Cefoxitin

Cefoxitin for 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 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 1gram to 2 grams should be given after each hemodialysis, and the maintenance dose should be given as indicated in Table 2.

Guidelines for Dosage of Cefoxitin for Injection [See table below.] *Including patients in whom bacteremia is absent or unlikely. Table 2. Maintenance Dosage of Cefoxitin for Injection in Adults with Reduced [See table below.] Table 3. Preparation of Solution for Intravenous Administration [See table below.] **Shake to dissolve and let stand until clear.

Preparation of Solution Table 3 is provided for convenience in constituting Cefoxitin for Injection for intravenous administration. For Vials One gram should be constituted with at least 10 mL, and 2 grams with 10 mL or 20 mL, of Sterile Water for Injection, Bacteriostatic Water for Injection, 0.9 percent Sodium Chloride Injection, or 5 percent Dextrose Injection.

These primary solutions may be further diluted in 50 mL to 1000 mL of the diluents listed under the Vials portion of the Compatibility and Stability section. Benzyl alcohol as a preservative has been associated with toxicity in neonates. While toxicity has not been demonstrated in pediatric patients greater than 3 months of age, in whom use of Cefoxitin for Injection may be indicated, small pediatric patients in this age range may also be at risk for benzyl alcohol toxicity.

Therefore, diluent containing benzyl alcohol should not be used when Cefoxitin for Injection is constituted for administration to pediatric patients in this age range. Administration Cefoxitin for Injection may be administered intravenously after constitution. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.

For intermittent intravenous administration, a solution containing 1 gram or 2 grams in 10 mL of Sterile Water for Injection can be injected over a period of 3 to 5 minutes. Using an infusion system, it may also be given over a longer 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 for Injection, it is advisable to temporarily discontinue administration of any other solutions at the same site. For the administration of higher doses by continuous intravenous infusion, a solution of Cefoxitin for Injection may be added to an intravenous bottle containing 5 percent Dextrose Injection, 0.9 percent Sodium Chloride Injection, or 5 percent Dextrose and 0.9 percent Sodium Chloride Injection.

BUTTERFLY ®†† or scalp vein-type needles are preferred for this type of infusion. 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 for Injection and aminoglycosides may be administered separately to the same patient.

Compatibility and Stability Vials Cefoxitin for Injection, as supplied in vials and constituted to 1 gram/10 mL with Sterile Water for Injection, Bacteriostatic Water for Injection, (see Preparation of Solution), 0.9 percent Sodium Chloride Injection, or 5 percent Dextrose Injection, maintains satisfactory potency for 6 hours at room temperature or for one week under refrigeration (below 5ºC).

These primary solutions may be further diluted in 50 mL to 1000 mL of the following diluents and maintain potency for an additional 18 hours at room temperature or an additional 48 hours under refrigeration: 0.9 percent Sodium Chloride Injection 5 percent or 10 percent Dextrose Injection 5 percent Dextrose and 0.9 percent Sodium Chloride Injection 5 percent Dextrose Injection with 0.2 percent or 0.45 percent saline solution Lactated Ringer’s Injection 5 percent Dextrose in Lactated Ringer’s Injection 5 percent Sodium Bicarbonate Injection M/6 sodium lactate solution Mannitol 5% and 10% After the periods mentioned above, any unused solutions should be discarded.