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- Cefotaxime Sodium
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Claforan in D5W: 1 g/50 mL (50 mL); 2 g/50 mL (50 mL)
Solution Reconstituted, Injection:
Claforan: 500 mg (1 ea); 1 g (1 ea); 2 g (1 ea); 10 g (1 ea)
Generic: 500 mg (1 ea); 1 g (1 ea); 2 g (1 ea); 10 g (1 ea)
Solution Reconstituted, Intravenous:
Claforan: 1 g (1 ea); 2 g (1 ea)
Brand Names: U.S.
- Claforan in D5W
- Antibiotic, Cephalosporin (Third Generation)
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.
Widely to body tissues and fluids including aqueous humor, ascitic and prostatic fluids, bone; penetrates CSF best when meninges are inflamed
Partially hepatic to active metabolite, desacetylcefotaxime
Urine (~60% as unchanged drug and metabolites)
Time to Peak
Serum: IM: Within 30 minutes
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)
31% to 50%
Use: Labeled Indications
Bacteremia/Septicemia: Treatment of bacteremia/septicemia caused by Escherichia coli, Klebsiella species, and Serratia marcescens, Staphylococcus aureus and Streptococcus species (including Streptococcus pneumoniae).
Bone or joint infections: Treatment of bone or joint infections caused by S. aureus (penicillinase and nonpenicillinase producing strains), Streptococcus species (including Streptococcus pyogenes), Pseudomonas species (including Pseudomonas aeruginosa), and Proteus mirabilis.
CNS infections: Treatment of CNS infections (eg, meningitis, ventriculitis) caused by Neisseria meningitidis, Haemophilus influenzae, S. pneumoniae, Klebsiella pneumoniae, and E. coli.
Genitourinary infections: Treatment of genitourinary infections, including urinary tract infections (UTIs), caused by Enterococcus species, Staphylococcus epidermidis, S. aureus (penicillinase and nonpenicillinase producing), Citrobacter species, Enterobacter species, E. coli, Klebsiella species, P. mirabilis, Proteus vulgaris, Providencia stuartii, Morganella morganii, Providencia rettgeri, S. marcescens, and Pseudomonas species (including P. aeruginosa). Also, uncomplicated gonorrhea (cervical/urethral and rectal) caused by Neisseria gonorrhoeae, including penicillinase-producing strains. Note: CDC STD guidelines do not recommend cefotaxime as a treatment option for uncomplicated gonorrhea; ceftriaxone is the preferred cephalosporin (CDC [Workowski 2015]).
Gynecologic infections: Treatment of gynecologic infections, including pelvic inflammatory disease, endometritis, and pelvic cellulitis, caused by S. epidermidis, Streptococcus species, Enterococcus species, Enterobacter species, Klebsiella species, E. coli, P. mirabilis, Bacteroides species (including Bacteroides fragilis), Clostridium species, and anaerobic cocci (including Peptostreptococcus and Peptococcus species) and Fusobacterium species (including Fusobacterium nucleatum).
Intra-abdominal infections: Treatment of intra-abdominal infections, including peritonitis caused by Streptococcus species, E. coli, Klebsiella species, Bacteroides species, and anaerobic cocci (including Peptostreptococcus species and Peptococcus species), P. mirabilis, and Clostridium species.
Lower respiratory tract infections: Treatment of lower respiratory tract infections, including pneumonia, caused by S. pneumoniae, S. pyogenes (group A streptococci) and other streptococci (excluding enterococci, [eg, Enterococcus faecalis]), S. aureus (penicillinase and nonpenicillinase producing), E. coli, Klebsiella species, H. influenzae (including ampicillin-resistant strains), H. parainfluenzae, P. mirabilis, S. marcescens, Enterobacter species, and indole-positive Proteus and Pseudomonas species (including P. aeruginosa).
Skin and skin structure infections: Treatment of skin and skin structure infections caused by S. aureus (penicillinase and nonpenicillinase producing), S. epidermidis, S. pyogenes (group A streptococci) and other streptococci, Enterococcus species, Acinetobacter species, E. coli, Citrobacter species (including Citrobacter freundii), Enterobacter species, Klebsiella species, P. mirabilis, P. vulgaris, M. morganii, P. rettgeri, Pseudomonas species, S. marcescens, Bacteroides species, and anaerobic cocci (including Peptostreptococcus species and Peptococcus species).
Surgical prophylaxis: Reduce the incidence of certain infections in patients undergoing surgical procedures (eg, abdominal or vaginal hysterectomy, GI and GU tract surgery) that may be classified as contaminated or potentially contaminated; reduce the incidence of certain postoperative infections in patients undergoing cesarean section.
Acute bacterial rhinosinusitis (ABRS)
Hypersensitivity to cefotaxime, any component of the formulation, or other cephalosporins
Usual dosage range: IM, IV:
Uncomplicated infections: IM, IV: 1 g every 12 hours
Moderate-to-severe infections: IM, IV: 1 to 2 g every 8 hours
Life-threatening infections: IV: 2 g every 4 hours
Acute bacterial rhinosinusitis, severe infection requiring hospitalization: IV: 2 g every 4 to 6 hours for 5 to 7 days (Chow 2012)
Arthritis (septic): IV: 1 g every 8 hours
Bacterial enteric infections in HIV-infected patients (empiric treatment) (off-label use): IV: 1 g every 8 hours (HHS [OI adult 2015])
Bite wounds (animal) (off-label use): IV: 1 to 2 g every 6 to 8 hours in combination with clindamycin or metronidazole for anaerobic coverage (IDSA [Stevens 2014])
Brain abscess, meningitis: IV: 2 g every 4 to 6 hours in combination with other antimicrobial therapy as warranted (Kowlessar 2006; Tunkel 2004)
Cesarean section: IM, IV: 1 g IV as soon as the umbilical cord is clamped, then 1 g IV or IM at 6 and 12 hours after the first dose
Complicated community-acquired intra-abdominal infection of mild-to-moderate severity, including hepatic abscess (in combination with metronidazole): IV: 1 to 2 g every 6 to 8 hours for 4 to 7 days (provided source controlled). Note: For severe infections consider other antimicrobial agents (Bradley, 1987; Kim 2010; Solomkin 2010).
Gonorrhea, uncomplicated infection of the cervix, urethra, or rectum: Note: CDC STD guidelines do not recommend cefotaxime as a treatment option for uncomplicated gonorrhea; ceftriaxone is the preferred cephalosporin (CDC [Workowski 2015])
Uncomplicated gonorrhea of the cervix or urethra (males or females) or of the rectum (females): Manufacturer’s labeling: IM: 0.5 g as a single dose
Uncomplicated gonorrhea of the rectum (males): Manufacturer’s labeling IM: 1 g as a single dose
Gonorrhea, disseminated infections (arthritis and arthritis-dermatitis syndrome) (alternative to preferred therapy) (off-label use): IV: 1 g every 8 hours in combination with azithromycin. Continue for 24 to 48 hours after improvement begins, then switch to oral therapy guided by antimicrobial susceptibility testing. Total duration of therapy at least 7 days (CDC [Workowski 2015])
Lyme disease (as an alternative to ceftriaxone):
Cardiac manifestations: IV: 2 g every 8 hours for 14 to 21 days (Wormser 2006)
CNS manifestations: IV: 2 g every 8 hours for 10 to 28 days (Halperin 2007; Wormser 2006)
Surgical (perioperative) prophylaxis (off-label use): IV: 1 g within 60 minutes prior to surgical incision. Doses may be repeated in 3 hours if procedure is lengthy or if there is excessive blood loss. Note: preferred agent (with ampicillin) in liver transplantation (Bratzler 2013).
Obesity: The ASHP/IDSA/SIS/SHEA guidelines recommend that for patients weighing ≥120 kg (or alternatively defined as BMI >30 kg/m2), a dose of 2 g within 60 minutes prior to surgical incision should be administered (Bratzler 2013).
Peritonitis (spontaneous): IV: 2 g every 8 hours, unless life-threatening then 2 g every 4 hours (Gilbert 2011; Runyon 2009)
Sepsis: IV: 2 g every 6 to 8 hours
Skin and soft tissue necrotizing infections (off-label use):
Polymicrobial infection: IV: 2 g every 6 hours, in combination with metronidazole or clindamycin for empiric therapy of polymicrobial infections. Continue until further debridement is not necessary, patient has clinically improved, and patient is afebrile for 48 to 72 hours (IDSA [Stevens 2014]).
Necrotizing infection due to Vibrio vulnificus: IV: 2 g every 8 hours, in combination with doxycycline. Continue until further debridement is not necessary, patient has clinically improved, and patient is afebrile for 48 to 72 hours (IDSA [Stevens 2014]).
Refer to adult dosing.
Usual dosage range for susceptible infections:
Infants, Children, and Adolescents:
<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)
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.
Community-acquired pneumonia (CAP) (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
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)
Peritonitis (spontaneous): Children ≥50 kg or Adolescents: Refer to adult dosing.
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)
Dosing: Renal Impairment
Manufacturer’s labeling: Note: Renal function may be estimated using Cockcroft-Gault formula for dosage adjustment purposes.
CrCl <20 mL/minute/1.73 m2: Dose should be decreased by 50%.
Dialysis: Moderately dialyzable (20% to 50%)
Adults: The following dosage adjustments have been used by some clinicians (Aronoff 2007; Heintz 2009; Trotman 2005):
GFR >50 mL/minute: Administer every 6 hours (Aronoff 2007)
GFR 10 to 50 mL/minute: Administer every 6 to 12 hours (Aronoff 2007)
GFR <10 mL/minute: Administer every 24 hours or decrease the dose by 50% (and administer at usual intervals) (Aronoff 2007)
Intermittent hemodialysis (IHD): Administer 1 to 2 g every 24 hours (on dialysis days, administer after hemodialysis). Note: Dosing dependent on the assumption of 3 times/week, complete IHD sessions (Heintz 2009).
Peritoneal dialysis (PD): 1 g every 24 hours (Aronoff 2007)
Continuous renal replacement therapy (CRRT) (Heintz 2009; Trotman 2005): Drug clearance is highly dependent on the method of renal replacement, filter type, and flow rate. Appropriate dosing requires close monitoring of pharmacologic response, signs of adverse reactions due to drug accumulation, as well as drug concentrations in relation to target trough (if appropriate). The following are general recommendations only (based on dialysate flow/ultrafiltration rates of 1 to 2 L/hour and minimal residual renal function) and should not supersede clinical judgment:
CVVH: 1 to 2 g every 8 to 12 hours
CVVHD: 1 to 2 g every 8 hours
CVVHDF: 1 to 2 g every 6 to 8 hours
Children: Note: Glomerular filtration rate (GFR) should be estimated using an acceptable pediatric method (eg, Schwartz equation, Traub-Johnson equation, or a height/weight nomogram):
The following dosage adjustments have been used by some clinicians (Aronoff 2007):
GFR 30 to 50 mL/minute/1.73 m2: 35 to 70 mg/kg/dose every 8 to 12 hours
GFR 10 to 29 mL/minute/1.73 m2: 35 to 70 mg/kg/dose every 12 hours
GFR <10 mL/minute/1.73 m2: 35 to 70 mg/kg/dose every 24 hours
Intermittent hemodialysis (IHD): 35 to 70 mg/kg/dose every 24 hours
Peritoneal dialysis: 35 to 70 mg/kg/dose every 24 hours
Continuous renal replacement therapy (CRRT): 35 to 70 mg/kg/dose every 12 hours
Dosing: Hepatic Impairment
There are no dosage adjustments provided in the manufacturer’s labeling.
Refer to indication-specific dosing for obesity-related information (may not be available for all indications).
IM: Reconstitute vials with SWFI or bacteriostatic water for injection; dilute with 2 mL for the 500 mg vial (resulting concentration ~230 mg/mL), 3 mL for the 1 g vial (resulting concentration ~300 mg/mL), and 5 mL for the 2 g vial (resulting concentration 330 mg/mL). Shake to dissolve.
IV: Reconstitute vials with ≥10 mL SWFI; resulting concentration: 50 mg/mL (500 mg vial), 95 mg/mL (1 g vial), or 180 mg/mL (2 g vial). Shake to dissolve. May be further diluted up to 1000 mL with NS, D5W, D10W, D5NS, D51/2NS, D51/4NS, or LR.
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.
Some products may contain sodium.
Stable in D51/4NS, D51/2NS, D5NS, D5W, D10W, LR, NS; variable stability (consult detailed reference) in peritoneal dialysis solutions
Y-site administration: Incompatible with allopurinol, anakinra, azithromycin, caspofungin, diphenhydramine, dobutamine, filgrastim, fluconazole, gemcitabine, hetastarch in NS, labetalol, methylprednisolone sodium succinate, pantoprazole, pemetrexed, pentamidine, phenytoin, sodium bicarbonate, trimethoprim/sulfamethoxazole, vecuronium. Variable (consult detailed reference): Cisatracurium, midazolam, vancomycin.
Store intact vials below 30°C (86°F). Protect from light. Reconstituted solution is stable for 12 to 24 hours at room temperature, 7 to 10 days when refrigerated, for 13 weeks when frozen. For IV infusion in NS or D5W, solution is stable for 24 hours at room temperature, 5 days when refrigerated, or 13 weeks when frozen in Viaflex plastic containers. Thawed solutions of frozen premixed bags are stable for 24 hours at room temperature or 10 days when refrigerated.
Aminoglycosides: Cephalosporins (3rd Generation) may enhance the nephrotoxic effect of Aminoglycosides. Monitor therapy
BCG (Intravesical): Antibiotics may diminish the therapeutic effect of BCG (Intravesical). Avoid combination
BCG Vaccine (Immunization): Antibiotics may diminish the therapeutic effect of BCG Vaccine (Immunization). Monitor therapy
Cholera Vaccine: Antibiotics may diminish the therapeutic effect of Cholera Vaccine. Avoid combination
Lactobacillus and Estriol: Antibiotics may diminish the therapeutic effect of Lactobacillus and Estriol. Monitor therapy
Probenecid: May increase the serum concentration of Cefotaxime. Management: Avoid cefotaxime doses greater than 6 g/day with concurrent probenecid. Any patients receiving this combination should be monitored closely for evidence of cefotaxime toxicity. Consider therapy modification
Sodium Picosulfate: Antibiotics may diminish the therapeutic effect of Sodium Picosulfate. Management: Consider using an alternative product for bowel cleansing prior to a colonoscopy in patients who have recently used or are concurrently using an antibiotic. Consider therapy modification
Typhoid Vaccine: Antibiotics may diminish the therapeutic effect of Typhoid Vaccine. Only the live attenuated Ty21a strain is affected. Management: Vaccination with live attenuated typhoid vaccine (Ty21a) should be avoided in patients being treated with systemic antibacterial agents. Use of this vaccine should be postponed until at least 3 days after cessation of antibacterial agents. Consider therapy modification
Vitamin K Antagonists (eg, warfarin): Cephalosporins may enhance the anticoagulant effect of Vitamin K Antagonists. Monitor therapy
Positive direct Coombs', false-positive urinary glucose test using cupric sulfate (Benedict's solution, Clinitest®, Fehling's solution), false-positive serum or urine creatinine with Jaffé reaction
1% to 10%:
Dermatologic: Pruritus (≤2%), skin rash (≤2%)
Gastrointestinal: Colitis (≤1%), diarrhea (≤1%), nausea (≤1%), vomiting (≤1%)
Hematologic & oncologic: Eosinophilia (≤2%)
Local: Induration at injection site (IM ≤4%), inflammation at injection site (IV ≤4%), pain at injection site (IM ≤4%), tenderness at injection site (IM ≤4%)
Miscellaneous: Fever (≤2%)
<1% (Limited to important or life-threatening): Acute generalized exanthematous pustulosis, acute renal failure, agranulocytosis, anaphylaxis, bone marrow failure, brain disease, candidiasis, cardiac arrhythmia (after rapid IV injection via central catheter), cholestasis, Clostridium difficile associated diarrhea, erythema multiforme, granulocytopenia, hemolytic anemia, hepatitis, increased blood urea nitrogen, increased gamma-glutamyl transferase, increased lactate dehydrogenase, increased serum alkaline phosphatase, increased serum ALT, increased serum AST, increased serum bilirubin, increased serum creatinine, injection site phlebitis, interstitial nephritis, jaundice, leukopenia, neutropenia, pancytopenia, positive direct Coombs test, pseudomembranous colitis, Stevens-Johnson syndrome, thrombocytopenia, toxic epidermal necrolysis, vaginitis
Concerns related to adverse effects:
• Arrhythmia: A potentially life-threatening arrhythmia has been reported in patients who received a rapid (<1 minute) bolus injection via central venous catheter.
• Granulocytopenia: Granulocytopenia and more rarely agranulocytosis may develop during prolonged treatment (>10 days).
• Penicillin allergy: Use with caution in patients with a history of penicillin allergy, especially IgE-mediated reactions (eg, anaphylaxis, angioedema, urticaria).
• Superinfection: Prolonged use may result in fungal or bacterial superinfection, including C. difficile-associated diarrhea (CDAD) and pseudomembranous colitis; CDAD has been observed >2 months postantibiotic treatment.
• Tissue inflammation: Minimize tissue inflammation by changing infusion sites when needed.
• Colitis: Use with caution in patients with a history of colitis.
• Renal impairment: Use with caution in patients with renal impairment; dosage adjustment may be required.
Concurrent drug therapy issues:
• Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information.
Observe for signs and symptoms of anaphylaxis during first dose; CBC with differential (especially with long courses [>10 days]); renal function
Pregnancy Risk Factor
Adverse events have not been observed in animal reproduction studies. Cefotaxime crosses the human placenta and can be found in fetal tissue. An increase in most types of birth defects was not found following first trimester exposure to cephalosporins. During pregnancy, peak cefotaxime serum concentrations are decreased and the serum half-life is shorter. Cefotaxime is approved for use in women undergoing cesarean section (consult current guidelines for appropriate use).
• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)
• Patient may experience diarrhea. Have patient report immediately to prescriber signs of liver problems (dark urine, feeling tired, lack of appetite, nausea, abdominal pain, light-colored stools, vomiting, or yellow skin or eyes); bruising; bleeding; chills; pharyngitis; seizures; severe loss of strength and energy; severe injection site pain; redness; burning; edema; or irritation; or signs of Clostridium difficile (C. diff)-associated diarrhea (stomach pain or cramps, very loose or watery stools, or bloody stools) (HCAHPS).
• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.
Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.
More about cefotaxime
- Other brands: Claforan