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Usual Diluents
D5W, NS
Standard Dilutions [Amount of drug] [Infusion volume] [Infusion rate]
[0 to 1 gram] [50 ml] [30 min] [ Over 1 gram] [100 ml] [30 min]
Stability / Miscellaneous
Label: Refrigerate.
Stability data:
Drug
Stability Refrigerated
Stability Room Temp.
Reconstituted Vial/Powder
Notes
Cefoxitin Powder
In the dry state should be stored between 2° to 25°C (36° to 77°F). Avoid exposure to temperatures above 50°C.
As supplied in vials and constituted to 1 gram/10 mL with Sterile Water for Injection, Bacteriostatic Water for Injection, 0.9 percent Sodium Chloride Injection, or 5 percent Dextrose Injection, maintains satisfactory potency for one week under refrigeration (below 5°C).
These primary solutions may be further diluted in 50 to 1000 mL of the following diluents and maintain potency for an additional 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.
In the dry state should be stored between 2° to 25°C (36° to 77°F). Avoid exposure to temperatures above 50°C.
As supplied in vials and constituted to 1 gram/10 mL with Sterile Water for Injection, Bacteriostatic Water for Injection, 0.9 percent Sodium Chloride Injection, or 5 percent Dextrose Injection, maintains satisfactory potency for 6 hours at room temperature.
These primary solutions may be further diluted in 50 to 1000 mL of the following diluents and maintain potency for an additional 18 hours at room temperature:
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.
Powder
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.
The dry material as well as solutions tend to darken, depending on storage conditions; product potency, however, is not adversely affected.
DOSAGE AND ADMINISTRATION 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 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.
MEFOXIN 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 male 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 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.
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 Effective prophylactic use depends on the time of administration. MEFOXIN 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. Table 1: Guidelines for Dosage of MEFOXIN
Type of Infection
Daily Dosage
Frequency and Route
*Including patients in whom bacteremia is absent or unlikely.
Uncomplicated forms* 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 2: Maintenance Dosage of MEFOXIN 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
Table 3: Preparation of Solution for Intravenous Administration
Strength
Amount of Diluent to be Added (mL)*
Approximate Withdrawable Volume (mL)
Approximate Average Concentration (mg/mL)
*Shake to dissolve and let stand until clear.
1 gram Vial
10
10.5
95
2 gram Vial
10 or 20
11.1 or 21.0
180 or 95
1 gram Infusion Bottle
50 or 100
50 or 100
20 or 10
2 gram Infusion Bottle
50 or 100
50 or 100
40 or 20
10 gram Bulk
43 or 93
49 or 98.5
200 or 100
PREPARATION OF SOLUTION Table 3 is provided for convenience in constituting MEFOXIN for intravenous administration.
For Vials One gram should be constituted with at least 10 mL, and 2 grams with 10 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 to 1000 mL of the diluents listed under the Vials and Bulk Packages portion of the COMPATIBILITY AND STABILITY section.
For Bulk Packages The 10 gram bulk packages should be constituted with 43 or 93 mL of Sterile Water for Injection, Bacteriostatic Water for Injection, 0.9 percent Sodium Chloride Injection, or 5 percent Dextrose Injection. CAUTION: THE 10 GRAM BULK STOCK SOLUTION IS NOT FOR DIRECT INFUSION. These primary solutions may be further diluted in 50 to 1000 mL of the diluents listed under the Vials and Bulk Packages 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 three months of age, in whom use of MEFOXIN 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 MEFOXIN is constituted for administration to pediatric patients in this age range.
For Infusion Bottles One or 2 grams of MEFOXIN for infusion may be constituted with 50 or 100 mL of 0.9 percent Sodium Chloride Injection, or 5 percent or 10 percent Dextrose Injection.
For ADD-Vantage® Vials Registered trademark of Abbott Laboratories, Inc.
See separate INSTRUCTIONS FOR USE OF MEFOXIN IN ADD-Vantage® VIALS. MEFOXIN in ADD-Vantage® vials should be constituted with ADD-Vantage® diluent containers containing 50 mL or 100 mL of either 0.9 percent Sodium Chloride Injection or 5 percent Dextrose Injection. MEFOXIN in ADD-Vantage® vials is for IV use only.
ADMINISTRATION MEFOXIN 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.
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, a solution containing 1 gram or 2 grams in 10 mL of Sterile Water for Injection can be injected over a period of three to five 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 MEFOXIN, 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 MEFOXIN 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®4 or scalp vein-type needles are preferred for this type of infusion.
Solutions of MEFOXIN, 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, MEFOXIN and aminoglycosides may be administered separately to the same patient.
COMPATIBILITY AND STABILITY Vials and Bulk Packages MEFOXIN, as supplied in vials or the bulk package 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 5°C).
These primary solutions may be further diluted in 50 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%
Infusion Bottles MEFOXIN, as supplied in infusion bottles and constituted with 50 to 100 mL of 0.9 percent Sodium Chloride Injection, or 5 percent or 10 percent Dextrose Injection, maintains satisfactory potency for 24 hours at room temperature or for 1 week under refrigeration (below 5°C).
ADD-Vantage® Vials MEFOXIN is supplied in single dose ADD-Vantage® vials and should be prepared as directed in the accompanying INSTRUCTIONS FOR USE OF MEFOXIN IN ADD-Vantage® VIALS using ADD-Vantage® diluent containers containing 50 mL or 100 mL of either 0.9 percent Sodium Chloride Injection or 5 percent Dextrose Injection. When prepared with either of these diluents, MEFOXIN maintains satisfactory potency for 24 hours at room temperature.
After the periods mentioned above, any unused solutions should be discarded.
HOW SUPPLIED
Sterile MEFOXIN is a dry white to off-white powder supplied in vials and infusion bottles containing cefoxitin sodium as follows:
No. 3356 — 1 gram cefoxitin equivalent NDC 0006-3356-45 in trays of 25 vials. No. 3357 — 2 gram cefoxitin equivalent NDC 0006-3357-53 in trays of 25 vials. No. 3388 — 10 gram cefoxitin equivalent NDC 0006-3388-67 in trays of 6 bulk bottles. No. 3548 — 1 gram cefoxitin equivalent NDC 0006-3548-45 in trays of 25 ADD-Vantage® vials. No. 3549 — 2 gram cefoxitin equivalent NDC 0006-3549-53 in trays of 25 ADD-Vantage® vials.
Special storage instructions MEFOXIN in the dry state should be stored between 2-25°C (36-77°F). Avoid exposure to temperatures above 50°C. The dry material as well as solutions tend to darken, depending on storage conditions; product potency, however, is not adversely affected.
Merck & CO., INC., Whitehouse Station, NJ 08889, USA Issued October 2006 7882343
