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.
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.
There are no dosage adjustments provided in the manufacturer's labeling.
(For additional information see "Cefotetan: Drug information")
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 2021]).
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.
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.
There are no dosage adjustments provided in the manufacturer’s labeling.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product
Solution Reconstituted, Injection:
Cefotan: 2 g (1 ea [DSC])
Solution Reconstituted, Injection [preservative free]:
Cefotan: 1 g (1 ea [DSC])
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)
Yes
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.
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.
Vials: Store intact vials at 20°C to 25°C (68°F to 77°F). Reconstituted solution is stable for 24 hours at 25°C (77°F), 96 hours at 5°C (41°F) and 7 days at -20°C (-4°F). In disposable glass or plastic syringes, solution is stable for 24 hours at 25°C (77°F) and 96 hours at 5°C (41°F). .
Duplex containers: Store at 20°C to 25°C (68°F to 77°F) prior to reconstitution; excursions permitted to 15°C to 30°C (59°F to 86°F). Foil strip should not be removed until ready for use; after foil strip removal, use product within 7 days. After reconstitution, use within 12 hours if stored at room temperature or within 5 days if stored under refrigeration.
Treatment of susceptible bone and joint, gynecologic, intra-abdominal, lower respiratory tract, skin and soft tissue, and urinary tract infections; surgical prophylaxis for clean-contaminated or possibly contaminated procedures (All indications: FDA approved in adults); has also been used in the prophylaxis of peritonitis in patients with peritoneal catheters undergoing GI or genitourinary procedures.
CefoTEtan may be confused with ceFAZolin, cefOXitin, cefTAZidime, Ceftin, cefTRIAXone
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
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.
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.
None known.
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
Immune Checkpoint Inhibitors: Antibiotics may diminish the therapeutic effect of Immune Checkpoint Inhibitors. Risk C: Monitor therapy
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
Concurrent use with ethanol may cause a disulfiram-like reaction. Management: Monitor patients.
Some products may contain sodium.
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.
Monitor renal, hepatic, and hematologic function periodically with prolonged therapy. Monitor PT in patients at risk of prolongation during cephalosporin therapy (eg, nutritionally deficient, prolonged treatment, renal or hepatic disease). Monitor number and type of stools/day for diarrhea; signs and symptoms of hemolytic anemia (including hematologic parameters where appropriate); monitor for signs of anaphylaxis during first dose.
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.
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)
Sodium content of 1000 mg: 3.5 mEq.
Solution (reconstituted) (cefoTEtan Disodium Injection)
1 g (per each): $25.27
2 g (per each): $50.54
Solution (reconstituted) (cefoTEtan Disodium-Dextrose Intravenous)
1GM 3.58%(50ML) (per each): $27.24
2GM 2.08%(50ML) (per each): $38.31
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