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Cefotetan: Drug information

Cefotetan: Drug information
(For additional information see "Cefotetan: Patient drug information" and see "Cefotetan: Pediatric drug information")

For abbreviations and symbols that may be used in Lexicomp (show table)
Brand Names: US
  • Cefotan
Pharmacologic Category
  • Antibiotic, Cephalosporin (Second Generation)
Dosing: Adult

Usual dosage range: IM, IV: 1 to 2 g every 12 hours (maximum dose/day: IV: 6 g/day; IM: 4 g/day).

Pelvic inflammatory disease: IV: 2 g every 12 hours in combination with doxycycline. Total duration of therapy (which may include oral step-down therapy) is 14 days; oral therapy can usually be initiated within 24 to 48 hours of clinical improvement (CDC [Workowski 2015]).

Skin and soft tissue infection:

Mild to moderate:

IM: 1 g every 12 hours.

IV: 1 g every 12 hours or 2 g every 24 hours.

Severe: IV: 2 g every 12 hours.

Surgical prophylaxis: IV: 2 g within 60 minutes prior to surgery. Doses may be repeated in 6 hours if procedure is lengthy or if there is excessive blood loss (ASHP/IDSA/SIS/SHEA [Bratzler 2013]).

Urinary tract infection: IM, IV: 500 mg every 12 hours or 1 to 2 g every 12 to 24 hours.

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Renal Impairment: Adult

IM, IV:

Manufacturer’s labeling: Note: Renal function estimated using the Cockcroft-Gault formula:

CrCl >30 mL/minute: No dosage adjustment necessary.

CrCl 10 to 30 mL/minute: Administer usual dose every 24 hours or 50% of the usual dose administered every 12 hours

CrCl <10 mL/minute: Administer usual dose every 48 hours or 25% of the usual dose administered every 12 hours.

End-stage renal disease (ESRD) on intermittent hemodialysis: Dialyzable (5% to 20%); administer 25% the usual dose every 24 hours on days between dialysis; administer 50% the usual dose on the day of dialysis (administer after dialysis).

Alternate recommendations: Note: Renally adjusted dose recommendations are based on a dose of 1 to 2 g every 12 hours (Aronoff 2007):

GFR >50 mL/minute/1.73 m2: No dosage adjustment necessary.

GFR 10 to 50 mL/minute/1.73 m2: Administer every 24 hours.

GFR <10 mL/minute/1.73 m2: Administer every 48 hours.

Peritoneal dialysis: 1 g every 24 hours

Continuous renal replacement therapy: Administer every 24 hours.

Dosing: Hepatic Impairment: Adult

There are no dosage adjustments provided in the manufacturer’s labeling.

Dosing: Pediatric

(For additional information see "Cefotetan: Pediatric drug information")

General dosing, susceptible infection: Infants, Children, and Adolescents: IM, IV: 30 to 50 mg/kg/dose every 12 hours; maximum dose: 3,000 mg/dose (Red Book [AAP 2021]).

Intra-abdominal infection: Limited data available: Note: Not recommended for empiric treatment due to high rates of resistant anaerobes, including Bacteroides fragilis, and potential for decreased efficacy.

Infants, Children, and Adolescents: IV: 20 to 40 mg/kg/dose every 12 hours (IDSA [Solomkin 2010]; Surgical Infection Society [Mazuski 2017]).

Pelvic inflammatory disease: Limited data available: Children ≥45 kg and Adolescents: IV: 2,000 mg every 12 hours in combination with doxycycline for 14 days. Oral step-down therapy can usually be initiated within 24 to 48 hours of clinical improvement and may be used to complete 14-day treatment course (CDC [Workowski 2015]; Red Book [AAP 2021]).

Peritonitis, prophylaxis for patients receiving peritoneal dialysis undergoing GI or genitourinary procedures: Limited data available: Infants, Children, and Adolescents: IV: 30 to 40 mg/kg administered 30 to 60 minutes before procedure; maximum dose: 2,000 mg/dose (ISPD [Warady 2012]).

Surgical prophylaxis: Limited data available: Children and Adolescents: IV: 40 mg/kg within 60 minutes prior to procedure; may repeat dose in 6 hours for prolonged procedure or excessive blood loss; maximum dose: 2,000 mg/dose (ASHP/IDSA/SIS/SHEA [Bratzler 2013]).

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Renal Impairment: Pediatric

Infants, Children, and Adolescents: Dosage adjustments are not provided in the manufacturer's labeling; however, the following guidelines have been used by some clinicians (Aronoff 2007). Note: Renally adjusted dose recommendations are based on doses of 20 to 40 mg/kg/dose every 12 hours:

GFR ≥30 mL/minute/1.73 m2: No adjustment required.

GFR 10 to 29 mL/minute/1.73 m2: 20 to 40 mg/kg/dose every 24 hours.

GFR <10 mL/minute/1.73 m2: 20 to 40 mg/kg/dose every 48 hours.

Intermittent hemodialysis: 20 to 40 mg/kg/dose every 48 hours; give after dialysis on dialysis days.

Peritoneal dialysis (PD): 20 to 40 mg/kg/dose every 48 hours.

Continuous renal replacement therapy (CRRT): 20 to 40 mg/kg/dose every 12 hours.

Dosing: Hepatic Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Geriatric

Refer to adult dosing.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Solution Reconstituted, Injection:

Cefotan: 2 g (1 ea)

Solution Reconstituted, Injection [preservative free]:

Cefotan: 1 g (1 ea)

Generic: 1 g (1 ea); 2 g (1 ea); 10 g (1 ea [DSC])

Solution Reconstituted, Intravenous [preservative free]:

Generic: 1 g (1 ea); 2 g (1 ea)

Generic Equivalent Available: US

Yes

Administration: Adult

IM: Inject deep IM into large muscle mass.

IV: Inject via direct IV over 3 to 5 minutes. Infuse via intermittent infusion over 30 minutes.

Administration: Pediatric

Parenteral:

IM: Inject deep IM into large muscle mass such as the upper outer quadrant of the gluteus maximus.

IV intermittent: Infuse over 20 to 60 minutes.

IV push: Inject over 3 to 5 minutes.

Use: Labeled Indications

Gynecologic infection: Treatment of gynecologic infection caused by S. aureus, (including penicillinase- and non-penicillinase-producing strains), Staphylococcus epidermidis, Streptococcus spp. (excluding enterococci), Streptococcus agalactiae, Escherichia coli, Proteus mirabilis, Neisseria gonorrhoeae, Bacteroides spp. (excluding Bacteroides distasonis, Bacteroides ovatus, Bacteroides thetaiotaomicron), Fusobacterium spp., and gram-positive anaerobic cocci (including Peptococcus and Peptostreptococcus spp.).

Limitations of use: Cefotetan has no activity against Chlamydia (Chlamydophila) trachomatis. When treating pelvic inflammatory disease, add appropriate antichlamydial coverage.

Lower respiratory tract infection: Treatment of lower respiratory tract infection caused by Streptococcus pneumoniae, S. aureus (penicillinase- and non-penicillinase-producing strains), Haemophilus influenzae (including ampicillin-resistant strains), Klebsiella spp. (including K. pneumoniae), E. coli, P. mirabilis, and Serratia marcescens.

Skin and soft tissue infection: Treatment of skin and skin structure infection due to S. aureus (penicillinase- and non-penicillinase-producing strains), Staphylococcus epidermidis, Streptococcus pyogenes, Streptococcus spp. (excluding enterococci), E. coli, K. pneumoniae, Peptococcus niger, Peptostreptococcus spp.

Surgical prophylaxis: Preoperative administration in surgical procedures that are classified as clean contaminated or potentially contaminated (eg, cesarean section, abdominal or vaginal hysterectomy, transurethral surgery, biliary tract surgery, GI surgery).

Urinary tract infection: Treatment of urinary tract infection caused by E. coli, Klebsiella spp. (including K. pneumoniae), P. mirabilis and Proteus spp. (which may include the organisms now called Proteus vulgaris, Providencia rettgeri, and Morganella morganii).

Medication Safety Issues
Sound-alike/look-alike issues:

CefoTEtan may be confused with ceFAZolin, cefOXitin, cefTAZidime, Ceftin, cefTRIAXone

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.

1% to 10%:

Gastrointestinal: Diarrhea (1%)

Hepatic: Increased serum transaminases (1%)

Hypersensitivity: Hypersensitivity reaction (1%)

<1%, postmarketing, and/or case reports: Agranulocytosis, anaphylaxis, eosinophilia, fever, hemolytic anemia, hemorrhage, increased blood urea nitrogen, increased serum creatinine, leukopenia, nausea, nephrotoxicity, phlebitis, prolonged prothrombin time, pruritus, pseudomembranous colitis, skin rash, thrombocythemia, thrombocytopenia, urticaria, vomiting

Contraindications

Hypersensitivity to cefotetan, any component of the formulation, or other cephalosporins; previous cephalosporin-associated hemolytic anemia.

Documentation of allergenic cross-reactivity for beta-lactams (eg, penicillins, cephalosporins) is limited; however, because of similarities in chemical structure and/or pharmacologic actions, the possibility of cross-sensitivity cannot be ruled out with certainty.

Warnings/Precautions

Concerns related to adverse effects:

• Elevated INR: May be associated with increased INR and subsequent bleeding, especially in nutritionally deficient patients, prolonged treatment, or patients with cancer, hepatic or renal disease. Monitor coagulation parameters and manage as clinically indicated (eg, administration of phytonadione).

• Hemolytic anemia: May rarely cause hemolytic anemia (including fatalities). Has been associated with a higher risk of hemolytic anemia relative to other cephalosporins (approximately threefold); monitor carefully during use and consider cephalosporin-associated immune anemia in patients who have received cefotetan within 2 to 3 weeks (either as treatment or prophylaxis). Discontinue drug, if applicable, and institute supportive measures as clinically indicated.

• Hypersensitivity: Hypersensitivity reactions, including anaphylaxis, may occur. If an allergic reaction occurs, discontinue treatment and institute appropriate supportive measures.

• Penicillin allergy: Use with caution in patients with a history of penicillin allergy.

• 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.

Disease-related concerns:

• GI disease: Use with caution in patients with a history of GI disease, particularly colitis.

• Renal impairment: Use with caution in patients with renal impairment; dosage adjustment required.

Metabolism/Transport Effects

None known.

Drug Interactions

Alcohol (Ethyl): CefoTEtan may enhance the adverse/toxic effect of Alcohol (Ethyl). Risk C: Monitor therapy

Aminoglycosides: Cephalosporins may enhance the nephrotoxic effect of Aminoglycosides. Cephalosporins may decrease the serum concentration of Aminoglycosides. Risk C: Monitor therapy

BCG (Intravesical): Antibiotics may diminish the therapeutic effect of BCG (Intravesical). Risk X: Avoid combination

BCG Vaccine (Immunization): Antibiotics may diminish the therapeutic effect of BCG Vaccine (Immunization). Risk C: Monitor therapy

Carbocisteine: CefoTEtan may enhance the adverse/toxic effect of Carbocisteine. Specifically, cefotetan may enhance adverse effects of alcohol that is present in liquid formulations of carbocisteine-containing products. Risk C: Monitor therapy

Cholera Vaccine: Antibiotics may diminish the therapeutic effect of Cholera Vaccine. Management: Avoid cholera vaccine in patients receiving systemic antibiotics, and within 14 days following the use of oral or parenteral antibiotics. Risk X: Avoid combination

Lactobacillus and Estriol: Antibiotics may diminish the therapeutic effect of Lactobacillus and Estriol. Risk C: Monitor therapy

Probenecid: May increase the serum concentration of Cephalosporins. Risk C: Monitor therapy

RifAMPin: Cephalosporins (N-methylthiotetrazole [NMTT] Side Chain Containing) may enhance the adverse/toxic effect of RifAMPin. Specifically, the risk for bleeding may be increased. Management: Avoid concomitant use of rifampin with cephalosporins that contain an N-methylthiotetrazole (NMTT) side chain when possible. If combined, closely monitor prothrombin time or other coagulation tests and administer vitamin K as needed. Risk D: 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. Risk D: Consider therapy modification

Typhoid Vaccine: Antibiotics may diminish the therapeutic effect of Typhoid Vaccine. Only the live attenuated Ty21a strain is affected. Management: Avoid use of live attenuated typhoid vaccine (Ty21a) in patients being treated with systemic antibacterial agents. Postpone vaccination until 3 days after cessation of antibiotics and avoid starting antibiotics within 3 days of last vaccine dose. Risk D: Consider therapy modification

Vitamin K Antagonists (eg, warfarin): Cephalosporins may enhance the anticoagulant effect of Vitamin K Antagonists. Risk C: Monitor therapy

Food Interactions

Concurrent use with ethanol may cause a disulfiram-like reaction. Management: Monitor patients.

Pregnancy Considerations

Cefotetan crosses the placenta and produces therapeutic concentrations in the amniotic fluid and cord serum. Cefotetan is one of the antibiotics recommended for prophylactic use prior to cesarean delivery.

Breast-Feeding Considerations

Cefotetan is present in breast milk

Although the manufacturer recommends to use with caution, cephalosporins are generally considered acceptable for use in breastfeeding women (Ito 2000). In general, antibiotics that are present in breast milk may cause nondose-related modification of bowel flora. Monitor infants for GI disturbances, such as thrush or diarrhea (WHO 2002).

Dietary Considerations

Some products may contain sodium.

Monitoring Parameters

Monitor renal, hepatic, and hematologic function periodically with prolonged therapy. Monitor prothrombin time in patients at risk of prolongation during cephalosporin therapy (nutritionally-deficient, prolonged treatment, renal or hepatic disease). Monitor for signs and symptoms of hemolytic anemia, including hematologic parameters where appropriate.

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 and Pharmacokinetics

Distribution: Widely to body tissues and fluids including bile, gallbladder, kidney, skin, tonsils, uterus, sputum, prostatic and peritoneal fluids

Protein binding: 88%

Half-life elimination: 3 to 4.6 hours, prolonged in patients with moderately impaired renal function (up to 10 hours)

Time to peak, serum: IM: 1 to 3 hours

Excretion: Urine (51% to 81%, as unchanged drug)

Pricing: US

Solution (reconstituted) (Cefotan Injection)

1 g (per each): $47.40

2 g (per each): $95.40

Solution (reconstituted) (cefoTEtan Disodium Injection)

1 g (per each): $23.08

2 g (per each): $46.16

Solution (reconstituted) (cefoTEtan Disodium-Dextrose Intravenous)

1GM 3.58%(50ML) (per each): $27.24

2GM 2.08%(50ML) (per each): $38.31

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Brand Names: International
  • Apacef (BE, FR, LU);
  • Apatef (AU, DE, IT, PT);
  • Ceftenon (AT);
  • Darvilen (DE);
  • Maxtetan (EG);
  • Trixosporin (EG);
  • Yamatetan (JP, KR)


For country abbreviations used in Lexicomp (show table)

REFERENCES

  1. American Academy of Pediatrics (AAP). In: Kimberlin DW, Barnett ED, Lynfield R, Sawyer MH, eds. Red Book: 2021-2024 Report of the Committee on Infectious Diseases. 32nd ed. American Academy of Pediatrics; 2021.
  2. Aronoff GR, Bennett WM, Berns JS, et al. Drug Prescribing in Renal Failure: Dosing Guidelines for Adults and Children, 5th ed. Philadelphia, PA: American College of Physicians; 2007.
  3. Bailey K, “Orbital Cellulitits and Abscess,” Roy and Fraunfelder's Current Ocular Therapy, Chapter 325, 6th ed, Roy FH, Fraunfelder FW, and Fraunfelder FT, eds, New York, NY: Saunders, 2007, 601.
  4. Berbari EF, Kanj SS, Kowalski TJ, et al; Infectious Diseases Society of America. 2015 Infectious Diseases Society of America (IDSA) clinical practice guidelines for the diagnosis and treatment of native vertebral osteomyelitis in adults. Clin Infect Dis. 2015;61(6):e26-e46. doi:10.1093/cid/civ482 [PubMed 26229122]
  5. Bratzler DW, Dellinger EP, Olsen KM, et al, “Clinical Practice Guidelines for Antimicrobial Prophylaxis in Surgery,” Am J Health Syst Pharm, 2013, 70(3):195-283. [PubMed 23327981]
  6. Cefotan (cefotetan) [prescribing information]. Buena, NJ: Teligent Pharma, Inc.; November 2018.
  7. Cefotan (cefotetan) [prescribing information]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; January 2004.
  8. Cefotetan [prescribing information]. Lake Zurich, IL: Fresenius Kabi; January 2020.
  9. Cefotetan and Dextrose (cefotetan for injection and dextrose for injection) [prescribing information]. Bethlehem, PA: B. Braun Medical Inc; January 2020.
  10. Donowitz GR and Mandell GL, “Beta-Lactam Antibiotics,” N Engl J Med, 1988, 318(7):419-26 and 318(8):490-500. [PubMed 3277054]
  11. Ito S. Drug therapy for breast-feeding women [published correction appears in N Engl J Med. 2000;343(18):1348]. N Engl J Med. 2000;343(2):118‐126. doi:10.1056/NEJM200007133430208 [PubMed 10891521]
  12. Marshall WF and Blair JE, “The Cephalosporins,” Mayo Clin Proc, 1999, 74(2):187-95. [PubMed 10069359]
  13. Martin C, Thomachot L, and Albanese J, “Clinical Pharmacokinetics of Cefotetan,” Clin Pharmacokinet, 1994, 26(4):248-58. [PubMed 8013159]
  14. Mazuski JE, Tessier JM, May AK, et al. The Surgical Infection Society revised guidelines on the management of intra-abdominal infection. Surg Infect (Larchmt). 2017;18(1):1-76. doi: 10.1089/sur.2016.261. [PubMed 28085573]
  15. Murray KL, Wright D, Laxton B, Miller KM, Meyers J, Englebright J. Implementation of standardized pediatric i.v. medication concentrations. Am J Health Syst Pharm. 2014;71(17):1500-1508. doi:10.2146/ajhp140024 [PubMed 25147175]
  16. Quayle AA, Russell C, and Hearn B, “Organisms Isolated from Severe Odontogenic Soft Tissue Infections: Their Sensitivities to Cefotetan and Seven Other Antibiotics, and Implications for Therapy and Prophylaxis,” Br J Oral Maxillofac Surg, 1987, 25(1):34-44. [PubMed 2948542]
  17. Rhodes A, Evans LE, Alhazzani W, et al. Surviving sepsis campaign: international guidelines for management of sepsis and septic shock: 2016. Intensive Care Med. 2017;43(3):304-377. doi:10.1007/s00134-017-4683-6 [PubMed 28101605]
  18. Solomkin JS, Mazuski JE, Bradley JS, et al, “Diagnosis and Management of Complicated Intra-Abdominal Infections in Adults and Children: Guidelines by the Surgical Infection Society and the Infectious Diseases Society of America,” Clin Infect Dis, 2010, 50(2):133-64. [PubMed 20034345]
  19. Warady BA, Bakkaloglu S, Newland J, et al. Consensus guidelines for the prevention and treatment of catheter-related infections and peritonitis in pediatric patients receiving peritoneal dialysis: 2012 update. Perit Dial Int. 2012;(32 Suppl 2):S32-S86. [PubMed 22851742]
  20. Workowski KA, Bolan GA; Centers for Disease Control and Prevention (CDC). Sexually transmitted diseases treatment guidelines, 2015. MMWR Recomm Rep. 2015;64(RR-03):1-137. [PubMed 26042815]
  21. World Health Organization (WHO). Breastfeeding and maternal medication, recommendations for drugs in the eleventh WHO model list of essential drugs. 2002. Available at http://www.who.int/maternal_child_adolescent/documents/55732/en/
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