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Medication Safety Issues
Sound-alike/look-alike issues:
Cefotaxime may be confused with cefoxitin, ceftizoxime, cefuroxime
International issues:
Spectrocef® [Italy] may be confused with Spectracef® which is a brand name for cefditoren in the U.S.
Pronunciation
(sef oh TAKS eem)
U.S. Brand Names
Index Terms
Generic Available
Yes: Powder
Canadian Brand Names
Pharmacologic Category
Pharmacologic Category Synonyms
Use: Labeled Indications
Treatment of susceptible infection in respiratory tract, skin and skin structure, bone and joint, urinary tract, gynecologic as well as septicemia, and documented or suspected meningitis. Active against most gram-negative bacilli (not Pseudomonas) and gram-positive cocci (not enterococcus). Active against many penicillin-resistant pneumococci.
Pregnancy Risk Factor
B
Pregnancy Considerations
Teratogenic effects were not observed in animal studies; therefore, cefotaxime is classified as pregnancy category B. Cefotaxime crosses the placenta and can be found in fetal tissue. An increased risk of teratogenic effects has not been observed following maternal use. During pregnancy, peak cefotaxime serum concentrations are decreased and the serum half-life is shorter.
Lactation
Enters breast milk/use caution (AAP rates “compatible”)
Breast-Feeding Considerations
Very small amounts of cefotaxime are excreted in breast milk. The manufacturer recommends that caution be exercised when administering cefotaxime to nursing women. The American Academy of Pediatrics considers cefotaxime to be "usually compatible with breast-feeding." Nondose-related effects could include modification of bowel flora. The pregnancy-related changes in cefotaxime pharmacokinetics continue into the early postpartum period.
Contraindications
Hypersensitivity to cefotaxime, any component of the formulation, or other cephalosporins
Warnings/Precautions
Concerns related to adverse effects:
• Arrhythmia: A potentially life-threatening arrhythmia has been reported in patients who received a rapid bolus injection via central line.
• Granulocytopenia: Granulocytopenia and more rarely agranulocytosis may develop during prolonged treatment (>10 days).
• Penicillin allergy: Use with caution in patients with a history of penicillin allergy, especially IgE-mediated reactions (eg, anaphylaxis, angioedema, urticaria).
• Superinfection: Prolonged use may result in fungal or bacterial superinfection, including C. difficile-associated diarrhea (CDAD) and pseudomembranous colitis; CDAD has been observed >2 months postantibiotic treatment.
• Tissue inflammation: Minimize tissue inflammation by changing infusion sites when needed.
Disease-related concerns:
• Renal impairment: Use with caution in patients with renal impairment; modify dosage in severe impairment.
Adverse Reactions
1% to 10%:
Dermatologic: Rash, pruritus
Gastrointestinal: Diarrhea, nausea, vomiting, colitis
Local: Pain at injection site
<1%: Anaphylaxis, arrhythmia (after rapid I.V. injection via candidiasis, central catheter), BUN increased, creatinine increased, eosinophilia, erythema multiforme, fever, headache, interstitial nephritis, neutropenia, phlebitis, pseudomembranous colitis, Stevens-Johnson syndrome, thrombocytopenia, toxic epidermal necrolysis, transaminases increased, urticaria, vaginitis
Reactions reported with other cephalosporins: Agranulocytosis, aplastic anemia, cholestasis, hemolytic anemia, hemorrhage, pancytopenia, renal dysfunction, seizure, superinfection, toxic nephropathy.
Drug Interactions
Typhoid Vaccine: Antibiotics may diminish the therapeutic effect of Typhoid Vaccine. Only the live attenuated Ty21a strain is affected. Risk D: Consider therapy modification
Uricosuric Agents: May decrease the excretion of Cephalosporins. Risk C: Monitor therapy
Reconstitution
Reconstituted solution is stable for 12-24 hours at room temperature and 7-10 days when refrigerated and for 13 weeks when frozen. For I.V. 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 previously of frozen premixed bags are stable for 24 hours at room temperature or 10 days when refrigerated.
Compatibility
Stable in D51/4NS, D51/2NS, D5NS, D5W, D10W, LR, NS; variable stability (consult detailed reference) in peritoneal dialysis solutions
Y-site administration: Compatible: Acyclovir, amifostine, aztreonam, cyclophosphamide, diltiazem, docetaxel, etoposide, famotidine, fludarabine, granisetron, hydromorphone, levofloxacin, lorazepam, magnesium sulfate, melphalan, meperidine, midazolam, morphine, ondansetron, perphenazine, propofol, remifentanil, sargramostim, teniposide, thiotepa, tolazoline, vinorelbine. Incompatible: Allopurinol, filgrastim, fluconazole, gemcitabine, hetastarch, pentamidine. Variable (consult detailed reference): Cisatracurium, vancomycin.
Compatibility in syringe: Compatible: Heparin, ofloxacin. Incompatible: Doxapram.
Compatibility when admixed: Compatible: Clindamycin, metronidazole, verapamil. Incompatible: Aminoglycosides, aminophylline, sodium bicarbonate.
Mechanism of Action
Inhibits bacterial cell wall synthesis by binding to one or more of the penicillin-binding proteins (PBPs) which in turn inhibits the final transpeptidation step of peptidoglycan synthesis in bacterial cell walls, thus inhibiting cell wall biosynthesis. Bacteria eventually lyse due to ongoing activity of cell wall autolytic enzymes (autolysins and murein hydrolases) while cell wall assembly is arrested.
Pharmacodynamics/Kinetics
Distribution: Widely to body tissues and fluids including aqueous humor, ascitic and prostatic fluids, bone; penetrates CSF best when meninges are inflamed
Metabolism: Partially hepatic to active metabolite, desacetylcefotaxime
Half-life elimination:
Cefotaxime: Premature neonates <1 week: 5-6 hours; Full-term neonates <1 week: 2-3.4 hours; Adults: 1-1.5 hours; prolonged with renal and/or hepatic impairment
Desacetylcefotaxime: 1.5-1.9 hours; prolonged with renal impairment
Time to peak, serum: I.M.: Within 30 minutes
Excretion: Urine (as unchanged drug and metabolites)
Dosage
Usual dosage range:
Infants and Children 1 month to 12 years <50 kg: I.M., I.V.: 50-200 mg/kg/day in divided doses every 6-8 hours
Children >12 years and Adults: I.M., I.V.: 1-2 g every 4-12 hours
Indication-specific dosing:
Infants and Children 1 month to 12 years:
Epiglottitis: I.M., I.V.: 150-200 mg/kg/day in 4 divided doses with clindamycin for 7-10 days
Meningitis: I.M., I.V.: 200 mg/kg/day in divided doses every 6 hours
Pneumonia: I.V.: 200 mg/kg/day divided every 8 hours
Sepsis: I.V.: 150 mg/kg/day divided every 8 hours
Typhoid fever: I.M., I.V.: 150-200 mg/kg/day in 3-4 divided doses (maximum: 12 g/day); fluoroquinolone resistant: 80 mg/kg/day in 3-4 divided doses (maximum: 12 g/day)
Children >12 years and Adults:
Arthritis (septic): I.V.: 1 g every 8 hours
Brain abscess, meningitis: I.V.: 2 g every 4-6 hours
Caesarean section: I.M., I.V.: 1 g as soon as the umbilical cord is clamped, then 1 g at 6- and 12-hour intervals
Epiglottitis: I.V.: 2 g every 4-8 hours
Gonorrhea: I.M.: 1 g as a single dose
Disseminated: I.V.: 1 g every 8 hours
Life-threatening infections: I.V.: 2 g every 4 hours
Liver abscess: I.V.: 1-2 g every 6 hours
Lyme disease:
Cardiac manifestations: I.V.: 2 g every 4 hours
CNS manifestations: I.V.: 2 g every 8 hours for 14-28 days
Moderate-to-severe infections: I.M., I.V.: 1-2 g every 8 hours
Orbital cellulitis: I.V.: 2 g every 4 hours
Peritonitis (spontaneous): I.V.: 2 g every 8 hours, unless life-threatening then 2 g every 4 hours
Septicemia: I.V.: 2 g every 6-8 hours
Skin and soft tissue:
Mixed, necrotizing: I.V.: 2 g every 6 hours, with metronidazole or clindamycin
Bite wounds (animal): I.V.: 2 g every 6 hours
Surgical prophylaxis: I.M., I.V.: 1 g 30-90 minutes before surgery
Uncomplicated infections: I.M., I.V.: 1 g every 12 hours
Dosing interval in renal impairment:
Clcr 10-50 mL/minute: Administer every 8-12 hours
Clcr <10 mL/minute: Administer every 24 hours
Hemodialysis: Moderately dialyzable
Continuous ambulatory peritoneal dialysis (CAPD): Administer 0.5-1 g every 24 hours
Continuous renal replacement therapy (CRRT): 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 levels in relation to target trough (if appropriate). The following are general recommendations only (based on dialysate flow/ultrafiltration rates of 1 L/hour) and should not supersede clinical judgment:
CVVH: 1-2 g every 12 hours
CVVHD/CVVHDF: 2 g every 12 hours
Dosing adjustment in hepatic impairment: Moderate dosage reduction is recommended in severe liver disease
Continuous arteriovenous or venovenous hemodiafiltration effects: Administer 1 g every 12 hour
Administration: I.M.
Inject deep I.M. into large muscle mass.
Administration: I.V.
Inject direct I.V. over 3-5 minutes. Infuse intermittent infusion over 30 minutes.
Administration: I.V. Detail
pH: 5.0-7.5 (injectable solution)
Monitoring Parameters
Observe for signs and symptoms of anaphylaxis during first dose; CBC with differential (especially with long courses)
Test Interactions
Positive direct Coombs', false-positive urinary glucose test using cupric sulfate (Benedict's solution, Clinitest®, Fehling's solution), false-positive serum or urine creatinine with Jaffé reaction
Dietary Considerations
Some products may contain sodium.
Patient Education
Do not take any new medication during therapy unless approved by prescriber. This medication is administered by injection or infusion. Report immediately any redness, swelling, burning, or pain at injection/infusion site; chest pain, palpitations, respiratory difficulty or swallowing; or itching or hives. Maintain adequate hydration unless instructed to restrict fluid intake. May cause false test results with Clinitest®; use of another type of glucose testing is preferable. May cause diarrhea (yogurt, Bifidobacterium bifidum, Lactobacillus acidophilus, Saccharomyces boulardii may help); GI distress or nausea (small, frequent meals, frequent oral care, chewing gum, or sucking lozenges may help). Report unresolved or persistent diarrhea; opportunistic infection (vaginal itching or drainage, sores in mouth, blood in stool or urine, easy bleeding or bruising, unusual fever or chills); or respiratory difficulty. Breast-feeding precaution: Consult prescriber if breast-feeding.
Geriatric Considerations
Adjust dose for renal impairment.
Dental Health: Effects on Dental Treatment
No significant effects or complications reported
Dental Health: Vasoconstrictor/Local Anesthetic Precautions
No information available to require special precautions
Mental Health: Effects on Mental Status
May cause nervousness; case reports of euphoria, delusion, illusions, and depersonalization with cephalosporins
Mental Health: Effects on Psychiatric Treatment
May rarely cause neutropenia; use caution with clozapine and carbamazepine
Nursing: Physical Assessment/Monitoring
Assess results of culture/sensitivity tests and patient's allergy history prior to therapy. Assess other pharmacological or herbal products patient may be taking for potential interactions (eg, nephrotoxicity). Evaluate results of laboratory tests (prothrombin time, CBC with differential), therapeutic response, and adverse effects (diarrhea, nausea/vomiting, nephrotoxicity) regularly during therapy. Advise patients with diabetes about use of Clinitest®. Teach patient proper use, possible side effects/appropriate interventions, and adverse symptoms to report (eg, hypersensitivity, opportunistic infection).
Dosage Forms
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Infusion [premixed iso-osmotic solution]:
Claforan®: 1 g (50 mL); 2 g (50 mL) [contains sodium 50.5 mg (2.2 mEq) per cefotaxime 1 g]
Injection, powder for reconstitution: 500 mg, 1 g, 2 g, 10 g, 20 g
Claforan®: 500 mg, 1 g, 2 g, 10 g [contains sodium 50.5 mg (2.2 mEq) per cefotaxime 1 g]
References
Brogden RN and Spencer CM, “Cefotaxime. A Reappraisal of Its Antibacterial Activity and Pharmacokinetic Properties, and a Review of Its Therapeutic Efficacy When Administered Twice Daily for the Treatment of Mild-to-Moderate Infections,” Drugs, 1997, 53(3):483-510.
Deeter RG, Weinstein MP, Swanson KA, et al, “Crossover Assessment of Serum Bactericidal Activity and Pharmacokinetics of Five Broad-Spectrum Cephalosporins in the Elderly,” Antimicrob Agents Chemother, 1990, 34(6):1007-13.
Donowitz GR and Mandell GL, “Beta-Lactam Antibiotics,” N Engl J Med, 1988, 318(7):419-26 and 318(8):490-500.
Gilbert DN, Moellering RC, Eliopoulos GM, et al, eds, The Sanford Guide To Antimicrobial Therapy, 37th ed, Sperryville, VA: Antimicrobial Therapy, Inc, 2007, 170.
Klein NC and Cunha BA, “Third-Generation Cephalosporins,” Med Clin North Am, 1995, 79(4):705-19.
Ludwig E, Székely É, Csiba A, et al, “Pharmacokinetics of Cefotaxime and Desacetylcefotaxime in Elderly Patients,” Drugs, 1988, 35(Suppl 2):51-6.
Marshall WF and Blair JE, “The Cephalosporins,” Mayo Clin Proc, 1999, 74(2):187-95.
Spritzer R, Kamp HJ, Dzoljic G, et al, “Five Years of Cefotaxime Use in a Neonatal Intensive Care Unit,” Pediatr Infect Dis J, 1990, 9(2):92-6.
Trotman RL, Williamson JC, Shoemaker DM, et al, "Antibiotic Dosing in Critically Ill Adult Patients Receiving Continuous Renal Replacement Therapy," Clin Infect Dis, 2005, 41(8):1159-66.
Tunkel AR, Hartman BJ, Kaplan SL, et al, “Practice Guidelines for the Management of Bacterial Meningitis,” Clin Infect Dis, 2004, 39(9):1267-84.
International Brand Names
Lexi-Comp.com
Last full review/revision October 2009
Content last modified October 2009
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