Cefotetan

Mechanism-of-action class: Enzyme Inhibitors.

• To reduce the development of drug-resistant bacteria and maintain the effectiveness of cefotetan and other antibacterial drugs, cefotetan should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy.

• Cefotetan is contraindicated in patients with a known allergy to the cephalosporin group of antibiotics and in those individuals who have experienced a cephalosporin associated hemolytic anemia.contraindicated

Treatment The usual adult dosage is 1 or 2 grams of Cefotetan for Injection administered intravenously or intramuscularly. Proper dosage and route of administration should be determined by the condition of the patient, severity of the infection, and susceptibility of the causative organism. General Guidelines for Dosage of Cefotetan for Injection Type of Infection Daily Dose Frequency and Route Urinary Tract 1 to 4 grams 500 mg every 12 hours IV or IM 1 or 2 g every 24 hours IV or IM 1 or 2 g every 12 hours IV or IM Skin & Skin Structure Mild - Moderate a Severe 2 grams 4 grams 2 g every 24 hours IV 1 g every 12 hours IV or IM 2 g every 12 hours IV Other Sites 2 to 4 grams 1 or 2 g every 12 hours IV or IM Severe 4 grams 2 g every 12 hours IV Life-Threatening 6 grams b 3 g every 12 hours IV a Klebsiella pneumoniae skin and skin structure infections should be treated with 1 or2 grams every 12 hours IV or IM. b Maximum daily dosage should not exceed 6 grams. If Chlamydia trachomatis is a suspected pathogen in gynecologic infections, appropriate antichlamydial coverage should be added, since cefotetan has no activity against this organism. Prophylaxis To prevent postoperative infection in clean contaminated or potentially contaminated surgery in adults, the recommended dosage is 1 or 2 g of Cefotetan for Injection administered once, intravenously, 30 to 60 minutes prior to surgery. In patients undergoing cesarean section, the dose should be administered as soon as the umbilical cord is clamped.

BEFORE THERAPY WITH CEFOTETAN IS INSTITUTED, CAREFUL INQUIRY SHOULD BE MADE TO DETERMINE WHETHER THE PATIENT HAS HAD PREVIOUS HYPERSENSITIVITY REACTIONS TO CEFOTETAN, CEPHALOSPORINS, PENICILLINS, OR OTHER DRUGS. IF THIS PRODUCT IS TO BE GIVEN TO PENICILLIN-SENSITIVE PATIENTS, CAUTION SHOULD BE EXERCISED BECAUSE CROSS-HYPERSENSITIVITY AMONG BETA-LACTAM ANTIBIOTICS HAS BEEN CLEARLY DOCUMENTED AND MAY OCCUR IN UP TO 10% OF PATIENTS WITH A HISTORY OF PENICILLIN ALLERGY. IF AN ALLERGIC REACTION TO CEFOTETAN OCCURS, DISCONTINUE THE DRUG. SERIOUS ACUTE HYPERSENSITIVITY REACTIONS MAY REQUIRE TREATMENT WITH EPINEPHRINE AND OTHER EMERGENCY MEASURES, INCLUDING OXYGEN, INTRAVENOUS FLUIDS, INTRAVENOUS ANTIHISTAMINES, CORTICOSTEROIDS, PRESSOR AMINES, AND AIRWAY MANAGEMENT, AS CLINICALLY INDICATED. AN IMMUNE MEDIATED HEMOLYTIC ANEMIA HAS BEEN OBSERVED IN PATIENTS RECEIVING CEPHALOSPORIN CLASS ANTIBIOTICS. SEVERE CASES OF HEMOLYTIC ANEMIA, INCLUDING FATALITIES, HAVE BEEN REPORTED IN ASSOCIATION WITH THE ADMINISTRATION OF CEFOTETAN. SUCH REPORTS ARE UNCOMMON. THERE APPEARS TO BE AN INCREASED RISK OF DEVELOPING HEMOLYTIC ANEMIA ON CEFOTETAN RELATIVE TO OTHER CEPHALOSPORINS OF AT LEAST 3 FOLD. IF A PATIENT DEVELOPS ANEMIA ANYTIME WITHIN 2 TO 3 WEEKS SUBSEQUENT TO THE ADMINISTRATION OF CEFOTETAN, THE DIAGNOSIS OF A CEPHALOSPORIN ASSOCIATED ANEMIA SHOULD BE CONSIDERED AND THE DRUG STOPPED UNTIL THE ETIOLOGY IS DETERMINED WITH CERTAINTY. BLOOD TRANSFUSIONS MAY BE CONSIDERED AS NEEDED (SEE CONTRAINDICATIONS ).

In clinical studies, the following adverse effects were considered related to cefotetan therapy. Those appearing in italics have been reported during postmarketing experience. Gastrointestinal : symptoms occurred in 1.5% of patients, the most frequent were diarrhea (1 in 80) and nausea (1 in 700); pseudomembranous colitis. Onset of pseudomembranous colitis symptoms may occur during or after antibiotic treatment or surgical prophylaxis (see WARNINGS ). Hematologic : laboratory abnormalities occurred in 1.4% of patients and included eosinophilia (1 in 200), positive direct Coombs test (1 in 250), and thrombocytosis (1 in 300); agranulocytosis, hemolytic anemia, leukopenia, thrombocytopenia, and prolonged prothrombin time with or without bleeding. Hepatic : enzyme elevations occurred in 1.2% of patients and included a rise in ALT (SGPT) (1 in 150), AST (SGOT) (1 in 300), alkaline phosphatase (1 in 700), and LDH (1 in 700). Hypersensitivity : reactions were reported in 1.2% of patients and included rash (1 in 150) and itching (1 in 700); anaphylactic reactions and urticaria. Local : effects were reported in less than 1% of patients and included phlebitis at the site of injection (1 in 300), and discomfort (1 in 500). Renal : Elevations in BUN and serum creatinine have been reported. Urogenital : Nephrotoxicity has rarely been reported.

Pregnancy Teratogenic Effects. Pregnancy Category B Reproduction studies have been performed in rats and monkeys at doses up to 20 times the human dose and have revealed no evidence of impaired fertility or harm to the fetus due to cefotetan. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Information on overdosage with cefotetan in humans is not available. If overdosage should occur, it should be treated symptomatically and hemodialysis considered, particularly if renal function is compromised.

• Dec 27, 1985NDANDA050588Pai Holdings Pharm
• Aug 9, 2007ANDAANDA065374Fresenius Kabi Usa
• Oct 26, 2011ANDAANDA091031Hikma

1. 1Haemolytic Anaemia2014%
2. 2Nausea107.0%
3. 3Dyspnoea96.3%
4. 4Renal Failure96.3%
5. 5Abdominal Pain85.6%
6. 6Asthenia85.6%
7. 7Chronic Kidney Disease85.6%
8. 8Hypertension85.6%
9. 9Urticaria85.6%
10. 10Anaemia74.9%
11. 11Dizziness74.9%
12. 12Haemoglobin Decreased74.9%
13. 13Pain74.9%
14. 14Anaphylactic Reaction64.2%
15. 15Anxiety64.2%

Recent PubMed references pinned to Cefotetan as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

• Use of single agent Cefotetan for Gustilo-Anderson type III open fracture prophylaxis.
  Injury · 2023 · Via GG, Brueggeman DA, Murray VA, et al.
  PMID 37441857DOI 10.1016/j.injury.2023.110914
• Cefotetan-bound human RKIP involves in Ras/Raf1/MEK/ERK signaling pathway.
  Acta biochimica et biophysica Sinica · 2022 · Guo C, Xu H, Zhou Y, et al.
  PMID 36789691DOI 10.3724/abbs.2022188
• Cutaneous lymphoid hyperplasia developing on the site of a positive intradermal allergy test to cefotetan.
  Indian journal of dermatology, venereology and leprology · 2021 · Lee EH, Kim JY
  PMID 34379959DOI 10.25259/IJDVL_922_19
• In Vitro Activity of Cefotetan against ESBL-Producing Escherichia coli and Klebsiella pneumoniae Bloodstream Isolates from the MERINO Trial.
  Microbiology spectrum · 2021 · Stewart AG, Cottrell K, Henderson A, et al.
  PMID 34232101DOI 10.1128/Spectrum.00226-21
• Pharmacokinetics and Tolerability of Single and Multiple Intravenous Doses of Cefotetan Disodium in Healthy Chinese Volunteers.
  Drug design, development and therapy · 2020 · Liu J, Zhai Y, Wu L, et al.
  PMID 32103903DOI 10.2147/DDDT.S234619
• Maternal anaphylactic shock in pregnancy: A case report.
  Medicine · 2018 · Jeon HJ, Ryu A, Min J, et al.
  PMID 30212990DOI 10.1097/MD.0000000000012351
• Cefotetan-Induced Hemolytic Anemia: Case Series and Review.
  Journal of pharmacy practice · 2019 · Lim K, Tran H, Hirai-Yang A, et al.
  PMID 30189781DOI 10.1177/0897190018798198
• Higher versus Lower Dose of Cefotetan or Cefoxitin for Surgical Prophylaxis in Patients Weighing One Hundred Twenty Kilograms or More.
  Surgical infections · 2018 · Banoub M, Curless MS, Smith JM, et al.
  PMID 29717917DOI 10.1089/sur.2017.296

The 7 most recently updated of 7 ClinicalTrials.gov registrations naming Cefotetan as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• Cefotetan Therapy for Escherichia Coli Infections
  Not yet recruiting · Phase 2 · Interventional · 84 enrolled · Oregon Health and Science University
  NCT07318584updated 2026-01-06
• Patients Response to Early Switch To Oral:Osteomyelitis Study
  Terminated · Early phase 1 · Interventional · 11 enrolled · Julio Ramirez
  NCT02099240updated 2021-04-06
• Effectiveness of Prophylactic Antibiotics Therapy in Laparoscopic Cholecystectomy on Infection Rate
  Completed · Phase 1 · Interventional · 529 enrolled · Chonbuk National University Hospital
  NCT04726046updated 2021-01-27
• A Single Dose of a Marketed Drug Being Studied for a New Indication to Treat Surgical Site Infection Following Colorectal Surgery as Compared to a Marketed Drug Approved for This Indication (0826-039)
  Completed · Phase 3 · Interventional · 952 enrolled · Merck Sharp & Dohme LLC
  NCT00090272updated 2017-02-17
• Arthroscopic Rotator Cuff Repair With Multimodal Analgesia(MMA)
  Completed · Interventional · 54 enrolled · Seoul National University Hospital
  NCT01204606updated 2013-03-12
• Safety and Efficacy of One Dose Prophylactic Antibiotic in Laparoscopic Colorectal Surgery
  Completed · Phase 2 · Interventional · 312 enrolled · National Cancer Center, Korea
  NCT01220661updated 2011-12-13
• Antibiotics for Postpartum Third and Fourth Degree Perineal Tear Repairs
  Completed · Interventional · 147 enrolled · Stanford University
  NCT00186082updated 2011-06-15

Frequently asked questions

How does Cefotetan work?

Mechanism-of-action class: Enzyme Inhibitors.

What is Cefotetan used for?

According to FDA labeling, Cefotetan carries indications including: To reduce the development of drug-resistant bacteria and maintain the effectiveness of cefotetan and other antibacterial drugs, cefotetan should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Cefotetan?

Cefotetan is classified as Second-generation cephalosporins, Cephalosporin Antibacterial, Enzyme Inhibitors, Decreased Cell Wall Synthesis & Repair.

What are the brand names for Cefotetan?

Cefotetan is marketed under brand names including Cefotan.

What are the contraindications for Cefotetan?

Cefotetan labeling lists contraindications including: Cefotetan is contraindicated in patients with a known allergy to the cephalosporin group of antibiotics and in those individuals who have experienced a cephalosporin associated hemolytic anemia.. Always consult the full prescribing information and a clinician.