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CEFOTETAN (CEFOTAN ®)
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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
DOSAGE AND 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.
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)]
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
For Intravenous Use:
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:
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.
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:
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
(DO NOT REFRIGERATE OR FREEZE CEFOTAN IN ADD-VANTAGE VIALS.)
NOTE: Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.
1 g ADD-Vantage Vial (NDC 0310-0376-31)
CEFOTAN is also available as a 10 g pharmacy bulk package.
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)
© AstraZeneca 2002, 2004
CEFOTAN® (cefotetan disodium for injection) is manufactured by GlaxoSmithKline for: