Cefoxitin (Page 3 of 4)

OVERDOSAGE:

The acute intravenous LD50 in the adult female mouse and rabbit was about 8 grams/kg and greater than 1 gram/kg, respectively. The acute intraperitoneal LD50 in the adult rat was greater than 10 grams/kg.

DOSAGE AND ADMINISTRATION

Cefoxitin for Injection USP, Pharmacy Bulk Package bag SmartPak® should be used only in patients who require a 1 gram dose and not any fraction thereof.

Cefoxitin for Injection USP, Pharmacy Bulk Package bag SmartPak® should not be used in patients who require less than the 1 gram dose of cefoxitin.

THE INTENT OF THIS PHARMACY BULK PACKAGE IS FOR THE PREPARATION OF SOLUTIONS FOR INTRAVENOUS INFUSION ONLY. BEFORE ADMINISTRATION, THIS PHARMACY BULK PACKAGE REQUIRES RECONSTITUTION TO A CONCENTRATION OF 100 MG/ML AND FURTHER DILUTION IN 50 mL OF A COMPATIBLE SOLUTION.

THIS IS A PHARMACY BULK PACKAGE – NOT FOR DIRECT INJECTION

USE THIS FORMULATION OF CEFOXITIN ONLY IN PATIENTS WHO REQUIRE A 1 GRAM DOSE.

Treatment

Adults

Cefoxitin for Injection, USP, Pharmacy Bulk Package bag SmartPak® should be used only in patients who require a 1 gram dose and not any fraction thereof.

Cefoxitin for Injection USP, Pharmacy Bulk Package bag SmartPak® should not be used in patients who require less than the 1 gram dose of cefoxitin.

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).

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

This formulation of Cefoxitin for Injection USP, Pharmacy Bulk Package SmartPak® should not be used in patients who require less than the 1 gram dose of cefoxitin.

Cefoxitin for Injection may be used in patients with reduced renal function with the following dosage adjustments:

In adults with renal insufficiency , Cefoxitin for Injection, USP, Pharmacy Bulk Package bag SmartPak® should be used only in patients who require a 1 gram dose and not any fraction thereof. Cefoxitin for Injection USP, Pharmacy Bulk Package bag SmartPak® should not be used in patients with renal impairment who require less than the 1 gram dose of cefoxitin. 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.

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

Cefoxitin for Injection, USP, Pharmacy Bulk Package bag SmartPak® should be used only in patients who require a 1 gram dose and not any fraction thereof. Cefoxitin for Injection USP, Pharmacy Bulk Package bag SmartPak® should not be used in pediatric patients who require less than the 1 gram dose of cefoxitin.

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 2).

Prevention

Cefoxitin for Injection, USP, Pharmacy Bulk Package bag SmartPak® should be used only in patients who require a 1 gram dose and not any fraction thereof. Cefoxitin for Injection USP, Pharmacy Bulk Package bag SmartPak® should not be used in patients who require less than the 1 gram dose of cefoxitin.

Effective prophylactic use depends on the time of administration. Cefoxitin for 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:

Cefoxitin for Injection USP, Pharmacy Bulk Package bag SmartPak® should be used only in patients who require a 1 gram dose and not any fraction thereof. Cefoxitin for Injection USP, Pharmacy Bulk Package bag SmartPak® should not be used in patients who require less than the 1 gram dose of cefoxitin.

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 1. Guidelines for Dosage of Cefoxitin for Injection

* Including patients in whom bacteremia is absent or unlikely.

Cefoxitin for Injection USP, Pharmacy Bulk Package bag SmartPak® should be used only in patients who require a 1 gram dose and not any fraction thereof.

Cefoxitin for Injection USP, Pharmacy Bulk Package bag SmartPak® should not be used in patients who require less than the 1 gram dose of cefoxitin.

Type of Infection Daily Dosage Frequency and Route
Uncomplicated forms* of infections such as pneumonia, urinary tract infection, cutaneous infection3 to 4 grams1 gram every 6 to 8 hours I.V.
Moderately severe or severe infections6 to 8 grams1 gram every 4 hoursor 2 grams every 6 to 8 hours I.V.
Infections commonly needing antibiotics in higher dosage (e.g., gas gangrene)12 grams2 grams every 4 hoursor 3 grams every 6 hours I.V.

Renal Impairment

Cefoxitin for Injection USP, Pharmacy Bulk Package bag SmartPak® should be used only in patients who require a 1 gram dose and not any fraction thereof.

Cefoxitin for Injection USP, Pharmacy Bulk Package bag SmartPak® should not be used in patients with renal impairment who require less than the 1 gram dose of cefoxitin.

Table 2. Maintenance Dosage of Cefoxitin for Injection in Adults with Reduced Renal Function
Renal FunctionCreatinineClearance(mL/min)Dose(grams)Frequency
Mild impairmentModerate impairmentSevere impairmentEssentially no function50 to 3029 to 109 to 5<51 to 21 to 20.5 to 10.5 to 1Every 8 to 12 hoursEvery 12 to 24 hoursEvery 12 to 24 hoursEvery 24 to 48 hours

Cefoxitin for Injection, USP, Pharmacy Bulk Package bag SmartPak® should be used only in patients who require a 1 gram dose and not any fraction thereof.

Cefoxitin for Injection USP, Pharmacy Bulk Package bag SmartPak® should not be used in patients who require less than the 1 gram dose of cefoxitin.

Directions for Proper Use of a Pharmacy Bulk Package

  • NOT FOR DIRECT INFUSION. The Pharmacy Bulk Package is for use in the hospital pharmacy admixture service only in a suitable work area, such as a laminar flow hood. Using aseptic technique, the container closure may be penetrated only one time after reconstitution using a suitable sterile dispensing set or transfer device that allows measured dispensing of the contents. Use of a syringe and needle is not recommended as it may cause leakage. The withdrawal of container contents should be accomplished without delay. However, should this not be possible, a maximum time of 4 HOURS from initial reconstitution port closure entry is permitted to complete fluid transfer operations. This time limit should begin with the introduction of the solvent or diluent into the Pharmacy Bulk Package. Discard any unused portion after 4 HOURS. This pharmacy bulk package is not intended to be dispensed as a unit.
  • PRIOR TO RECONSTITUTION: DO NOT USE THE INNER BAG IF PARTICULATE OR FOREIGN MATTER IS PRESENT, IF THE DRY POWDER IS DARK YELLOW OR BROWN, IF THE SEALS ARE NOT INTACT, OR IF THERE IS ANY OTHER DAMAGE TO THE BAG. IN SUCH CASES, DISCARD THE BAG IMMEDIATELY.
  • After initial reconstitution port entry, use entire contents of the Pharmacy Bulk Package promptly. Any unused portion must be discarded after 4 HOURS.
  • Gather the following items prior to the reconstitution of the product: Appropriate number of bags of Sterile Water for Injection and, depending upon the method of filling, appropriate sterile tubing and adapters.

INSTRUCTION FOR RECONSTITUTION OF THE PHARMACY BULK PACKAGE BAG SmartPak®

The entire contents of the bag and the preparation process (reconstitution and dilution) should be completed within 4 hours of initial entry.

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  • Document the date and time reconstitution starts in the designated place on the container label. The entire contents of the bag must be used within 4 hours from the time of initial entry.
  • Remove the translucent unthreaded cap from the reconstitution (smaller) port and discard it.
  • Reconstitute the powder through the reconstitution (smaller) port, using Sterile Water for Injection according to the table below.
Table 3. RECONSTITUTION TABLE
SmartPak® Bag SizeAmount of Sterile WaterApproximate Concentration
100 grams930 mL100 mg/mL(1 gram/10 mL)
  • After reconstitution is complete, remove the transfer needle from the reconstitution port.
  • Place the bag on a flat surface of a laminar flow hood and mix for at least 15 minutes by rocking gently from side to side. CAUTION: To avoid possible leakage caused by the heavy weight of the added water, do not shake vigorously or pull strongly on the bag.
  • When foam dissipates, visually inspect the bag to verify the solution is clear, colorless to pale yellow and free of particulate matter. DO NOT USE THE INNER BAG IF PARTICULATE OR FOREIGN MATTER IS PRESENT.
  • Unscrew the clear threaded cap from the transfer (larger) port and discard it. Attach sterile tubing and filling adapter unit to the transfer port.
  • Reconstituted solution can now be transferred using the transfer port and the filling adapter.

It should be noted that the spike placed into the transfer port of the Pharmacy Bulk Package SmartPak® is NEVER removed during this procedure and that the reconstitution port is self-sealing.

Dilution

  • Hang the bag from two eyelets.
  • Following reconstitution, transfer 10 mL of the reconstituted solution into transfusion bags, each containing 50 mL of one of the compatible solutions below.

Compatible solutions for dilution are the following:

Sodium Chloride Injection, USP

5% Dextrose Injection, USP

  • Dilution should be completed within the 4 hour preparation process.
  • When diluted according to the instructions above, cefoxitin is stable for 18 hours at room temperature or for 48 hours if stored under refrigeration (5°C or 41°F).

After the periods mentioned above, any unused solutions should be discarded.

Administration

This formulation of Cefoxitin for Injection USP, Pharmacy Bulk Package SmartPak® is for intravenous infusion only after reconstitution.

Parenteral products should be inspected visually for particulates and discoloration prior to administration whenever solution and container permit.

Intravenous 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.

For intermittent intravenous administration: Using an infusion system, a solution containing 1 gram or 2 grams may be given over a period of time through the tubing system by which the patient may be receiving other intravenous solutions. However, during infusion of the solution containing cefoxitin, it is advisable to temporarily discontinue administration of any other solutions at the same site.

Solutions of Cefoxitin for 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 and aminoglycosides may be administered separately to the same patient.

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