Brand name: Claforan
Drug class: Third Generation Cephalosporins
VA class: AM117
CAS number: 64485-93-4

Medically reviewed by Drugs.com on Sep 20, 2024. Written by ASHP.

Introduction

Antibacterial; β-lactam antibiotic; third generation cephalosporin.

Uses for Cefotaxime

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.

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.

GI Infections

Empiric treatment of infectious diarrhea^{† [off-label]}. Alternative for empiric treatment of severe diarrhea in HIV-infected individuals; ciprofloxacin is drug of choice.

Treatment of gastroenteritis caused by Salmonella^{† [off-label]}. (See Typhoid Fever and Other Salmonella Infections under Uses.)

Treatment of GI infections caused by Yersinia enterocolitica or Y. pseudotuberculosis^{† [off-label]}. Usually self-limited infections, but anti-infectives may be indicated in immunocompromised individuals, for severe infections, or when septicemia or other invasive disease occurs.

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.

When parenteral regimen is used for treatment of PID, CDC recommends IV cefoxitin or cefotetan given in conjunction with oral doxycycline or IV clindamycin given in conjunction with gentamicin. While other parenteral cephalosporins (e.g., cefotaxime, ceftriaxone) also may be effective, CDC states these drugs are less active than cefoxitin or cefotetan against anaerobic bacteria.

When 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 cefotaxime given in conjunction with oral doxycycline (with or without oral metronidazole).

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).

Meningitis and Other CNS Infections

Treatment of meningitis and ventriculitis caused by susceptible H. influenzae, N. meningitidis, S. pneumoniae, E. coli, or K. pneumoniae.

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

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

Respiratory Tract Infections

Treatment of serious lower respiratory tract infections, including community-acquired pneumonia (CAP) 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).

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. Also recommended in certain combination regimens used for empiric treatment of CAP. 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).

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).

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).

Septicemia

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

Select anti-infective for treatment of sepsis syndrome based on probable source of infection, causative organism, immune status of patient, and local patterns of bacterial resistance.

For initial treatment of life-threatening sepsis in adults, some clinicians suggest that a third or fourth generation cephalosporin (cefepime, cefotaxime, ceftriaxone, ceftazidime), the fixed combination of piperacillin and tazobactam, or a carbapenem (doripenem, imipenem, meropenem) be used in conjunction with vancomycin; some also suggest including an aminoglycoside or fluoroquinolone during initial few days of treatment.

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).

Capnocytophaga Infections

Alternative to penicillin G for treatment of infections caused by Capnocytophaga^{† [off-label]} (e.g., septicemia, meningitis, endocarditis).

Gonorrhea and Associated Infections

Alternative for treatment of uncomplicated cervical, urethral, or rectal gonorrhea caused by susceptible Neisseria gonorrhoeae in adults or adolescents. Drug of choice is IM ceftriaxone. Although IM cefotaxime may be effective for urogenital and anorectal gonorrhea, CDC states it offers no advantages over IM ceftriaxone and has uncertain efficacy for pharyngeal gonorrhea.

Alternative for initial treatment of disseminated gonococcal infections^† caused by susceptible N. gonorrhoeae. Ceftriaxone is drug of choice for initial parenteral treatment of disseminated gonorrhea in adults, adolescents, or children.

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

Lyme Disease

Treatment of early neurologic Lyme disease^† with acute neurologic manifestations such as meningitis or radiculopathy. IV ceftriaxone is the drug of choice; alternatives are IV cefotaxime or IV penicillin G. 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, a parenteral regimen usually is recommended when there are acute neurologic manifestations.

Treatment of Lyme carditis^† when a parenteral regimen is indicated. IV ceftriaxone is the drug of choice; alternatives are IV cefotaxime or IV penicillin G. 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.

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

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

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.

Treatment of gastroenteritis caused by Salmonella^† (e.g., S. enteritidis, S. typhimurium) in individuals with severe Salmonella gastroenteritis and in those who are at increased risk of invasive disease.

Alternative for treatment of Salmonella gastroenteritis in HIV-infected individuals to prevent extraintestinal spread of the infection. CDC, NIH, and IDSA recommend ciprofloxacin as drug of choice for treatment of Salmonella gastroenteritis (with or without bacteremia) in HIV-infected adults; other fluoroquinolones (levofloxacin, moxifloxacin) also may be effective. Depending on in vitro susceptibility, alternatives are co-trimoxazole or third generation cephalosporins (ceftriaxone, cefotaxime).

Vibrio Infections

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

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

Perioperative Prophylaxis

Has been used for perioperative prophylaxis in patients undergoing liver transplantation^†; some experts recommend a regimen of cefotaxime and ampicillin for such prophylaxis.

Has been used for perioperative prophylaxis to reduce the incidence of infection in patients undergoing contaminated or potentially contaminated surgery (e.g., biliary tract, colorectal, other intra-abdominal or GI surgery, genitourinary surgery, abdominal or vaginal hysterectomy) and in patients undergoing cesarean section. Other anti-infectives (e.g., cefazolin) usually recommended for these procedures.

First or second generation cephalosporins (cefazolin, cefotetan, cefoxitin, cefuroxime) generally preferred when a cephalosporin is used for perioperative prophylaxis. Third generation cephalosporins (cefotaxime, ceftriaxone, ceftazidime) and fourth generation cephalosporins (cefepime) not usually recommended for perioperative prophylaxis since they are expensive, some are less active against staphylococci than first or second generation cephalosporins, they have wider spectrums of activity than necessary for organisms encountered in elective surgery, and their use for prophylaxis may promote emergence of resistant organisms.

Cefotaxime Dosage and Administration

Administration

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

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.

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

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.

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.

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

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. May be diluted further in 50 mL to 1 L of compatible IV solution.

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

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

Thaw the commercially available premixed injection (frozen) at room temperature or in a refrigerator; do not thaw by immersion in a water bath or by exposure to microwave radiation. A precipitate may have formed in the frozen injection, but should dissolve with little or no agitation after reaching room temperature. Discard thawed injection if an insoluble precipitate is present or if container seals or outlet ports are not intact or leaks are found. Do not use in series connections with other plastic containers; 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.

Rate of Administration

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

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

IM Injection

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

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

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.

Dosage

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

Pediatric Patients

General Dosage for Neonates

IV or IM

Manufacturer recommends 50 mg/kg every 12 hours for those <1 week of age and 50 mg/kg every 8 hours for those 1–4 weeks of age.

Neonates ≤7 days of age: AAP recommends 50 mg/kg every 12 hours, regardless of weight.

Neonates 8–28 days of age: AAP recommends 50 mg/kg every 8–12 hours in those weighing ≤2 kg and 50 mg/kg every 8 hours in those weighing >2 kg.

General Dosage for Infants and 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. The higher dosage should be used for more severe or serious infections.

Children beyond neonatal period: AAP recommends 50–180 mg/kg daily given in 3 or 4 equally divided doses for treatment of mild to moderate infections and 200–225 mg/kg daily given in 4 or 6 equally divided doses for treatment of severe infections.

Children weighing >50 kg should receive the usual adult dosage. (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. Some clinicians recommend that infants and children <18 years of age with meningitis receive 50 mg/kg IV every 6 hours. 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.

AAP recommends up to 300 mg/kg daily given in 4 or 6 divided doses for treatment of meningitis in pediatric patients beyond the neonatal period.

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.

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.

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

IV

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

Uncomplicated Urethral, Cervical, or Rectal Gonorrhea in Adolescents

IM

Single 500-mg dose recommended by CDC and AAP.

Lyme Disease†

Early Neurologic Lyme Disease†

IV

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).

Lyme Carditis†

IV

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).

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

Lyme Arthritis†

IV

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.

Late Neurologic Lyme Disease†

IV

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.

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

Adults

General Adult Dosage

Uncomplicated Infections

IV or IM

1 g every 12 hours.

Moderate to Severe Infections

IV or IM

1–2 g every 8 hours.

Severe or Life-threatening Infections

IV

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

Meningitis and Other CNS Infections

IV

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

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.

Meningitis Caused by S. pneumoniae

IV

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.

GI Infections†

Infectious Diarrhea†

IV

HIV-infected: 1 g every 8 hours. If no clinical response after 5–7 days, consider stool culture and in vitro susceptibility testing.

Salmonella Gastroenteritis†

IV

HIV-infected: 1 g every 8 hours.

Recommended duration is 7–14 days if CD4⁺ T-cells ≥200 cells/mm³ (≥14 days if patient is bacteremic or infection is complicated) or 2–6 weeks if CD4⁺ T-cells <200 cells/mm³.

Respiratory Tract Infections

Community-acquired Pneumonia

IV or IM

1 g every 6–8 hours.

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

Gonorrhea and Associated Infections

Uncomplicated Urethral, Cervical, or Rectal Gonorrhea

IM

Single 500-mg dose recommended by CDC.

Manufacturers recommend single 500-mg dose for treatment of gonococcal urethritis/cervicitis in males and females and rectal gonorrhea in females and single 1-g dose for treatment of rectal gonorrhea in males.

Disseminated Gonorrhea†

IV

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

Lyme Disease †

Early Neurologic Lyme Disease†

IV

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).

Lyme Carditis†

IV

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).

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

Lyme Arthritis†

IV

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.

Late Neurologic Lyme Disease†

IV

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.

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

Perioperative Prophylaxis

Contaminated or Potentially Contaminated Surgery

IV or IM

Manufacturers recommend 1 g 30–90 minutes prior to surgery.

Some experts recommend 1 g in most adults and 2 g in obese patients given within 60 minutes prior to surgical incision.

If procedure is prolonged (>3–4 hours) or if major blood loss occurs, additional intraoperative doses may be given every 3 hours. Duration of prophylaxis should be <24 hours for most procedures; no evidence to support continuing prophylaxis after wound closure or until all indwelling drains and intravascular catheters are removed.

Cesarean Section

IV or IM

Manufacturers recommend 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.

Prescribing Limits

Pediatric Patients

Maximum 12 g daily for children weighing >50 kg.

Adults

Maximum 12 g daily.

Special Populations

Hepatic Impairment

No dosage adjustments required.

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.

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

Cautions for Cefotaxime

Contraindications

• Known hypersensitivity to cefotaxime or other cephalosporins.

Warnings/Precautions

Warnings

Superinfection/Clostridium difficile-associated Diarrhea and Colitis

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

Treatment with anti-infectives alters normal colon flora and may permit overgrowth of Clostridium difficile. C. difficile infection (CDI) and C. difficile-associated diarrhea and colitis (CDAD; also known as antibiotic-associated diarrhea and colitis or pseudomembranous colitis) reported with nearly all anti-infectives, including cefotaxime, and may range in severity from mild diarrhea to fatal colitis. C. difficile produces toxins A and B which contribute to development of CDAD; 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.

Consider CDAD if diarrhea develops during or after therapy and manage accordingly. Obtain careful medical history since CDAD may occur as late as 2 months or longer after anti-infective therapy is discontinued.

If CDAD is suspected or confirmed, discontinue anti-infectives not directed against C. difficile whenever possible. Initiate appropriate supportive therapy (e.g., fluid and electrolyte management, protein supplementation), anti-infective therapy directed against C. difficile (e.g., metronidazole, vancomycin), and surgical evaluation as clinically indicated.

Cardiac Effects

Potentially life-threatening arrhythmia reported with rapid injection (<1 minute) through a central venous catheter. Do not inject IV over <3 minutes. (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.

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).

Cross-hypersensitivity

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

Prior to initiation of therapy, make careful inquiry concerning previous hypersensitivity reactions to cephalosporins, penicillins, or other drugs. Cautious use recommended in individuals hypersensitive to penicillins: 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.

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.

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

History of GI Disease

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

Local Effects

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

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

Regularly monitor infusion sites and change site when appropriate.

Hematologic Effects

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

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

CNS Effects

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

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

Sodium Content

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

Specific Populations

Pregnancy

Category B.

Lactation

Distributed into milk; use with caution.

Pediatric Use

Adverse effects similar to those reported in adults.

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

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.

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

Hepatic Impairment

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

Renal Impairment

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

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

Common Adverse Effects

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

Drug Interactions

Specific Drugs and Laboratory Tests

Cefotaxime Pharmacokinetics

Absorption

Bioavailability

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

Following IM administration, peak serum concentrations attained within 30 minutes.

Distribution

Extent

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

Distributed into CSF; highest concentrations attained in those with inflamed meninges.

Crosses the placenta and is distributed into milk.

Plasma Protein Binding

13–38%.

Elimination

Metabolism

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

Elimination Route

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

Half-life

Terminal serum half-life of cefotaxime and desacetylcefotaxime is 0.9–1.7 and 1.4–1.9 hours, respectively.

Special Populations

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

Terminal half-life of cefotaxime only slightly prolonged in adults with Cl_cr ≥20 mL/minute per 1.73 m². 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.

Stability

Storage

Parenteral

Powder for Injection or IV Infusion

15–30°C; protect from light.

Following reconstitution with sterile water for injection, IV solutions containing 50 or 95 mg/mL are stable for 24 hours at room temperature (≤22°C) or 7 days when refrigerated (≤5°C). 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 when refrigerated (≤5°C).

Following reconstitution with sterile or bacteriostatic water for injection, IM solutions containing 230–330 mg/mL are stable in their original containers for 12 hours at room temperature (≤22°C) or 10 days when refrigerated (≤5°C).

Powder for injection and solutions may darken.

For Injection, for IV Infusion

Claforan ADD-Vantage vials: <30°C; protect from light. After reconstitution as directed in 0.9% sodium chloride injection or 5% dextrose injection, stable for 24 hours at ≤22°C; do not freeze.

Injection (Frozen)

-20°C or lower. Thawed solution stable 24 hours at room temperature (≤22°C) or 7 days under refrigeration (≤5°C).

Do not refreeze after thawing.

Compatibility

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).

Solution Compatibility

Drug Compatibility

Actions and Spectrum

• Based on spectrum of activity, classified as a third generation cephalosporin. 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.

• Usually bactericidal.

• Like other β-lactam antibiotics, antibacterial activity results from inhibition of bacterial cell wall synthesis.

• Spectrum of activity includes many gram-positive aerobic bacteria, some gram-negative aerobic bacteria, and some anaerobic bacteria; inactive against Chlamydia, fungi, and viruses.

• 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). Also active in vitro against some viridans streptococci. Oxacillin-resistant (methicillin-resistant) staphylococci and some enterococci are resistant.

• 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. Also active in vitro against Campylobacter, Capnocytophaga, Eikenella corrodens, Moraxella, Salmonella, Shigella, and Vibrio vulnificus. Active against some strains of Pseudomonas aeruginosa, but less active against susceptible Ps. aeruginosa than ceftazidime.

• Anaerobes and other organisms: active in vitro and in clinical infections against Bacteroides, Eubacterium, Fusobacterium, Peptococcus, Peptostreptococcus, Propionibacterium, Veillonella, and some strains of Clostridium. Also active against the spirochete Borrelia burgdorferi.

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).

• Importance of completing full course of therapy, even if feeling better after a few days.

• 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.

• Advise patients that diarrhea is a common problem caused by anti-infectives and usually ends when the drug is discontinued. 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.

• Importance of informing clinicians if an allergic reaction occurs.

• Importance of informing clinicians of existing or contemplated therapy, including prescription and OTC drugs as well as any concomitant illnesses.

• 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.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

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

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

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