Cefoxitin and Dextrose CEFOXITIN SODIUM 2 g/50mL Injection, Solution
🆔 Identity & classification
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🏷️ RxNorm drug class
This medicine belongs to the Cephalosporin Antibacterial class.
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🏭 Manufacturer & labeler
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🩺 Clinical
- Cefoxitin is used for serious bacterial infections in several parts of the body — including the lungs, urinary tract, abdomen, female reproductive system, bloodstream, bones and jo...
- What kinds of infections does cefoxitin treat?
- Cefoxitin is given through an IV — directly into a vein — by a nurse or other healthcare professional. It's not a pill or something you take at home on your own. You'll receive it...
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Patient education
Supplement & herbal interactions
Cefoxitin may be associated with lower levels of 7 nutrients — worth a chat with your pharmacist, not a cause for alarm.
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🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
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1.1 g / 50 mL
UNII IY9XDZ35W2
Dextrose is a simple sugar derived from corn or other sources. It serves as a filler and sweetener in medicines to add bulk, improve taste, and help stabilize the medication's form.
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UNII 059QF0KO0R
Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.
2 inactive ingredients listed in the exact product block matched to this NDC.
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ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
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💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per mL | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | $2.08 | $2,499.24 / 1200 ml |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
| Medicare Part B allowsASP · J0694 | $4.285 / J0694 unit | — |
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🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Cefoxitin 2 g 00143-9877-25 | Hikma | 25 vials | — | AP | FDA listed | — |
| Cefoxitin and Dextrose 2 g/50mLthis 00264-3125-11 | B. | 50 ml | — | AP | FDA listed | — |
| Cefoxitin 2 g 25021-0110-20 | Sagent | 10 vials | — | AP | FDA listed | — |
| Cefoxitin 2 g 44567-0246-25 | WG | 25 vials | — | AP | FDA listed | — |
| Cefoxitin 2 g 63323-0342-25 | Fresenius | 25 vials | — | AP | FDA listed | — |
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⏳ Availability & generic status
The FDA lists approved generic versions of this medicine, but that does not always mean a pharmacy can get one today. Patent rules, launch agreements, supply and pricing can affect when generics actually arrive.
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🗺️ Medicaid utilization & spend
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
🔬 Reported adverse events (FAERS)
Top reported reactions
Reporter sex
Serious outcomes
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📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 00264-3125-11 You're viewing this | 24 CONTAINER in 1 CASE (0264-3125-11) / 50 mL in 1 CONTAINER | 2006-03-10 | Active |
🧭 About this NDC listing & data coverage
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| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | ✓ Available |
| Inactive ingredients (structured) | ✓ Available |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | ✓ Available |
| HCPCS J-code billing crosswalk | ✓ Available |
| Medicaid utilization (CMS SDUD) | ✓ Available |
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📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE Cefoxitin for Injection and Dextrose Injection is a cephalosporin antibacterial indicated for the treatment of the following infections caused by susceptible isolates of the designated bacteria ( 1 ): Lower respiratory tract infections ( 1.1 ); Urinary tract infections ( 1.2 ); Intra-abdominal infections ( 1.3 ); Gynecological infections ( 1.4 ); Septicemia ( 1.5 ); Bone and joint infections ( 1.6 ); Skin and skin structure infections ( 1.7 ); Prophylaxis ( 1.8 ). To reduce the development of drug-resistant bacteria and maintain the effectiveness of Cefoxitin for Injection and Dextrose Injection and other antibacterial drugs, Cefoxitin for Injection and Dextrose Injection should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria ( 1.9 ).
1.1Lower Respiratory Tract Infections Cefoxitin for Injection and Dextrose Injection is indicated for the treatment of lower respiratory tract infections, including pneumonia and lung abscess, caused by Streptococcus pneumoniae , other streptococci (excluding enterococci, e.g., Enterococcus faecalis [formerly Streptococcus faecalis ]), Staphylococcus aureus (including penicillinase-producing strains), Escherichia coli , Klebsiella species, Haemophilus influenzae , and Bacteroides species.
1.2Urinary Tract Infections Cefoxitin for Injection and Dextrose Injection is indicated for the treatment of urinary tract infections caused by Escherichia coli , Klebsiella species, Proteus mirabilis , Morganella morganii , Proteus vulgaris and Providencia species (including P. rettgeri ).
1.3Intra-abdominal Infections Cefoxitin for Injection and Dextrose Injection is indicated for the treatment of intra-abdominal infections , including peritonitis and intra-abdominal abscess, caused by Escherichia coli, Klebsiella species, Bacteroides species including Bacteroides fragilis , and Clostridium species.
1.4Gynecological Infections Cefoxitin for Injection and Dextrose Injection is indicated for the treatment of gynecological infections , including endometritis, pelvic cellulitis, and pelvic inflammatory disease caused by Escherichia coli , Neisseria gonorrhoeae (including penicillinase-producing strains), Bacteroides species including B. fragilis , Clostridium species, Peptococcus niger , Peptostreptococcus species, and Streptococcus agalactiae . Cefoxitin has no activity against Chlamydia trachomatis . Therefore, when cefoxitin is used in the treatment of patients with pelvic inflammatory disease and C. trachomatis is one of the suspected pathogens, appropriate anti-chlamydial coverage should be added.
1.5Septicemia Cefoxitin for Injection and Dextrose Injection is indicated for the treatment of Septicemia caused by Streptococcus pneumoniae , Staphylococcus aureus (including penicillinase-producing strains), Escherichia coli , Klebsiella species, and Bacteroides species including B. fragilis .
1.6Bone and Joint Infections Cefoxitin for Injection and Dextrose Injection is indicated for the treatment of bone and joint infections caused by Staphylococcus aureus (including penicillinase-producing strains).
1.7Skin and Skin Structure Infections Cefoxitin for Injection and Dextrose Injection is indicated for the treatment of skin and skin structure infections caused by Staphylococcus aureus (including penicillinase-producing strains), Staphylococcus epidermidis , Streptococcus pyogenes and other streptococci (excluding enterococci, e.g., Enterococcus faecalis [formerly Streptococcus faecalis ]), Escherichia coli , Proteus mirabilis , Klebsiella species, Bacteroides species including B. fragilis , Clostridium species, Peptococcus niger , and Peptostreptococcus species.
1.8Prophylaxis Cefoxitin for Injection and Dextrose Injection is indicated for the prophylaxis of infection in patients undergoing uncontaminated gastrointestinal surgery, vaginal hysterectomy, abdominal hysterectomy, or cesarean section. If there are signs of infect…
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION For intravenous use only. ( 2 ) Use this formulation of cefoxitin only in patients who require the entire 1 or 2 gram dose and not any fraction thereof. ( 2.3 ) See full prescribing information for dose adjustment in patients with impaired renal function. ( 2.3 ) Recommended dosing schedule in patients with normal renal function. ( 2.1 )
2.1Dosage in Adults for Treatment The usual adult dosage range is 1 gram to 2 grams every six to eight hours. Dosage should be determined by susceptibility of the causative organisms, severity of infection, and the condition of the patient (see Table 1 for dosage guidelines). Administer Cefoxitin for Injection and Dextrose Injection intravenously over approximately 30 minutes.
If C. trachomatis is a suspected pathogen, appropriate anti-chlamydial coverage should be added, because cefoxitin sodium has no activity against this organism [see Indications and Usage (1.4) ] . Antibacterial therapy for group A beta-hemolytic streptococcal infections should be maintained for at least 10 days to guard against the risk of rheumatic fever or glomerulonephritis. In staphylococcal and other infections involving a collection of pus, surgical drainage should be carried out where indicated.
Use this formulation of cefoxitin only in patients who require the entire 1 or 2 gram dose and not any fraction thereof. Table 1: Guidelines for Dosage of Cefoxitin for Injection Type of Infection Daily Dosage Frequency and Route Uncomplicated forms Including patients in whom bacteremia is absent or unlikely. of infections such as pneumonia, urinary tract infection, cutaneous infection 3-4 grams 1 gram every 6-8 hours IV Moderately severe or severe infections 6-8 grams 1 gram every 4 hours or 2 grams every 6-8 hours IV Infections commonly needing antibacterial drugs in higher dosage (e.g., gas gangrene) 12 grams 2 grams every 4 hours or 3 grams every 6 hours IV
2.2Dosage in Adults for Prophylaxis Effective prophylactic use depends on the time of administration. Cefoxitin for Injection and Dextrose Injection usually should be given one-half to one hour before the operation, which is sufficient time to achieve effective levels in the wound during the procedure. Prophylactic administration should usually be stopped within 24 hours since continuing administration of any antibacterial increases the possibility of adverse reactions but, in the majority of surgical procedures, does not reduce the incidence of subsequent infection.
For prophylactic use in uncontaminated gastrointestinal surgery, vaginal hysterectomy, or abdominal hysterectomy, the following doses are recommended: • 2 grams administered intravenously just prior to surgery (approximately one-half to one hour before the initial incision) followed by • 2 grams every 6 hours after the first dose for no more than 24 hours. For patients undergoing cesarean section, either a single 2 gram dose administered intravenously as soon as the umbilical cord is clamped OR a 3-dose regimen consisting of 2 grams given intravenously as soon as the umbilical cord is clamped followed by 2 grams 4 and 8 hours after the initial dose is recommended [see Clinical Studies (14.1) ].
2.3Dosage in Patients with Renal Impairment In adults with renal impairment, an initial loading dose of 1 gram to 2 grams may be given. After a loading dose, the recommendations for maintenance dosage (Table 2) may be used as a guide. When only the serum creatinine level is available, the following formula (based on sex, weight, and age of the patient) may be used to convert this value into creatinine clearance.
The serum creatinine should represent a steady state of renal function. Males: Weight (kg) x (140 - age) 72 x serum creatinine (mg/100 mL) Females: 0.85 x above value In patients undergoing hemodialysis, the loading dose of 1 to 2 grams should be given after each hemodialysis, and the maintenance dose should be given as indicated in Table 2. Table 2: Maintenance Dosage of Ce…
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS Single-dose DUPLEX ® (Dual-chamber), Container: • 1 g cefoxitin for injection and 50 mL of 5% dextrose injection • 2 g cefoxitin for injection and 50 mL of 5% dextrose injection Single-dose DUPLEX ® Container consisting of: 1 g cefoxitin for injection and 50 mL 5% dextrose injection ( 3 ) 2 g cefoxitin for injection and 50 mL 5% dextrose injection ( 3 )
⛔ Contraindications ▾
4 CONTRAINDICATIONS Hypersensitivity to cefoxitin or other beta-lactam antibacterial drugs. ( 4.1 ) Hypersensitivity to corn products. ( 4.2 )
4.1Hypersensitivity to Cefoxitin or other Beta-lactam Antibacterial Drugs Cefoxitin for Injection and Dextrose Injection is contraindicated in patients who have shown hypersensitivity to cefoxitin or to other β-lactam antibacterial drugs (e.g., penicillins and cephalosporins).
4.2Hypersensitivity to Corn Products Solutions containing dextrose may be contraindicated in patients with hypersensitivity to corn products.
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS Hypersensitivity reactions including anaphylaxis and serious skin reactions. If an allergic reaction occurs, discontinue the drug. ( 5.1 ) Use in patients with renal impairment: Dosage adjustment required for patients with impaired renal function. ( 2.3 ) Clostridium difficile -associated diarrhea: May range from mild diarrhea to fatal colitis. Evaluate if diarrhea occurs. ( 5.2 )
5.1Hypersensitivity Reactions to Cefoxitin or other Beta-lactam Antibacterial Drugs Serious and occasionally fatal hypersensitivity reactions (e.g., anaphylaxis) have been reported in patients on β-lactam antibacterials, including cefoxitin [see Adverse Reactions (6.1) ] . These reactions are more likely to occur in individuals with a history of β-lactam hypersensitivity and/or a history of sensitivity to multiple allergens. There have been reports of individuals with a history of penicillin hypersensitivity who have experienced severe reactions when treated with cephalosporins.
Cefoxitin for Injection and Dextrose Injection is contraindicated in patients with a known hypersensitivity to Cefoxitin for Injection and Dextrose Injection or other β-lactam antibacterial drugs [see Contraindications (4) ] . Before initiating therapy with Cefoxitin for Injection and Dextrose Injection, inquire about previous hypersensitivity reactions to penicillins, cephalosporins, or other allergens. If an allergic reaction occurs, discontinue Cefoxitin for Injection and Dextrose Injection and institute appropriate therapy.
5.2Clostridium difficile -associated Diarrhea Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including Cefoxitin for Injection and Dextrose Injection, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile . C. difficile produces toxins A and B which contribute to the development of CDAD.
Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents.
If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile , and surgical evaluation should be instituted as clinically indicated.
5.3Risk of Development of Drug-resistant Bacteria Prescribing Cefoxitin for Injection and Dextrose Injection in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria. Prolonged use of Cefoxitin for Injection and Dextrose Injection may result in overgrowth of non-susceptible microorganisms. Repeated evaluation of the patient's condition is essential.
Should superinfection occur during therapy, appropriate measures should be taken.
5.4Drug/Laboratory Test Interactions As with cephalothin, high concentrations of cefoxitin (>100 mcg/mL) may interfere with measurement of serum and urine creatinine levels by Jaffé reaction, and produce false increases of modest degree in the levels of creatinine reported. Serum samples from patients treated with cefoxitin should not be analyzed for creatinine if withdrawn within 2 hours of drug administration. High concentrations of cefoxitin in the urine may interfere with measurement of urinary 17-hydroxy-corticosteroids by the Porter-Silber reaction, and produce false increases of modest degree in the levels reported.
A false-positive reaction for glucose in the urine may occur…
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS The following clinically significant adverse reactions are discussed in greater detail in other sections of labeling: • Hypersensitivity Reactions to Cefoxitin or other Beta-lactam Antibacterial Drugs [see Warnings and Precautions (5.1)] • Use in Patients with Renal Impairment [see Dosage and Administration (2.3) , Use in Specific Populations (8.6)] • Clostridium difficile -associated Diarrhea [see Warnings and Precautions (5.2)] • Risk of Development of Drug-resistant Bacteria [see Warnings and Precautions (5.3)] • Drug/Laboratory Test Interactions [see Warnings and Precautions (5.4)] • Patients with a History of Gastrointestinal Disease [see Warnings and Precautions (5.5) ] • Patients with Overt or Known Subclinical Diabetes Mellitus or Carbohydrate Intolerance [see Warnings and Precautions (5.6) ] The most common adverse reactions have been local reactions following intravenous injection.
Local Reactions Thrombophlebitis has occurred with intravenous administration. Skin and Subcutaneous Tissue Disorders Rash (including exfoliative dermatitis and toxic epidermal necrolysis), urticaria, flushing, pruritus, eosinophilia, fever, dyspnea, and other allergic reactions including anaphylaxis, interstitial nephritis and angioedema have been noted. Cardiovascular Disorders Hypotension.
Gastrointestinal Disorders Diarrhea, including documented pseudomembranous colitis which can appear during or after antibiotic treatment. Nausea and vomiting have been reported. Nervous System Disorders Possible exacerbation of myasthenia gravis.
Blood and Lymphatic System Disorders Eosinophilia, leukopenia including granulocytopenia, neutropenia, anemia including hemolytic anemia, thrombocytopenia, and bone marrow depression. A positive direct Coombs test may develop in some individuals, especially those with azotemia. Hepatobiliary Disorders Reversible elevation in SGOT, SGPT, serum LDH, and serum alkaline phosphatase; and jaundice have been reported.
Renal and Urinary Disorders Elevations in serum creatinine and/or blood urea nitrogen levels have been observed. Acute renal failure has been reported. Most common adverse reactions: Local reactions.
( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact B. Braun Medical Inc. at 1-800-854-6851 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1Cephalosporin-class Adverse Reactions In addition to the adverse reactions listed above which have been observed in patients treated with cefoxitin, the following adverse reactions and altered laboratory test results have been reported for cephalosporin class antibacterials: pruritus, Stevens-Johnson syndrome, erythema multiforme, toxic epidermal necrolysis, vomiting, abdominal pain, colitis, superinfection, vaginitis including vaginal candidiasis, renal dysfunction, toxic nephropathy, hepatic dysfunction including cholestasis, aplastic anemia, hemorrhage, elevated bilirubin, pancytopenia, and neutropenia.
Several cephalosporins, including Cefoxitin for Injection and Dextrose Injection, have been implicated in triggering seizures, particularly in patients with renal impairment, when the dosage was not reduced [ see Dosage and Administration (2.3) and Overdosage (10 ) ] . If seizures associated with drug therapy occur, the drug should be discontinued. Anticonvulsant therapy can be given if clinically indicated.
🔄 Drug Interactions ▾
7 DRUG INTERACTIONS Aminoglycosides: Increased potential of nephrotoxicity. ( 7.1 )
7.1Aminoglycosides Increased nephrotoxicity has been reported following concomitant administration of cephalosporins and aminoglycoside antibacterials.
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS Pediatric use: Safety and efficacy of this formulation not established ( 8.4 )
8.1Pregnancy Risk Summary Available data from published prospective cohort studies, case series, and case reports over several decades with cephalosporin use, including cefoxitin, in pregnant women have not established drug-associated risks of major birth defects, miscarriage, or adverse maternal or fetal outcomes (see Data) . In animal reproduction studies, no adverse developmental effects were observed in pregnant rats and mice administered parenteral doses of cefoxitin at approximately 1 to 7.5 times the maximum recommended human dose (see Data).
The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.
Cefoxitin is found in umbilical cord blood and amniotic fluid after maternal administration. Clinical Considerations Disease-Associated Maternal and/or Embryo/Fetal Risk Maternal gonorrhea may be associated with preterm birth, low neonatal birth weight, chorioamnionitis, intrauterine growth restriction, small for gestational age and premature rupture of membranes. Perinatal transmission of gonorrhea to the offspring can result in infant blindness, joint infections and bloodstream infections.
Data Human Data While available studies cannot definitively establish the absence of risk, published data from prospective cohort studies, case series, and case reports over several decades have not identified an association with cephalosporin use, including cefoxitin, during pregnancy, and major birth defects, miscarriage, or other adverse maternal or fetal outcomes. Available studies have methodologic limitations, including small sample size, retrospective data collection, and inconsistent comparator groups. Animal Data Reproduction studies performed in pregnant rats and mice at parenteral doses of approximately one to seven and one-half times the maximum recommended human dose did not reveal teratogenic or fetal toxic effects, although a slight decrease in fetal weight was observed.
In the rabbit, cefoxitin was associated with a high incidence of abortion and maternal death. This was not considered to be a teratogenic effect but an expected consequence of the rabbit’s unusual sensitivity to antibiotic-induced changes in the population of the microflora of the intestine.
8.2Lactation Risk Summary Limited data from published literature report the presence of cefoxitin in human milk. For an infant fed exclusively with human milk, the estimated infant daily dose through breastfeeding is less than 0.1% of maternal daily IV dose (see Data). Minimal data are available on the effects of the drug on the breastfed infant; none of these reports suggest serious safety concerns.
No data are available on the effects of the drug on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for cefoxitin and any potential adverse effects on the breastfed infant from cefoxitin or from the underlying maternal condition. Data In a published clinical lactation study, the concentration of cefoxitin ranged from 11.6 ± 0.8 to 0.49 ± 0.01 mcg/mL and 1.71 ± 0.08 to 0.57 ± 0.02 mcg/mL in human plasma and breast milk, respectively, at 1, 1.5, 2 or 2.5 hours following IV administration of 1 g cefoxitin twice daily.
8.4Pediatric Use Safety and efficacy of this formulation are not established. This formulation of cefoxitin is indicated for use only in patients who require the entire 1 or 2 gram dose.
8.5Geriatric Use Of the 1,775 subjects who received cefoxitin in clinical studies, 424 (24%) were 65 and over, while 124 (7%) were 75 and over. No overall differences in safety o…
🤰 Pregnancy ▾
8.1Pregnancy Risk Summary Available data from published prospective cohort studies, case series, and case reports over several decades with cephalosporin use, including cefoxitin, in pregnant women have not established drug-associated risks of major birth defects, miscarriage, or adverse maternal or fetal outcomes (see Data) . In animal reproduction studies, no adverse developmental effects were observed in pregnant rats and mice administered parenteral doses of cefoxitin at approximately 1 to 7.5 times the maximum recommended human dose (see Data).
The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.
Cefoxitin is found in umbilical cord blood and amniotic fluid after maternal administration. Clinical Considerations Disease-Associated Maternal and/or Embryo/Fetal Risk Maternal gonorrhea may be associated with preterm birth, low neonatal birth weight, chorioamnionitis, intrauterine growth restriction, small for gestational age and premature rupture of membranes. Perinatal transmission of gonorrhea to the offspring can result in infant blindness, joint infections and bloodstream infections.
Data Human Data While available studies cannot definitively establish the absence of risk, published data from prospective cohort studies, case series, and case reports over several decades have not identified an association with cephalosporin use, including cefoxitin, during pregnancy, and major birth defects, miscarriage, or other adverse maternal or fetal outcomes. Available studies have methodologic limitations, including small sample size, retrospective data collection, and inconsistent comparator groups. Animal Data Reproduction studies performed in pregnant rats and mice at parenteral doses of approximately one to seven and one-half times the maximum recommended human dose did not reveal teratogenic or fetal toxic effects, although a slight decrease in fetal weight was observed.
In the rabbit, cefoxitin was associated with a high incidence of abortion and maternal death. This was not considered to be a teratogenic effect but an expected consequence of the rabbit’s unusual sensitivity to antibiotic-induced changes in the population of the microflora of the intestine.
🧒 Pediatric Use ▾
8.4Pediatric Use Safety and efficacy of this formulation are not established. This formulation of cefoxitin is indicated for use only in patients who require the entire 1 or 2 gram dose.
🧓 Geriatric Use ▾
8.5Geriatric Use Of the 1,775 subjects who received cefoxitin in clinical studies, 424 (24%) were 65 and over, while 124 (7%) were 75 and over. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out [ see Clinical Pharmacology (12.3 ) ] . 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.
Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function [ see Dosage and Administration (2. 3 ) , and Clinical Pharmacology (12.3) ] .
🆘 Overdosage ▾
10 OVERDOSAGE Information on overdosage with Cefoxitin for Injection and Dextrose Injection in humans is not available. If overdosage should occur, it should be treated symptomatically.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action Cefoxitin is an antibacterial drug [ see Microbiology (12.4) ] .
12.2Pharmacodynamics The pharmacodynamic properties of cefoxitin are unknown.
12.3Pharmacokinetics Absorption Following an intravenous dose of 1 gram, serum concentrations were 110 mcg/mL at 5 minutes, declining to less than 1 mcg/mL at 4 hours. Distribution Cefoxitin passes into pleural and joint fluids and is detectable in antibacterial concentrations in bile. Elimination Metabolism The half-life after an intravenous dose is 41 to 59 minutes.
Excretion Approximately 85 percent of cefoxitin is excreted unchanged by the kidneys over a 6-hour period, resulting in high urinary concentrations. Probenecid slows tubular excretion and produces higher serum levels and increases the duration of measurable serum concentrations. Specific Populations Geriatric Patients In a published study of geriatric patients ranging in age from 64 to 88 years with normal renal function for their age (creatinine clearance ranging from 31.5 to 174.0 mL/min), the half-life for cefoxitin ranged from 51 to 90 minutes, resulting in higher plasma concentrations than in younger adults.
These changes were attributed to decreased renal function associated with the aging process.
12.4Microbiology Mechanism of Action Cefoxitin is a bactericidal agent that acts by inhibition of bacterial cell wall synthesis. Cefoxitin has activity in the presence of some beta-lactamases, both penicillinases and cephalosporinases, of Gram-negative and Gram-positive bacteria. Resistance Resistance to Cefoxitin is primarily through hydrolysis by beta-lactamase, alteration of penicillin-binding proteins (PBPs), and decreased permeability.
Antimicrobial Activity Cefoxitin has been shown to be active against most isolates of the following microorganisms, both in vitro and in clinical infections [see Indications and Usage (1) ]. Gram-positive bacteria Staphylococcus aureus Staphylococcus epidermidis Streptococcus agalactiae Streptococcus pneumoniae Streptococcus pyogenes Gram-negative bacteria Escherichia coli Haemophilus influenzae Klebsiella spp. Morganella morganii Neisseria gonorrhoeae Proteus mirabilis Proteus vulgaris Providencia spp.
Anaerobic bacteria Clostridium spp. Peptococcus niger Peptostreptococcus spp. Bacteroides distasonis Bacteroides fragilis Bacteroides ovatus Bacteroides thetaiotaomicron Bacteroides spp.
The following in vitro data are available, but their clinical significance is unknown. At least 90 percent of the following bacteria exhibit an in vitro minimum inhibitory concentration (MIC) less than or equal to the susceptible breakpoint for cefoxitin against isolates of similar genus or organism group. However, the efficacy of cefoxitin in treating clinical infections caused by these bacteria has not been established in adequate and well-controlled clinical trials.
Gram-negative bacteria Eikenella corrodens [non- β-lactamase producers] Anaerobic bacteria Clostridium perfringens Prevotella bivia Susceptibility Testing For specific information regarding susceptibility test interpretive criteria, and associated test methods and quality control standards recognized by FDA for this drug, please see: http://www.fda.gov/STIC .
🧬 Mechanism of Action ▾
12.1Mechanism of Action Cefoxitin is an antibacterial drug [ see Microbiology (12.4) ] .
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied Cefoxitin for Injection and Dextrose Injection in the DUPLEX® Container is a flexible dual chamber single-dose container supplied in two concentrations. After reconstitution, the delivered doses are equivalent to 1 g and 2 g cefoxitin. The diluent chamber contains approximately 50 mL of Dextrose Injection.
Dextrose Injection has been adjusted to 4% w/v and 2.2% w/v for the 1 g and 2 g doses, respectively, such that the reconstituted solution is iso-osmotic. Cefoxitin for Injection and Dextrose Injection is supplied sterile and nonpyrogenic in the DUPLEX® Container packaged 24 units per case. NDC REF Dose Volume 0264-3123-11 3123-11 1 g 50 mL 0264-3125-11 3125-11 2 g 50 mL Not made with natural rubber latex, PVC or Di(2-ethylhexyl)phthalate (DEHP).
Storage Store the unactivated unit at 20-25°C (68-77°F). Excursions permitted to 15-30°C (59-86°F). [See USP Controlled Room Temperature.] Do not freeze. As with other cephalosporins, reconstituted Cefoxitin for Injection and Dextrose Injection tends to darken depending on storage conditions, within the stated recommendations.
However, product potency is not adversely affected. Use only if prepared solution is clear and free from particulate matter.
📋 Description ▾
11 DESCRIPTION Cefoxitin for Injection and Dextrose Injection is a sterile, nonpyrogenic, single-dose packaged combination of cefoxitin sodium USP and Dextrose Injection (diluent) in the DUPLEX ® sterile container. The DUPLEX ® Container is a flexible dual chamber container. The drug chamber is filled with cefoxitin sodium USP, a semi-synthetic, broad-spectrum cephalosporin antibacterial sealed under nitrogen for intravenous administration.
Cefoxitin sodium USP is derived from cephamycin C, which is produced by Streptomyces lactamdurans . Its chemical name is sodium (6 R ,7 S )-3-(hydroxymethyl)-7-methoxy-8-oxo-7-[2-(2-thienyl)acetamido]-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylate carbamate (ester). The empirical formula is C 16 H 16 N 3 NaO 7 S 2 , and the molecular weight is 449.44.
The structural formula is: Cefoxitin sodium contains approximately 53.8 mg (2.3 mEq) of sodium per gram of cefoxitin activity. The diluent chamber contains Dextrose Injection. The concentration of Dextrose Hydrous USP in Water for Injection USP has been adjusted to render the reconstituted drug product iso-osmotic.
Dextrose Hydrous USP has been added to adjust the osmolality to approximately 290 mOsmol/kg (approximately 2 g (4% w/v) and 1.1 g (2.2% w/v) to the 1 g and 2 g doses, respectively). Dextrose Injection is sterile, nonpyrogenic, and contains no bacteriostatic and antimicrobial agents. Dextrose Hydrous USP has the following structural (molecular) formula: The molecular weight of Dextrose Hydrous USP is 198.17.
After removing the peelable foil strip, activating the seals, and thoroughly mixing, the reconstituted drug product is intended for single intravenous use. When reconstituted according to instructions in the product labeling, the approximate osmolality of the reconstituted solution of Cefoxitin for Injection and Dextrose Injection is approximately 290 mOsmol/kg. After reconstitution, each 50 mL contains 1 gram of cefoxitin (equivalent to 1.05 gram of cefoxitin sodium) or 2 grams of cefoxitin (equivalent to 2.10 grams of cefoxitin sodium), with a pH of approximately 6.5.
Solutions of Cefoxitin for Injection and Dextrose Injection range from colorless to light amber. The DUPLEX® dual chamber container is made from a specially formulated material. The product (diluent and drug) contact layer is a mixture of thermoplastic rubber and a polypropylene ethylene copolymer that contains no plasticizers.
The safety of the container system is supported by USP biological evaluation procedures. Structural Formula illustration Molecular Formula illustration
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Allergic Reactions Inform patients that Cefoxitin for Injection and Dextrose Injection is a cephalosporin that can cause allergic reactions in some individuals [see Warnings and Precautions (5.1) ]. Clostridium difficile -Associated Diarrhea Inform patients that diarrhea is a common problem caused by antibacterials, including Cefoxitin for Injection and Dextrose Injection, and it usually ends when the antibacterial is discontinued. Sometimes after starting treatment with antibacterials, patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as 2 or more months after having taken their last dose of the antibacterial.
If this occurs, advise patients to contact their physician as soon as possible. Drug Resistance Patients should be counseled that antibacterial drugs including Cefoxitin for Injection and Dextrose Injection should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold).
When Cefoxitin for Injection and Dextrose Injection is prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may: (1) decrease the effectiveness of the immediate treatment, and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by Cefoxitin for Injection and Dextrose Injection or other antibacterial drugs in the future.