Cefotetan dosage and administration
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.
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.
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:0.9 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.
Directions for Use of CEFOTAN (cefotetan disodium for injection) in ADD-Vantage Vials:
To Open Diluent Container: Peel overwrap from the corner and remove container. Some opacity of the plastic due to moisture absorption during the sterilization process may be observed. This is normal and does not affect the solution quality or safety. The opacity will diminish gradually.
To Assemble ADD-Vantage Vial and Flexible Diluent Container: (Use Aseptic Technique)
1.Remove the protective covers from the top of the vial and the vial port on the diluent container as follows:
To remove the breakaway vial cap, swing the pull ring over the top of the vial and pull down far enough to start the opening (See Figure 1), then pull straight up to remove the cap. (See Figure 2.)
NOTE: Once the breakaway cap has been removed, do not access vial with syringe.
b.To remove the vial port cover, grasp the tab on the pull ring, pull up to break the three tie strings, then pull back to remove the cover. (See Figure 3.)
2.Screw the vial into the vial port until it will go no further. THE VIAL MUST BE SCREWED IN TIGHTLY TO ASSURE A SEAL. This occurs approximately 1/2 turn (180) after the first audible click. (See Figure 4.) The clicking sound does not assure a seal; the vial must be turned as far as it will go. NOTE:ONCE VIAL IS SEATED, DO NOT ATTEMPT TO REMOVE. (See Figure 4.).
3.Recheck the vial to assure that it is tight by trying to turn it further in the direction of assembly.
4.Label appropriately.
To Prepare Admixture:
1.Squeeze the bottom of the diluent container gently to inflate the portion of the container surrounding the end of the drug vial.
2.With the other hand, push the drug vial down into the container telescoping the walls of the container. Grasp the inner cap of the vial through the walls of the container. (See Figure 5.)
3.Pull the inner cap from the drug vial. (See Figure 6.) Verify that the rubber stopper has been pulled out and invert the system several times, allowing the drug and diluent to mix.
4.Mix contents thoroughly and use within the specified time.
Preparation For Administration: (Use Aseptic
Technique)
1.Confirm the activation and admixture of vial contents.
2.Check for leaks by squeezing container firmly. If leaks are found, discard unit as sterility may be impaired.
3.Close flow control clamp of administration set.
4.Remove cover from outlet port at bottom of container.
5.Insert piercing pin of administration set into port with a twisting motion until the pin is firmly seated.
NOTE: See full directions on administration set carton.
6.Lift the free end of the hanger loop on the bottom of the vial, breaking the two tie strings. Bend the loop outward to lock it in the upright position, then suspend container from hanger.
7.Squeeze and release drip chamber to establish proper fluid level in chamber.
8.Open flow control clamp and clear air from set. Close clamp.
9.Attach set to venipuncture device. If device is not indwelling, prime and make venipuncture.
10.Regulate rate of administration with flow control clamp.
WARNING:Do not use flexible container in series connections.
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.
CEFOTETAN INJECTION
Directions for Use of CEFOTAN (cefotetan injection) in Galaxy Plastic Container (PL 2040)
CEFOTAN (cefotetan injection) in Galaxy plastic container (PL 2040) is for intravenous administration only.
Storage:
Store in a freezer capable of maintaining a temperature of -20C/-4F.
Thawing of Plastic Container:
Thaw frozen container at room temperature (25C/77F) or in a refrigerator (5C/41F). 
Check for minute leaks by squeezing container firmly. If leaks are detected, discard solution as sterility may be impaired.
The container should be visually inspected. Components of the solution may precipitate in the frozen state and will dissolve upon reaching room temperature with little or no agitation. Potency is not affected. Agitate after solution has reached room temperature. If after visual inspection the solution remains cloudy or if an insoluble precipitate is noted or if any seals or outlet ports are not intact, the container should be discarded.
Preparation of Intravenous Use (Use aseptic technique):
1.Suspend container from eyelet support.
2.Remove protector from outlet port at bottom of container.
3.Attach administration set. Refer to complete directions accompanying set.
Caution: Do not use plastic containers in series connections. Such use could 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.
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.