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Mefoxin

Generic Name: Cefoxitin Sodium
Class: Cephamycins
CAS Number: 33564-30-6

Introduction

Antibacterial; β-lactam antibiotic; cephamycin.c

Uses for Mefoxin

Bone and Joint Infections

Treatment of bone and joint infections caused by susceptible Staphylococcus aureus (including penicillinase-producing strains).149 150 151 156

Gynecologic Infections

Treatment of gynecologic infections (including endometritis, pelvic cellulitis, pelvic inflammatory disease [PID]) caused by susceptible Streptococcus agalactiae (group B streptococci), Escherichia coli, Neisseria gonorrhoeae, Bacteroides (including B. fragilis), Clostridium, Peptococcus niger, or Peptostreptococcus.149 150 151 156

Cefoxitin (or cefotetan) in conjunction with doxycycline considered a regimen of choice by CDC and others when a parenteral regimen indicated for treatment of PID.344 346

When an oral regimen is used for treatment of mild to moderately severe acute PID, CDC recommends a single IM dose of ceftriaxone, cefoxitin (with oral probenecid), or other parenteral third-generation cephalosporin (e.g., cefotaxime) given in conjunction with a 14-day regimen of oral doxycycline.344

Because cefoxitin (like cephalosporins) is not active against Chlamydia, concomitant use of a drug active against Chlamydia (e.g., doxycycline) is necessary when these organisms are suspected pathogens.344 346

Intra-abdominal Infections

Treatment of intra-abdominal infections (including peritonitis and intra-abdominal abscess) caused by susceptible E. coli, Klebsiella, Bacteroides (including B. fragilis), or Clostridium.149 150 151 156

Has been effective in mixed aerobic-anaerobic infections.c However, cefoxitin may no longer provide reliable coverage against B. fragilis, and metronidazole is recommended by many clinicians to provide coverage against B. fragilis in combination anti-infective regimens used for empiric treatment of intra-abdominal infections.123

For initial empiric treatment of mild to moderate community-acquired, extrabiliary, complicated intra-abdominal infections in adults (e.g., perforated or abscessed appendicitis), IDSA recommends either monotherapy with cefoxitin, ertapenem, moxifloxacin, tigecycline, or the fixed combination of ticarcillin and clavulanic acid, or a combination regimen that includes either a cephalosporin (cefazolin, cefotaxime, ceftriaxone, cefuroxime) or fluoroquinolone (ciprofloxacin, levofloxacin) in conjunction with metronidazole.161

Slideshow: Flashback: FDA Drug Approvals 2013

Respiratory Tract Infections

Treatment of lower respiratory tract infections (including pneumonia and lung abscess) caused by susceptible S. aureus (including penicillinase-producing strains), S. pneumoniae, or other streptococci (except enterococci), Haemophilus influenzae, E. coli, Klebsiella, or Bacteroides.149 150 151 156

Septicemia

Treatment of septicemia caused by susceptible S. aureus (including penicillinase-producing strains), S. pneumoniae, E. coli, Klebsiella, or Bacteroides (including B. fragilis).149 150 151 156

Skin and Skin Structure Infections

Treatment of skin and skin structure infections caused by susceptible S. aureus (including penicillinase-producing strains), S. epidermidis, S. pyogenes (group A β-hemolytic streptococci), or other streptococci (except enterococci), E. coli, Klebsiella, Proteus mirabilis, Bacteroides (including B. fragilis), Clostridium, P. niger, or Peptostreptococcus.149 150 151 156

Urinary Tract Infections (UTIs)

Treatment of UTIs caused by susceptible E. coli, Klebsiella, Morganella morganii, P. mirabilis, P. vulgaris, or Providencia (including P. rettgeri).149 150 151 156

Gonorrhea and Associated Infections

Alternative for treatment of uncomplicated cervical, urethral, or rectal gonorrhea caused by susceptible Neisseria gonorrhoeae in adults or adolescents.344

Regimen of choice is IM ceftriaxone and either azithromycin or doxycycline.344 Although IM cefoxitin (with probenecid) may be effective for uncomplicated urogenital and anorectal gonorrhea, CDC states it offers no advantage over IM ceftriaxone for urogenital infections and has uncertain efficacy for pharyngeal gonorrhea.344

Mycobacterial Infections

Treatment of infections caused by Mycobacterium abscessus157 or M. fortuitum;157 used in conjunction with other antimycobacterial anti-infectives.157

For serious skin, soft tissue, and bone infections caused by M. abscessus, ATS and IDSA recommend a multiple-drug regimen of oral clarithromycin (or azithromycin) used in conjunction with parenteral anti-infectives (e.g., amikacin, cefoxitin, imipenem).157 This multiple-drug regimen also used in treatment of M. abscessus lung disease;157 however, anti-infectives may help control symptoms and disease progression, but long-term sputum conversion is unlikely.157 In patients with focal infections and limited lung disease, curative therapy may be possible if surgical resection is used in conjunction with a multiple-drug treatment regimen.157

Although optimum regimens not identified for treatment of M. fortuitum infections, ATS and IDSA recommend that pulmonary infections be treated with a regimen consisting of at least 2 anti-infectives selected based on results of in vitro susceptibility testing and tolerability (e.g., amikacin, clarithromycin, cefoxitin, ciprofloxacin or ofloxacin, a sulfonamide, imipenem, doxycycline).157 In serious skin, bone, and soft tissue infections, ≥4 months of treatment with ≥2 anti-infectives active against the clinical isolate is necessary to provide a high likelihood of cure;157 6 months of treatment recommended for bone infections.157 Surgery usually indicated for extensive disease, abscess formation, or when drug therapy is difficult.157

Perioperative Prophylaxis

Perioperative prophylaxis in women undergoing hysterectomy or cesarean section.136 149 150 151 156 360 374 Cefazolin, cefotetan, cefoxitin, or ampicillin and sulbactam usually recommended for women undergoing vaginal, abdominal, or laparoscopic hysterectomy;360 374 cefazolin usually recommended for women undergoing cesarean section.360 374

Perioperative prophylaxis in patients undergoing colorectal or other GI surgery.127 149 150 151 156 360 374 Cefoxitin, cefotetan, cefazolin (in conjunction with metronidazole), ampicillin and sulbactam, or ertapenem usually recommended.360 374 Many clinicians recommend using both a parenteral and oral regimen (i.e., neomycin in conjunction with erythromycin or metronidazole and mechanical bowel preparation) for perioperative prophylaxis in patients undergoing colorectal surgery,153 360 374

Perioperative prophylaxis in patients undergoing uncomplicated (nonperforated) appendectomy.360 Cefoxitin, cefotetan, or cefazolin (in conjunction with metronidazole) usually recommended for patients undergoing appendectomy.360

Perioperative prophylaxis in patients undergoing biliary tract surgery.360 374 Cefazolin usually recommended for high-risk patients undergoing open biliary tract surgery;360 374 alternatives include cefotetan, cefoxitin, or ampicillin and sulbactam.360 374 Prophylaxis not considered necessary for low-risk patients undergoing elective laparoscopic cholecystectomy.360 374

Mefoxin Dosage and Administration

Administration

Administer by IV injection or infusion.149 150 151 156 Also has been given by IM injection.344

IV route preferred in patients with bacteremia, septicemia, or other severe or life-threatening infections, or in patients with lowered resistance resulting from debilitating conditions (e.g., malnutrition, trauma, surgery, diabetes, heart failure, malignancy), particularly with shock.149 150 151 156

For solution and drug compatibility information, see Compatibility under Stability.

IV Injection

Reconstitution

Vials containing 1 or 2 g of cefoxitin: Reconstitute with 10 mL of sterile water for injection to provide solutions containing approximately 95 or 180 mg/mL, respectively.150 Shake to dissolve; let stand until clear.150

Rate of Administration

Inject appropriate dose of reconstituted solution directly into a vein over a 3- to 5-minute period or slowly into the tubing of a compatible IV solution.150

IV Infusion

Other IV solutions flowing through a common administration tubing or site should be discontinued while cefoxitin is infused.149 151 156

Reconstitution

Vials containing 1 or 2 g of cefoxitin: Reconstitute with 10 mL or 10–20 mL, respectively, of sterile or bacteriostatic water for injection, 0.9% sodium chloride injection, or 5% dextrose injection to provide solutions containing approximately 95 or 95–180 mg/mL, respectively.150 Shake to dissolve; let stand until clear.150 Then, further dilute reconstituted solution in 50 mL to 1 L of a compatible IV solution.150

Pharmacy bulk package containing 10 g of cefoxitin: Reconstitute with 43 or 93 mL of sterile or bacteriostatic water for injection, 0.9% sodium chloride injection, or 5% dextrose injection to provide solutions containing approximately 200 or 100 mg/mL, respectively.151 Shake to dissolve; let stand until clear.151 Not intended for direct IV infusion; prior to administration, doses from reconstituted pharmacy bulk package vial must be further diluted in 50 mL to 1 L of a compatible IV solution within 4 hours.151 Transfer individual doses to a compatible IV solution using suitable sterile transfer device or dispensing set; do not use syringe with needle since leakage could occur.151 Consult manufacturer’s directions for additional information.151

Duplex drug delivery system containing 1 or 2 g of cefoxitin powder and 50 mL of 4 or 2.2% dextrose injection, respectively, in separate chambers: Reconstitute (activate) according to the manufacturer’s directions.149 If refrigerated after reconstitution (see Storage under Stability), allow solution to reach room temperature prior to administration.149

Commercially available premixed injection (frozen): Thaw at room temperature (25°C) or under refrigeration (5°C); do not thaw by immersion in a water bath or by exposure to microwave radiation.156 A precipitate may have formed in the frozen injection, but should dissolve with little or no agitation after reaching room temperature.156 Discard thawed injection if an insoluble precipitate is present or if container seals or outlet ports are not intact or leaks are found.156 Do not use in series connections with other plastic containers; such use could result in air embolism from residual air being drawn from the primary container before administration of fluid from the secondary container is complete.156

Rate of Administration

Administer by intermittent or continuous IV infusion.149 150 151 156

IM Injection

Administer IM injections deeply into a large muscle, such as upper outer quadrant of gluteus maximus.c Use aspiration to ensure needle is not in a blood vessel.c

Reconstitution

IM injections are prepared by adding 2 mL of sterile water for injection or 0.5 or 1% lidocaine hydrochloride injection (without epinephrine) to each g of cefoxitin.c

Dosage

Available as cefoxitin sodium; dosage expressed in terms of cefoxitin.149 150 151 156

Pediatric Patients

General Pediatric Dosage
IV

Children ≥3 months of age: Manufacturers recommend 80–160 mg/kg daily given in 4–6 equally divided doses.149 150 151 156

Children beyond neonatal period: AAP recommends 80 mg/kg daily given in 3–4 divided doses for mild to moderate infections or 160 mg/kg daily given in 4 divided doses for severe infections.292

Perioperative Prophylaxis
Colorectal Surgery, Appendectomy (Nonperforated), or Other GI Surgery
IV

Children ≥3 months of age: Manufacturers recommend 30–40 mg/kg given within 0.5–1 hour prior to incision.149 150 151 156 Although manufacturers state 30–40 mg/kg can be given every 6 hours after the procedure for up to 24 hours,149 150 151 156 postoperative doses usually unnecessary.360

Children ≥1 year of age: Some clinicians recommend 40 mg/kg given within 1 hour prior to incision.374

If procedure is prolonged >3–4 hours, major blood loss occurs, or other factors are present that shorten drug half-life, additional intraoperative doses may be given.360 374

Duration of prophylaxis should be <24 hours for most procedures;360 374 no evidence to support continuing prophylaxis after wound closure or until all indwelling drains and intravascular catheters are removed.360 374

Adults

General Adult Dosage
Uncomplicated Infections (Bacteremia Absent or Unlikely)
IV

1 g every 6–8 hours.149 150 151 156

Moderately Severe or Severe Infections
IV

1 g every 4 hours or 2 g every 6–8 hours.149 150 151 156

Infections Requiring Higher Dosage (e.g., Gangrene)
IV

2 g every 4 hours or 3 g every 6 hours.149 150 151 156

Gonorrhea and Associated Infections
Uncomplicated Urethral, Cervical, or Rectal Gonorrhea
IM

2 g as a single dose given with oral probenecid (1 g).344

Pelvic Inflammatory Disease
IV

2 g every 6 hours;344 346 used in conjunction with IV or oral doxycycline (100 mg every 12 hours).344 346 Cefoxitin may be discontinued 24–48 hours after clinical improvement occurs and oral doxycycline (100 mg every 12 hours) continued to complete 14 days of treatment.344

IM

2 g as a single dose given with oral probenecid (1 g);344 followed by a 14-day regimen of oral doxycycline (100 mg twice daily) with or without oral metronidazole (500 mg twice daily).344

Mycobacterium abscessus Infections
IV

If used in initial combination regimens for treatment of serious skin, soft tissue, and bone infections (see Mycobacterial Infections under Uses), ATS and IDSA recommend up to 12 g daily given in divided doses for at least 2 weeks until clinical improvement.157 At least 4 months of antimycobacterial treatment is necessary for treatment of serious skin and soft tissue infections; 6 months of antimycobacterial treatment recommended for bone infections.157

Perioperative Prophylaxis
Gynecologic and Obstetric Surgery
IV

Hysterectomy (abdominal, vaginal, laparoscopic): 1 or 2 g given within 0.5–1 hour prior to incision.149 150 151 156 360 374 Although manufacturers also recommend additional 2-g doses every 6 hours (for up to 24 hours), 149 150 151 156 postoperative doses usually unnecessary.360

Cesarean section: 1 or 2 g given 0.5–1 hour prior to incision.149 150 151 156 360 374 Manufacturers recommend giving the dose as soon as umbilical cord is clamped,149 150 151 156 but there is some evidence that giving the dose prior to incision is more effective than after clamping.360 Although manufacturers state additional 2-g doses can be given at 4 and 8 hours after initial dose,149 150 151 156 postoperative doses usually unnecessary.360

If procedure is prolonged >3–4 hours, major blood loss occurs, or other factors are present that shorten drug half-life, additional intraoperative doses may be given (e.g., every 2 hours, measured from time of initiation of preoperative dose).360 374

Duration of prophylaxis should be <24 hours for most procedures; no evidence to support continuing prophylaxis after wound closure or until all indwelling drains and intravascular catheters are removed.360 374

Colorectal Surgery, Appendectomy (Nonperforated), or Other GI Surgery
IV

1 or 2 g given within 0.5–1 hour prior to incision.149 150 151 360 374 Although manufacturers state 2 g can be given every 6 hours after the procedure for up to 24 hours,149 150 151 postoperative doses usually unnecessary.360

If procedure is prolonged >3–4 hours, major blood loss occurs, or other factors are present that shorten drug half-life, additional intraoperative doses may be given (e.g., every 2 hours, measured from time of initiation of preoperative dose).360 374

Duration of prophylaxis should be <24 hours for most procedures; no evidence to support continuing prophylaxis after wound closure or until all indwelling drains and intravascular catheters are removed.360 374

Prescribing Limits

Pediatric Patients

Maximum 12 g daily.149 150 151 156

Adults

Maximum 12 g daily.149 150 151 156

Special Populations

Renal Impairment

Dosage adjustments necessary in those with Clcr ≤50 mL/minute.149 150 151 156

Adults with Clcr ≤50 mL/minute: Give an initial loading dose of 1–2 g followed by maintenance dosage based on Clcr (see Table 1).149 150 151 156

Table 1. Maintenance Dosage of Cefoxitin for Adults with Renal Impairment149150151156

Clcr (mL/min)

Dosage

30–50

1–2 g every 8–12 h

10–29

1–2 g every 12–24 h

5–9

0.5–1 g every 12–24 h

<5

0.5–1 g every 24–48 h

Adults undergoing hemodialysis: Give a loading dose of 1–2 g after each dialysis period followed by maintenance dosage based on Clcr (see Table 1).149 150 151 156

Pediatric patients with renal impairment: Make dosage adjustments similar to those recommended for adults.149 150 151 156

Geriatric Patients

Cautious dosage selection because of age-related decreases in renal function.149 150 151 156 (See Renal Impairment under Dosage and Administration.)

Cautions for Mefoxin

Contraindications

  • Known hypersensitivity to cefoxitin or cephalosporins.149 150 151 156

Warnings/Precautions

Warnings

Superinfection/Clostridium difficile-associated Diarrhea and Colitis (CDAD)

Possible emergence and overgrowth of nonsusceptible organisms with prolonged therapy.149 150 151 156 Careful observation of the patient is essential.149 150 151 156 Institute appropriate therapy if superinfection occurs.149 150 151 156

Treatment with anti-infectives alters normal colon flora and may permit overgrowth of Clostridium difficile.149 150 151 156 302 303 304 C. difficile infection (CDI) and C. difficile-associated diarrhea and colitis (CDAD; also known as antibiotic-associated diarrhea and colitis or pseudomembranous colitis) reported with nearly all anti-infectives, including cefoxitin, and may range in severity from mild diarrhea to fatal colitis.149 150 151 156 302 303 304 C. difficile produces toxins A and B which contribute to development of CDAD;149 150 151 156 302 hypertoxin producing strains of C. difficile are associated with increased morbidity and mortality since they may be refractory to anti-infectives and colectomy may be required.149 150 151 156

Consider CDAD if diarrhea develops during or after therapy and manage accordingly.149 150 151 156 302 303 304 Obtain careful medical history since CDAD may occur as late as ≥2 months after anti-infective therapy is discontinued.149 151 156

If CDAD suspected or confirmed, discontinue anti-infective therapy not directed against C. difficile whenever possible.149 150 151 151 156 302 Initiate appropriate supportive therapy (e.g., fluid and electrolyte management, protein supplementation), anti-infective therapy directed against C. difficile (e.g., metronidazole, vancomycin), and surgical evaluation as clinically indicated.149 150 151 151 156 302 303 304

Sensitivity Reactions

Hypersensitivity Reactions

Possible hypersensitivity reactions, including rash (maculopapular or erythematous), pruritus, fever, eosinophilia, urticaria, anaphylaxis, erythema multiforme, Stevens-Johnson syndrome, and toxic epidermal necrolysis.149 150 151 a 156

If an allergic reaction occurs, discontinue cefoxitin and institute appropriate therapy as indicated (e.g., epinephrine, corticosteroids, and maintenance of an adequate airway and oxygen).149 150 151 156

Cross-hypersensitivity

Partial cross-allergenicity among β-lactam antibiotics, including penicillins, cephalosporins, and cephamycins.149 150 151 156

Prior to initiation of therapy, make careful inquiry concerning previous hypersensitivity reactions to cefoxitin, cephalosporins, penicillins, or other drugs.149 150 151 156 Cautious use recommended in individuals hypersensitive to penicillins.149 150 151 156 a Avoid use in those who have had an immediate-type (anaphylactic) hypersensitivity reaction and administer with caution in those who have had a delayed-type (e.g., rash, fever, eosinophilia) reaction.a

General Precautions

History of GI Disease

Use with caution in patients with history of GI disease, particularly colitis.149 150 151 156 (See Superinfection/Clostridium difficile-associated Diarrhea and Colitis [CDAD] under Cautions.)

Laboratory Monitoring

Periodically assess organ system functions, including renal, hepatic, and hematopoietic, during prolonged therapy.149 150 151 156

Patients with Diabetes

Like other dextrose-containing solutions, use commercially available Duplex drug delivery system containing 1 or 2 g of cefoxitin powder and 50 mL of 4 or 2.2% dextrose injection, respectively, with caution in patients with overt or known subclinical diabetes mellitus or in patients with carbohydrate intolerance for any reason.149

Selection and Use of Anti-infectives

To reduce development of drug-resistant bacteria and maintain effectiveness of cefoxitin and other antibacterials, use only for treatment or prevention of infections proven or strongly suspected to be caused by susceptible bacteria.149 150 151 156

When selecting or modifying anti-infective therapy, use results of culture and in vitro susceptibility testing.149 150 151 156 In the absence of such data, consider local epidemiology and susceptibility patterns when selecting anti-infectives for empiric therapy.149 150 151 156

Sodium Content

Contains approximately 53.8 mg (2.3 mEq) of sodium per g of cefoxitin.149 150 151 156

Specific Populations

Pregnancy

Category B.149 150 151 156

Lactation

Distributed into milk in low concentrations; use with caution.149 150 151 156

Pediatric Use

Safety and efficacy in infants <3 months of age not established.149 150 151 156

Use of high doses in children ≥3 months of age have been associated with an increased incidence of eosinophilia and elevated serum AST concentration.149 150 151 156

Cefoxitin reconstituted with bacteriostatic water for injection containing benzyl alcohol should not be used in infants.150 151 Benzyl alcohol as a preservative has been associated with toxicity in neonates; although these effects have not been demonstrated in infants >3 months of age, small infants in this age range may also be at risk for benzyl alcohol toxicity.150 151

Geriatric Use

No overall differences in safety and efficacy in those ≥65 years of age compared with younger adults, but the possibility of increased sensitivity in some geriatric individuals cannot be ruled out.149 150 151 156

Substantially eliminated by kidneys; risk of toxicity may be greater in those with impaired renal function.149 150 151 156 Select dosage with caution and consider monitoring renal function because of age-related decreases in renal function.149 150 151 156 (See Renal Impairment under Dosage and Administration.)

Renal Impairment

High and prolonged serum concentrations may occur.149 150 151 156

Reduce dosage in those with Clcr ≤50 mL/minute.149 150 151 156 See Renal Impairment under Dosage and Administration.

Common Adverse Effects

Local reactions at the IV administration site (including thrombophlebitis), hypersensitivity reactions, diarrhea.149 150 151 156

Interactions for Mefoxin

Specific Drugs and Laboratory Tests

Drug or Test

Interaction

Comments

Aminoglycosides

Possible increased risk of nephrotoxicity149 150 151 156

Physical incompatibility if solutions directly mixed together149 150 151 156

Closely monitor renal function if used concomitantly149 150 151 156

Administer separately; do not admix149 150 151 156

Probenecid

Decreased renal excretion and higher and more prolonged serum concentrations of cefoxitin149 150 151 156

Tests for creatinine

High concentrations (>100 mcg/mL) may cause falsely elevated serum or urine creatinine values when the Jaffe reaction is used149 150 151 156

Avoid using blood samples for creatinine determinations if they were drawn from the patient within 2 hours after a cefoxitin dose149 150 151 156

Tests for glucose

Possible false-positive reactions in urine glucose tests using Clinitest, Benedict’s solution, or Fehling’s solution149 150 151 156 a

Use glucose tests based on enzymatic glucose oxidase reactions (e.g., Clinistix, Tes-Tape)149 150 151

Mefoxin Pharmacokinetics

Absorption

Bioavailability

Not appreciably absorbed from the GI tract; must be administered parenterally.c

Following IM administration in healthy adults, peak serum concentrations attained within 20–30 minutes.c

Distribution

Extent

Widely distributed into body tissues and fluids, including ascitic, pleural, and synovial fluid.c

Therapeutic concentrations may be obtained in bile if biliary obstruction is not present.c

Diffuses poorly into CSF following IM or IV administration, even when meninges are inflamed.c

Readily crosses the placentac and is distributed into milk in low concentrations.c

Plasma Protein Binding

50–80%.c

Elimination

Metabolism

≤2% of a dose is metabolized to descarbamylcefoxitin, which is microbiologically inactive.c

Elimination Route

Rapidly eliminated in urine by glomerular filtration and renal tubular excretion.c About 85% of a dose excreted unchanged in urine within 6 hoursc

Half-life

Adults with normal renal function: 0.7–1.1 hours.c

Special Populations

Patients with renal impairment: Serum concentrations higher and serum half-life prolonged.c Serum half-life averages 6.3 hours or 21.5 hours in adults with Clcr about 18 mL/min or 2 mL/min, respectively.c

Geriatric adults 64–88 years of age with renal function normal for their age: 0.9–1.5 hours.149 150 151 156

Stability

Storage

Parenteral

Powder for Injection or IV Infusion

Vials containing 1 or 2 g of cefoxitin: 2–25° C;150 151 avoid exposure to temperatures >50° C.150 151

Reconstituted solutions for IV administration prepared using sterile or bacteriostatic water, 0.9% sodium chloride, or 5% dextrose are stable for 6 hours at room temperature or 1 week when refrigerated at <5°C.150 After further dilution in 50 mL to 1 L of a compatible IV infusion solution, stable for an additional 18 hours at room temperature or an additional 48 hours if refrigerated.150

Powder and reconstituted solutions may darken; does not indicate loss of potency.150 151 156

Powder for IV infusion

Pharmacy bulk package vial containing 10 g of cefoxitin: 2–25°C;151 avoid temperatures >50°C.151 Transfer and dilute reconstituted solution in a compatible IV infusion solution within 4 hours after vial originally entered;151 discard any portion of reconstituted solution not used within 4 hours.151 After further dilution in 50 mL to 1 L of a compatible IV infusion solution, stable for an additional 18 hours at room temperature or an additional 48 hours if refrigerated.151

Store commercially available Duplex drug delivery system containing 1 or 2 g of cefoxitin powder and 50 mL of dextrose injection at 20–25°C (may be exposed to 15–30°C).149 Following reconstitution (activation), use within 12 hours if stored at room temperature or within 7 days if stored in a refrigerator; do not freeze.149

Injection (Frozen) for IV Infusion

-20°C or lower.156 After thawing, stable for 24 hours at room temperature (25°C) or 21 days under refrigeration (2–8°C).156

Do not refreeze after thawing.156

Compatibility

For information on systemic interactions resulting from concomitant use, see Interactions.

Parenteral

Solution CompatibilityHID

Compatible

Dextrose 5% in Ringer’s injection, lactated

Dextrose 5% in sodium chloride 0.2, 0.45, or 0.9%

Dextrose 5 or 10% in water

Ionosol B with dextrose 5% in water

Mannitol 5 or 10% in water

Normosol M in dextrose 5% in water

Ringer’s injection

Ringer’s injection, lactated

Sodium bicarbonate 5%

Sodium chloride 0.9%

Sodium lactate (1/6) M

TPN #107

Drug Compatibility
Admixture CompatibilityHID

Compatible

Amikacin sulfate

Clindamycin phosphate

Gentamicin sulfate

Metronidazole

Multivitamins

Sodium bicarbonate (Neut)

Tobramycin sulfate

Verapamil HCl

Incompatible

Ranitidine HCl

Variable

Aztreonam

Y-Site CompatibilityHID

Compatible

Acyclovir sodium

Amifostine

Amphotericin B cholesteryl sulfate complex

Anidulafungin

Aztreonam

Bivalirudin

Cyclophosphamide

Dexmedetomidine HCl

Diltiazem HCl

Docetaxel

Doxorubicin HCl liposome injection

Etoposide phosphate

Famotidine

Fluconazole

Foscarnet sodium

Gemcitabine HCl

Granisetron HCl

Hetastarch in lactated electrolyte

Hydromorphone HCl

Linezolid

Magnesium sulfate

Meperidine HCl

Morphine sulfate

Ondansetron HCl

Propofol

Ranitidine HCl

Remifentanil HCl

Teniposide

Thiotepa

Incompatible

Fenoldopam mesylate

Filgrastim

Hetastarch in sodium chloride 0.9%

Pemetrexed disodium

Pentamidine isethionate

Variable

Cisatracurium besylate

Vancomycin HCl

Actions and Spectrum

  • Cephamycin;149 150 151 a sometimes classified with second generation cephalosporin based on spectrum of activity.a

  • Usually bactericidal.149 150 151 a

  • Like other β-lactam antibiotics, antibacterial activity results from inhibition of bacterial cell wall synthesis.149 150 151 a

  • Spectrum of activity includes some gram-positive and -negative aerobic bacteria and some anaerobic bacteria; inactive against Chlamydia, fungi, and viruses.a

  • Gram-positive aerobes: Active in vitro and in clinical infections against S. aureus (including penicillinase-producing strains), S. epidermidis, S. pneumoniae, S. pyogenes (group A β-hemolytic streptococci), and S. agalactiae (group B streptococci).149 150 151 Oxacillin-resistant staphylococci (methicillin-resistant staphylococci) and most enterococci (e.g., Enterococcus faecalis) are resistant.149 150 151

  • Gram-negative aerobes: Active in vitro and in clinical infections against E. coli, H. influenzae, Klebsiella (including K. pneumoniae), M. morganii, N. gonorrhoeae, P. mirabilis, P. vulgaris, and Providencia (including P. rettgeri).149 150 151 Also active in vitro against Eikenella corrodens (non-β-lactamase-producing strains),149 150 151 K. oxytoca,149 150 151 Salmonella,c and Shigella.c Many strains of Enterobacter cloacae and most strains of Pseudomonas aeruginosa are resistant.149 150 151

  • Anaerobes: Active in vitro and in clinical infections against Bacteroides distasonis, B. fragilis, B. ovatus, B. thetaiotaomicron, Clostridium (including C. perfringens but not C. difficile), Peptococcus niger, and Peptostreptococcus.149 150 151 c Also active in vitro against Fusobacterium, Prevotella bivia,149 150 151 and Propionibacterium.c

  • Active in vitro against some mycobacteria, including Mycobacterium abscessus,157 M. fortuitum,157 and M. mucogenicum.157 Has variable activity against M. smegmatis;157 however, M. chelonae157 and M. immunogenum157 are resistant.

Advice to Patients

  • Advise patients that antibacterials (including cefoxitin) should only be used to treat bacterial infections; they do not treat viral infections (e.g., the common cold).149 150 151

  • Importance of completing full course of therapy, even if feeling better after a few days.149 150 151

  • Advise patients that skipping doses or not completing the full course of therapy may decrease effectiveness and increase the likelihood that bacteria will develop resistance and will not be treatable with cefoxitin or other antibacterials in the future.149 150 151

  • Advise patients that diarrhea is a common problem caused by anti-infectives and usually ends when the drug is discontinued.156 Importance of contacting a clinician if watery and bloody stools (with or without stomach cramps and fever) occur during or as late as 2 months or longer after the last dose.156

  • Importance of informing clinicians if an allergic reaction occurs.149 150 151

  • Importance of women informing clinician if they are or plan to become pregnant or plan to breast-feed.149 150 151

  • Importance of informing clinicians of existing or contemplated therapy, including prescription and OTC drugs.149 150 151

  • Importance of informing patients of other important precautionary information. (See Cautions.)

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Cefoxitin Sodium

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Parenteral

For injection

1 g (of cefoxitin)*

Cefoxitin Sodium for Injection

2 g (of cefoxitin)*

Cefoxitin Sodium for Injection

For injection, for IV infusion

1 g (of cefoxitin)

Cefoxitin Sodium for Injection (available in dual-chambered Duplex drug delivery system with 4% dextrose injection)

B Braun

2 g (of cefoxitin)

Cefoxitin Sodium for Injection (available in dual-chambered Duplex drug delivery system with 2.2% dextrose injection)

B Braun

10 g (of cefoxitin) pharmacy bulk package*

Cefoxitin Sodium for Injection

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Cefoxitin Sodium in Dextrose

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Parenteral

Injection (frozen), for IV infusion

20 mg (of cefoxitin) per mL (1 g) in 4% Dextrose*

Mefoxin in Dextrose Injection

Bioniche

40 mg (of cefoxitin) per mL (2 g) in 2.2% Dextrose*

Mefoxin in Dextrose Injection

Bioniche

AHFS DI Essentials. © Copyright, 2004-2014, Selected Revisions October 20, 2014. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

† Use is not currently included in the labeling approved by the US Food and Drug Administration.

References

Only references cited for selected revisions after 1984 are available electronically.

101. Arsura EL, Fazio RA, Wickremesinghe PC. Pseudomembranous colitis following prophylactic antibiotic use in primary cesarean section. Am J Obstet Gynecol. 1985; 151:87-9. [IDIS 195132] [PubMed 3966512]

102. Block BS, Mercer LJ, Ismail MA et al. Clostridium difficile-associated diarrhea follows perioperative prophylaxis with cefoxitin. Am J Obstet Gynecol. 1985; 153:835-8. [IDIS 211025] [PubMed 4073152]

103. Austin SM, Barooah B, Kim CS. Reversible acute cardiac injury during cefoxitin-induced anaphylaxis in a patient with normal coronary arteries. Am J Med. 1984; 77:729-32. [IDIS 191619] [PubMed 6486149]

105. Clinical and Laboratory Standards Institute. Performance standards for antimicrobial susceptibility testing: Twenty-first informational supplement. CLSI document M100-S21. Wayne, PA; 2011.

107. DiPiro JT, Bowden TA Jr, Hooks VH III. The prophylactic use of cephalosporins for surgery. JAMA. 1985; 253:3399-400. [PubMed 3999322]

108. Burnakis TG. Surgical antimicrobial prophylaxis: principles and guidelines. Pharmacotherapy. 1984; 4:248-71. [IDIS 393587] [PubMed 6438611]

110. Platt R. Antibiotic prophylaxis in surgery. Rev Infect Dis. 1984; 6(Suppl 4):S880-6.

111. Van Scoy RE, Wilkowske CJ. Prophylactic use of antimicrobial agents. Mayo Clin Proc. 1983; 58:241-5. [IDIS 169724] [PubMed 6403778]

112. Guglielmo BJ, Hohn DC, Koo PJ et al. Antibiotic prophylaxis in surgical procedures: a critical analysis of the literature. Arch Surg. 1983; 118:943-55. [IDIS 173790] [PubMed 6347124]

113. Neu HC. Cephalosporin antibiotics as applied in surgery of bones and joints. Clin Orthop. 1984; 190:50-64. [PubMed 6386261]

122. Sawaya GF, Grady D, Kerlikowske K et al. Antibiotics at the time of induced abortion: the case for universal prophylaxis based on a meta-analysis. Obstet Gynecol. 1996; 87:884-90. [IDIS 367107] [PubMed 8677129]

123. Anon. Choice of antibacterial drugs. Med Lett Treat Guid. 2007; 5:33-50.

124. Nichols Rl, Smith JW, Garcia RY et al. Current practices of preoperative bowel preparation among North American colorectal surgeons. Clin Infect Dis. 1997; 24:609-19. [IDIS 384359] [PubMed 9145734]

125. Schoetz DJ, Roberts PL, Murray JJ et al. Addition of parenteral cefoxitin to regimen of oral antibiotics for elective colorectal operations: a randomized prospective study. Ann Surg. 1990; 212:209-12. [IDIS 269407] [PubMed 2100983]

127. Kaiser AB. Antimicrobial prophylaxis in surgery. N Engl J Med. 1986; 315:1129-38. [IDIS 222343] [PubMed 3531863]

128. Brown RB, Klar J, Lemeshow S et al. Enhanced bleeding with cefoxitin or moxalactam: statistical analysis within a defined population of 1493 patients. Arch Intern Med. 1986; 146:2159-64. [IDIS 223647] [PubMed 3778044]

131. Rice RJ, Thompson SE. Treatment of uncomplicated infections due to Neisseria gonorrhoeae: a review of clinical efficacy and in vitro susceptibility studies from 1982 through 1985. JAMA. 1986; 255:1739-46. [IDIS 213027] [PubMed 3005679]

132. Miller DW, Shove GA, Jones T et al. Disseminated gonorrhea caused by penicillinase-producing Neisseria gonorrhoeae—Wisconsin, Pennsylvania. MMWR Morb Mortal Wkly Rep. 1987; 36:161-2,167. [PubMed 3102922]

133. Knapp JS, Zenilman JM, Biddle JW et al. Frequency and distribution in the United States of strains of Neisseria gonorrhoeae with plasmid-mediated, high-level resistance to tetracycline. J Infect Dis. 1987; 155:819-22. [PubMed 3102635]

134. Bowie WR, Shaw CE, Chan DGW et al. In-vitro susceptibility of 400 isolates of Neisseria gonorrhoeae in Vancouver, 1982–84. CMAJ. 1986; 135:489-93. [IDIS 222427] [PubMed 3091234]

135. Anon. Infection with Mycobacterium abscessus associated with intramuscular injection of adrenal cortex extract—Colorado and Wyoming, 1995–1996. MMWR Morb Mortal Wkly Rep. 1996; 45:713-5. [IDIS 371154] [PubMed 8769652]

136. Hemsell DL, Wendel GD, Gall SA et al. Multicenter comparison of cefotetan and cefoxitin in the treatment of acute obstetric and gynecologic infections. Am J Obstet Gynecol. 1988; 158:722-7. [IDIS 310460] [PubMed 3281462]

138. Bartlett JG. Antibiotic-associated diarrhea. Clin Infect Dis. 1992; 573-81.

139. Kelly CP, Pothoulakis C, LaMont JT. Clostridium difficile colitis. N Engl J Med. 1994; 330:257-62. [IDIS 324298] [PubMed 8043060]

140. Spangler SK, Jacobs MR, Appelbaum PC. Activity of CP 99,219 compared with those of ciprofloxacin, grepafloxacin, metronidazole, cefoxitin, piperacillin, and piperacillin-tazobactam against 489 anaerobes. Antimicrob Agents Chemother. 1994; 38:2471-6. [PubMed 7840591]

141. O’Keefe JP, Venezio FR, Divincenzo CA et al. Activity of newer β-lactam agents against clinical isolates of Bacteroides fragilis and other Bacteroides species. Antimicrob Agents Chemother. 1987; 31:2002-4. [IDIS 253333] [PubMed 3439807]

142. Goldstein EJC, Citron DM. Annual incidence, epidemiology, and comparative in vitro susceptibilities to cefoxitin, cefotetan, cefmetazole, and ceftizoxime of recent community-acquired isolates of the Bacteroides fragilis group. J Clin Microbiol. 1988; 26:2361-6. [PubMed 3235664]

143. Grimes DA, Bount JH, Patrick J et al. Antibiotic treatment of pelvic inflammatory disease: trends among private physicians in the United States, 1966 through 1983. JAMA. 1986; 256:3223-6. [PubMed 3783865]

149. B Braun Medical. Cefoxitin for injection and dextrose injection (1 g and 2 g in Duplex container) prescribing information. Irvine, CA; 2013 Apr.

150. Apotex. Cefoxitin for injection, USP prescribing information. Weston, FL. 2013 Aug.

151. APP Pharmaceuticals, LLC. Cefoxitin for injection, USP pharmacy bulk package prescribing information. Schaumburg, IL. 2011 Nov.

152. Lewis RT. Oral versus systemic antibiotic prophylaxis in elective colon surgery: a randomized study and meta-analysis send a message from the 1990s. Can J Surg. 2002; 45:173-80. [PubMed 12067168]

153. Espin-Basany E, Sanchez-Garcia JL, Lopez-Cano M et al. Prospective, randomized study on antibiotic prophylaxis in colorectal surgery. Is it really necessary to use oral antibiotics? Int J Colorectal Dis. 2005; 20:542-6.

154. Wren SM, Ahmed N, Jamal A et al. Preoperative oral antibiotics in colorectal surgery increase the rate of Clostridium difficile colitis. Arch Surg. 2005; 140:752-6. [PubMed 16103284]

156. Bioniche Pharma USA. Mefoxin (cefoxitin sodium) injection, iso-osmotic solution in dextrose prescribing information. Lake Forest, IL; 2009 Oct.

157. Griffith DE, Aksamit T, Brown-Elliott BA et al. An official ATS/IDSA statement: diagnosis, treatment, and prevention of nontuberculous mycobacterial diseases. Am J Respir Crit Care Med. 2007; 175:367-416. [PubMed 17277290]

161. Solomkin JS, Mazuski JE, Bradley JS et al. Diagnosis and management of complicated intra-abdominal infection in adults and children: guidelines by the Surgical Infection Society and the Infectious Diseases Society of America. Clin Infect Dis. 2010; 50:133-64. [PubMed 20034345]

292. American Academy of Pediatrics. Red Book: 2012 Report of the Committee on Infectious Diseases. 29th ed. Elk Grove Village, IL: American Academy of Pediatrics; 2012.

302. Cohen SH, Gerding DN, Johnson S et al. Clinical practice guidelines for Clostridium difficile infection in adults: 2010 update by the Society for Healthcare Epidemiology of America (SHEA) and the Infectious Diseases Society of America (IDSA). Infect Control Hosp Epidemiol. 2010; 31:431-55. [PubMed 20307191]

303. Fekety R for the American College of Gastroenterology Practice Parameters Committee. Guidelines for the diagnosis and management of Clostridium difficile-associated diarrhea and colitis. Am J Gastroenterol. 1997; 92:739-50. [IDIS 386628] [PubMed 9149180]

304. American Society of Health-System Pharmacists Commission on Therapeutics. ASHP therapeutic position statement on the preferential use of metronidazole for the treatment of Clostridium difficile-associated disease. Am J Health-Syst Pharm. 1998; 55:1407-11. [IDIS 407213] [PubMed 9659970]

344. Workowski KA, Berman S, Centers for Disease Control and Prevention (CDC). Sexually transmitted diseases treatment guidelines, 2010. MMWR Recomm Rep. 2010; 59(RR-12):1-110.

346. Anon. Drugs for sexually transmitted infections. Treat Guidel Med Lett. 2010; 8:53-60. [PubMed 20585282]

360. . Antimicrobial prophylaxis for surgery. Treat Guidel Med Lett. 2012; 10:73-8; quiz 79-80. [PubMed 22996382]

374. Bratzler DW, Dellinger EP, Olsen KM et al. Clinical practice guidelines for antimicrobial prophylaxis in surgery. Am J Health Syst Pharm. 2013; 70:195-283. [PubMed 23327981]

417. Cunha BA. Treatment of pelvic inflammatory disease. Clin Pharm. 1990; 9:275-85. [IDIS 265474] [PubMed 2184973]

418. Walker CK, Kahn JG, Washington AE et al. Pelvic inflammatory disease: metaanalysis of antimicrobial regimen efficacy. J Infect Dis. 1993; 168:969-78. [IDIS 320603] [PubMed 8376843]

419. Hemsell DL, Little BB, Faro S et al. Comparison of three regimens recommended by the Centers for Disease Control and Prevention for the treatment of women hospitalized with acute pelvic inflammatory disease. Clin Infect Dis. 1994; 19:720-7. [IDIS 337500] [PubMed 7803638]

a. AHFS Drug Information 2009. McEvoy GK, ed. Cephalosporins General Statement. Bethesda, MD: American Society of Health-System Pharmacists; 2009:93-109.

c. AHFS Drug Information. McEvoy GK, ed. Cefoxitin sodium. Bethesda, MD: American Society of Health-System Pharmacists; 2009:209-14.

HID. Trissel LA. Handbook on injectable drugs. 17th ed. Bethesda, MD: American Society of Health-System Pharmacists; 2013:221–7.

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