Data from FDA - Curated by EPG Health - Last updated 20 December 2016
PRECAUTIONS General Prescribing Cefoxitin for Injection and Dextrose Injection in
Antibiotics (including cephalosporins) should be prescribed with
As with other antibiotics,
Repeated evaluation of the patient 's condition is essential.
If superinfection occurs during therapy,
As with other dextrose-containing solutions, Cefoxitin for Injection and Dextrose Injection should be prescribed with
If administration is controlled by a pumping device,
Use only if
Sometimes after starting treatment with antibiotics,
If this occurs, patients should contact their physician as soon as
Patients should be counseled that antibacterial drugs including Cefoxitin for Injection and Dextrose Injection should only be used to treat bacterial
They do not treat
When Cefoxitin for Injection and Dextrose Injection is prescribed to treat a bacterial
Skipping doses or not completing the full course of therapy may (1)
Laboratory Tests As with any
Drug/Laboratory Test Interactions As with cephalothin,
reaction, and produce
Serum samples from patients treated with cefoxitin should not be analyzed for creatinine if withdrawn within 2 hours of drug administration.
A false-positive reaction for glucose in the
This has been observed with CLINITEST® reagent tablets.
Pregnancy Pregnancy Category B Reproduction studies performed in
There are, however,
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
This was not considered to be a teratogenic effect but an expected consequence of the rabbit 's
Cefoxitin is excreted in human milk in low concentrations.
In pediatric patients three months of age and older, higher doses of cefoxitin have been associated with an
Because elderly patients are more likely to have
Local Reactions Thrombophlebitis has occurred with intravenous administration.
Gastrointestinal Diarrhea, including documented pseudomembranous colitis which can appear during or after antibiotic treatment.
Blood Eosinophilia, leukopenia including granulocytopenia, neutropenia, anemia, including hemolytic anemia, thrombocytopenia, and bone marrow
direct Coombs test may
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
As with the cephalosporins,
The role of cefoxitin in
In addition to the
Several cephalosporins have been implicated in triggering seizures, particularly in
(See DOSAGE AND ADMINISTRATION.
) If seizures associated with drug therapy occur,
Anticonvulsant therapy can be given if clinically indicated.
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
If C. trachomatis is a suspected pathogen,
Cefoxitin for Injection and Dextrose Injection may be used in patients with
After a loading dose, the
The serum creatinine should represent a
Males: Weight (kg)?
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
In staphylococcal and other
Pediatric Patients The
The higher dosages should be used for more
At this time
Cefoxitin for Injection and Dextrose Injection usually should be given one-half to one hour before the operation, which is
Prophylactic administration should usually be stopped within 24 hours since continuing
For prophylactic use in uncontaminated gastrointestinal surgery, vaginal hysterectomy, or abdominal hysterectomy,
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
(See CLINICAL STUDIES.
) Table 3 - Guidelines for Dosage of Cefoxitin for Injection Type of
or for patients who may be
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
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.
Such use would result in air embolism due to residual air being drawn from the primary container before
NOTE: Parenteral drug products should be inspected visually for particulate matter and
DUPLEX® Drug Delivery System Directions for Use To avoid
Patient Labeling and Drug Powder/Diluent Inspection Apply patient-specific label on foil side of container.
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
To inspect the drug powder for foreign matter or
(See Diagram 2.)
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.
Activation) Do not
Unfold the DUPLEX® Container and point the set port in a
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.
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
If leaks are found,
Using aseptic technique, peel foil cover from the set port and attach
(See Diagram 5.)
Refer to Directions for Use accompanying the administration set.
Precautions As with other cephalosporins,
Use only if
Do not introduce additives into the DUPLEX® Container.
Do not freeze.
Diagram 1 Diagram 2 Diagram 3 Diagram 4 Diagram 55>
|Date Last Revised||21-06-2013|
|Type||HUMAN PRESCRIPTION DRUG|
|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.|