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Cefoxitin: Pediatric drug information

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

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
Therapeutic Category
  • Antibiotic, Cephalosporin (Second Generation)
Dosing: Neonatal

General dosing: Limited data available:

Weight-directed dosing: Preterm and term neonates: IV: 90 to 100 mg/kg/day divided every 8 hours (Farmer 1982; Regazzi 1983; Roos 1980). Note: The youngest patient evaluated was 26 weeks GA.

Gestational age-directed dosing (Red Book [AAP 2021]):

GA <32 weeks:

PNA ≤7 days: IV, IM: 35 mg/kg/dose every 12 hours.

PNA >7 days: IV, IM: 35 mg/kg/dose every 8 hours.

GA ≥32 weeks: IV, IM: 35 mg/kg/dose every 8 hours.

Dosing: Pediatric

General dosing: Infants, Children, and Adolescents: Limited data available in infants <3 months of age: IM, IV: 80 to 160 mg/kg/day divided every 4 to 8 hours; maximum daily dose: 12 g/day (Red Book [AAP 2021]; manufacturer's labeling).

Intra-abdominal infections

Intra-abdominal infections: Note: Cefoxitin is not recommended for the empiric treatment of intra-abdominal infection due to increasing resistance of anaerobic bacteria (ie, Bacteroides fragilis group); other options are preferred (SIS [Mazuski 2017]).

Infants, Children, and Adolescents: Limited data available in infants <3 months of age: IV: 80 to 160 mg/kg/day divided every 4 to 8 hours; maximum dose: 2,000 mg/dose. Use doses on the higher end of the range (ie, 160 mg/kg/day) for severe, complicated, or undrained infections (Gutiérrez 1987; IDSA [Solomkin 2010]; SIS [Mazuski 2017]; manufacturer's labeling). Treatment duration should be 4 to 7 days unless source control inadequate; in some circumstances (ie, acute or gangrenous appendicitis without perforation) therapy should be limited to ≤24 hours (IDSA [Solomkin 2010]; SIS [Mazuski 2017]).

Mycobacterial infection, pulmonary infection in patients with or without cystic fibrosis

Mycobacterial (nontuberculous) infection (eg, Mycobacterium abscessus), pulmonary infection in patients with or without cystic fibrosis: Limited data available:

Infants, Children, and Adolescents: IV: 150 mg/kg/day divided every 6 to 8 hours; maximum daily dose: 12 g/day. The duration of parenteral therapy is generally 4 to 12 weeks depending on clinical response, followed by transition to oral and/or inhaled therapy; total antibiotic treatment duration is ≥12 months after culture conversion (BTS [Haworth 2017]; CFF/ECFS [Floto 2016]).

Pelvic inflammatory disease

Pelvic inflammatory disease:

Children ≥45 kg and Adolescents:

Mild to moderate (outpatient management): IM: 2,000 mg as a single dose, in combination with a single dose of probenecid, followed by 14 days of oral therapy with doxycycline and metronidazole (CDC [Workowski 2021]; Red Book [AAP 2021]).

Severe (inpatient management): IV: 2,000 mg every 6 hours in combination with doxycycline; once patient has clinically improved (typically within 24 to 48 hours), may transition to oral therapy with doxycycline and metronidazole to complete a total of 14 days of therapy (CDC [Workowski 2021]; Red Book [AAP 2021]).

Peritonitis, prophylaxis in patients undergoing GI or genitourinary procedures

Peritonitis (peritoneal dialysis), prophylaxis in patients 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

Surgical prophylaxis:

Infants, Children, and Adolescents: Limited data available in infants <3 months of age: IV: 40 mg/kg within 60 minutes prior to surgery; may repeat dose in 2 hours for prolonged procedure or excessive blood loss; maximum dose: 2,000 mg/dose (ASHP/IDSA/SIS/SHEA [Bratzler 2013]; Red Book [AAP 2021]).

Dosing: Kidney Impairment: Pediatric

Infants, Children, and Adolescents: The manufacturer's labeling suggests dosing modification consistent with the adult recommendations. Some clinicians have used the following guidelines (Aronoff 2007); Note: Renally adjusted dose recommendations are based on doses of 20 to 40 mg/kg/dose every 6 hours.

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

GFR 30 to 50 mL/minute/1.73 m2: 20 to 40 mg/kg/dose every 8 hours.

GFR 10 to 29 mL/minute/1.73 m2: 20 to 40 mg/kg/dose every 12 hours.

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

Intermittent hemodialysis: Moderately dialyzable (20% to 50%): 20 to 40 mg/kg/dose every 24 hours.

Peritoneal dialysis (PD): 20 to 40 mg/kg/dose every 24 hours.

Continuous renal replacement therapy (CRRT): 20 to 40 mg/kg/dose every 8 hours.

Dosing: Hepatic Impairment: Pediatric

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

Dosing: Adult

(For additional information see "Cefoxitin: Drug information")

Usual dosage range: IV: 1 to 2 g every 6 to 8 hours.

Bite wounds

Bite wounds (animal) (off-label use): IV: 1 g every 6 to 8 hours (IDSA [Stevens 2014]).

Gonococcal infection, uncomplicated

Gonococcal infection, uncomplicated (infection of the cervix, rectum, or urethra) (alternative agent) (off-label use):

Note: Use cefoxitin only if ceftriaxone is unavailable given a lack of contemporary efficacy data (CDC [Workowski 2021]).

IM: 2 g as a single dose plus oral probenecid; give in combination with treatment for chlamydia if it has not been excluded (CDC [Workowski 2021]). When treatment failure is suspected (eg, detection of N. gonorrhoeae after treatment without additional sexual exposure), consult an infectious diseases specialist. Report failures to the CDC through state and local health departments (CDC [Workowski 2021]).

Mycobacterial infection

Mycobacterial (nontuberculous, rapidly growing) infection (off-label use):

Patients without cystic fibrosis: 2 to 4 g two to three times daily or 200 mg/kg/day in 3 divided doses (maximum daily dosage: 12 g/day) as part of an appropriate combination regimen (ATS/ERS/ESCMID/IDSA [Daley 2020]; BTS [Haworth 2017]).

Patients with cystic fibrosis: 200 mg/kg/day in 3 divided doses (maximum daily dosage: 12 g/day) as part of an appropriate combination regimen (CFF/ECFS [Floto 2016]).

Duration of therapy: The optimal duration of therapy is unknown, but generally the duration of parenteral therapy is ≤12 weeks depending on severity of infection, tolerability, and other patient-specific factors, followed by long-term oral maintenance therapy; consult an infectious diseases specialist for specific recommendations (ATS/ERS/ESCMID/IDSA [Daley 2020]; BTS [Haworth 2017]; CFF/ECFS [Floto 2016]).

Pelvic inflammatory disease

Pelvic inflammatory disease:

Inpatients: IV: 2 g every 6 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]).

Outpatients: IM: 2 g as a single dose plus oral probenecid, followed by oral doxycycline and metronidazole for 14 days (CDC [Workowski 2021]).

Surgical prophylaxis

Surgical (perioperative) prophylaxis: IV: 2 g within 60 minutes prior to surgical incision. Doses may be repeated in 2 hours if procedure is lengthy or if there is excessive blood loss (Bratzler 2013).

Dosing: Kidney Impairment: Adult

Loading dose: 1 to 2 g, followed by maintenance dosing according to CrCl.

Maintenance dosage:

CrCl 30 to 50 mL/minute: 1 to 2 g every 8 to 12 hours

CrCl 10 to 29 mL/minute: 1 to 2 g every 12 to 24 hours

CrCl 5 to 9 mL/minute: 0.5 to 1 g every 12 to 24 hours

CrCl <5 mL/minute: 0.5 to 1 g every 24 to 48 hours

Hemodialysis: Loading dose: 1 to 2 g after each hemodialysis; maintenance dose as noted above based on creatinine clearance

Dosing: Hepatic Impairment: Adult

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

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Solution Reconstituted, Injection [preservative free]:

Generic: 10 g (1 ea)

Solution Reconstituted, Intravenous:

Generic: 2 g (1 ea)

Solution Reconstituted, Intravenous [preservative free]:

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

Generic Equivalent Available: US

Yes

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Solution Reconstituted, Injection:

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

Solution Reconstituted, Intravenous:

Generic: 10 g (1 ea)

Administration: Pediatric

Parenteral:

IV Push: Administer over 3 to 5 minutes.

Intermittent IV infusion: Administer over 15 to 60 minutes (Garrelts 1988; Jacobson 1979; Regazzi 1983; Santos 1981).

IM: Inject into a large muscle mass (Buchanan 1980; Rosaschino 1985; Sonneville 1977).

Administration: Adult

IM: Inject deep IM into large muscle mass. Note: IM injection is painful and this route of administration is not described in the prescribing information.

IV: Can be administered IVP over 3 to 5 minutes or by IV intermittent infusion over 10 to 60 minutes

Storage/Stability

Prior to reconstitution store between 2°C and 25°C (36°F and 77°F). Avoid exposure to temperatures >50°C (122°F). Cefoxitin tends to darken depending on storage conditions; however, product potency is not adversely affected.

Reconstituted solutions of 1 g per 10 mL in sterile water for injection, bacteriostatic water for injection, sodium chloride 0.9% injection, or dextrose 5% injection are stable for 6 hours at room temperature or for 7 days under refrigeration (<5°C [43°F]).

DUPLEX container: Store unactivated container at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F); do not freeze. Following activation, solution is stable for 12 hours at room temperature and 7 days refrigerated.

Use

Treatment of the following susceptible bacterial infections: Lower respiratory tract, skin and soft tissue, bone and joint, urinary tract, gynecologic, and intra-abdominal infections; bacteremia/sepsis; surgical prophylaxis (All indications: FDA approved in ages ≥3 months and adults); has also been used for treatment of nontuberculous mycobacterial infections and in the prophylaxis of peritonitis in patients with peritoneal catheters undergoing GI or genitourinary procedures.

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

CefOXitin may be confused with ceFAZolin, cefotaxime, cefoTEtan, cefTAZidime, cefTRIAXone, Cytoxan

Mefoxin may be confused with Lanoxin

Adverse Reactions

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

1% to 10%: Gastrointestinal: Diarrhea

<1%: Anaphylaxis, angioedema, bone marrow depression, dyspnea, eosinophilia, exacerbation of myasthenia gravis, exfoliative dermatitis, fever, hemolytic anemia, hypotension, increased blood urea nitrogen, increased serum creatinine, increased serum transaminases, interstitial nephritis, jaundice, leukopenia, nausea, nephrotoxicity (increased; with aminoglycosides), phlebitis, prolonged prothrombin time, pruritus, pseudomembranous colitis, skin rash, thrombocytopenia, thrombophlebitis, toxic epidermal necrolysis, urticaria, vomiting

Contraindications

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

Warnings/Precautions

Concerns related to adverse effects:

• Hypersensitivity: Use with caution in patients with a history of penicillin allergy, especially IgE-mediated hypersensitivity reactions (eg, anaphylaxis, angioedema, urticaria). If a hypersensitivity reaction occurs, discontinue immediately.

• 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 gastrointestinal disease, particularly colitis.

• Renal impairment: Use with caution in patients with renal impairment; modify dosage in severe impairment.

• Seizure disorders: Use with caution in patients with a history of seizure disorder; high levels, particularly in the presence of renal impairment, may increase risk of seizures.

Special populations:

• Children: In pediatric patients ≥3 months of age, higher doses have been associated with an increased incidence of eosinophilia and elevated AST.

• Older adult: This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Elderly patients are more likely to have decreased renal function; use care in dose selection and monitor renal function.

Other warnings/precautions:

• Discontinuation of therapy: For group A beta-hemolytic streptococcal infections, antimicrobial therapy should be given for at least 10 days to guard against the risk of rheumatic fever or glomerulonephritis.

Metabolism/Transport Effects

Substrate of OAT1/3

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.

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

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

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

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

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

Dietary Considerations

Some products may contain sodium.

Pregnancy Considerations

Cefoxitin crosses the placenta and reaches the cord serum and amniotic fluid.

An increased risk of major birth defects or other adverse fetal or maternal outcomes has generally not been observed following use of cephalosporin antibiotics, including cefoxitin, during pregnancy.

Cefoxitin is one of the antibiotics recommended for prophylactic use prior to cesarean delivery (ACOG 199 2018).

Monitoring Parameters

Renal function; CBC and LFTs (with prolonged use); prothrombin time (in patients at risk of bleeding or as clinically appropriate); number and type of stools/day for diarrhea. Observe for signs and symptoms 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 ascitic, pleural, synovial, bile; poorly penetrates into CSF even with inflammation of the meninges (Landesman 1981).

Vd:

Neonates and Infants <2 months of age (PNA: 10 to 53 days): 0.5 ± 0.21 L/kg (Regazzi 1983).

Protein binding: 65% to 79%.

Half-life elimination:

Neonates and Infants <2 months of age (PNA: 10 to 53 days): 1.4 hours (Regazzi 1983).

Infants ≥3 months of age and Children: 42.4 ± 5.3 minutes (Feldman 1980).

Adults: 41 to 59 minutes; prolonged with renal impairment.

Time to peak, serum: IM: Within 20 to 30 minutes.

Excretion: Urine (85% as unchanged drug).

Pricing: US

Solution (reconstituted) (cefOXitin Sodium Intravenous)

1 g (per each): $3.60 - $11.94

2 g (per each): $7.20 - $23.94

10 g (per each): $60.00 - $112.25

Solution (reconstituted) (cefOXitin Sodium-Dextrose Intravenous)

1GM 4%(50ML) (per each): $19.58

2GM 2.2%(50ML) (per each): $35.07

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
  • Aboxitin (BD);
  • Acifox (PH);
  • Advoxin (EG);
  • Cefmore (TW);
  • Cefotin (TW);
  • Cefovex (PH);
  • Cefoxitin Sodium (AU);
  • Cefxitin (TH);
  • Cenomycin (JP);
  • Daliding (CN);
  • Dintaxin (PH);
  • Foxitane (BD);
  • Foxitin (AE, JO, SA);
  • Gamacef (BR);
  • Irva (BD);
  • Jeitin (KR);
  • Lofatin (TW);
  • Mefoxil (GR);
  • Mefoxin (AE, AU, BB, BE, BF, BG, BJ, BM, BR, BS, BZ, CI, CY, CZ, ET, FI, FR, GB, GH, GM, GN, GY, HN, HU, IE, IL, IQ, IR, IT, JM, JO, KE, KW, LB, LR, LU, LY, MA, ML, MR, MU, MW, NE, NG, NL, NZ, OM, PT, SA, SC, SD, SL, SN, SR, SY, TN, TT, TZ, UG, YE, ZA, ZM, ZW);
  • Mefoxitin (AT, CH, DE, DK, NO, SE);
  • Merxin (JP);
  • Monodin (PH);
  • Monowel (PH);
  • Orfixitin (EG);
  • Pacetin (KR);
  • Panafox (PH);
  • Plucefox (EG);
  • Primafoxin (EG);
  • Sephros (MY);
  • Voxitin (AE, CY, IL, IQ, IR, JO, KW, LB, LY, OM, SA, SY, YE);
  • Zepax (PH);
  • Zepotin (PH);
  • Zoxin (JO)


For country code abbreviations (show table)
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