Cefotaxime

Name: Cefotaxime

Cefotaxime Overview

Cefotaxime is a prescription medication used to treat bacterial infections, including lung, skin, joint, bone, urinary tract, and gynecological infections. Cefotaxime belongs to a group of drugs called cephalosporin antibiotics, which work to stop the growth of bacteria in the body.

This medication is available in an injectable form to be given directly into a vein (IV) or muscle (IM) by a healthcare professional.

Common side effects of cefotaxime include irritation at the site of injection, rash, itching, diarrhea, and nausea.

Cefotaxime Drug Class

Cefotaxime is part of the drug class:

  • Third generation cephalosporins

Cefotaxime and Pregnancy

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Cefotaxime falls into category B. There are no well-done studies that have been done in humans with cefotaxime. But in animal studies, pregnant animals were given this medication, and the babies did not show any medical issues related to this medication.

Cefotaxime Overdose

If cefotaxime is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.
 

Cefotaxime dosing information

Usual Adult Dose for Bacteremia:

Uncomplicated infections: 1 g IM or IV every 12 hours
Moderate to severe infections: 1 to 2 g IM or IV every 8 hours
Infections needing higher-doses: 2 g IV every 6 to 8 hours
Life-threatening infections: 2 g IV every 4 hours
Maximum dose: 12 g/day

Use: Treatment of bacteremia or septicemia caused by Escherichia coli, Klebsiella species, Serratia marcescens, Staphylococcus aureus, and Streptococcus species

Usual Adult Dose for Septicemia:

Uncomplicated infections: 1 g IM or IV every 12 hours
Moderate to severe infections: 1 to 2 g IM or IV every 8 hours
Infections needing higher-doses: 2 g IV every 6 to 8 hours
Life-threatening infections: 2 g IV every 4 hours
Maximum dose: 12 g/day

Use: Treatment of bacteremia or septicemia caused by Escherichia coli, Klebsiella species, Serratia marcescens, Staphylococcus aureus, and Streptococcus species

Usual Adult Dose for Sepsis:

Uncomplicated infections: 1 g IM or IV every 12 hours
Moderate to severe infections: 1 to 2 g IM or IV every 8 hours
Infections needing higher-doses: 2 g IV every 6 to 8 hours
Life-threatening infections: 2 g IV every 4 hours
Maximum dose: 12 g/day

Use: Treatment of bacteremia or septicemia caused by Escherichia coli, Klebsiella species, Serratia marcescens, Staphylococcus aureus, and Streptococcus species

Usual Adult Dose for Cesarean Section:

1 g IV as soon as the umbilical cord is clamped, then additional 1 g IM or IV doses at 6 and 12 hours after the initial dose

Use: To reduce the incidence of postoperative infections

Usual Adult Dose for Meningitis:

Uncomplicated infections: 1 g IM or IV every 12 hours
Moderate to severe infections: 1 to 2 g IM or IV every 8 hours
Infections needing higher-doses: 2 g IV every 6 to 8 hours
Life-threatening infections: 2 g IV every 4 hours
Maximum dose: 12 g/day

Comment: Efficacy in treating Klebsiella pneumoniae and E coli have been studied in less than 10 infections.

Use: Treatment of central nervous system infections (including meningitis and ventriculitis) caused by Neisseria meningitides, Haemophilus influenzae, Streptococcus pneumoniae, K pneumoniae, and E coli

Infectious Diseases Society of America (IDSA), American Academy of Neurology (AAN), American Association of Neurological Surgeons (AANS), and Neurocritical Care Society (NCS) Recommendations: 8 to 12 g per day, given at 4 to 6 hour intervals

Comment: Vancomycin should be added to isolates with a penicillin MIC of 0.12 mcg/mL or higher and a third-generation cephalosporin MIC of 1 mcg/mL or greater.

Uses:
-Treatment of healthcare-associated ventriculitis and meningitis caused by gram-negative bacilli susceptible to third-generation cephalosporins
-Recommended treatment of bacterial meningitis caused by N meningitides, H influenzae, S pneumoniae, and E coli
-Empirical antimicrobial therapy in patients 50 years and younger with purulent meningitis caused by N meningitides or S pneumoniae
-Empirical antimicrobial therapy in patients over 50 years of age with purulent meningitis caused by S pneumoniae, N meningitides, Listeria monocytogenes, or aerobic gram-negative bacilli
-Empirical antimicrobial therapy in patients with basilar skull fractures with purulent meningitis caused by S pneumoniae, H influenzae, Group A beta-hemolytic streptococci

Usual Adult Dose for CNS Infection:

Uncomplicated infections: 1 g IM or IV every 12 hours
Moderate to severe infections: 1 to 2 g IM or IV every 8 hours
Infections needing higher-doses: 2 g IV every 6 to 8 hours
Life-threatening infections: 2 g IV every 4 hours
Maximum dose: 12 g/day

Comment: Efficacy in treating Klebsiella pneumoniae and E coli have been studied in less than 10 infections.

Use: Treatment of central nervous system infections (including meningitis and ventriculitis) caused by Neisseria meningitides, Haemophilus influenzae, Streptococcus pneumoniae, K pneumoniae, and E coli

Infectious Diseases Society of America (IDSA), American Academy of Neurology (AAN), American Association of Neurological Surgeons (AANS), and Neurocritical Care Society (NCS) Recommendations: 8 to 12 g per day, given at 4 to 6 hour intervals

Comment: Vancomycin should be added to isolates with a penicillin MIC of 0.12 mcg/mL or higher and a third-generation cephalosporin MIC of 1 mcg/mL or greater.

Uses:
-Treatment of healthcare-associated ventriculitis and meningitis caused by gram-negative bacilli susceptible to third-generation cephalosporins
-Recommended treatment of bacterial meningitis caused by N meningitides, H influenzae, S pneumoniae, and E coli
-Empirical antimicrobial therapy in patients 50 years and younger with purulent meningitis caused by N meningitides or S pneumoniae
-Empirical antimicrobial therapy in patients over 50 years of age with purulent meningitis caused by S pneumoniae, N meningitides, Listeria monocytogenes, or aerobic gram-negative bacilli
-Empirical antimicrobial therapy in patients with basilar skull fractures with purulent meningitis caused by S pneumoniae, H influenzae, Group A beta-hemolytic streptococci

Usual Adult Dose for Pelvic Inflammatory Disease:

Uncomplicated infections: 1 g IM or IV every 12 hours
Moderate to severe infections: 1 to 2 g IM or IV every 8 hours
Infections needing higher-doses: 2 g IV every 6 to 8 hours
Life-threatening infections: 2 g IV every 4 hours
Maximum dose: 12 g/day

Comments:
-Efficacy in treating Enterobacter species, Klebsiella species, Bacteriodes fragilis, and Fusobacterium nucleatum have been studied in less than 10 infections.
-This drug is not active against Chlamydia trachomatis. Patients with pelvic inflammatory disease suspected to be caused by C trachomatis should be given appropriate anti-chlamydial treatment.

Use: Treatment of endometriosis, pelvic inflammatory disease, and pelvic cellulitis caused by Staphylococcus epidermidis, Streptococcus species, Enterococcus species, Enterobacter species, E coli, Klebsiella species, Proteus mirabilis, Bacteroides species, Clostridium species, anaerobic cocci (e.g., Peptostreptococcus species, Peptococcus species), and Fusobacterium species

Usual Adult Dose for Endometritis:

Uncomplicated infections: 1 g IM or IV every 12 hours
Moderate to severe infections: 1 to 2 g IM or IV every 8 hours
Infections needing higher-doses: 2 g IV every 6 to 8 hours
Life-threatening infections: 2 g IV every 4 hours
Maximum dose: 12 g/day

Comments:
-Efficacy in treating Enterobacter species, Klebsiella species, Bacteriodes fragilis, and Fusobacterium nucleatum have been studied in less than 10 infections.
-This drug is not active against Chlamydia trachomatis. Patients with pelvic inflammatory disease suspected to be caused by C trachomatis should be given appropriate anti-chlamydial treatment.

Use: Treatment of endometriosis, pelvic inflammatory disease, and pelvic cellulitis caused by Staphylococcus epidermidis, Streptococcus species, Enterococcus species, Enterobacter species, E coli, Klebsiella species, Proteus mirabilis, Bacteroides species, Clostridium species, anaerobic cocci (e.g., Peptostreptococcus species, Peptococcus species), and Fusobacterium species

Usual Adult Dose for Gonococcal Infection -- Uncomplicated:

Urethritis/cervicitis: 0.5 g IM once

Rectal gonorrhea:
-Females: 0.5 g IM once
-Males: 1 g IM once

Use: Treatment of uncomplicated cervical/urethral and rectal gonorrhea caused by Neisseria gonorrhoeae, including penicillinase producing strains

US Centers for Disease Control and Prevention (CDC) Recommendations:
Urogenital and anorectal infections: 500 mg IM once

Use: Alternative treatment of uncomplicated gonococcal infections of the cervix, urethra, and rectum

Usual Adult Dose for Intraabdominal Infection:

Uncomplicated infections: 1 g IM or IV every 12 hours
Moderate to severe infections: 1 to 2 g IM or IV every 8 hours
Infections needing higher-doses: 2 g IV every 6 to 8 hours
Life-threatening infections: 2 g IV every 4 hours
Maximum dose: 12 g/day

Comment: Efficacy in treating Streptococcus species, Peptostreptococcus species, Pseudomonas aeruginosa, P mirabilis, and Clostridium species have been studied in less than 10 infections.

Use: Treatment of intraabdominal infections caused by Streptococcus species, E coli, Klebsiella species, Bacteroides species, anaerobic cocci, P mirabilis, and Clostridium species

IDSA and National Institutes of Health (NIH) Recommendations: 1 g IV every 8 hours

Uses:
-Empiric treatment of bacterial enteric infections for patients with advanced HIV and clinically severe diarrhea (e.g., 6 or more liquid stools/day or bloody stool and/or with fever/chills)
-Treatment of salmonellosis in patients with HIV

Surgical Infection Society (SIS) and IDSA Recommendations: 1 to 2 g IV every 6 to 8 hours PLUS metronidazole

Use: Empirical treatment of community-acquired mild-to-moderate perforated/abscessed appendicitis and other infections of mild-to-moderate severity

Usual Adult Dose for Joint Infection:

Uncomplicated infections: 1 g IM or IV every 12 hours
Moderate to severe infections: 1 to 2 g IM or IV every 8 hours
Infections needing higher-doses: 2 g IV every 6 to 8 hours
Life-threatening infections: 2 g IV every 4 hours
Maximum dose: 12 g/day

Comment: Efficacy in treating Streptococcus pyogenes, P aeruginosa, and P mirabilis have been studied in less than 10 infections.

Use: Treatment of bone and/or joint infections caused by penicillinase and non-penicillinase producing S aureus, Streptococcus species, Pseudomonas species, and P mirabilis

Usual Adult Dose for Osteomyelitis:

Uncomplicated infections: 1 g IM or IV every 12 hours
Moderate to severe infections: 1 to 2 g IM or IV every 8 hours
Infections needing higher-doses: 2 g IV every 6 to 8 hours
Life-threatening infections: 2 g IV every 4 hours
Maximum dose: 12 g/day

Comment: Efficacy in treating Streptococcus pyogenes, P aeruginosa, and P mirabilis have been studied in less than 10 infections.

Use: Treatment of bone and/or joint infections caused by penicillinase and non-penicillinase producing S aureus, Streptococcus species, Pseudomonas species, and P mirabilis

Usual Adult Dose for Peritonitis:

Uncomplicated infections: 1 g IM or IV every 12 hours
Moderate to severe infections: 1 to 2 g IM or IV every 8 hours
Infections needing higher-doses: 2 g IV every 6 to 8 hours
Life-threatening infections: 2 g IV every 4 hours
Maximum dose: 12 g/day

Comment: Efficacy in treating Streptococcus species, Peptostreptococcus species, P aeruginosa, P mirabilis, and Clostridium species have been studied in less than 10 infections.

Use: Treatment of peritonitis caused by Streptococcus species, E coli, Klebsiella species, Bacteroides species, anaerobic cocci, P mirabilis, and Clostridium species

International Society for Peritoneal Dialysis (ISPD) Recommendations:
Intermittent: 500 to 1000 mg intraperitoneally once a day

Use: Empirical treatment of peritonitis suspected to be caused by gram-negative organisms

Usual Adult Dose for Pneumonia:

Uncomplicated infections: 1 g IM or IV every 12 hours
Moderate to severe infections: 1 to 2 g IM or IV every 8 hours
Infections needing higher-doses: 2 g IV every 6 to 8 hours
Life-threatening infections: 2 g IV every 4 hours
Maximum dose: 12 g/day

Comment: Efficacy in treating S pyogenes and S marcescens have been studied in less than 10 infections.

Use: Treatment of serious lower respiratory tract infections (including pneumonia) caused by S pneumoniae/Diplococcus pneumoniae, S pyogenes (Group A streptococci), other streptococci (except enterococci), penicillinase/non-penicillinase producing S aureus, E coli, Klebsiella species, H influenzae (including ampicillin-resistant organisms), Haemophilus parainfluenzae, P mirabilis, S marcescens, Enterobacter species, and indole positive Proteus and Pseudomonas species

Usual Adult Dose for Skin or Soft Tissue Infection:

Uncomplicated infections: 1 g IM or IV every 12 hours
Moderate to severe infections: 1 to 2 g IM or IV every 8 hours
Infections needing higher-doses: 2 g IV every 6 to 8 hours
Life-threatening infections: 2 g IV every 4 hours
Maximum dose: 12 g/day

Comment: Efficacy in treating Acinetobacter species, Citrobacter freundii, Proteus vulgaris, Providencia rettgeri, and Peptostreptococcus have been studied in less than 10 infections.

Use: Treatment of skin and structure infections caused by penicillinase and non-penicillinase producing S aureus, Staphylococcus epidermidis, Streptococcus pyogenes (Group A streptococci), other streptococci, Enterococcus species, Acinetobacter species, E coli, Citrobacter species, Enterobacter species, Klebsiella species, P mirabilis, P vulgaris, Morganella morganii, P rettgeri, Pseudomonas species, S marcescens, Bacteroides species, and anaerobic cocci

IDSA Recommendations:
Animal bites: 1 to 2 g IV every 6 to 8 hours
Mixed infections: 2 g IV every 6 hours PLUS metronidazole or clindamycin
Vibrio infections: 2 g IV 3 times a day PLUS doxycycline

Uses:
-Treatment of necrotizing infections of the skin, fascia, and muscle caused by mixed infections or Vibrio vulnificus
-Treatment of infections following animal bites

Usual Adult Dose for Surgical Prophylaxis:

1 g IM or IV once

Comments:
-This drug should be given 30 to 90 minutes prior to surgery.
-Some experts recommend preoperative bowel preparation with mechanical cleansing and use of a non-absorbable antibiotic in patients undergoing gastrointestinal procedures.

Use: To reduce the incidence of specific infections in patients undergoing contaminated or possibly contaminated surgical procedures (e.g., abdominal/vaginal hysterectomy, gastrointestinal/genitourinary tract surgery)

American Society of Health-System Pharmacists (ASHP), IDSA, SIS, and Society for Healthcare Epidemiology of America (SHEA) Recommendations:
Non-obese patients: 1 g IV once PLUS ampicillin
Obese patients: 2 g IV once PLUS ampicillin

Comment: The recommended redosing interval is 3 hours.

Use: Surgical antimicrobial prophylaxis in patients undergoing liver transplantation

Usual Adult Dose for Urinary Tract Infection:

Uncomplicated infections: 1 g IM or IV every 12 hours
Moderate to severe infections: 1 to 2 g IM or IV every 8 hours
Infections needing higher-doses: 2 g IV every 6 to 8 hours
Life-threatening infections: 2 g IV every 4 hours
Maximum dose: 12 g/day

Comment: Efficacy in treating S aureus, P vulgaris, M morganii, and P rettgeri have been studied in less than 10 infections.

Use: Treatment of urinary tract infections caused by Enterococcus species, S epidermidis, penicillinase/non-penicillinase producing S aureus, Citrobacter species, Enterobacter species, E coli, Klebsiella species, P mirabilis, P vulgaris, P stuartii, M morganii, P rettgeri, S marcescens, and Pseudomonas species

Usual Adult Dose for Gonococcal Infection -- Disseminated:

US CDC Recommendations: 1 g IV every 8 hours

Comment: The patient's sexual partner(s) within the past 60 days should be evaluates/treated.

Use: Alternative treatment of arthritis and arthritis-dermatitis syndrome caused by N gonorrhoeae

Usual Adult Dose for Lyme Disease -- Neurologic:

AAN and IDSA Recommendations: 2 g IV every 8 hours
-Duration of therapy: 14 to 28 days

Use: Treatment of nervous system Lyme disease

Usual Adult Dose for Sinusitis:

IDSA Recommendations: 2 g IV every 4 to 6 hours

Uses: Treatment of severe acute bacterial rhinosinusitis requiring hospitalization

Usual Adult Dose for Rhinitis:

IDSA Recommendations: 2 g IV every 4 to 6 hours

Uses: Treatment of severe acute bacterial rhinosinusitis requiring hospitalization

Usual Pediatric Dose for Bacteremia:

0 to 1 week: 50 mg/kg IV every 12 hours
1 to 4 weeks: 50 mg/kg IV every 8 hours

1 month to 12 years:
Less than 50 kg: 50 to 180 mg/kg IM or IV per day, given in 4 to 6 equal doses
50 kg or more:
-Uncomplicated infections: 1 g IM or IV every 12 hours
-Moderate to severe infections: 1 to 2 g IM or IV every 8 hours
-Infections needing higher-doses: 2 g IV every 6 to 8 hours
-Life-threatening infections: 2 g IV every 4 hours
Maximum dose: 12 g/day

12 years and older:
Uncomplicated infections: 1 g IM or IV every 12 hours
Moderate to severe infections: 1 to 2 g IM or IV every 8 hours
Infections needing higher-doses: 2 g IV every 6 to 8 hours
Life-threatening infections: 2 g IV every 4 hours
Maximum dose: 12 g/day

Comment: Higher doses should be used to treat more severe/serious infections.

Use: Treatment of bacteremia or septicemia caused by E coli, Klebsiella species, S marcescens, S aureus, and Streptococcus species

IDSA Recommendations:
Neonates 0 to 4 weeks and less than 1200 g: 100 mg/kg IV per day, given in divided doses every 12 hours
Postnatal age 7 days or less and 1200 to 2000 g: 100 mg/kg IV per day, given in divided doses every 12 hours
Postnatal age 7 days or less and greater than 2000 g: 100 to 150 mg/kg IV per day, given in divided doses every 8 to 12 hours
Postnatal age over 7 days and 1200 to 2000 g: 150 mg/kg IV per day, given in divided doses every 8 hours
Postnatal age over 7 days and over 2000 g: 150 to 200 mg/kg IV per day, given in divided doses every 6 to 8 hours
Infants and children 12 years and younger: 100 to 150 mg/kg per day, given in divided doses every 8 hours

Use: Treatment of catheter-related infections

Usual Pediatric Dose for Septicemia:

0 to 1 week: 50 mg/kg IV every 12 hours
1 to 4 weeks: 50 mg/kg IV every 8 hours

1 month to 12 years:
Less than 50 kg: 50 to 180 mg/kg IM or IV per day, given in 4 to 6 equal doses
50 kg or more:
-Uncomplicated infections: 1 g IM or IV every 12 hours
-Moderate to severe infections: 1 to 2 g IM or IV every 8 hours
-Infections needing higher-doses: 2 g IV every 6 to 8 hours
-Life-threatening infections: 2 g IV every 4 hours
Maximum dose: 12 g/day

12 years and older:
Uncomplicated infections: 1 g IM or IV every 12 hours
Moderate to severe infections: 1 to 2 g IM or IV every 8 hours
Infections needing higher-doses: 2 g IV every 6 to 8 hours
Life-threatening infections: 2 g IV every 4 hours
Maximum dose: 12 g/day

Comment: Higher doses should be used to treat more severe/serious infections.

Use: Treatment of bacteremia or septicemia caused by E coli, Klebsiella species, S marcescens, S aureus, and Streptococcus species

IDSA Recommendations:
Neonates 0 to 4 weeks and less than 1200 g: 100 mg/kg IV per day, given in divided doses every 12 hours
Postnatal age 7 days or less and 1200 to 2000 g: 100 mg/kg IV per day, given in divided doses every 12 hours
Postnatal age 7 days or less and greater than 2000 g: 100 to 150 mg/kg IV per day, given in divided doses every 8 to 12 hours
Postnatal age over 7 days and 1200 to 2000 g: 150 mg/kg IV per day, given in divided doses every 8 hours
Postnatal age over 7 days and over 2000 g: 150 to 200 mg/kg IV per day, given in divided doses every 6 to 8 hours
Infants and children 12 years and younger: 100 to 150 mg/kg per day, given in divided doses every 8 hours

Use: Treatment of catheter-related infections

Usual Pediatric Dose for Sepsis:

0 to 1 week: 50 mg/kg IV every 12 hours
1 to 4 weeks: 50 mg/kg IV every 8 hours

1 month to 12 years:
Less than 50 kg: 50 to 180 mg/kg IM or IV per day, given in 4 to 6 equal doses
50 kg or more:
-Uncomplicated infections: 1 g IM or IV every 12 hours
-Moderate to severe infections: 1 to 2 g IM or IV every 8 hours
-Infections needing higher-doses: 2 g IV every 6 to 8 hours
-Life-threatening infections: 2 g IV every 4 hours
Maximum dose: 12 g/day

12 years and older:
Uncomplicated infections: 1 g IM or IV every 12 hours
Moderate to severe infections: 1 to 2 g IM or IV every 8 hours
Infections needing higher-doses: 2 g IV every 6 to 8 hours
Life-threatening infections: 2 g IV every 4 hours
Maximum dose: 12 g/day

Comment: Higher doses should be used to treat more severe/serious infections.

Use: Treatment of bacteremia or septicemia caused by E coli, Klebsiella species, S marcescens, S aureus, and Streptococcus species

IDSA Recommendations:
Neonates 0 to 4 weeks and less than 1200 g: 100 mg/kg IV per day, given in divided doses every 12 hours
Postnatal age 7 days or less and 1200 to 2000 g: 100 mg/kg IV per day, given in divided doses every 12 hours
Postnatal age 7 days or less and greater than 2000 g: 100 to 150 mg/kg IV per day, given in divided doses every 8 to 12 hours
Postnatal age over 7 days and 1200 to 2000 g: 150 mg/kg IV per day, given in divided doses every 8 hours
Postnatal age over 7 days and over 2000 g: 150 to 200 mg/kg IV per day, given in divided doses every 6 to 8 hours
Infants and children 12 years and younger: 100 to 150 mg/kg per day, given in divided doses every 8 hours

Use: Treatment of catheter-related infections

Usual Pediatric Dose for Meningitis:

0 to 1 week: 50 mg/kg IV every 12 hours
1 to 4 weeks: 50 mg/kg IV every 8 hours

1 month to 12 years:
Less than 50 kg: 50 to 180 mg/kg IM or IV per day, given in 4 to 6 equal doses
50 kg or more:
-Uncomplicated infections: 1 g IM or IV every 12 hours
-Moderate to severe infections: 1 to 2 g IM or IV every 8 hours
-Infections needing higher-doses: 2 g IV every 6 to 8 hours
-Life-threatening infections: 2 g IV every 4 hours
Maximum dose: 12 g/day

12 years and older:
Uncomplicated infections: 1 g IM or IV every 12 hours
Moderate to severe infections: 1 to 2 g IM or IV every 8 hours
Infections needing higher-doses: 2 g IV every 6 to 8 hours
Life-threatening infections: 2 g IV every 4 hours
Maximum dose: 12 g/day

Comments:
-Higher doses should be used to treat more severe/serious infections.
-Efficacy in treating K pneumoniae and E coli have been studied in less than 10 infections.

Use: Treatment of central nervous system infections (including meningitis and ventriculitis) caused by N meningitides, H influenzae, S pneumoniae, K pneumoniae, and E coli

IDSA, AAN, AANS, and NCS Recommendations:
Bacterial meningitis:
0 to 7 days: 100 to 150 mg/kg IV per day, given in divided doses every 8 to 12 hours PLUS ampicillin
8 to 28 days: 150 to 200 mg/kg IV per day, given in divided doses every 6 to 8 hours PLUS ampicillin
Infants and children: 225 to 300 mg/kg IV per day, given in divided doses every 6 to 8 hours PLUS vancomycin

Nosocomial meningitis:
Children: 300 mg/kg IV per day, given at 6 to 8 hour intervals

Comment: Vancomycin should be added to patients over 1 month of age and/or in isolates with a penicillin MIC of 0.12 mcg/mL or higher and a third-generation cephalosporin MIC of 1 mcg/mL or greater.

Uses:
-Empirical antimicrobial therapy in patients less than 1 month of age with purulent meningitis caused by S agalactiae, E coli, L monocytogenes, or Klebsiella species
-Empirical antimicrobial therapy in patients 1 to 23 months of age with purulent meningitis caused by S pneumoniae, N meningitides, S agalactiae, H influenzae, or E coli
-Empirical antimicrobial therapy in patients 2 years and older with purulent meningitis caused by N meningitides or S pneumoniae
-Empirical antimicrobial therapy in patients with basilar skull fractures with purulent meningitis caused by S pneumoniae, H influenzae, Group A beta-hemolytic streptococci

Usual Pediatric Dose for CNS Infection:

0 to 1 week: 50 mg/kg IV every 12 hours
1 to 4 weeks: 50 mg/kg IV every 8 hours

1 month to 12 years:
Less than 50 kg: 50 to 180 mg/kg IM or IV per day, given in 4 to 6 equal doses
50 kg or more:
-Uncomplicated infections: 1 g IM or IV every 12 hours
-Moderate to severe infections: 1 to 2 g IM or IV every 8 hours
-Infections needing higher-doses: 2 g IV every 6 to 8 hours
-Life-threatening infections: 2 g IV every 4 hours
Maximum dose: 12 g/day

12 years and older:
Uncomplicated infections: 1 g IM or IV every 12 hours
Moderate to severe infections: 1 to 2 g IM or IV every 8 hours
Infections needing higher-doses: 2 g IV every 6 to 8 hours
Life-threatening infections: 2 g IV every 4 hours
Maximum dose: 12 g/day

Comments:
-Higher doses should be used to treat more severe/serious infections.
-Efficacy in treating K pneumoniae and E coli have been studied in less than 10 infections.

Use: Treatment of central nervous system infections (including meningitis and ventriculitis) caused by N meningitides, H influenzae, S pneumoniae, K pneumoniae, and E coli

IDSA, AAN, AANS, and NCS Recommendations:
Bacterial meningitis:
0 to 7 days: 100 to 150 mg/kg IV per day, given in divided doses every 8 to 12 hours PLUS ampicillin
8 to 28 days: 150 to 200 mg/kg IV per day, given in divided doses every 6 to 8 hours PLUS ampicillin
Infants and children: 225 to 300 mg/kg IV per day, given in divided doses every 6 to 8 hours PLUS vancomycin

Nosocomial meningitis:
Children: 300 mg/kg IV per day, given at 6 to 8 hour intervals

Comment: Vancomycin should be added to patients over 1 month of age and/or in isolates with a penicillin MIC of 0.12 mcg/mL or higher and a third-generation cephalosporin MIC of 1 mcg/mL or greater.

Uses:
-Empirical antimicrobial therapy in patients less than 1 month of age with purulent meningitis caused by S agalactiae, E coli, L monocytogenes, or Klebsiella species
-Empirical antimicrobial therapy in patients 1 to 23 months of age with purulent meningitis caused by S pneumoniae, N meningitides, S agalactiae, H influenzae, or E coli
-Empirical antimicrobial therapy in patients 2 years and older with purulent meningitis caused by N meningitides or S pneumoniae
-Empirical antimicrobial therapy in patients with basilar skull fractures with purulent meningitis caused by S pneumoniae, H influenzae, Group A beta-hemolytic streptococci

Usual Pediatric Dose for Intraabdominal Infection:

0 to 1 week: 50 mg/kg IV every 12 hours
1 to 4 weeks: 50 mg/kg IV every 8 hours

1 month to 12 years:
Less than 50 kg: 50 to 180 mg/kg IM or IV per day, given in 4 to 6 equal doses
50 kg or more:
-Uncomplicated infections: 1 g IM or IV every 12 hours
-Moderate to severe infections: 1 to 2 g IM or IV every 8 hours
-Infections needing higher-doses: 2 g IV every 6 to 8 hours
-Life-threatening infections: 2 g IV every 4 hours
Maximum dose: 12 g/day

12 years and older:
Uncomplicated infections: 1 g IM or IV every 12 hours
Moderate to severe infections: 1 to 2 g IM or IV every 8 hours
Infections needing higher-doses: 2 g IV every 6 to 8 hours
Life-threatening infections: 2 g IV every 4 hours
Maximum dose: 12 g/day

Comments:
-Higher doses should be used to treat more severe/serious infections.
-Efficacy in treating Streptococcus species, Peptostreptococcus species, P aeruginosa, P mirabilis, and Clostridium species have been studied in less than 10 infections.

Use: Treatment of peritonitis caused by Streptococcus species, E coli, Klebsiella species, Bacteroides species, anaerobic cocci, P mirabilis, and Clostridium species

IDSA and NIH Recommendations:
Adolescents: 1 g IV every 8 hours

Uses:
-Empiric treatment of bacterial enteric infections for patients with advanced HIV and clinically severe diarrhea (e.g., 6 or more liquid stools/day or bloody stool and/or with fever/chills)
-Treatment of salmonellosis in patients with HIV

Surgical Infection Society (SIS) and Infectious Diseases Society of America (IDSA) Recommendations: 150 to 200 mg/kg IV per day, given in divided doses every 6 to 8 hours

Use: Empirical treatment of community-acquired infections

Usual Pediatric Dose for Joint Infection:

0 to 1 week: 50 mg/kg IV every 12 hours
1 to 4 weeks: 50 mg/kg IV every 8 hours

1 month to 12 years:
Less than 50 kg: 50 to 180 mg/kg IM or IV per day, given in 4 to 6 equal doses
50 kg or more:
-Uncomplicated infections: 1 g IM or IV every 12 hours
-Moderate to severe infections: 1 to 2 g IM or IV every 8 hours
-Infections needing higher-doses: 2 g IV every 6 to 8 hours
-Life-threatening infections: 2 g IV every 4 hours
Maximum dose: 12 g/day

12 years and older:
Uncomplicated infections: 1 g IM or IV every 12 hours
Moderate to severe infections: 1 to 2 g IM or IV every 8 hours
Infections needing higher-doses: 2 g IV every 6 to 8 hours
Life-threatening infections: 2 g IV every 4 hours
Maximum dose: 12 g/day

Comments:
-Higher doses should be used to treat more severe/serious infections.
-Efficacy in treating S pyogenes, P aeruginosa, and P mirabilis have been studied in less than 10 infections.

Use: Treatment of bone and/or joint infections caused by penicillinase and non-penicillinase producing S aureus, Streptococcus species, Pseudomonas species, and P mirabilis

Usual Pediatric Dose for Osteomyelitis:

0 to 1 week: 50 mg/kg IV every 12 hours
1 to 4 weeks: 50 mg/kg IV every 8 hours

1 month to 12 years:
Less than 50 kg: 50 to 180 mg/kg IM or IV per day, given in 4 to 6 equal doses
50 kg or more:
-Uncomplicated infections: 1 g IM or IV every 12 hours
-Moderate to severe infections: 1 to 2 g IM or IV every 8 hours
-Infections needing higher-doses: 2 g IV every 6 to 8 hours
-Life-threatening infections: 2 g IV every 4 hours
Maximum dose: 12 g/day

12 years and older:
Uncomplicated infections: 1 g IM or IV every 12 hours
Moderate to severe infections: 1 to 2 g IM or IV every 8 hours
Infections needing higher-doses: 2 g IV every 6 to 8 hours
Life-threatening infections: 2 g IV every 4 hours
Maximum dose: 12 g/day

Comments:
-Higher doses should be used to treat more severe/serious infections.
-Efficacy in treating S pyogenes, P aeruginosa, and P mirabilis have been studied in less than 10 infections.

Use: Treatment of bone and/or joint infections caused by penicillinase and non-penicillinase producing S aureus, Streptococcus species, Pseudomonas species, and P mirabilis

Usual Pediatric Dose for Peritonitis:

0 to 1 week: 50 mg/kg IV every 12 hours
1 to 4 weeks: 50 mg/kg IV every 8 hours

1 month to 12 years:
Less than 50 kg: 50 to 180 mg/kg IM or IV per day, given in 4 to 6 equal doses
50 kg or more:
-Uncomplicated infections: 1 g IM or IV every 12 hours
-Moderate to severe infections: 1 to 2 g IM or IV every 8 hours
-Infections needing higher-doses: 2 g IV every 6 to 8 hours
-Life-threatening infections: 2 g IV every 4 hours
Maximum dose: 12 g/day

12 years and older:
Uncomplicated infections: 1 g IM or IV every 12 hours
Moderate to severe infections: 1 to 2 g IM or IV every 8 hours
Infections needing higher-doses: 2 g IV every 6 to 8 hours
Life-threatening infections: 2 g IV every 4 hours
Maximum dose: 12 g/day

Comments:
-Higher doses should be used to treat more severe/serious infections.
-Efficacy in treating Streptococcus species, Peptostreptococcus species, P aeruginosa, P mirabilis, and Clostridium species have been studied in less than 10 infections.

Use: Treatment of peritonitis caused by Streptococcus species, E coli, Klebsiella species, Bacteroides species, anaerobic cocci, P mirabilis, and Clostridium species

ISPD Recommendations:
Continuous peritoneal dialysis:
-Loading dose: 500 mg/L intraperitoneally once
-Maintenance dose: 250 mg/L intraperitoneally

Intermittent peritoneal dialysis: 30 mg/kg intraperitoneally once a day
-Duration of therapy: 2 weeks

Comments:
-Patients receiving continuous dialysis should allow the loading dose to dwell for 3 to 6 hours.
-Patients receiving intermittent dialysis should be given the dose once a day in the long dwell.

Use: Treatment of peritonitis caused by E coli or Klebsiella species

Usual Pediatric Dose for Pneumonia:

0 to 1 week: 50 mg/kg IV every 12 hours
1 to 4 weeks: 50 mg/kg IV every 8 hours

1 month to 12 years:
Less than 50 kg: 50 to 180 mg/kg IM or IV per day, given in 4 to 6 equal doses
50 kg or more:
-Uncomplicated infections: 1 g IM or IV every 12 hours
-Moderate to severe infections: 1 to 2 g IM or IV every 8 hours
-Infections needing higher-doses: 2 g IV every 6 to 8 hours
-Life-threatening infections: 2 g IV every 4 hours
Maximum dose: 12 g/day

12 years and older:
Uncomplicated infections: 1 g IM or IV every 12 hours
Moderate to severe infections: 1 to 2 g IM or IV every 8 hours
Infections needing higher-doses: 2 g IV every 6 to 8 hours
Life-threatening infections: 2 g IV every 4 hours
Maximum dose: 12 g/day

Comments:
-Higher doses should be used to treat more severe/serious infections.
-Efficacy in treating S pyogenes and S marcescens have been studied in less than 10 infections.

Use: Treatment of serious lower respiratory tract infections (including pneumonia) caused by S pneumoniae/D pneumoniae, S pyogenes (Group A streptococci), other streptococci (except enterococci), penicillinase/non-penicillinase producing S aureus, E coli, Klebsiella species, H influenzae (including ampicillin-resistant organisms), H parainfluenzae, P mirabilis, S marcescens, Enterobacter species, and indole positive Proteus and Pseudomonas species

IDSA and NIH Recommendations:
Children: 40 to 50 mg/kg IV 4 times a day OR 50 to 65 mg/kg IV 3 times a day
-Maximum dose: 8 to 10 g/day

Use: Treatment of bacterial pneumonia caused by S pneumoniae, S aureus, H influenzae, or P aeruginosa in patients exposed to or with HIV

Pediatric Infectious Diseases Society (PIDS) and IDSA Recommendations:
Older than 3 months: 150 mg/kg IV per day, given in divided doses every 8 hours

Uses:
-Preferred treatment of community-acquired pneumonia caused by H influenzae types A to
F or non-typeable
-Alternative treatment of community-acquired pneumonia caused by Group A Streptococcus or S pneumoniae with penicillin MICs of 2 mcg/mL or less

Usual Pediatric Dose for Skin or Soft Tissue Infection:

0 to 1 week: 50 mg/kg IV every 12 hours
1 to 4 weeks: 50 mg/kg IV every 8 hours

1 month to 12 years:
Less than 50 kg: 50 to 180 mg/kg IM or IV per day, given in 4 to 6 equal doses
50 kg or more:
-Uncomplicated infections: 1 g IM or IV every 12 hours
-Moderate to severe infections: 1 to 2 g IM or IV every 8 hours
-Infections needing higher-doses: 2 g IV every 6 to 8 hours
-Life-threatening infections: 2 g IV every 4 hours
Maximum dose: 12 g/day

12 years and older:
Uncomplicated infections: 1 g IM or IV every 12 hours
Moderate to severe infections: 1 to 2 g IM or IV every 8 hours
Infections needing higher-doses: 2 g IV every 6 to 8 hours
Life-threatening infections: 2 g IV every 4 hours
Maximum dose: 12 g/day

Comments:
-Higher doses should be used to treat more severe/serious infections.
-Efficacy in treating Acinetobacter species, C freundii, P vulgaris, P rettgeri, and Peptostreptococcus have been studied in less than 10 infections.

Use: Treatment of skin and structure infections caused by penicillinase and non-penicillinase producing S aureus, S epidermidis, S pyogenes (Group A streptococci), other streptococci, Enterococcus species, Acinetobacter species, E coli, Citrobacter species, Enterobacter species, Klebsiella species, P mirabilis, P vulgaris, M morganii, P rettgeri, Pseudomonas species, S marcescens, Bacteroides species, and anaerobic cocci

IDSA Recommendations:
Children: 50 mg/kg IV per day, given in divided doses every 6 hours PLUS metronidazole or clindamycin

Use: Treatment of necrotizing infections of the skin, fascia, and muscle caused by mixed infections

Usual Pediatric Dose for Urinary Tract Infection:

0 to 1 week: 50 mg/kg IV every 12 hours
1 to 4 weeks: 50 mg/kg IV every 8 hours

1 month to 12 years:
Less than 50 kg: 50 to 180 mg/kg IM or IV per day, given in 4 to 6 equal doses
50 kg or more:
-Uncomplicated infections: 1 g IM or IV every 12 hours
-Moderate to severe infections: 1 to 2 g IM or IV every 8 hours
-Infections needing higher-doses: 2 g IV every 6 to 8 hours
-Life-threatening infections: 2 g IV every 4 hours
Maximum dose: 12 g/day

12 years and older:
Uncomplicated infections: 1 g IM or IV every 12 hours
Moderate to severe infections: 1 to 2 g IM or IV every 8 hours
Infections needing higher-doses: 2 g IV every 6 to 8 hours
Life-threatening infections: 2 g IV every 4 hours
Maximum dose: 12 g/day

Comments:
-Higher doses should be used to treat more severe/serious infections.
-Efficacy in treating S aureus, P vulgaris, M morganii, and P rettgeri have been studied in less than 10 infections.

Use: Treatment of urinary tract infections caused by Enterococcus species, S epidermidis, penicillinase/non-penicillinase producing S aureus, Citrobacter species, Enterobacter species, E coli, Klebsiella species, P mirabilis, P vulgaris, P stuartii, M morganii, P rettgeri, S marcescens, and Pseudomonas species

Usual Pediatric Dose for Surgical Prophylaxis:

ASHP, IDSA, SIS, and SHEA Recommendations:
Pediatric patients: 50 mg/kg IV once PLUS ampicillin
-Maximum dose: 1 g/dose

Comment: The recommended redosing interval is 3 hours.

Use: Surgical antimicrobial prophylaxis in patients undergoing liver transplantation

Usual Pediatric Dose for Gonococcal Infection -- Uncomplicated:

US CDC Recommendations:
Adolescents:
Urogenital and anorectal infections: 500 mg IM once

Use: Alternative treatment of uncomplicated gonococcal infections of the cervix, urethra, and rectum

Usual Pediatric Dose for Gonococcal Infection -- Disseminated:

US CDC Recommendations:
Neonates: 25 mg/kg IM or IV every 12 hours
Duration of therapy:
-Disseminated gonococcal infection (DGI): 7 days
-DGI with meningitis: 10 to 14 days

Adolescents: 1 g IV every 8 hours

Comments:
-The patient's sexual partner(s) within the past 60 days should be evaluates/treated.
-Treatment should be used with caution in infants with hyperbilirubinemia.

Uses:
-Treatment of DGI and gonococcal scalp abscesses
-Alternative treatment of arthritis and arthritis-dermatitis syndrome caused by N gonorrhoeae

Usual Pediatric Dose for Lyme Disease -- Neurologic:

AAN and IDSA Recommendations:
Pediatric patients: 150 to 200 mg/kg IV per day, given in 3 to 4 divided doses
-Maximum dose: 6 g/day
-Duration of therapy: 14 to 28 days

Use: Treatment of nervous system Lyme disease

Usual Pediatric Dose for Sinusitis:

IDSA Recommendations:
Children: 100 to 200 mg/kg IV per day, given in divided doses every 6 hours

Use: Treatment of severe acute bacterial rhinosinusitis requiring hospitalization

Usual Pediatric Dose for Rhinitis:

IDSA Recommendations:
Children: 100 to 200 mg/kg IV per day, given in divided doses every 6 hours

Use: Treatment of severe acute bacterial rhinosinusitis requiring hospitalization

How is this medicine (Cefotaxime) best taken?

Use this medicine as ordered by your doctor. Read all information given to you. Follow all instructions closely.

  • To gain the most benefit, do not miss doses.
  • Keep taking cefotaxime as you have been told by your doctor or other health care provider, even if you feel well.
  • It is given as a shot into a muscle or vein.
  • Your doctor may teach you how to use.
  • Follow how to use carefully.
  • Do not use if the solution is cloudy, leaking, or has particles.
  • Do not use if solution changes color.
  • Throw away needles in a needle/sharp disposal box. Do not reuse needles or other items. When the box is full, follow all local rules for getting rid of it. Talk with a doctor or pharmacist if you have any questions.

What do I do if I miss a dose?

  • Take a missed dose as soon as you think about it.
  • If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
  • Do not take 2 doses at the same time or extra doses.

Overdosage

The acute toxicity of Cefotaxime was evaluated in neonatal and adult mice and rats. Significant mortality was seen at parenteral doses in excess of 6000 mg/kg/day in all groups. Common toxic signs in animals that died were a decrease in spontaneous activity, tonic and clonic convulsions, dyspnea, hypothermia, and cyanosis. Cefotaxime sodium overdosage has occurred in patients. Most cases have shown no overt toxicity. The most frequent reactions were elevations of BUN and creatinine. There is a risk of reversible encephalopathy in cases of administration of high doses of beta-lactam antibiotics including Cefotaxime. No specific antidote exists. Patients who receive an acute overdosage should be carefully observed and given supportive treatment.

Cefotaxime Dosage and Administration

Adults

Dosage and route of administration should be determined by susceptibility of the causative organisms, severity of the infection, and the condition of the patient (see table for dosage guideline). Cefotaxime for injection in ADD-Vantage vial is intended for IV use only after reconstitution. The maximum daily dosage should not exceed 12 grams.

GUIDELINES FOR DOSAGE OF Cefotaxime FOR INJECTION
Type of Infection Daily Dose (grams) Frequency and Route

Uncomplicated infections

2

1 gram every 12 hours IV

Moderate to severe infections

3 to 6

1 to 2 grams every 8 hours IV

Infections commonly needing
antibiotics in higher dosage
(e.g., septicemia)

6 to 8

2 grams every 6 to 8 hours IV

Life-threatening infections

up to 12

2 grams every 4 hours IV

If C. trachomatis is a suspected pathogen, appropriate anti-chlamydial coverage should be added, because Cefotaxime sodium has no activity against this organism.

To prevent postoperative infection in contaminated or potentially contaminated surgery, the recommended dose is a single 1 gram IV administered 30 to 90 minutes prior to start of surgery.

Cesarean Section Patients

The first dose of 1 gram is administered intravenously as soon as the umbilical cord is clamped. The second and third doses should be given as 1 gram intravenously at 6 and 12 hours after the first dose.

Neonates, Infants, and Children

The following dosage schedule is recommended:

  Neonates (birth to 1 month):

    0 to 1 week of age      50 mg/kg per dose every 12 hours IV
    1 to 4 weeks of age    50 mg/kg per dose every 8 hours IV

It is not necessary to differentiate between premature and normal-gestational age infants.

Infants and Children (1 month to 12 years):

For body weights less than 50 kg, the recommended daily dose is 50 to 180 mg/kg IV body weight divided into four to six equal doses. The higher dosages should be used for more severe or serious infections, including meningitis. For body weights 50 kg or more, the usual adult dosage should be used; the maximum daily dosage should not exceed 12 grams.

Geriatric Use

This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function. (See PRECAUTIONS, General and PRECAUTIONS, Geriatric Use.)

Impaired Renal Function

see PRECAUTIONS, General.

NOTE: As with antibiotic therapy in general, administration of Cefotaxime for injection should be continued for a minimum of 48 to 72 hours after the patient defervesces or after evidence of bacterial eradication has been obtained; a minimum of 10 days of treatment is recommended for infections caused by Group A beta-hemolytic streptococci in order to guard against the risk of rheumatic fever or glomerulonephritis; frequent bacteriologic and clinical appraisal is necessary during therapy of chronic urinary tract infection and may be required for several months after therapy has been completed; persistent infections may require treatment of several weeks and doses smaller than those indicated above should not be used.

IV Administration

The IV route is preferable for patients with bacteremia, bacterial septicemia, peritonitis, meningitis, or other severe or life-threatening infections, or for patients who may be poor risks because of lowered resistance resulting from such debilitating conditions as malnutrition, trauma, surgery, diabetes, heart failure, or malignancy, particularly if shock is present or impending.

Preparation of Cefotaxime for Injection in ADD-Vantage System

Cefotaxime for injection 1 gram or 2 gram may be reconstituted in 50 mL or 100 mL of 5% Dextrose or 0.9% Sodium Chloride in the ADD-Vantage diluent container. Refer to enclosed, INSTRUCTIONS FOR ADD-VANTAGE SYSTEM.

Compatibility and Stability

Solutions of Cefotaxime for Injection reconstituted in 0.9% Sodium Chloride Injection or 5% Dextrose Injection in the ADD-Vantage flexible containers maintain satisfactory potency for 24 hours at or below 22°C. DO NOT FREEZE.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

Ca- 4287

Cefotaxime 
Cefotaxime injection, powder, for solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0409-0811
Route of Administration INTRAVENOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Cefotaxime SODIUM (Cefotaxime) Cefotaxime 1 g
Packaging
# Item Code Package Description
1 NDC:0409-0811-01 25 VIAL, PATENT DELIVERY SYSTEM in 1 CARTON
1 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, PATENT DELIVERY SYSTEM
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA203132 02/19/2016
Cefotaxime 
Cefotaxime injection, powder, for solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0409-0812
Route of Administration INTRAVENOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Cefotaxime SODIUM (Cefotaxime) Cefotaxime 2 g
Packaging
# Item Code Package Description
1 NDC:0409-0812-01 25 VIAL, PATENT DELIVERY SYSTEM in 1 CARTON
1 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, PATENT DELIVERY SYSTEM
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA203132 02/19/2016
Labeler - Hospira, Inc. (141588017)
Revised: 01/2016   Hospira, Inc.

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. 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.

Distribution

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

Metabolism

Partially hepatic to active metabolite, desacetylcefotaxime

Excretion

Urine (~60% as unchanged drug and metabolites)

Time to Peak

Serum: IM: Within 30 minutes

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)

Protein Binding

31% to 50%

Dosing Pediatric

Usual dosage range for susceptible infections:

Infants, Children, and Adolescents:

Manufacturer's labeling:

<50 kg: IM, IV: 50 to 180 mg/kg/day in divided doses every 4 to 6 hours (maximum dose: 12 g daily)

≥50 kg: Refer to adult dosing

Alternate recommendations (Red Book [AAP] 2012): IM, IV:

Mild to moderate infection: 50 to 180 mg/kg/day in divided doses every 6 to 8 hours (maximum dose: 6 g daily)

Severe infection: 200 to 225 mg/kg/day in divided doses every 4 to 6 hours; up to 300 mg/kg per day has been used for meningitis (maximum dose: 12 g daily)

Indication-specific dosing:

Acute bacterial rhinosinusitis, severe infection requiring hospitalization (off-label use): Children: IV: 100 to 200 mg/kg/day divided every 6 hours for 10 to 14 days (Chow 2012)

Arthritis (septic): Children ≥50 kg or Adolescents: Refer to adult dosing.

Bacterial enteric infections in HIV-infected patients (empiric treatment) (off-label use): Adolescents: IV: Refer to adult dosing.

Brain abscess: Children ≥50 kg or Adolescents: Refer to adult dosing.

Cesarean section: Children ≥50 kg or Adolescents: Refer to adult dosing.

Complicated community-acquired intra-abdominal infection (in combination with metronidazole): Infants and Children: IV: 150 to 200 mg/kg/day divided every 6 to 8 hours (Solomkin 2010)

Gonorrhea (off-label use):

Disseminated gonococcal infection (DGI): IV, IM: 25 mg/kg every 12 hours for 7 days; continue for 10 to 14 days if meningitis is documented (CDC [Workowski 2015])

Gonococcal scalp abscesses: IV, IM: 25 mg/kg every 12 hours for 7 days (CDC [Workowski 2015])

Disseminated infections (arthritis and arthritis-dermatitis syndrome) (alternative to preferred therapy): Adolescents: Refer to adult dosing.

Lyme disease (as an alternative to ceftriaxone): Cardiac or CNS manifestations: Infants and Children: 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 daily (Halperin 2007; Wormser 2006)

Meningitis (in combination with vancomycin): Infants and Children: IV: 225 to 300 mg/kg/day in divided doses every 6 to 8 hours (Tunkel 2004)

Pneumonia, community-acquired (IDSA/PIDS 2011): Infants >3 months and Children: IV: 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.

Empiric treatment, Haemophilus influenzae, group A Streptococcus, or S. pneumoniae (MICs to penicillin ≤2.0 mcg/mL), patient fully immunized for H. influenzae type b and S. pneumoniae, or minimal local resistance to penicillin in invasive pneumococcal strains (alternative to ampicillin or penicillin): 50 mg/kg/dose every 8 hours

Moderate to severe infection, patient not fully immunized for H. influenzae type b and S. pneumoniae, or significant local resistance to penicillin in invasive pneumococcal strains (preferred): 50 mg/kg/dose every 8 hours

Moderate to severe infection, H. influenzae (beta-lactamase producing) (preferred): 50 mg/kg/dose every 8 hours

Sepsis:

Infants and Children ≤12 years: IV: 150 mg/kg/day divided every 8 hours

Children ≥50 kg or Adolescents: Refer to adult dosing.

Skin and soft tissue necrotizing infections (off-label use): Infants and Children: IV: 50 mg/kg 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])

Surgical (perioperative) prophylaxis (off-label use): Children ≥1 year: IV: 50 mg/kg within 60 minutes prior to surgical incision (maximum: 1000 mg per dose). Doses may be repeated in 3 hours if procedure is lengthy or if there is excessive blood loss. Note: preferred agent (with ampicillin) in liver transplantation (Bratzler 2013).

Typhoid fever: Infants and Children ≤12 years: IM, IV: 150 to 200 mg/kg/day in 3 to 4 divided doses (maximum: 12 g daily); fluoroquinolone resistant: 80 mg/kg/day in 3 to 4 divided doses (maximum: 12 g daily)

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.

IV: Can be administered IV bolus over at least 3 to 5 minutes or as an IV intermittent infusion over 15 to 30 minutes.

Usual Adult Dose for Septicemia

Uncomplicated infections: 1 g IM or IV every 12 hours
Moderate to severe infections: 1 to 2 g IM or IV every 8 hours
Infections needing higher-doses: 2 g IV every 6 to 8 hours
Life-threatening infections: 2 g IV every 4 hours
Maximum dose: 12 g/day

Use: Treatment of bacteremia or septicemia caused by Escherichia coli, Klebsiella species, Serratia marcescens, Staphylococcus aureus, and Streptococcus species

Usual Adult Dose for Sepsis

Uncomplicated infections: 1 g IM or IV every 12 hours
Moderate to severe infections: 1 to 2 g IM or IV every 8 hours
Infections needing higher-doses: 2 g IV every 6 to 8 hours
Life-threatening infections: 2 g IV every 4 hours
Maximum dose: 12 g/day

Use: Treatment of bacteremia or septicemia caused by Escherichia coli, Klebsiella species, Serratia marcescens, Staphylococcus aureus, and Streptococcus species

Usual Adult Dose for CNS Infection

Uncomplicated infections: 1 g IM or IV every 12 hours
Moderate to severe infections: 1 to 2 g IM or IV every 8 hours
Infections needing higher-doses: 2 g IV every 6 to 8 hours
Life-threatening infections: 2 g IV every 4 hours
Maximum dose: 12 g/day

Comment: Efficacy in treating Klebsiella pneumoniae and E coli have been studied in less than 10 infections.

Use: Treatment of central nervous system infections (including meningitis and ventriculitis) caused by Neisseria meningitides, Haemophilus influenzae, Streptococcus pneumoniae, K pneumoniae, and E coli

Infectious Diseases Society of America (IDSA), American Academy of Neurology (AAN), American Association of Neurological Surgeons (AANS), and Neurocritical Care Society (NCS) Recommendations: 8 to 12 g per day, given at 4 to 6 hour intervals

Comment: Vancomycin should be added to isolates with a penicillin MIC of 0.12 mcg/mL or higher and a third-generation cephalosporin MIC of 1 mcg/mL or greater.

Uses:
-Treatment of healthcare-associated ventriculitis and meningitis caused by gram-negative bacilli susceptible to third-generation cephalosporins
-Recommended treatment of bacterial meningitis caused by N meningitides, H influenzae, S pneumoniae, and E coli
-Empirical antimicrobial therapy in patients 50 years and younger with purulent meningitis caused by N meningitides or S pneumoniae
-Empirical antimicrobial therapy in patients over 50 years of age with purulent meningitis caused by S pneumoniae, N meningitides, Listeria monocytogenes, or aerobic gram-negative bacilli
-Empirical antimicrobial therapy in patients with basilar skull fractures with purulent meningitis caused by S pneumoniae, H influenzae, Group A beta-hemolytic streptococci

Usual Adult Dose for Endometritis

Uncomplicated infections: 1 g IM or IV every 12 hours
Moderate to severe infections: 1 to 2 g IM or IV every 8 hours
Infections needing higher-doses: 2 g IV every 6 to 8 hours
Life-threatening infections: 2 g IV every 4 hours
Maximum dose: 12 g/day

Comments:
-Efficacy in treating Enterobacter species, Klebsiella species, Bacteriodes fragilis, and Fusobacterium nucleatum have been studied in less than 10 infections.
-This drug is not active against Chlamydia trachomatis. Patients with pelvic inflammatory disease suspected to be caused by C trachomatis should be given appropriate anti-chlamydial treatment.

Use: Treatment of endometriosis, pelvic inflammatory disease, and pelvic cellulitis caused by Staphylococcus epidermidis, Streptococcus species, Enterococcus species, Enterobacter species, E coli, Klebsiella species, Proteus mirabilis, Bacteroides species, Clostridium species, anaerobic cocci (e.g., Peptostreptococcus species, Peptococcus species), and Fusobacterium species

Usual Adult Dose for Joint Infection

Uncomplicated infections: 1 g IM or IV every 12 hours
Moderate to severe infections: 1 to 2 g IM or IV every 8 hours
Infections needing higher-doses: 2 g IV every 6 to 8 hours
Life-threatening infections: 2 g IV every 4 hours
Maximum dose: 12 g/day

Comment: Efficacy in treating Streptococcus pyogenes, P aeruginosa, and P mirabilis have been studied in less than 10 infections.

Use: Treatment of bone and/or joint infections caused by penicillinase and non-penicillinase producing S aureus, Streptococcus species, Pseudomonas species, and P mirabilis

Usual Adult Dose for Peritonitis

Uncomplicated infections: 1 g IM or IV every 12 hours
Moderate to severe infections: 1 to 2 g IM or IV every 8 hours
Infections needing higher-doses: 2 g IV every 6 to 8 hours
Life-threatening infections: 2 g IV every 4 hours
Maximum dose: 12 g/day

Comment: Efficacy in treating Streptococcus species, Peptostreptococcus species, P aeruginosa, P mirabilis, and Clostridium species have been studied in less than 10 infections.

Use: Treatment of peritonitis caused by Streptococcus species, E coli, Klebsiella species, Bacteroides species, anaerobic cocci, P mirabilis, and Clostridium species

International Society for Peritoneal Dialysis (ISPD) Recommendations:
Intermittent: 500 to 1000 mg intraperitoneally once a day

Use: Empirical treatment of peritonitis suspected to be caused by gram-negative organisms

Usual Adult Dose for Sinusitis

IDSA Recommendations: 2 g IV every 4 to 6 hours

Uses: Treatment of severe acute bacterial rhinosinusitis requiring hospitalization

Usual Adult Dose for Rhinitis

IDSA Recommendations: 2 g IV every 4 to 6 hours

Uses: Treatment of severe acute bacterial rhinosinusitis requiring hospitalization

Usual Pediatric Dose for Septicemia

0 to 1 week: 50 mg/kg IV every 12 hours
1 to 4 weeks: 50 mg/kg IV every 8 hours

1 month to 12 years:
Less than 50 kg: 50 to 180 mg/kg IM or IV per day, given in 4 to 6 equal doses
50 kg or more:
-Uncomplicated infections: 1 g IM or IV every 12 hours
-Moderate to severe infections: 1 to 2 g IM or IV every 8 hours
-Infections needing higher-doses: 2 g IV every 6 to 8 hours
-Life-threatening infections: 2 g IV every 4 hours
Maximum dose: 12 g/day

12 years and older:
Uncomplicated infections: 1 g IM or IV every 12 hours
Moderate to severe infections: 1 to 2 g IM or IV every 8 hours
Infections needing higher-doses: 2 g IV every 6 to 8 hours
Life-threatening infections: 2 g IV every 4 hours
Maximum dose: 12 g/day

Comment: Higher doses should be used to treat more severe/serious infections.

Use: Treatment of bacteremia or septicemia caused by E coli, Klebsiella species, S marcescens, S aureus, and Streptococcus species

IDSA Recommendations:
Neonates 0 to 4 weeks and less than 1200 g: 100 mg/kg IV per day, given in divided doses every 12 hours
Postnatal age 7 days or less and 1200 to 2000 g: 100 mg/kg IV per day, given in divided doses every 12 hours
Postnatal age 7 days or less and greater than 2000 g: 100 to 150 mg/kg IV per day, given in divided doses every 8 to 12 hours
Postnatal age over 7 days and 1200 to 2000 g: 150 mg/kg IV per day, given in divided doses every 8 hours
Postnatal age over 7 days and over 2000 g: 150 to 200 mg/kg IV per day, given in divided doses every 6 to 8 hours
Infants and children 12 years and younger: 100 to 150 mg/kg per day, given in divided doses every 8 hours

Use: Treatment of catheter-related infections

Usual Pediatric Dose for Intraabdominal Infection

0 to 1 week: 50 mg/kg IV every 12 hours
1 to 4 weeks: 50 mg/kg IV every 8 hours

1 month to 12 years:
Less than 50 kg: 50 to 180 mg/kg IM or IV per day, given in 4 to 6 equal doses
50 kg or more:
-Uncomplicated infections: 1 g IM or IV every 12 hours
-Moderate to severe infections: 1 to 2 g IM or IV every 8 hours
-Infections needing higher-doses: 2 g IV every 6 to 8 hours
-Life-threatening infections: 2 g IV every 4 hours
Maximum dose: 12 g/day

12 years and older:
Uncomplicated infections: 1 g IM or IV every 12 hours
Moderate to severe infections: 1 to 2 g IM or IV every 8 hours
Infections needing higher-doses: 2 g IV every 6 to 8 hours
Life-threatening infections: 2 g IV every 4 hours
Maximum dose: 12 g/day

Comments:
-Higher doses should be used to treat more severe/serious infections.
-Efficacy in treating Streptococcus species, Peptostreptococcus species, P aeruginosa, P mirabilis, and Clostridium species have been studied in less than 10 infections.

Use: Treatment of peritonitis caused by Streptococcus species, E coli, Klebsiella species, Bacteroides species, anaerobic cocci, P mirabilis, and Clostridium species

IDSA and NIH Recommendations:
Adolescents: 1 g IV every 8 hours

Uses:
-Empiric treatment of bacterial enteric infections for patients with advanced HIV and clinically severe diarrhea (e.g., 6 or more liquid stools/day or bloody stool and/or with fever/chills)
-Treatment of salmonellosis in patients with HIV

Surgical Infection Society (SIS) and Infectious Diseases Society of America (IDSA) Recommendations: 150 to 200 mg/kg IV per day, given in divided doses every 6 to 8 hours

Use: Empirical treatment of community-acquired infections

Usual Pediatric Dose for Joint Infection

0 to 1 week: 50 mg/kg IV every 12 hours
1 to 4 weeks: 50 mg/kg IV every 8 hours

1 month to 12 years:
Less than 50 kg: 50 to 180 mg/kg IM or IV per day, given in 4 to 6 equal doses
50 kg or more:
-Uncomplicated infections: 1 g IM or IV every 12 hours
-Moderate to severe infections: 1 to 2 g IM or IV every 8 hours
-Infections needing higher-doses: 2 g IV every 6 to 8 hours
-Life-threatening infections: 2 g IV every 4 hours
Maximum dose: 12 g/day

12 years and older:
Uncomplicated infections: 1 g IM or IV every 12 hours
Moderate to severe infections: 1 to 2 g IM or IV every 8 hours
Infections needing higher-doses: 2 g IV every 6 to 8 hours
Life-threatening infections: 2 g IV every 4 hours
Maximum dose: 12 g/day

Comments:
-Higher doses should be used to treat more severe/serious infections.
-Efficacy in treating S pyogenes, P aeruginosa, and P mirabilis have been studied in less than 10 infections.

Use: Treatment of bone and/or joint infections caused by penicillinase and non-penicillinase producing S aureus, Streptococcus species, Pseudomonas species, and P mirabilis

Usual Pediatric Dose for Gonococcal Infection - Disseminated

US CDC Recommendations:
Neonates: 25 mg/kg IM or IV every 12 hours
Duration of therapy:
-Disseminated gonococcal infection (DGI): 7 days
-DGI with meningitis: 10 to 14 days

Adolescents: 1 g IV every 8 hours

Comments:
-The patient's sexual partner(s) within the past 60 days should be evaluates/treated.
-Treatment should be used with caution in infants with hyperbilirubinemia.

Uses:
-Treatment of DGI and gonococcal scalp abscesses
-Alternative treatment of arthritis and arthritis-dermatitis syndrome caused by N gonorrhoeae

Renal Dose Adjustments

CrCl 20 to 90 mL/min: Dose adjustment(s) may be required; however, no specific guidelines have been suggested. Caution recommended.
CrCl less than 20 mL/min: The dose should be reduced by 50% of the normal dose.
Duration of therapy: At least 10 days (Infections caused by Group A beta-hemolytic streptococci)

Comments:
-Treatment should continue for at least 48 to 72 hours after the patient's condition improves and/or evidence of bacterial eradication occurs.
-Patients with persistent infections may require weeks of treatment, but should not receive doses lower than indicated.

Other Comments

Administration advice:
-IM: This drug should be injected deep into the body of a large muscle. Providers should aspirate the solution to ensure that treatment did not enter blood vessels. Doses up to 2 g may be given if divided and administered into different areas of the body.
-Intermittent IV: This drug should be injected over at least 3 to 5 minutes.

Storage requirements:
-Premixed injection solution: Store in the freezer until ready to use. Once thawed, this drug is stable for 10 days (5C or below) or 24 hours (22C or below); the solution should not be refrozen.
-Powder for reconstitution: Once reconstituted in original containers or disposable plastic syringes, this drug is stable for up to 13 weeks (frozen), 5 days (at 5C or below), or 24 hours (at 22C or below

IV compatibility:
-This drug should not be admixed with aminoglycoside antibiotics.

General:
-Limitation of use: This drug is not active against Chlamydia trachomatis.
-IV administration is preferred in patients with severe or life-threatening infections (e.g., bacteremia, septicemia, peritonitis, meningitis) or those with lower resistance due to debilitating conditions (e.g., malnutrition, trauma, surgery, diabetes, heart failure, malignancy [especially with present/impending shock]).
-Spectrum of Activity: Susceptibility varies geographically and may change over time; local susceptibility data should be consulted, if available. This drug has shown activity in vitro and in clinical infections against most isolates of Enterococcus species (may be intrinsically resistant), S aureus (methicillin-susceptible isolates only), S epidermidis, S pneumoniae, S pyogenes, viridans group streptococci, Acinetobacter species, Citrobacter species, Enterobacter species, E coli, H influenzae, H parainfluenzae, Klebsiella species, M morganii, N gonorrhoeae, N meningitidis, Proteus mirabilis, P vulgaris, P rettgeri, P stuartii, S marcescens, Bacteroides species, Clostridium species (most Clostridium difficile isolates are resistant), Fusobacterium species, Peptococcus species, and Peptostreptococcus species; most extended spectrum beta-lactamase-producing and carbapenemase-producing isolates are resistant. This drug has shown in vitro activity against Providencia species, Salmonella species, and Shigella species; however, efficacy has not been established in treating clinical infections.

Monitoring:
-Hematologic: White blood cell counts, especially in patients receiving treatment for longer than 7 days
-Hepatic: Hepatic function tests, especially in patients with hepatic dysfunction or with decreased hepatic blood flow
-Renal: Renal function tests, especially in patients with renal dysfunction or when given with aminoglycoside antibiotics

Patient advice:
-Patients should be told to report any unusual or severe side effects.
-Patients should be instructed to report signs/symptoms of C difficile infection (e.g., watery/bloody stools, stomach cramps, fever), for up to 2 months after stopping treatment.
-Patients should be directed to take the full course of treatment, even if they feel better.

Cefotaxime Pregnancy Warnings

Animal models have failed to reveal evidence of embryotoxicity or teratogenicity. Compared to pups not exposed to this drug, pups exposed to 0.8 times the recommended human dose (in body surface area) during pregnancy and throughout lactation were lighter in weight at birth and were smaller during the first 21 days of nursing. There are no controlled data in human pregnancy. AU TGA pregnancy category B1: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals have not shown evidence of an increased occurrence of fetal damage. US FDA pregnancy category B: Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women.

Use is recommended only if clearly needed and the benefit outweighs the risk to the fetus. AU TGA pregnancy category: B1 US FDA pregnancy category: B

Cefotaxime Levels and Effects while Breastfeeding

Summary of Use during Lactation

Cefotaxime is acceptable to use during breastfeeding. Limited information indicates that maternal doses of cefotaxime up to 4 grams daily produce low levels in milk that are not expected to cause adverse effects in breastfed infants. Occasionally, disruption of the infant's gastrointestinal flora, resulting in diarrhea or thrush, has been reported with cephalosporins, but these effects have not been adequately evaluated.

Drug Levels

Maternal Levels. Five postpartum women were given 2 grams of cefotaxime twice daily for 4 days. The average peak milk level on day 4 was 0.68 mg/L (range 0.29 to1.57 mg/L). By 12 hours after the dose the drug was undetectable in milk of all 5 women.[1]

After a single 1 gram dose of cefotaxime to 12 women, average peak levels of 0.32 mg/L occurred 2 hours after the dose. The highest milk level recorded was 0.52 mg/L in one woman at 3 hours after the dose.[2][3]

After a single 1 gram dose of cefotaxime to 5 women, the drug was not measurable (<0.1 mg/L) in the mothers' milk at any time up to 6 hours after the dose.[4]

After a single 1gram intravenous dose in 2 women, cefotaxime milk levels were not measurable at any time up to 6 hours after the dose.[5]

Infant Levels. Relevant published information was not found as of the revision date.

Effects in Breastfed Infants

Relevant published information was not found as of the revision date.

Effects on Lactation and Breastmilk

Relevant published information was not found as of the revision date.

References

1. Harms K, Gerke G, Zaloudek D. Konzentrationsbestimmungen von cefotaxim aus der muttermilch. Infection. 1980;8(suppl 4):S451-3.

2. Kafetzis DA, Lazarides CV, Siafas CA et al. Transfer of cefotaxime in human milk and from mother to foetus. J Antimicrob Chemother. 1980;6(suppl A):135-41. PMID: 6252147

3. Kafetzis DA, Siafas CA, Georgakopoulos PA et al. Passage of cephalosporins and amoxicillin into the breast milk. Acta Paediatr Scand. 1981;70:285-8. PMID: 7246123

4. Takase Z, Fujiwara M, Kohmoto Y et al. Study of cefotaxime in the perinatal period. Jpn J Antibiot. 1982;35:1893-7. PMID: 6294369

5. Matsuda S. Transfer of antibiotics into maternal milk. Biol Res Pregnancy. 1984;5:57-60. PMID: 6743732

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