax (IN); Oritaxim (BF, BJ, CI, ET, GH, GM, GN, KE, LR, MA, ML, MR, MU, MW, NE, NG, SC, SD, SL, SN, TN, TZ, UG, ZM, ZW); Oritaxim-1000 (LK); Pantaxin (PH); Pentatrox (EG); Primocef (AE); Prinocef (BH); Procefa (ID); Racotax (LK); Ralopar (PT); Reftax (ZA); Rekaxime (MY); Saifulong (CN); Sefotak (AE, BH, CY, CZ, IQ, IR, JO, KW, LY, OM, SA, SY, YE); Sefox (PH); Soclaf (ID); Spirosine (GR); Stoparen (GR, LB); Talcef (PE); Taporin (MX); Tax-O-Bid (UA); Taxibiotic (VN); Taxim (BD); Taximax (ID); Taxime (AE, BH, CY, IQ, IR, JO, KW, LY, OM, SA, SY, YE); Taximed (CZ); Taximmed (VN); Tebruxim (MX); Tirdicef (ID); Tirotax (BH, MX, PL, QA); Ultracef (UY); Unitax (TW); Valoran (EE, MT); Viken (MX); Xedin (MX); Xendin (CR, DO, GT, HN, NI, PA, SV); Ximvex (PH); Xorin (EG); Zariviz (IT); Zefocent (PH); Zefotax (PH); Zentro (PH); Zetax (ET)

Last Updated 3/6/20

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