IV Dilution &
Medication Reference

CEFOTETAN (CEFOTAN ®)

Usual Diluents

Standard Dilutions [Amount of drug] [Infusion volume] [Infusion rate]

Stability / Miscellaneous

Label: Refrigerate.
Maximum dose: 3 grams ivpb q12h.

DOSAGE AND ADMINISTRATION
Treatment
Cefotetan injection in Galaxy® plastic container should not be used for intramuscular administration.

CEFOTAN in the ADD-Vantage Vial is intended for intravenous infusion only, after dilution with the appropriate volume of ADD-Vantage diluent solution.

The usual adult dosage is 1 or 2 grams of CEFOTAN (cefotetan disodium for injection) administered intravenously or intramuscularly or CEFOTAN (cefotetan injection) in the Galaxy® plastic container (PL 2040) administered intravenously every 12 hours for 5 to 10 days. Proper dosage and route of administration should be determined by the condition of the patient, severity of the infection, and susceptibility of the causative organism.

General Guidelines for Dosage of CEFOTAN

If Chlamydia trachomatis is a suspected pathogen in gynecologic infections, appropriate antichlamydial coverage should be added, since cefotetan has no activity against this organism.

Prophylaxis:
To prevent postoperative infection in clean contaminated or potentially contaminated surgery in adults, the recommended dosage is 1 or 2 g of CEFOTAN administered once, intravenously, 30 to 60 minutes prior to surgery. In patients undergoing cesarean section, the dose should be administered as soon as the umbilical cord is clamped.

Impaired Renal Function
When renal function is impaired, a reduced dosage schedule must be employed. The following dosage guidelines may be used.
DOSAGE GUIDELINES FOR PATIENTS WITH IMPAIRED RENAL FUNCTION

Alternatively, the dosing interval may remain constant at 12 hour intervals, but the dose reduced to one-half the usual recommended dose for patients with a creatinine clearance of 10-30 mL/min, and one-quarter the usual recommended dose for patients with a creatinine clearance of less than 10 mL/min.

When only serum creatinine levels are available, creatinine clearance may be calculated from the following formula. The serum creatinine level 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 value for males

Cefotetan is dialyzable and it is recommended that for patients undergoing intermittent hemodialysis, one-quarter of the usual recommended dose be given every 24 hours on days between dialysis and one-half the usual recommended dose on the day of dialysis.

CEFOTETAN DISODIUM FOR INJECTION
Preparation of Solution From Cefotetan Disodium For Injection:

For Intravenous Use:
Reconstitute with Sterile Water for Injection. Shake to dissolve and let stand until clear.

Infusion bottles (100 mL) may be reconstituted with 50 to 100 mL of Dextrose Injection 5% or Sodium Chloride Injection 0.9%.

NOTE: ADD-VANTAGE VIALS ARE NOT TO BE USED IN THIS MANNER

For ADD-Vantage Vials: ADD-Vantage Vials of CEFOTAN are to be reconstituted only with Sodium Chloride Injection 0.9% or Dextrose Injection 5% in the 50 mL, 100 mL or 250 mL Flexible Diluent Containers. CEFOTAN supplied in single-use ADD-Vantage Vials should be prepared as directed.

For Intramuscular Use:
Reconstitute with Sterile Water for Injection; Bacteriostatic Water for Injection; Sodium Chloride Injection 0.9%, USP; 0.5% Lidocaine HCl; or 1% Lidocaine HCl. Shake to dissolve and let stand until clear.

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 of CEFOTAN (cefotetan disodium for injection) in Sterile Water for Injection can be injected over a period of three to five minutes. Using an infusion system, the solution may also be given over a longer period of time through the tubing system by which the patient may be receiving other intravenous solutions. Butterfly® or scalp vein-type needles are preferred for this type of infusion. However, during infusion of the solution containing CEFOTAN (cefotetan disodium for injection), it is advisable to discontinue temporarily the administration of other solutions at the same site.

NOTE: Solutions of CEFOTAN must not be admixed with solutions containing aminoglycosides. If CEFOTAN and aminoglycosides are to be administered to the same patient, they must be administered separately and not as a mixed injection.

Intramuscular Administration
As with all intramuscular preparations, CEFOTAN (cefotetan disodium for injection) should be injected well within the body of a relatively large muscle such as the upper outer quadrant of the buttock (ie, gluteus maximus); aspiration is necessary to avoid inadvertent injection into a blood vessel.

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.

Using an infusion system, CEFOTAN (cefotetan injection) in Galaxy® plastic container (PL 2040) should be given over 20 to 60 minutes through the tubing system by which the patient may be receiving other intravenous solutions. Butterfly® or scalp vein-type needles are preferred for this type of infusion. However, during infusion of the solution containing CEFOTAN (cefotetan injection) in Galaxy® plastic container (PL 2040), it is advisable to discontinue temporarily the administration of other solutions at the same site.

Compatibility and Stability of CEFOTAN Products:
Frozen samples should be thawed at room temperature before use. After the periods mentioned below, any unused solutions or frozen material should be discarded. DO NOT REFREEZE.

NOTE: Solutions of CEFOTAN must not be admixed-with solutions containing aminoglycosides. If CEFOTAN and aminoglycosides are to be administered to the same patient, they must be administered separately and not as a mixed injection. DO NOT ADD SUPPLEMENTARY MEDICATION.

CEFOTEAN DISODIUM FOR INJECTION
CEFOTAN (cefotetan disodium for injection) reconstituted as described above (PREPARATION OF SOLUTION) maintains satisfactory potency for 24 hours at room temperature (25°C/77°F), for 96 hours under refrigeration (5°C/41°F), and for at least 1 week in the frozen state (-20°C/-4°F). After reconstitution and subsequent storage in disposable glass or plastic syringes, CEFOTAN (cefotetan disodium for injection) is stable for 24 hours at room temperature and 96 hours under refrigeration.

ADD-Vantage Vials
Ordinarily, ADD-Vantage Vials should be reconstituted only when it is certain that the patient is ready to receive the drug. However, ADD-Vantage Vials of CEFOTAN reconstituted as described in Preparation of Solution, for ADD-Vantage Vials, maintains satisfactory potency for 24 hours at room temperature (25°C/77°F).

(DO NOT REFRIGERATE OR FREEZE CEFOTAN IN ADD-VANTAGE VIALS.)

CEFOTETAN INJECTION
The thawed solution in Galaxy® plastic container (PL 2040) remains chemically stable for 48 hours at room temperature (25°C/77°F) or for 21 days under refrigeration (5°C/41°F).

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

HOW SUPPLIED
CEFOTAN (cefotetan disodium for injection) is a dry, white to pale yellow powder supplied in vials containing cefotetan disodium equivalent to 1 g and 2 g cefotetan activity for intravenous and intramuscular administration. The vials should not be stored at temperatures above 22°C (72°F) and should be protected from light.

1 g ADD-Vantage Vial (NDC 0310-0376-31)
2 g ADD-Vantage Vial (NDC 0310-0377-32)
1 g Vial (NDC 0310-0376-10)
2 g Vial (NDC 0310-0377-20)
1 g Piggyback Vial (NDC 0310-0376-11)
2 g Piggyback Vial (NDC 0310-0377-21)

CEFOTAN is also available as a 10 g pharmacy bulk package.
10 g in 100 mL Vial (NDC 0310-0375-10)

CEFOTAN (cefotetan injection) is supplied as a frozen, iso-osmotic, premixed solution in single dose Galaxy® plastic containers (PL 2040) as follows:

1 g in 50 mL plastic container (NDC 0310-0378-51)
2 g in 50 mL plastic container (NDC 0310-0379-51)
Store containers at or below -20°C/-4°F.

© AstraZeneca 2002, 2004
CEFOTAN® (cefotetan injection) in Galaxy® plastic container (PL 2040) is manufactured by Baxter Healthcare Corporation, Deerfield, Illinois 60015 USA for AstraZeneca Pharmaceuticals LP.

CEFOTAN® (cefotetan disodium for injection) is manufactured by GlaxoSmithKline for:
AstraZeneca Pharmaceuticals LP, Wilmington, DE 19850
Rev 01/04 SIC 64173-03