Cefoxitin and Dextrose (Page 2 of 6)

2.3 Dosage 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 Cefoxitin for Injection in Adults with Renal Impairment
Renal Function	Creatinine Clearance (mL/min)	Dose (grams)	Frequency
Mild impairmentModerate impairmentSevere impairmentEssentially no function	50-3029-109-5<5	1-21-20.5-10.5-1	every 8-12 hoursevery 12-24 hoursevery 12-24 hoursevery 24-48 hours

2.4 Preparation and Administration of Cefoxitin for Injection and Dextrose Injection in DUPLEX® Container

Important Administration Instructions

• This reconstituted solution is for intravenous use only.

• Administer Cefoxitin for Injection and Dextrose Injection intravenously over approximately 30 minutes.

• Do not use 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. 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.

• Do not introduce additives into the DUPLEX® Container.

• 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.

• Cefoxitin for Injection and Dextrose Injection, like 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.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

Use only if solution is clear and free from particulate matter and container and seals are intact. 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.

DUPLEX® Container Storage

• 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, the container should be re-folded and the side tab latched until ready to activate. The product must then be used within 7 days, but not beyond the labeled expiration date.

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 compromised.

• 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.

• Discard unused portions.

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

4 CONTRAINDICATIONS

4.1 Hypersensitivity 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).

4.2 Hypersensitivity to Corn Products

Solutions containing dextrose may be contraindicated in patients with hypersensitivity to corn products.

5 WARNINGS AND PRECAUTIONS