Data from FDA - Curated by EPG Health - Last updated 20 December 2016
PRECAUTIONS General Prescribing Cefotetan for Injection USP and Dextrose Injection USP in
As with other broad-spectrum antibiotics,
If superinfection does occur during therapy,
Cefotetan for Injection USP and Dextrose Injection USP should be used with
As with other dextrose-containing solutions, Cefotetan for Injection USP and Dextrose Injection USP should be prescribed with
If administration is controlled by a pumping device,
Use only if
Sometimes after starting treatment with antibiotics,
If this occurs, patients should contact their physician as soon as
Patients should be counseled that antibacterial drugs, including Cefotetan for Injection USP and Dextrose Injection USP, should only be used to treat bacterial
They do not treat
When Cefotetan for Injection USP and Dextrose Injection USP is prescribed to treat a bacterial
Skipping doses or not completing the full course of therapy may (1)
As with some other cephalosporins, a disulfiram-like reaction characterized by flushing, sweating,
Injection USP and Dextrose Injection USP was given alone.
If Cefotetan for Injection USP and Dextrose Injection USP and an aminoglycoside are used concomitantly,
Drug/Laboratory Test Interactions The administration of Cefotetan for Injection USP and Dextrose Injection USP may result in a
As with other cephalosporins,
reaction and produce
Subcutaneous administration of 500 mg/kg/day (approximately 8-16 times the usual adult human dose) on days 6-35 of life (thought to be developmentally analogous to late childhood and prepuberty in humans) resulted in
Similar lesions have been observed in experiments of comparable design with other methylthiotetrazole-containing antibiotics and
The relevance of these findings in humans is unknown.
Pregnancy Teratogenic Effects Pregnancy Category B Reproduction studies have been performed in
There are, however,
Because animal reproductive studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.
Nursing Mothers Cefotetan is excreted in human milk in
Geriatric Use Of the 925 subjects who received cefotetan in clinical studies, 492 (53 %) were 60 years and older, while 76 (8 %) were 80 years and older.
Because elderly patients are more likely to have
(See DOSAGE AND ADMINISTRATION -
Those appearing in italics have been reported during postmarketing experience.
Gastrointestinal: symptoms occurred in 1.5 % of patients, the most frequent were diarrhea (1 in 80) and
Onset of pseudomembranous colitis symptoms may occur during or after antibiotic treatment or surgical prophylaxis.
) Hematologic: laboratory
Hepatic: enzyme elevations occurred in 1.2 % of patients and included a rise in ALT (SGPT) (1 in 150), AST (SGOT) (1 in 300), alkaline phosphatase (1 in 700), and LDH (1 in 700).
Hypersensitivity: reactions were reported in 1.2 % of patients and included rash (1 in 150) and
Local: effects were reported in less than 1 % of patients and included phlebitis at the site of injection (1 in 300), and
Renal: Elevations in BUN and serum creatinine have been reported.
Urogenital: Nephrotoxicity has rarely been reported.
Miscellaneous: Fever In addition to the
Several cephalosporins have been implicated in triggering seizures, particularly in
(See DOSAGE AND ADMINISTRATION and OVERDOSAGE.
) If seizures associated with drug therapy occur,
Anticonvulsant therapy can be given if clinically indicated.
DOSAGE AND ADMINISTRATION Cefotetan for Injection USP and Dextrose Injection USP in the DUPLEX® Container is intended for intravenous use only.
Treatment The usual adult dosage is 1 or 2 grams of Cefotetan for Injection USP and Dextrose Injection USP administered intravenously every 12 hours for 5 to 10 days.
General Guidelines for Dosage of Cefotetan for Injection USP and Dextrose Injection USP Type of
every 12 hours IV
3 g every 12 hours IV If Chlamydia trachomatis is a suspected pathogen in
Prophylaxis To prevent
In patients undergoing cesarean section, the dose should be administered as soon as the umbilical cord is clamped.
The following dosage guidelines may be used.
DOSAGE GUIDELINES FOR PATIENTS WITH
Every 12 hours 10 - 30 Usual
The serum creatinine level should represent a
Males: Weight (kg)?
(140 - age) 72?
serum creatinine (mg/100 mL) Females: 0.9?
value for males Cefotetan is dialyzable and
Using an infusion system, Cefotetan for Injection USP and Dextrose Injection USP may 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 Cefotetan for Injection USP and Dextrose Injection USP, it is advisable to
NOTE: Solutions of Cefotetan for Injection
USP and Dextrose
Injection USP must not be admixed with solutions containing aminoglycosides.
If Cefotetan for Injection USP and Dextrose Injection USP and aminoglycosides are to be administered to the same patient, they must be administered separately and not as a mixed injection.
Such use could result in air embolism due to residual air being drawn from the primary container before
NOTE: Parenteral drug products should be inspected visually for particulate matter and
DUPLEX® Drug Delivery System Directions for Use To avoid
Patient Labeling and Drug Powder/Diluent Inspection Apply patient-specific label on foil side of container.
Do not cover any portion of foil strip with patient label.
Unlatch side tab and unfold DUPLEX® Container.
(See Diagram 1.)
Visually inspect diluent chamber for particulate matter.
Use only if
To inspect the drug powder for foreign matter or
(See Diagram 2.)
If foil strip is removed, product must be used within 7 days, but not beyond the labeled expiration date.
The product should be re-folded and the side tab latched until ready to activate.
Reconstitution (Activation) Do not
Unfold the DUPLEX® Container and point the set port in a
Starting at the hanger tab end, fold the DUPLEX® Container just below the diluent meniscus trapping all air above the fold.
To activate, squeeze the folded diluent chamber until the seal between the diluent and powder opens, releasing diluent into the drug powder chamber.
(See Diagram 3.)
Agitate the liquid-powder mixture until the drug powder is completely dissolved.
Following reconstitution (activation), product must be used within 12 hours if stored at room temperature or within 5 days if stored under refrigeration.
Administration Visually inspect the reconstituted solution for particulate matter.
Point the set port in a downwards direction.
Starting at the hanger tab end, fold the DUPLEX® Container just below the solution meniscus trapping all air above the fold.
Squeeze the folded DUPLEX® Container until the seal between reconstituted drug solution and set port opens, releasing liquid to set port.
(See Diagram 4.)
Prior to attaching the IV set, check for minute leaks by squeezing
If leaks are found,
Using aseptic technique, peel foil cover from the set port and attach
(See Diagram 5.)
Refer to Directions for Use accompanying the administration set.
Precautions As with other cephalosporins,
Use only if
Do not introduce additives into the DUPLEX® Container.
Do not freeze.
Figure Figure Figure Figure Figure
|Date Last Revised||14-02-2013|
|Type||HUMAN PRESCRIPTION DRUG|
|Storage and handling||Store the unactivated unit at 20–25°C (68–77°F). Excursions permitted to 15–30°C (59–86°F). [See USP Controlled Room Temperature.]|
|Marketing authorisation holder||B. Braun Medical Inc.|