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Cefotetan: Pediatric drug information

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

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
Brand Names: US
  • Cefotan [DSC]
Therapeutic Category
  • Antibiotic, Cephalosporin (Second Generation)
Dosing: Pediatric

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 (Ref).

Intra-abdominal infection

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 (Ref).

Pelvic inflammatory disease

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 (Ref).

Peritonitis, prophylaxis for patients receiving peritoneal dialysis undergoing GI or genitourinary procedures

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 (Ref).

Surgical prophylaxis

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 (Ref).

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

Dosing: Kidney 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 (Ref). 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: Adult

(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

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 (Ref).

Skin and soft tissue infection

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

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 (Ref).

Urinary tract infection

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: Kidney 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 (Ref):

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.

Adverse Reactions

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

1% to 10%:

Gastrointestinal: Diarrhea (1%)

Hepatic: Increased liver enzymes (1%; including increased serum alanine aminotransferase, increased serum alkaline phosphatase, increased serum aspartate aminotransferase)

Hypersensitivity: Hypersensitivity reaction (1%)

<1%:

Dermatologic: Pruritus, skin rash

Endocrine & metabolic: Increased lactate dehydrogenase

Gastrointestinal: Nausea

Hematologic & oncologic: Eosinophilia, positive direct Coombs’ test, thrombocythemia

Local: Discomfort at injection site, injection-site phlebitis

Postmarketing:

Dermatologic: Urticaria

Gastrointestinal: Clostridioides difficile colitis

Hematologic & oncologic: Agranulocytosis, hemolytic anemia (Martin 2006), leukopenia, prolonged prothrombin time (Williams 1991), thrombocytopenia (Christie 1988)

Hypersensitivity: Anaphylaxis (Jeon 2018)

Renal: Increased blood urea nitrogen, increased serum creatinine, nephrotoxicity

Contraindications

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

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.

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 [DSC])

Solution Reconstituted, Injection [preservative free]:

Cefotan: 1 g (1 ea [DSC])

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

Solution Reconstituted, Intravenous [preservative free]:

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

Generic Equivalent Available: US

Yes

Pricing: US

Solution (reconstituted) (cefoTEtan Disodium Injection)

1 g (per each): $29.06

2 g (per each): $58.13

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.

Additional Information

Sodium content of 1000 mg: 3.5 mEq.

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.

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.

Storage/Stability

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.

Use

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.

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

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

Metabolism/Transport Effects

None known.

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.

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

Bacillus clausii: Antibiotics may diminish the therapeutic effect of Bacillus clausii. Management: Bacillus clausii should be taken in between antibiotic doses during concomitant therapy. Risk D: Consider therapy modification

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

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

Fecal Microbiota (Live) (Oral): May diminish the therapeutic effect of Antibiotics. Risk X: Avoid combination

Fecal Microbiota (Live) (Rectal): Antibiotics may diminish the therapeutic effect of Fecal Microbiota (Live) (Rectal). Risk X: Avoid combination

Furosemide: May enhance the nephrotoxic effect of Cephalosporins. Risk C: Monitor therapy

Immune Checkpoint Inhibitors (Anti-PD-1, -PD-L1, and -CTLA4 Therapies): Antibiotics may diminish the therapeutic effect of Immune Checkpoint Inhibitors (Anti-PD-1, -PD-L1, and -CTLA4 Therapies). 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

Food Interactions

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

Dietary Considerations

Some products may contain sodium.

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.

Monitoring Parameters

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.

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.

Pharmacokinetics (Adult Data Unless Noted)

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:

Infants and Children: 1.85 to 3.5 hours (Martin 1994).

Adults: 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).

Pharmacokinetics: Additional Considerations (Adult Data Unless Noted)

Anti-infective considerations:

Parameters associated with efficacy:

Time dependent; associated with time free drug concentration (fT) > minimum inhibitory concentration (MIC): Goal: ≥40% to 50% (fT) > MIC (bacteriostatic), ≥60% to 70% (fT) > MIC (bactericidal) (Abdul-Aziz 2020; Craig 1996; Craig 1998; Turnidge 1998).

Expected drug exposure in normal renal function:

Adults, Cmax (peak):

Single dose:

500 mg: ~69 to 79 mg/L (Liu 2020; Yates 1983).

1 g: ~126 to 142 mg/L (Liu 2020; Smith 1986; Yates 1983).

2 g: ~237 to 337 mg/L (Carver 1989; Liu 2020; Yates 1983).

Steady state: 1 g twice daily: 147.58 ± 22.71 mg/L (Liu 2020).

Postantibiotic effect: Generally <1 hour; varies based on organism (Craig 1991; Craig 1998). For Bacteroides spp, highly variable ranging from 0 to 36 hours (Siverhus 1988).

Brand Names: International
International Brand Names by Country
For country code abbreviations (show table)

  • (AU) Australia: Apatef;
  • (BE) Belgium: Apacef;
  • (IT) Italy: Apatef | Cepan;
  • (JP) Japan: Yamatetan;
  • (KR) Korea, Republic of: Bc cefotetan | Cefoten | Cefotetan | Cetetan | Ckd Cefotetan | Kukje cefotetan na | Reyon cefotetan | Teram | Tetan kit | Unitetan | Urotetan | Yamatetan | Yungjin Sefotetan Sodium;
  • (MA) Morocco: Apacef;
  • (NZ) New Zealand: Apatef;
  • (PR) Puerto Rico: Cefotan | Cefotetan;
  • (PT) Portugal: Apatef
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