Data from FDA - Curated by EPG Health - Last updated 20 December 2016

Indication(s)

INDICATIONS AND USAGE 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 susceptible bacteria.

When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy.

In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

Treatment Cefoxitin for Injection and Dextrose Injection is indicated for the treatment of serious infections caused by susceptible strains of the designated microorganisms in the diseases listed below.

(1) 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.

(2) Urinary tract infections caused by Escherichia coli, Klebsiella species, Proteus mirabilis, Morganella morganii, Proteus vulgaris and Providencia species (including P. rettgeri).

(3) Intra-abdominal infections, including peritonitis and intra-abdominal abscess, caused by Escherichia coli, Klebsiella species, Bacteroides species including Bacteroides fragilis, and Clostridium species.

(4) 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, like cephalosporins, 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.

(5) Septicemia caused by Streptococcus pneumoniae, Staphylococcus aureus (including penicillinase-producing strains), Escherichia coli, Klebsiella species, and Bacteroides species including B. fragilis.

(6) Bone and joint infections caused by Staphylococcus aureus (including penicillinase-producing strains).

(7) 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.

Appropriate culture and susceptibility studies should be performed to determine the susceptibility of the causative organisms to cefoxitin.

Therapy may be started while awaiting the results of these studies.

In randomized comparative studies, cefoxitin and cephalothin were comparably safe and effective in the management of infections caused by Gram-positive cocci and Gram-negative rods susceptible to the cephalosporins.

Cefoxitin has a high degree of stability in the presence of bacterial beta-lactamases, both penicillinases and cephalosporinases.

Many infections caused by aerobic and anaerobic Gram-negative bacteria resistant to some cephalosporins respond to cefoxitin.

Similarly, many infections caused by aerobic and anaerobic bacteria resistant to some penicillin antibiotics (ampicillin, carbenicillin, penicillin G) respond to treatment with cefoxitin.

Many infections caused by mixtures of susceptible aerobic and anaerobic bacteria respond to treatment with cefoxitin.

Prevention

Cefoxitin 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 infection, specimens for culture should be obtained for identification of the causative organism so that appropriate treatment may be instituted.

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Advisory information

contraindications
CONTRAINDICATIONS Cefoxitin for Injection and Dextrose Injection is contraindicated in patients who have shown hypersensitivity to cefoxitin and the cephalosporin group of antibiotics. Solutions containing dextrose may be contraindicated in patients with hypersensitivity to corn products.
Special warnings and precautions

PRECAUTIONS General 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.

The total daily dose should be reduced when Cefoxitin for Injection and Dextrose Injection is administered to patients with transient or persistent reduction of urinary output due to renal insufficiency (see DOSAGE AND ADMINISTRATION), because high and prolonged serum antibiotic concentrations can occur in such individuals from usual doses.

Antibiotics (including cephalosporins) should be prescribed with caution in individuals with a history of gastrointestinal disease, particularly colitis.

As with other antibiotics, prolonged use of cefoxitin may result in overgrowth of nonsusceptible organisms.

Repeated evaluation of the patient 's condition is essential.

If superinfection occurs during therapy, appropriate measures should be taken.

As with other dextrose-containing solutions, Cefoxitin for Injection and Dextrose Injection should be prescribed with caution in patients with overt or known subclinical diabetes mellitus or carbohydrate intolerance for any reason.

If administration is controlled by a pumping device, care must be taken to discontinue pumping action before the container runs dry or air embolism may result.

Use only if solution is clear and container and seals are intact.

Information for Patients Diarrhea is a common problem caused by antibiotics which usually ends when the antibiotic is discontinued.

Sometimes after starting treatment with antibiotics, patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as two or more months after having taken the last dose of the antibiotic.

If this occurs, patients should contact their physician as soon as possible.

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.

Laboratory Tests As with any potent antibacterial agent, periodic assessment of organ system functions, including renal, hepatic, and hematopoietic, is advisable during prolonged therapy.

Drug Interactions Increased nephrotoxicity has been reported following concomitant administration of cephalosporins and aminoglycoside antibiotics.

Drug/Laboratory Test Interactions As with cephalothin, high concentrations of cefoxitin (>100 mcg/mL) may interfere with measurement of serum and urine creatinine levels by Jaff?

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.

This has been observed with CLINITEST® reagent tablets.

Carcinogenesis, Mutagenesis, Impairment of Fertility Long term studies in animals have not been performed with cefoxitin to evaluate carcinogenic or mutagenic potential.

Studies in rats treated intravenously with 400 mg/kg of cefoxitin (approximately three times the maximum recommended human dose) revealed no effects on fertility or mating ability.

Pregnancy Pregnancy Category B Reproduction studies performed in 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.

There are, however, no adequate and well-controlled studies in pregnant women.

Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

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.

Nursing

Mothers

Cefoxitin is excreted in human milk in low concentrations.

Caution should be exercised when cefoxitin is administered to a nursing woman.

Pediatric Use Safety and efficacy in pediatric patients from birth to three months of age have not yet been established.

In pediatric patients three months of age and older, higher doses of cefoxitin have been associated with an increased incidence of eosinophilia and elevated SGOT. Geriatric 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 can not be ruled out (see CLINICAL PHARMACOLOGY).

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 and PRECAUTIONS).

Adverse reactions

ADVERSE REACTIONS Cefoxitin is generally well tolerated.

The most common adverse reactions have been local reactions following intravenous injection.

Other adverse reactions have been encountered infrequently.

Local Reactions Thrombophlebitis has occurred with intravenous administration.

Allergic Reactions 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 Hypotension.

Gastrointestinal Diarrhea, including documented pseudomembranous colitis which can appear during or after antibiotic treatment.

Nausea and vomiting have been reported rarely.

Neuromuscular Possible exacerbation of myasthenia gravis.

Blood 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.

Liver Function Transient elevation in SGOT, SGPT, serum LDH, and serum alkaline phosphatase; and jaundice have been reported.

Renal Function Elevations in serum creatinine and/or blood urea nitrogen levels have been observed.

As with the cephalosporins, acute renal failure has been reported rarely.

The role of cefoxitin in changes in renal function tests is difficult to assess, since factors predisposing to prerenal azotemia or to impaired renal function usually have been present.

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 antibiotics: Urticaria, erythema multiforme, Stevens-Johnson syndrome, serum sickness-like reactions, abdominal pain, colitis, renal dysfunction, toxic nephropathy, false-positive test for urinary glucose, hepatic dysfunction including cholestasis, elevated bilirubin, aplastic anemia, hemorrhage, prolonged prothrombin time, pancytopenia, agranulocytosis, superinfection, vaginitis including vaginal candidiasis.

Several cephalosporins have been implicated in triggering seizures, particularly in patients with renal impairment when the dosage was not reduced.

(See DOSAGE AND ADMINISTRATION.

) If seizures associated with drug therapy occur, the drug should be discontinued.

Anticonvulsant therapy can be given if clinically indicated.

Usage information

Dosing and administration

DOSAGE AND ADMINISTRATION Cefoxitin for Injection and Dextrose Injection in the DUPLEX ® Container is intended for intravenous use only.

TREATMENT Adults 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 3 for dosage guidelines).

If C. trachomatis is a suspected pathogen, appropriate anti-chlamydial coverage should be added, because cefoxitin sodium has no activity against this organism.

Cefoxitin for Injection and Dextrose Injection may be used in patients with reduced renal function with the following dosage adjustments: In adults with renal insufficiency, an initial loading dose of 1 gram to 2 grams may be given.

After a loading dose, the recommendations for maintenance dosage (Table 4) 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)?

(140?

age) 72?

serum creatinine (mg/100 mL) Females: 0.85?

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 4.

Antibiotic 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.

Pediatric Patients The recommended dosage in pediatric patients three months of age and older is 80 to 160 mg/kg of body weight per day divided into four to six equal doses.

The higher dosages should be used for more severe or serious infections.

The total daily dosage should not exceed 12 grams.

At this time no recommendation is made for pediatric patients from birth to three months of age (see PRECAUTIONS).

In pediatric patients with renal insufficiency, the dosage and frequency of dosage should be modified consistent with the recommendations for adults (see Table 4).

PREVENTION 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 antibiotic 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: Adults 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.

Pediatric Patients (3 months and older) 30 to 40 mg/kg doses may be given at the times designated above.

Cesarean section patients 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.

) Table 3 - Guidelines for Dosage of Cefoxitin for Injection Type of Infection Daily Dosage Frequency and Route Uncomplicated formsIncluding 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 antibiotics in higher dosage (e.g., gas gangrene) 12 grams 2 grams every 4 hours or 3 grams every 6 hours IV Table 4 - Maintenance Dosage of Cefoxitin for Injection in Adults with Reduced Renal Function Renal Function Creatinine Clearance (mL/min) Dose (grams) Frequency Mild impairment 50-30 1-2 every 8-12 hours Moderate impairment 29-10 1-2 every 12-24 hours Severe impairment 9-5 0.5-1 every 12-24 hours Essentially no function <5 0.5-1 every 24-48 hours ADMINISTRATION The intravenous route is preferable for patients with bacteremia, bacterial septicemia, or other severe or life-threatening infections

or for patients who may be poor risks because of lowered resistance resulting from such debilitating conditions as malnutrition, trauma, surgery, diabetes, heart failure, or malignancy, particularly if shock is present or impending.

Cefoxitin for Injection and

Dextrose Injection may be administered through the tubing system by which the patient may be receiving other intravenous solutions.

However, during infusion of the solution containing Cefoxitin for Injection and Dextrose Injection, it is advisable to temporarily discontinue administration of any other solutions at the same site.

Solutions of Cefoxitin for Injection and Dextrose Injection, like those of most beta-lactam antibiotics, should not be added to aminoglycoside solutions (e.g., gentamicin sulfate, tobramycin sulfate, amikacin sulfate) because of potential interaction.

However, Cefoxitin for Injection and Dextrose Injection and aminoglycosides may be administered separately to the same patient.

CAUTION: Do not use plastic containers in series connections.

Such use would result in air embolism due to residual air being drawn from the primary container before administration of the fluid from the secondary container is complete.

NOTE: Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration.

DUPLEX® Drug Delivery System Directions for Use To avoid inadvertent activation, DUPLEX® Container should remain in the folded position until activation is intended.

Patient Labeling and Drug Powder/Diluent Inspection Apply patient-specific label on foil side of container.

USE CARE to avoid activation.

Do not cover any portion of foil strip with patient label.

Unlatch side tab and unfold Duplex® Container.

(See Diagram 1.)

Visually inspect diluent chamber for particulate matter.

Use only if container and seals are intact.

To inspect the drug powder for foreign matter or discoloration, peel foil strip from drug chamber.

(See Diagram 2.)

Protect from light after removal of foil strip.

Note:

If foil strip is removed, product must be used within 7 days, but not beyond the labeled expiration date.

The product should be re-folded and the side tab latched until ready to activate.

Reconstitution (

Activation) Do not use directly after storage by refrigeration, allow the product to equilibrate to room temperature before patient use.

Unfold the DUPLEX® Container and point the set port in a downward direction.

Starting at the hanger tab end, fold the DUPLEX® Container just below the diluent meniscus trapping all air above the fold.

To activate, squeeze the folded diluent chamber until the seal between the diluent and powder opens, releasing diluent into the drug powder chamber.

(See Diagram 3.)

Agitate the liquid-powder mixture until the drug powder is completely dissolved.

Note:

Following reconstitution (activation), product must be used within 12 hours if stored at room temperature or within 7 days if stored under refrigeration.

Administration Visually inspect the reconstituted solution for particulate matter.

Point the set port in a downwards direction.

Starting at the hanger tab end, fold the DUPLEX® Container just below the solution meniscus trapping all air above the fold.

Squeeze the folded

DUPLEX® Container until the seal between reconstituted drug solution and set port opens, releasing liquid to set port.

(See Diagram 4.)

Prior to attaching the IV set, check for minute leaks by squeezing container firmly.

If leaks are found, discard container and solution as sterility may be impaired.

Using aseptic technique, peel foil cover from the set port and attach sterile administration set.

(See Diagram 5.)

Refer to Directions for Use accompanying the administration set.

Precautions 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.

Do not use in series connection.

Do not introduce additives into the DUPLEX® Container.

Do not freeze.

Diagram 1 Diagram 2 Diagram 3 Diagram 4 Diagram 5

Pregnancy and lactation
Nursing Mothers Cefoxitin is excreted in human milk in low concentrations. Caution should be exercised when cefoxitin is administered to a nursing woman.

Interactions

Drug Interactions Increased nephrotoxicity has been reported following concomitant administration of cephalosporins and aminoglycoside antibiotics.

More information

Category Value
Authorisation number NDA065214
Orphan designation No
Product NDC 0264-3123,0264-3125
Date Last Revised 21-06-2013
Type HUMAN PRESCRIPTION DRUG
RXCUI 1665107
Storage and handling 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.]
Marketing authorisation holder B. Braun Medical Inc.