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Cefotaxime Sodium

Class: Third Generation Cephalosporins
VA Class: AM117
CAS Number: 64485-93-4
Brands: Claforan

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Introduction

Antibacterial; β-lactam antibiotic; third generation cephalosporin.^a ^b

Uses for Cefotaxime Sodium

Bone and Joint Infections

Treatment of serious bone and joint infections caused by susceptible S. aureus, streptococci (including S. pyogenes), Pseudomonas (including Ps. aeruginosa), or P. mirabilis.²³⁰

Genitourinary Tract Infections

Treatment of serious genitourinary tract infections caused by susceptible S. aureus (including penicillinase-producing strains), S. epidermidis, enterococci, Citrobacter, Enterobacter, E. coli, Klebsiella, Morganella morganii, P. mirabilis, P. vulgaris, Providencia stuartii, P. rettgeri, Pseudomonas (including Ps. aeruginosa), or S. marcescens.²³⁰

Gynecologic Infections

Treatment of gynecologic infections (including pelvic inflammatory disease [PID], endometritis, pelvic cellulitis) caused by susceptible S. epidermidis, streptococci (including enterococci), E. coli, Enterobacter, Klebsiella, P. mirabilis, Bacteroides (including B. fragilis), Clostridium, Fusobacterium (including F. nucleatum), Peptococcus, and Peptostreptococcus.²³⁰

CDC states cefotaxime may be effective for PID, but is less active than cefoxitin against anaerobic bacteria.²⁰⁰ When an oral regimen is used for treatment of mild to moderately severe acute PID, CDC recommends a single IM dose of ceftriaxone, cefoxitin (with oral probenecid), or other parenteral third-generation cephalosporin (e.g., cefotaxime) given in conjunction with oral doxycycline (with or without oral metronidazole).²⁰⁰ ³⁶⁹ Because cefotaxime (like other cephalosporins) is not active against Chlamydia, concomitant use of a drug active against Chlamydia (e.g., doxycycline) is necessary when these organisms are suspected pathogens.²³⁰ ²⁹⁰

Intra-abdominal Infections

Treatment of serious intra-abdominal infections (including peritonitis) caused by susceptible streptococci, E. coli, Klebsiella, P. mirabilis, Clostridium, Bacteroides, or anaerobic cocci (including Peptococcus and Peptostreptococcus).²³⁰

Meningitis and Other CNS Infections

Treatment of meningitis and ventriculitis caused by susceptible H. influenzae, N. meningitidis, S. pneumoniae,²³⁰ ²⁷⁵ ²⁹¹ ²⁹⁴ ²⁹⁶ ³³⁵ E. coli, or K. pneumoniae.²³⁰ ²⁷⁵ ²⁹¹ ²⁹⁴ ²⁹⁶ ³³⁶

A drug of choice when a third generation cephalosporin is indicated for empiric treatment of bacterial meningitis;²⁷⁵ ²⁹⁰ ²⁹⁶ ³¹⁹ should not be used alone for empiric treatment when Listeria monocytogenes, enterococci, staphylococci, or Ps. aeruginosa may be involved.²⁷⁵ ²⁹⁰ ²⁹⁶ ³¹⁹

Treatment of brain abscesses and other CNS infections† (e.g., subdural empyema, intracranial epidural abscesses).³¹⁹ ³³⁶ ³⁴⁷ Concomitant metronidazole usually recommended for empiric therapy;³¹⁹ ³⁴⁷ used in conjunction with a penicillinase-resistant penicillin or vancomycin if staphylococci suspected.³¹⁹ ³⁴⁷

Respiratory Tract Infections

Treatment of serious lower respiratory tract infections, including community-acquired pneumonia (CAP)²¹¹ ²⁶⁹ ³⁴² caused by susceptible Streptococcus pneumoniae, S. pyogenes (group A β-hemolytic streptococci), other streptococci (except enterococci), Staphylococcus aureus (including penicillinase-producing strains), Escherichia coli, Klebsiella, Haemophilus influenzae (including ampicillin-resistant strains), H. parainfluenzae, Proteus mirabilis, indole-positive Proteus, Serratia marcescens, Enterobacter, or Pseudomonas (including Ps. aeruginosa).²³⁰

Recommended by ATS and IDSA as an alternative for treatment of CAP caused by penicillin-susceptible S. pneumoniae and as a preferred drug for treatment of CAP caused by penicillin-resistant S. pneumoniae, provided in vitro susceptibility has been demonstrated.²⁶⁹ Also recommended in certain combination regimens used for empiric treatment of CAP.²⁶⁹ Select regimen for empiric treatment of CAP based on most likely pathogens and local susceptibility patterns; after pathogen is identified, modify to provide more specific therapy (pathogen-directed therapy).²⁶⁹

For empiric inpatient treatment of CAP in patients not requiring treatment in an intensive care unit (non-ICU patients), IDSA and ATS recommend monotherapy with a fluoroquinolone (moxifloxacin, gemifloxacin, levofloxacin) or, alternatively, a combination regimen that includes a β-lactam (usually cefotaxime, ceftriaxone, or ampicillin) given in conjunction with a macrolide (azithromycin, clarithromycin, erythromycin).²⁶⁹

For empiric inpatient treatment of CAP in ICU patients when Pseudomonas and oxacillin-resistant (methicillin-resistant) S. aureus are not suspected, IDSA and ATS recommend a combination regimen that includes a β-lactam (cefotaxime, ceftriaxone, fixed combination of ampicillin and sulbactam) given in conjunction with either azithromycin or a fluoroquinolone (moxifloxacin, gemifloxacin, levofloxacin).²⁶⁹

Septicemia

Treatment of bacteremia/septicemia caused by E. coli, Klebsiella, S. marcescens, S. aureus, or streptococci (including S. pneumoniae).²³⁰ An aminoglycoside often is used concomitantly.²³⁰

Skin and Skin Structure Infections

Treatment of serious skin and skin structure infections caused by susceptible S. aureus, S. epidermidis, S. pyogenes, other streptococci (including enterococci), Acinetobacter, E. coli, Citrobacter (including C. freundii), Enterobacter, Klebsiella, P. mirabilis, P. vulgaris, M. morganii, P. rettgeri, Pseudomonas, Serratia, Bacteroides (including B. fragilis), Fusobacterium (including F. nucleatum), or anaerobic cocci (including Peptococcus and Peptostreptococcus).²³⁰

Capnocytophaga Infections

Alternative to penicillin G for treatment of infections caused by Capnocytophaga† (e.g., septicemia, meningitis, endocarditis).²¹¹

Gonorrhea and Associated Infections

Alternative for treatment of uncomplicated cervical, urethral, or rectal gonorrhea caused by susceptible Neisseria gonorrhoeae in adults or adolescents.²⁰⁰ ²³⁰ ³⁶⁶ ³⁶⁷ ³⁶⁹ Drug of choice is IM ceftriaxone or oral cefixime.²⁰⁰ ²⁵¹ ²⁷⁵ ³⁶⁹ Although effective, CDC states that IM cefotaxime appears to offer no advantage over IM ceftriaxone.²⁰⁰

Alternative for initial treatment of disseminated gonococcal infections† caused by susceptible N. gonorrhoeae.²⁰⁰ ²⁷⁵ ³⁶⁹ Ceftriaxone is usual drug of choice for initial parenteral treatment of disseminated gonorrhea in adults, adolescents, or children; CDC and AAP consider cefotaxime an alternative.²⁰⁰ ²⁷⁵ ³⁶⁹

Treatment of disseminated gonococcal infections†,²⁰⁰ ²⁷⁵ gonococcal scalp abscesses†,²⁰⁰ ²⁷⁵ and gonococcal ophthalmia neonatorum† in neonates.²⁰⁰ ²⁷⁵

Lyme Disease

Treatment of early neurologic Lyme disease† with acute neurologic manifestations such as meningitis or radiculopathy.²⁷³ ²⁷⁵ ³⁵¹ ³⁵⁴ IV ceftriaxone is the drug of choice; alternatives are IV cefotaxime or IV penicillin G.²⁷³ ²⁷⁵ ³⁵¹ ³⁵⁴ Although an oral regimen (doxycycline, amoxicillin, cefuroxime axetil) may be effective for early localized or early disseminated Lyme disease associated with erythema migrans in the absence of specific neurologic manifestations or advanced atrioventricular (AV) heart block,²⁷⁰ ²⁷³ ²⁷⁵ ²⁸⁴ ²⁸⁵ ²⁸⁶ ²⁸⁷ ³³⁸ ³⁵¹ ³⁵³ ³⁵⁵ ³⁵⁶ ³⁵⁷ a parenteral regimen usually is recommended when there are acute neurologic manifestations.²⁷⁰ ²⁷³ ²⁷⁵ ²⁸⁴ ²⁸⁵ ²⁸⁶ ²⁸⁷ ³³⁸ ³⁵¹ ³⁵³ ³⁵⁵ ³⁵⁶

Treatment of Lyme carditis† when a parenteral regimen is indicated.²⁷³ ²⁷⁵ ³⁵¹ ³⁵⁴ IV ceftriaxone is the drug of choice; alternatives are IV cefotaxime or IV penicillin G.²⁷³ ²⁷⁵ ³⁵¹ ³⁵⁴ Although a parenteral regimen usually is recommended for initial treatment of hospitalized patients, an oral regimen (doxycycline, amoxicillin, cefuroxime axetil) can be used to complete therapy and for the treatment of outpatients.²⁷³ ²⁷⁵ ³⁵¹ ³⁵⁴

Treatment of Lyme arthritis† when a parenteral regimen is indicated.²⁷³ ²⁷⁵ ³⁵¹ ³⁵⁴ ³⁶¹ IV ceftriaxone is the drug of choice; alternatives are IV cefotaxime or IV penicillin G.²⁷³ ²⁷⁵ ³⁵¹ ³⁵⁴ ³⁶¹ Although the comparative safety and efficacy of oral versus IV anti-infectives for treatment of Lyme arthritis have not been fully evaluated,³⁵¹ those with concomitant neurologic disease generally should receive a parenteral regimen.²⁷³ ²⁷⁵ ³⁵¹ ³⁵⁴ ³⁶¹

Treatment of late neurologic Lyme disease† affecting the CNS or peripheral nervous system (e.g., encephalopathy, neuropathy).³⁵¹ IV ceftriaxone is the drug of choice; alternatives are IV cefotaxime or IV penicillin G.³⁵¹

Typhoid Fever and Other Salmonella Infections

Treatment of typhoid fever (enteric fever) or septicemia caused by Salmonella typhi or S. paratyphi†, including multidrug-resistant strains.²⁷⁵ ³⁰⁶

Treatment of >;Salmonella gastroenteritis† caused by non-typhi Salmonella (e.g., S. enteritidis, S. typhimurium).²¹¹ ²⁴⁵ ²⁷⁵ ³⁰⁹ Anti-infective treatment is indicated only in those with severe disease and in those at increased risk of invasive disease, including those <3–6 months of age or >50 years of age, those with hemoglobinopathies, severe atherosclerosis or valvular heart disease, prostheses, uremia, chronic GI disease, or severe colitis, and those immunocompromised because of malignancy, immunosuppressive therapy, HIV infection, or other immunosuppressive illness.²¹¹ ²⁴⁵ ²⁷⁵ ³⁰⁹ Choice of anti-infective is based on in vitro susceptibility.²¹¹ ²⁴⁵ ²⁷⁵ ³⁰⁹

Vibrio Infections

Treatment of severe Vibrio parahaemolyticus† infection when anti-infective therapy is indicated in addition to supportive care.²¹⁸

Treatment of infections caused by V. vulnificus†.²¹¹ ²⁵⁰ Optimum anti-infective therapy has not been identified; a tetracycline or third generation cephalosporin (e.g., cefotaxime, ceftazidime) is recommended.²¹¹ ²¹⁸ ²⁵⁰ Because the case fatality rate associated with V. vulnificus is high, initiate anti-infective therapy promptly if indicated.²⁵⁰ ²⁹⁴

Yersinia Infections

Treatment of GI infections caused by Yersinia enterocolitica or Y. pseudotuberculosis†.²¹⁸ ²⁴⁵ ²⁷⁵ Usually self-limited infections, but anti-infectives may be indicated in immunocompromised individuals, for severe infections, or when septicemia or other invasive disease occurs.²¹⁸ ²⁴⁵ ²⁷⁵

Perioperative Prophylaxis

Perioperative prophylaxis to reduce the incidence of infection in patients undergoing contaminated or potentially contaminated surgery (e.g., GI and genitourinary surgery, abdominal or vaginal hysterectomy) and in patients undergoing cesarean section.²³⁰

Other cephalosporins or cephamycins (cefazolin, cefotetan, cefoxitin) are the preferred drugs for perioperative prophylaxis.²⁰¹ Cefotaxime and other third generation cephalosporins usually not used for perioperative prophylaxis since they are expensive, some are less active against staphylococci than cefazolin, they have a spectrum of activity wider than necessary for organisms encountered in elective surgery, and their use for prophylaxis promotes emergence of resistant organisms.²⁰¹

Cefotaxime Sodium Dosage and Administration

Administration

Administer by IV injection or infusion or by deep IM injection.²³⁰

IV route preferred in patients with septicemia, bacteremia, peritonitis, meningitis, or other severe or life-threatening infections or in patients with lowered resistance resulting from debilitating conditions (e.g., malnutrition, trauma, surgery, diabetes, heart failure, malignancy), particularly if shock is present.²³⁰

Large IM doses may be painful; IV administration may be preferred when large doses are indicated.^b

Cefotaxime ADD-Vantage vials and the commercially available frozen cefotaxime injection in dextrose should be used only for IV infusion.

For solution and drug compatibility information, see Compatibility under Stability.

IV Injection

Reconstitution

Reconstitute vials containing 500 mg, 1 g, or 2 g of cefotaxime with 10 mL of sterile water for injection to provide solutions containing approximately 50, 95, or 180 mg/mL, respectively.²³⁰

Rate of Administration

Inject directly into a vein over a period of 3-5 minutes or slowly into the tubing of a freely flowing compatible IV solution.²³⁰

Do not inject IV over <3 minutes; rapid (over <1 minute) injection is associated with potentially life-threatening arrhythmias.²³⁰

IV Infusion

Reconstitution and Dilution

Reconstitute infusion bottles containing 1 or 2 g of cefotaxime with 50–100 mL of 0.9% sodium chloride injection or 5% dextrose injection to provide solutions containing 10–20 or 20–40 mg/mL, respectively.²³⁰ May be diluted further in 50 mL to 1 L of compatible IV solution.²³⁰

Reconstitute 10-g pharmacy bulk package according to the manufacturer’s directions and then dilute further in a compatible IV solution.²³⁰

Reconstitute ADD-Vantage vials or infusion bottles containing 1 or 2 g of cefotaxime according to the manufacturer’s directions.²³⁰

Thaw the commercially available injection (frozen) at room temperature or in a refrigerator; do not force thaw by immersion in a water bath or by exposure to microwave radiation.²³⁰ A precipitate may have formed in the frozen injection, but should dissolve with little or no agitation after reaching room temperature.²³⁰ Discard thawed injection if an insoluble precipitate is present or if container seals or outlet ports are not intact.²³⁰ The injection should not be used in series connections with other plastic containers, since such use could result in air embolism from residual air being drawn from the primary container before administration of fluid from the secondary container is complete.²³⁰

Rate of Administration

For intermittent IV infusion, infuse over 20–30 minutes via butterfly or scalp vein-type needles.^b

During infusion, discontinue other IV solutions flowing through a common administration tubing or site²³⁰ unless the solutions are known to be compatible and the flow-rate is adequately controlled.^b

IM Injection

Inject IM deeply into a large muscle mass such as the upper outer quadrant of the gluteus maximus.²³⁰ Use aspiration to avoid inadvertent injection into a blood vessel.²³⁰

2-g IM doses should be divided and administered at 2 different injection sites.²³⁰

Reconstitution

Reconstitute vials containing 500 mg, 1 g, or 2 g of cefotaxime with 2, 3, or 5 mL, respectively, of sterile or bacteriostatic water for injection to provide solutions containing approximately 230, 300, or 330 mg/mL, respectively.²³⁰

Dosage

Available as cefotaxime sodium; dosage expressed in terms of cefotaxime.²³⁰

Pediatric Patients

General Dosage in Neonates <1 Week of Age

IV

50 mg/kg every 12 hours for premature or full-term neonates <1 week of age recommended by manufacturers.²³⁰ ³⁶⁶ ³⁶⁷

IV or IM

AAP recommends 50 mg/kg every 12 hours for neonates <1 week of age weighing ≤2 kg and 50 mg/kg every 8 or 12 hours for those weighing >2 kg.²⁷⁵

General Dosage in Neonates 1–4 Weeks of Age

IV

50 mg/kg every 8 hours recommended by manufacturers.²³⁰ ³⁶⁶ ³⁶⁷

IV or IM

AAP recommends 50 mg/kg every 12 hours for neonates 1–4 weeks of age weighing <1.2 kg; 50 mg/kg every 8 hours for those weighing 1.2–2 kg; and 50 mg/kg every 6 or 8 hours for those weighing >2 kg.²⁷⁵

General Dosage in Children 1 Month to 12 Years of Age

IV or IM

50–180 mg/kg daily given in 4–6 equally divided doses in those weighing <50 kg.²³⁰ ³⁶⁶ ³⁶⁷ The higher dosage should be used for more severe or serious infections.²³⁰ ³⁶⁶ ³⁶⁷

AAP recommends 75–100 mg/kg daily given in 3 or 4 equally divided doses for mild to moderate infections and 150–200 mg/kg daily given in 3 or 4 equally divided doses for severe infections.²⁷⁵

Children weighing >50 kg should receive the usual adult dosage.²³⁰ ³⁶⁶ ³⁶⁷ (See Adult Dosage under Dosage and Administration.)

Meningitis and Other CNS Infections

IV

Manufacturers recommend that children 1 month to 12 years of age weighing <50 kg receive dosage at the high end of the range of 50–180 mg/kg daily.²³⁰ ³⁶⁶ ³⁶⁷ Some clinicians recommend that infants and children <18 years of age with meningitis receive 50 mg/kg IV every 6 hours.²⁹⁶ Others recommend 100–150 mg/kg daily given in divided doses every 8–12 hours in neonates ≤7 days of age, 150–200 mg/kg daily given in divided doses every 6–8 hours in neonates 8–28 days of age, and 225–300 mg/kg daily given in divided doses every 6–8 hours in older infants and children.³⁶⁵

AAP recommends 300 mg/kg daily given in 3 or 4 divided doses for treatment of meningitis in pediatric patients beyond the neonatal period.²⁷⁵ If meningitis is known or suspected to be caused by S. pneumoniae, AAP recommends that infants and children ≥1 month of age or older receive 225–300 mg/kg daily given in divided doses every 6–8 hours.²⁷⁵ ²⁹⁷

Duration of treatment is 7 days for uncomplicated meningitis caused by susceptible H. influenzae or N. meningitidis; ≥10–14 days for complicated cases or meningitis caused by S. pneumoniae; and ≥21 days for meningitis caused by susceptible Enterobacteriaceae.²⁷⁵ ²⁹⁶ ³¹⁸

Gonorrhea and Associated Infections

Disseminated Gonococcal Infection or Gonococcal Scalp Abscess in Neonates†

IV or IM

25 mg/kg every 12 hours for 7 days recommended by CDC and AAP; if meningitis is documented, continue for 10–14 days.²⁰⁰ ²⁷⁵

Disseminated Gonorrhea in Children ≥8 Years of Age or Weighing ≥45 kg†

1 g every 8 hours recommended by CDC and AAP.²⁰⁰ ²⁷⁵ ³⁶⁹ Continue for 7 days²⁷⁵ or discontinue 24–48 hours after improvement occurs and switch to an oral regimen (e.g., cefixime or cefpodoxime) to complete ≥7 days of treatment.²⁰⁰ ²⁷⁵ ³⁶⁹

Lyme Disease†

Early Neurologic Lyme Disease†

150–200 mg/kg daily (up to 6 g daily) given in divided doses every 6–8 hours for 14 days (range: 10–28 days) recommended by IDSA and others for early Lyme disease in children with acute neurologic manifestations (e.g., meningitis, radiculopathy).²⁷³ ³⁵¹ ³⁵⁴

Lyme Carditis†

150–200 mg/kg daily (up to 6 g daily) given in divided doses every 6–8 hours for 14 days (range: 14–21 days) recommended by IDSA and others for those with AV heart block and/or myopericarditis associated with early Lyme disease when a parenteral regimen is indicated (e.g., hospitalized patients).²⁷³ ³⁵¹ ³⁵⁴

Parenteral regimen can be switched to an oral regimen (doxycycline, amoxicillin, cefuroxime axetil) to complete therapy when clinically indicated.³⁵¹

Lyme Arthritis†

150–200 mg/kg daily (up to 6 g daily) given in divided doses every 6–8 hours for 14 days (range: 14–28 days) for children with evidence of neurologic disease or when arthritis has not responded to an oral regimen.³⁵¹

Late Neurologic Lyme Disease†

150–200 mg/kg daily (up to 6 g daily) given in divided doses every 6–8 hours for 14 days (range: 14–28 days) recommended by IDSA for children with late neurologic disease affecting the CNS or peripheral nervous system.²⁷³ ³⁵¹

Response to anti-infective treatment usually is slow and may be incomplete in such patients.³⁵¹ IDSA states that retreatment is not recommended unless relapse is shown by reliable objective measures.³⁵¹

Adults

General Adult Dosage

Uncomplicated Infections

IV or IM

1 g every 12 hours.²³⁰ ³⁶⁶ ³⁶⁷

Moderate to Severe Infections

IV or IM

1–2 g every 8 hours.²³⁰ ³⁶⁶ ³⁶⁷

Severe or Life-threatening Infections

2 g every 6–8 hours.²³⁰ ³⁶⁶ ³⁶⁷ For life-threatening infections, 2 g every 4 hours.²³⁰ ³⁶⁶ ³⁶⁷

Meningitis and Other CNS Infections

IV

2 g every 6–8 hours for 7–21 days.²³⁰ ²⁹⁶ Some clinicians recommend 8–12 g daily in divided doses every 4–6 hours.³⁶⁵

Meningitis Caused by S. pneumoniae

Initially, 350 mg/kg daily given in 4 divided doses; reduce dosage to 225 mg/kg daily given in 3 divided doses if organism is susceptible to penicillin.³²⁷ ³³⁵

Respiratory Tract Infections

Community-acquired Pneumonia

IV or IM

1 g every 6–8 hours.²⁶⁹

Duration of treatment depends on the causative pathogen, illness severity at the onset of anti-infective therapy, response to treatment, comorbid illness, and complications.²⁶⁹

Gonorrhea and Associated Infections

Uncomplicated Urethral, Cervical, or Rectal Gonorrhea

500 mg as a single dose.²⁰⁰ ²³⁰ ³⁶⁶ ³⁶⁷ ³⁶⁹

Manufacturers recommend 1 g as a single dose for treatment of rectal gonorrhea in males.²³⁰ ³⁶⁶ ³⁶⁷

Disseminated Gonorrhea†

CDC recommends 1 g every 8 hours; continue for 24–48 hours after improvement begins and switch to an oral regimen (cefixime or cefpodoxime) to complete ≥1 week of treatment.²⁰⁰ ³⁶⁹

Lyme Disease†

Early Neurologic Lyme Disease†

2 g every 8 hours for 14 days (range: 10–28 days) recommended by IDSA and others for adults with acute neurologic manifestations (e.g., meningitis, radiculopathy).²⁷³ ³⁵¹ ³⁵⁴

Lyme Carditis†

2 g every 8 hours for 14 days (range: 14–21 days) recommended by IDSA and others for adults with AV heart block and/or myopericarditis associated with early Lyme disease when a parenteral regimen is indicated (e.g., hospitalized patients).³⁵¹ ³⁵⁴

Parenteral regimen can be switched to an oral regimen (doxycycline, amoxicillin, cefuroxime axetil) to complete therapy when clinically indicated.³⁵¹

Lyme Arthritis†

2 g every 8 hours for 14 days (range: 14–28 days) recommended by IDSA for adults with evidence of neurologic disease or when arthritis has not responded to an oral regimen.³⁵¹

Late Neurologic Lyme Disease†

2 g every 8 hours for 14 days (range: 14–28 days) recommended by IDSA for adults with late neurologic disease affecting the CNS or peripheral nervous system.²⁷³ ³⁵¹

Perioperative Prophylaxis

Contaminated or Potentially Contaminated Surgery

IV or IM

1 g 30–90 minutes prior to surgery.²³⁰

Cesarean Section

IV or IM

1 g IV as soon as the umbilical cord is clamped, followed by additional 1-g IM or IV doses given 6 and 12 hours after the first dose.²³⁰

Prescribing Limits

Pediatric Patients

Maximum 12 g daily for children weighing >50 kg.²³⁰ ³⁶⁶ ³⁶⁷

Adults

Maximum 12 g daily.²³⁰ ³⁶⁶ ³⁶⁷

Special Populations

Hepatic Impairment

No dosage adjustments required.²⁸⁹ ²⁹⁰

Renal Impairment

Patients with Cl_cr <20 mL/minute per 1.73 m² should receive 50% of the usual dose given at the usual time intervals.²³⁰

Patients undergoing hemodialysis should receive 0.5–2 g as a single daily dose with a supplemental dose after each dialysis period.²⁶⁵

Cautions for Cefotaxime Sodium

Contraindications

Known hypersensitivity to cefotaxime or other cephalosporins.²³⁰

Warnings/Precautions

Warnings

Superinfection/Clostridium difficile-associated Diarrhea and Colitis

Possible emergence and overgrowth of nonsusceptible organisms, especially Enterobacter, Pseudomonas, enterococci, or Candida.²³⁰ Careful observation of the patient is essential.²³⁰ Institute appropriate therapy if superinfection occurs.²³⁰

Treatment with anti-infectives alters normal colon flora and may permit overgrowth of Clostridium difficile.²³⁰ C. difficile-associated diarrhea and colitis (CDAD; also known as antibiotic-associated diarrhea and colitis or pseudomembranous colitis) has been reported with nearly all anti-infectives, including cefotaxime, and may range in severity from mild diarrhea to fatal colitis.²³⁰ Hypertoxin-producing strains of C. difficile are associated with increased morbidity and mortality since they may be refractory to anti-infectives and colectomy may be required.²³⁰

Consider CDAD if diarrhea develops during or after therapy and manage accordingly.²³⁰ Careful medical history is necessary since CDAD has been reported to occur as late as 2 months or longer after anti-infective therapy is discontinued.²³⁰

If CDAD is suspected or confirmed, the anti-infective may need to be discontinued.²³⁰ Some mild cases of CDAD may respond to discontinuance alone.²³⁰ ³⁴² ³⁴³ ³⁴⁴ ³⁴⁵ ³⁴⁶ Manage moderate to severe cases with fluid, electrolyte, and protein supplementation, anti-infective therapy active against C. difficile (e.g., oral metronidazole or vancomycin), and surgical evaluation when clinically indicated.²³⁰ ³⁴² ³⁴³ ³⁴⁴ ³⁴⁵ ³⁴⁶

Cardiac Effects

Potentially life-threatening arrhythmia reported with rapid injection (<1 minute) through a central venous catheter.²³⁰ Do not inject IV over <3 minutes.²³⁰ (See IV Injection under Dosage and Administration.)

Sensitivity Reactions

Hypersensitivity Reactions

Possible hypersensitivity reactions, including rash (maculopapular or erythematous), pruritus, fever, eosinophilia, urticaria, anaphylaxis, erythema multiforme, Stevens-Johnson syndrome, and toxic epidermal necrolysis.²³⁰

If a hypersensitivity reaction occurs, discontinue cefotaxime and institute appropriate therapy as indicated (e.g., epinephrine, corticosteroids, and maintenance of an adequate airway and oxygen).²³⁰

Cross-hypersensitivity

Partial cross-allergenicity among cephalosporins and other β-lactam antibiotics, including penicillins and cephamycins.^a

Prior to initiation of therapy, make careful inquiry concerning previous hypersensitivity reactions to cephalosporins, penicillins, or other drugs.²³⁰ Cautious use recommended in individuals hypersensitive to penicillins:^a avoid use in those who have had an immediate-type (anaphylactic) hypersensitivity reaction and administer with caution in those who have had a delayed-type (e.g., rash, fever, eosinophilia) reaction.^a

General Precautions

Selection and Use of Anti-infectives

To reduce development of drug-resistant bacteria and maintain effectiveness of cefotaxime and other antibacterials, use only for treatment or prevention of infections proven or strongly suspected to be caused by susceptible bacteria.²³⁰

When selecting or modifying anti-infective therapy, use results of culture and in vitro susceptibility testing.²³⁰ In the absence of such data, consider local epidemiology and susceptibility patterns when selecting anti-infectives for empiric therapy.²³⁰

History of GI Disease

Use with caution in patients with a history of GI disease, particularly colitis.²³⁰ (See Superinfection/Clostridium difficile-associated Diarrhea and Colitis under Cautions.)

Local Effects

May be locally irritating to tissues.²³⁰ Inflammation, phlebitis, and thrombophlebitis reported with IV administration;^b pain, induration, and tenderness may occur at IM injection sites.²³⁰

Perivascular extravasation responds to changing the infusion site;²³⁰ extensive perivascular extravasation may result in tissue damage requiring surgery.²³⁰

Regularly monitor infusion sites and change site when appropriate.²³⁰

Hematologic Effects

Possible transient neutropenia, granulocytopenia, leukopenia, eosinophilia, or thrombocytopenia.²³⁰

Agranulocytosis may occur rarely during prolonged therapy.²³⁰ Monitor blood cell counts if treatment lasts >10 days.²³⁰

CNS Effects

Seizures reported with some cephalosporins, especially in patients with renal impairment who received dosages inappropriate for the degree of renal impairment.²³⁰

If seizures occur, discontinue cefotaxime and administer anticonvulsant therapy as indicated.²³⁰

Sodium Content

Contains approximately 50.5 mg (2.2 mEq) of sodium per g of cefotaxime.²³⁰ ³⁶⁶ ³⁶⁷

Specific Populations

Pregnancy

Category B.²³⁰

Lactation

Distributed into milk; use with caution.²³⁰

Pediatric Use

Adverse effects similar to those reported in adults.²⁹¹

Safety of the chemical components that may leach out of the plastic containing commercially available frozen cefotaxime sodium injections not established.²³⁰

Geriatric Use

No overall differences in safety or efficacy in those ≥65 years of age compared with younger adults, but the possibility of increased sensitivity in some geriatric individuals cannot be ruled out.²³⁰ ³⁶⁶ ³⁶⁷

Substantially eliminated by kidneys; risk of toxicity may be greater in those with impaired renal function.²³⁰ ³⁶⁶ ³⁶⁷ Select dosage with caution and consider monitoring renal function because of age-related decreases in renal function.²³⁰ ³⁶⁶ ³⁶⁷ (See Renal Impairment under Dosage and Administration.)

Hepatic Impairment

Possible increased plasma half-life and clearance of cefotaxime and its major metabolite.¹¹⁷ ²⁸⁹

Renal Impairment

Plasma half-life of cefotaxime and its major metabolite increased in severe renal impairment.¹³ ¹⁶ ¹⁹ Possibility of seizures if dosage is inappropriately high for the degree of renal impairment.²³⁰

Dosage adjustment recommended in those with Cl_cr <20 mL/minute per 1.73 m³.²³⁰

Common Adverse Effects

Local reactions at injection sites, hypersensitivity reactions, GI effects.²³⁰

Interactions for Cefotaxime Sodium

Specific Drugs and Laboratory Tests

Drug or Test	Interaction	Comments
Aminoglycosides	Possible increased risk of nephrotoxicity.²³⁰ In vitro evidence of additive or synergistic antibacterial activity; antagonism also reported.^a	Closely monitor renal function, especially if high aminoglycoside dosage is used or therapy is prolonged.²³⁰ Administer separately; do not admix.²³⁰
Probenecid	Decreased renal clearance and increased concentrations of cefotaxime and its metabolites.^b
Tests for glucose	Possible false-positive reactions in urine glucose tests using Clinitest, Benedict’s solution, or Fehling’s solution.^a	Use glucose tests based on enzymatic glucose oxidase reactions (e.g., Clinistix, Tes-Tape.)^a

Cefotaxime Sodium Pharmacokinetics

Absorption

Bioavailability

Not appreciably absorbed from GI tract; must be administered parenterally.^b

Following IM administration, peak serum concentrations attained within 30 minutes.⁶ ⁸ ¹¹ ²³⁰

Distribution

Extent

Widely distributed into body tissues and fluids, including aqueous humor, bronchial secretions,²²⁴ sputum, middle ear effusions, bone,¹¹⁵ bile,¹¹⁵ ¹¹⁶ and ascitic,¹¹⁷ pleural, and prostatic fluids.⁹

Distributed into CSF; highest concentrations attained in those with inflamed meninges.²⁶³ ²⁶⁴ ²⁸⁸ ²⁹⁰ ^b

Crosses the placenta²¹ and is distributed into milk.²¹

Plasma Protein Binding

13–38%.² ⁶ ¹¹

Elimination

Metabolism

Partially metabolized in the liver to desacetylcefotaxime, which has antibacterial activity.² ⁷ ¹⁴ Desacetylcefotaxime is further metabolized into inactive metabolites in the liver.² ⁷ ¹⁴ ¹⁸

Elimination Route

Cefotaxime and its metabolites excreted principally in urine.² ¹⁴ In adults with normal renal function, 40–60% of a dose excreted as unchanged drug; 24% excreted as the active metabolite.^b

Half-life

Terminal serum half-life of cefotaxime and desacetylcefotaxime is 0.9–1.7 and 1.4–1.9 hours, respectively.² ⁷ ¹⁰ ¹¹ ¹³ ¹⁴ ¹⁹

Special Populations

Terminal half-lives of cefotaxime and desacetylcefotaxime may be prolonged in patients with hepatic impairment.¹¹⁷ ²⁸⁹

Terminal half-life of cefotaxime only slightly prolonged in adults with Cl_cr ≥20 mL/minute per 1.73 m².¹³ ¹⁶ In those with Cl_cr of ≤10 mL/minute per 1.73 m², terminal half-lives of 1.4–11.5 and 8.2–56.8 hours reported for cefotaxime and desacetylcefotaxime, respectively.¹³ ¹⁶ ¹⁹

Stability

Storage

Parenteral

Powder for Injection

15–30°C;²³⁰ ³⁶⁶ ³⁶⁷ protect from light.²³⁰ ³⁶⁶ ³⁶⁷

Powder for injection and solutions may darken.²³⁰

IV solutions reconstituted with 0.9% sodium chloride injection or 5% dextrose injection and further diluted in a compatible IV solution are stable for 24 hours at room temperature (≤22°C) or at least 5 days refrigerated at ≤5°C.²³⁰ When reconstituted as directed in 0.9% sodium chloride injection or 5% dextrose injection, solutions prepared from ADD-Vantage vials are stable for 24 hours at room temperature (≤22°C); these solutions should not be frozen.²³⁰

IM solutions containing 230–330 mg/mL prepared using sterile or bacteriostatic water for injection are stable in their original containers for 24 hours at room temperature (≤22°C) or 10 days refrigerated at ≤5°C and stable for 5 days in plastic syringes refrigerated at ≤5°C.²³⁰

Injection (Frozen)

-20°C or lower.²³⁰ After thawing, store up to 24 hours at room temperature (≤22°C) or up to 7 days under refrigeration (≤5°C).²³⁰

Do not refreeze after thawing.²³⁰

Compatibility

For information on systemic interactions resulting from concomitant use, see Interactions.

Parenteral

Cefotaxime sodium is most stable at a pH of 5–7 and should not be diluted with IV solutions that have a pH >7.5 (e.g., sodium bicarbonate).²³⁰

Solution Compatibility

Compatible
Dextrose 5 or 10% in water^HID ²³⁰
Dextrose 5% in sodium chloride 0.2, 0.45, or 0.9%²³⁰
Invert sugar 10%²³⁰
Ringer’s injection, lactated²³⁰
Sodium chloride 0.9%^HID
Sodium lactate (1/6) M²³⁰
Travasol 8.5% without electrolytes²³⁰

Drug Compatibility

Admixture CompatibilityHID
Compatible
Clindamycin phosphate
Metronidazole
Metronidazole HCl
Verapamil HCl
Variable
Amikacin sulfate
Gentamicin sulfate

Y-site CompatibilityHID
Compatible
Acyclovir sodium
Amifostine
Aztreonam
Bivalirudin
Cyclophosphamide
Dexmedetomidine HCl
Diltiazem HCl
Docetaxel
Etoposide phosphate
Famotidine
Fenoldopam mesylate
Fludarabine phosphate
Granisetron HCl
Hetastarch in lactated electrolyte injection (Hextend)
Hydromorphone HCl
Levofloxacin
Lorazepam
Magnesium sulfate
Melphalan HCl
Meperidine HCl
Midazolam HCl
Milrinone lactate
Morphine sulfate
Ondansetron HCl
Pemetrexed disodium
Perphenazine
Propofol
Remifentanil HCl
Sargramostim
Teniposide
Thiotepa
Tolazoline HCl
Vinorelbine tartrate
Incompatible
Allopurinol sodium
Azithromycin
Filgrastim
Fluconazole
Gemcitabine HCl
Hetastarch in sodium chloride 0.9%
Pentamidine isethionate
Variable
Vancomycin HCl

Actions and Spectrum

Based on spectrum of activity, classified as a third generation cephalosporin.^a Usually less active in vitro against susceptible staphylococci than first generation cephalosporins; has an expanded spectrum of activity against gram-negative bacteria compared with first and second generation cephalosporins.^a ^b
Usually bactericidal.^a
Like other β-lactam antibiotics, antibacterial activity results from inhibition of bacterial cell wall synthesis.²³⁰ ^a
Spectrum of activity includes many gram-positive aerobic bacteria, some gram-negative aerobic bacteria, and some anaerobic bacteria; inactive against Chlamydia, fungi, and viruses.^a
Gram-positive aerobes: active in vitro and in clinical infections against S. pneumoniae, S. pyogenes (group A β-hemolytic streptococci), S. agalactiae (group B streptococci), S. aureus (including β-lactamase-producing strains), and some enterococci (e.g., Enterococcus faecalis).²³⁰ ^a ^b Also active in vitro against some viridans streptococci.³⁵⁰ Oxacillin-resistant (methicillin-resistant) staphylococci and some enterococci are resistant.^a ^b
Gram-negative aerobes: active in vitro and in clinical infections against Acinetobacter, Citrobacter, Enterobacter, E. coli, H. influenzae (including ampicillin-resistant strains), H. parainfluenzae, Klebsiella, M. morganii, N. gonorrhoeae, N. meningitidis, P. mirabilis, P. vulgaris, P. rettgeri, P. stuartii, and Serratia.²³⁰ ^a ^b Also active in vitro against Campylobacter,²²² ²²³ Capnocytophaga,³¹² ³¹⁴ ³¹⁵ Eikenella corrodens,²²⁰ ²²¹ ²⁴⁹ Moraxella,²³² ²³⁶ ²⁴⁰ ²⁴⁴ Salmonella,^a ^b Shigella,^a ^b and Vibrio vulnificus.²⁹² Active against some strains of Pseudomonas aeruginosa, but less active against susceptible Ps. aeruginosa than ceftazidime.^b
Anaerobes and other organisms: active in vitro and in clinical infections against Bacteroides, Eubacterium, Fusobacterium, Peptococcus, Peptostreptococcus, Propionibacterium, Veillonella, and some strains of Clostridium.²³⁰ ²⁶⁵ ^a ^b Also active against the spirochete Borrelia burgdorferi.²⁶⁵

Advice to Patients

Advise patients that antibacterials (including cefotaxime) should only be used to treat bacterial infections and not used to treat viral infections (e.g., the common cold).²³⁰
Importance of completing full course of therapy, even if feeling better after a few days.²³⁰
Advise patients that skipping doses or not completing the full course of therapy may decrease effectiveness and increase the likelihood that bacteria will develop resistance and will not be treatable with cefotaxime or other antibacterials in the future.²³⁰
Advise patients that diarrhea is a common problem caused by anti-infectives and usually ends when the drug is discontinued.²³⁰ Importance of contacting a clinician if watery and bloody stools (with or without stomach cramps and fever) occur during or as late as 2 months or longer after the last dose.²³⁰
Importance of informing clinicians if an allergic reaction occurs.²³⁰
Importance of informing clinicians of existing or contemplated therapy, including prescription and OTC drugs as well as any concomitant illnesses.²³⁰
Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.
Importance of informing patients of other important precautionary information. (See Cautions.)

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Cefotaxime Sodium
Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Parenteral	For injection	500 mg (of cefotaxime)*	Cefotaxime Sodium for Injection
			Claforan	Sanofi-Aventis
		1 g (of cefotaxime)*	Cefotaxime Sodium for Injection
			Claforan	Sanofi-Aventis
		2 g (of cefotaxime)*	Cefotaxime Sodium for Injection
			Claforan	Sanofi-Aventis
		10 g (of cefotaxime) pharmacy bulk package*	Cefotaxime Sodium for Injection
			Claforan	Sanofi-Aventis
		20 g (of cefotaxime) pharmacy bulk package*	Cefotaxime Sodium for Injection
	For injection, for IV infusion	1 g (of cefotaxime)	Claforan	Sanofi-Aventis
			Claforan ADD-Vantage	Sanofi-Aventis
		2 g (of cefotaxime)	Claforan	Sanofi-Aventis
			Claforan ADD-Vantage	Sanofi-Aventis

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Cefotaxime Sodium in Dextrose
Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Parenteral	Injection (frozen), for IV infusion	20 mg (of cefotaxime) per mL (1 g) in 3.4% Dextrose*	Cefotaxime Sodium in Iso-osmotic Dextrose Injection (Galaxy)
		40 mg (of cefotaxime) per mL (2 g) in 1.4% Dextrose*	Cefotaxime Sodium in Iso-osmotic Dextrose Injection (Galaxy)

Disclaimer

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS Drug Information. © Copyright, 1959-2013, Selected Revisions December 1, 2008. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

† Use is not currently included in the labeling approved by the US Food and Drug Administration.

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