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Pronunciation:

(sef oh TAKS eem)

U.S. Brand Names:

Claforan®

Synonyms:

Cefotaxime Sodium

Generic Available:

Yes: Powder

Canadian Brand Names:

Claforan®

Use:

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:

Lactation:

Enters breast milk/use caution (AAP rates "compatible")

Contraindications:

Hypersensitivity to cefotaxime, any component of the formulation, or other cephalosporins

Warnings/Precautions:

Modify dosage in patients with severe renal impairment; prolonged use may result in superinfection; a potentially life-threatening arrhythmia has been reported in patients who received a rapid bolus injection via central line. Use caution in patients with colitis; minimize tissue inflammation by changing infusion sites when needed. Use with caution in patients with a history of penicillin allergy especially IgE-mediated reactions (eg, anaphylaxis, urticaria). May cause antibiotic-associated colitis or colitis secondary to C. difficile.

Adverse Reactions:

1% to 10%:

Dermatologic: Rash, pruritus

Gastrointestinal: Diarrhea, nausea, vomiting, colitis

Local: Pain at injection site

<1%: Anaphylaxis, arrhythmia (after rapid IV 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 include agranulocytosis, aplastic anemia, cholestasis, hemolytic anemia, hemorrhage, pancytopenia, renal dysfunction, seizure, superinfection, toxic nephropathy.

Overdosage/Toxicology:

Symptoms of overdose include neuromuscular hypersensitivity and convulsions. Many beta-lactam containing antibiotics have the potential to cause neuromuscular hyperirritability or convulsive seizures. Hemodialysis may be helpful to aid in removal of the drug from blood; otherwise, treatment is supportive or symptom-directed.

Drug Interactions:

Increased effect: Probenecid may decrease cephalosporin elimination

Increased toxicity: Furosemide, aminoglycosides may be a possible additive to nephrotoxicity

Stability:

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; crosses placenta; enters breast milk

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:

Infants and Children 1 month to 12 years: I.M., I.V.: <50 kg: 50-180 mg/kg/day in divided doses every 4-6 hours

Meningitis: 200 mg/kg/day in divided doses every 6 hours

Children >12 years and Adults:

Uncomplicated infections: I.M., I.V.: 1 g every 12 hours

Moderate/severe infections: I.M., I.V.: 1-2 g every 8 hours

Infections commonly needing higher doses (eg, septicemia): I.V.: 2 g every 6-8 hours

Life-threatening infections: I.V.: 2 g every 4 hours

Preop: I.M., I.V.: 1 g 30-90 minutes before surgery

C-section: 1 g as soon as the umbilical cord is clamped, then 1 g I.M., I.V. at 6- and 12-hour intervals

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

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:

Can be administered IVP over 3-5 minutes or I.V. intermittent infusion over 15-30 minutes

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:

Sodium content of 1 g: 50.5 mg (2.2 mEq)

Patient Education:

Inform prescriber of all prescriptions, OTC medications, or herbal products you are taking, and any allergies you have. 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 (2-3 L/day of fluids) 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, boiled milk, or buttermilk may help); GI distress or nausea (small, frequent meals, frequent oral care, chewing gum, or sucking lozenges may help). Report unresolved 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.

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

Dosage Forms:

Infusion, as sodium [premixed in D5W] (Claforan®): 1 g (50 mL); 2 g (50 mL)

Injection, powder for reconstitution, as sodium: 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]

International Brand Names:

Abricef® (BG); Aximad® (IT); Batixim® (IT); Baxima® (ID); Benaxima® (MX); Betaksim® (TR); Biosint® (MX); Biotaksym® (PL); Biotaxime® (TH); Biotax® (IN); Cefacolin® (AR); Cefalekol® (HU); Cefantral® (RO); Cefapan® (YU); Cefomic® (TH); Cefomit® (IT); Ceforan® (BR, TH); Cefotaksim® (HR, SI); Cefotamax® (BR); Cefotax® (DO, JP, RO, TH); Cefotaxima Ahimsa® (AR); Cefotaxima Argentia® (AR); Cefotaxima Bayvit® (ES); Cefotaxim Abbott® (AT, DE); Cefotaxima Biochemie® (CO); Cefotaxima Centrum® (ES); Cefotaxima Combino Pharm® (ES); Cefotaxima Duncan® (AR); Cefotaxima Edigen® (ES); Cefotaxima Fabra® (AR); Cefotaxima Ges® (ES); Cefotaxima/Grifotaxima® (BR); Cefotaxima ICN® (ES); Cefotaxima IPS® (ES); Cefotaxima Level® (ES); Cefotaxima Normon® (ES); Cefotaxima Richet® (AR); Cefotaxima Rigo® (AR); Cefotaxima Rovi® (ES); Cefotaxima Salvat® (ES); Cefotaxima Sodica® [inj.] (BR); Cefotaxima Torlan® (ES); Cefotaxim AZU® (DE); Cefotaxim Biochemie® (DK, SE); Cefotaxim curasan® (DE); Cefotaxime ACS Dobfar® (IT); Cefotaxime® (CZ, GB, NO, NZ, RO); Céfotaxime Dakota Pharm® (FR); Cefotaxime Drawer® (AR); Cefotaxime Faulding® (IT); Cefotaxime Hexpharm® (ID); Cefotaxime IBI® (IT); Cefotaxime Levofarma® (IT); Cefotaxime Max Farma® (IT); Cefotaxime Merck® (IT); Cefotaxime N&P® (IT); Cefotaxime Piam® (IT); Cefotaxime PRC® (IT); Cefotaxim Hexal® (DE); Cefotaxim® (ID, RO, RU); Cefotaxim-ratiopharm® (DE); Cefot® (DO); Cefradil® [inj.] (MX); Ceftaran® (TH); Ceftax® (EG, JO, KW, LB, SY); Celaxin® (EC); Centiax® (IT); Clacef® (ID, SG); Claforan® (AR, AT, AU, BD, BE, CA, CH, CL, CR, CZ, DE, DK, DO, EC, ES, FI, FR, GB, GT, HK, HN, HU, ID, IE, IL, IN, IT, LU, MX, NL, NO, NZ, PA, PL, RO, RU, SE, SG, SI, SV, TH, TR, ZA); Claforan® [inj.] (NO, ZA); Clafotaxim® (RU); Claraxim® (TH); Clatax® (ID); Combicef® (ID); Deforan® [inj.] (TR); Doksetil® (TR); Efotax® (ID); Fortax® (TH); Fotax® (TH); Fotexina® (CO, EC, MX); Foxim® (ID); Gefotaxima® (AR); Grifotaxima® (CL); Kalfoxim® (ID); Kefotax® (ZA); Kepoxin® (BR); Klafotaxim® (ZA); Lancef® (ID); Lyforan® (IN, RO, RU); Makrocef® (SI); Naspor® (RO); Omnatax® (IN); Pharmacare-Cefotaxime® (ZA); Primafen® (ES); Ralopar® (PT); Rantaksym® (PL); Refotax® (IT); Reftax® (ZA); Rycef® (ID); Sefagen® (TR); Sefoksim® (TR); Sefotak® (CZ, RO, TR); Spectrocef® (IT); Spirosine® (RO); Starclaf® (ID); Talcef® (RU); Taporin® [inj.] (MX); Tarcefoksym® (PL); Taxcef® (CZ); Taxegram® (ID); Terasep® (AR); Tirotax® (HU, PL); Tizoxim® (AR); Tolycar® (YU); Totam® (ZA); Viken® (MX); Zariviz® (IT); Zetaxim® (IN); Zimanel® (IT)

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.

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.

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