Cefotan (Page 5 of 6)

Prophylaxis

To prevent postoperative infection in clean contaminated or potentially contaminated surgery in adults, the recommended dosage is 1 or 2 g of CEFOTAN ^® (cefotetan for Injection, USP) 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
Creatinine Clearance mL/min	Dose	Frequency
Greater than 30	Usual Recommended Dosage*	Every 12 hours
10 to 30	Usual Recommended Dosage*	Every 24 hours
Less than 10	Usual Recommended Dosage*	Every 48 hours

* Dose determined by the type and severity of infection, and susceptibility of the causative organism.

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 to 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.

Preparation of Solution

For Intravenous Use

Reconstitute with Sterile Water for Injection. Shake to dissolve and let stand until clear.

Vial Size	Amount of Diluent Added (mL)	Approximate Withdrawable Volume (mL)	Approximate Average Concentration (mg/mL)
1 gram	10	10.5	95
2 gram	10 to 20	11 to 21	182 to 95

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.

Vial Size	Amount of Diluent Added (mL)	Approximate Withdrawable Volume (mL)	Approximate Average Concentration (mg/mL)
1 gram	2	2.5	400
2 gram	3	4	500

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 for Injection, USP) 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 for Injection, USP), it is advisable to discontinue temporarily the administration of other solutions at the same site.

NOTE: Solutions of cefotetan 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 for Injection, USP) should be injected well within the body of a relatively large muscle such as the upper outer quadrant of the buttock (i.e., gluteus maximus); aspiration is necessary to avoid inadvertent injection into a blood vessel.

Compatibility and Stability

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^® (cefotetan for Injection, USP) must not be admixed with solutions containing aminoglycosides. If CEFOTAN^® (cefotetan for Injection, USP) 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.

CEFOTAN^® (cefotetan for Injection, USP) reconstituted as described above (see DOSAGE AND ADMINISTRATION,Preparation of Solution) maintains satisfactory potency for 24 hours at room temperature (25ºC/77ºF), for 96 hours under refrigeration (5ºC/41ºF), and for at least 1 week in the frozen state (-20ºC/-4ºF). After reconstitution and subsequent storage in disposable glass or plastic syringes, CEFOTAN^® (cefotetan for Injection, USP) is stable for 24 hours at room temperature and 96 hours under refrigeration.

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