Cefotetan And Dextrose
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Questions & Answers
Side Effects & Adverse Reactions
BEFORE THERAPY WITH CEFOTETAN FOR INJECTION USP AND DEXTROSE INJECTION USP IS INSTITUTED, CAREFUL INQUIRY SHOULD BE MADE TO DETERMINE WHETHER THE PATIENT HAS HAD PREVIOUS HYPERSENSITIVITY REACTIONS TO CEFOTETAN DISODIUM, CEPHALOSPORINS, PENICILLINS, OR OTHER DRUGS. IF THIS PRODUCT IS TO BE GIVEN TO PENICILLIN-SENSITIVE PATIENTS, CAUTION SHOULD BE EXERCISED BECAUSE CROSS-HYPERSENSITIVITY AMONG BETA-LACTAM ANTIBIOTICS HAS BEEN CLEARLY DOCUMENTED AND MAY OCCUR IN UP TO 10% OF PATIENTS WITH A HISTORY OF PENICILLIN ALLERGY. IF AN ALLERGIC REACTION TO CEFOTETAN FOR INJECTION USP AND DEXTROSE INJECTION USP OCCURS, DISCONTINUE THE DRUG. SERIOUS ACUTE HYPERSENSITIVITY REACTIONS MAY REQUIRE TREATMENT WITH EPINEPHRINE AND OTHER EMERGENCY MEASURES, INCLUDING OXYGEN, INTRAVENOUS FLUIDS, INTRAVENOUS ANTIHISTAMINES, CORTICOSTEROIDS, PRESSOR AMINES, AND AIRWAY MANAGEMENT, AS CLINICALLY INDICATED.
AN IMMUNE MEDIATED HEMOLYTIC ANEMIA HAS BEEN OBSERVED IN PATIENTS RECEIVING CEPHALOSPORIN CLASS ANTIBIOTICS. SEVERE CASES OF HEMOLYTIC ANEMIA, INCLUDING FATALITIES, HAVE BEEN REPORTED IN ASSOCIATION WITH THE ADMINISTRATION OF CEFOTETAN. SUCH REPORTS ARE UNCOMMON. THERE APPEARS TO BE AN INCREASED RISK OF DEVELOPING HEMOLYTIC ANEMIA ON CEFOTETAN RELATIVE TO OTHER CEPHALOSPORINS OF AT LEAST 3 FOLD. IF A PATIENT DEVELOPS ANEMIA ANYTIME WITHIN 2–3 WEEKS SUBSEQUENT TO THE ADMINISTRATION OF CEFOTETAN, THE DIAGNOSIS OF A CEPHALOSPORIN ASSOCIATED ANEMIA SHOULD BE CONSIDERED AND THE DRUG STOPPED UNTIL THE ETIOLOGY IS DETERMINED WITH CERTAINTY. BLOOD TRANSFUSIONS MAY BE CONSIDERED AS NEEDED (see CONTRAINDICATIONS).
PATIENTS WHO RECEIVE COURSES OF CEFOTETAN FOR THE TREATMENT OR PROPHYLAXIS OF INFECTIONS SHOULD HAVE PERIODIC MONITORING FOR SIGNS AND SYMPTOMS OF HEMOLYTIC ANEMIA INCLUDING A MEASUREMENT OF HEMATOLOGICAL PARAMETERS WHERE APPROPRIATE.
Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including Cefotetan for Injection USP and Dextrose Injection USP, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile.
C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents.
If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated.
In common with many other broad-spectrum antibiotics, Cefotetan for Injection USP and Dextrose Injection USP may be associated with a fall in prothrombin activity and, possibly, subsequent bleeding. Those at increased risk include patients with renal or hepatobiliary impairment or poor nutritional state, the elderly, and patients with cancer. Prothrombin time should be monitored and exogenous vitamin K administered as indicated.
Legal Issues
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FDA Safety Alerts
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Manufacturer Warnings
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FDA Labeling Changes
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Uses
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Cefotetan for Injection USP and Dextrose Injection USP and other antibacterial drugs, Cefotetan for Injection USP and Dextrose Injection USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antimicrobial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
Cefotetan for Injection USP and Dextrose Injection USP is indicated for the therapeutic treatment of the following infections when caused by susceptible strains of the designated organisms:
Urinary Tract Infections caused by E. coli, Klebsiella spp (including K. pneumoniae), Proteus mirabilis and Proteus spp (which may include the organisms now called Proteus vulgaris, Providencia rettgeri, and Morganella morganii).
Lower Respiratory Tract Infections caused by Streptococcus pneumoniae, Staphylococcus aureus (penicillinase- and nonpenicillinase-producing strains), Haemophilus influenzae (including ampicillin-resistant strains), Klebsiella species (including K. pneumoniae), E. coli, Proteus mirabilis, and Serratia marcescens1.
Skin and Skin Structure Infections due to Staphylococcus aureus (penicillinase- and nonpenicillinase-producing strains), Staphylococcus epidermidis, Streptococcus pyogenes, Streptococcus species (excluding enterococci), Escherichia coli, Klebsiella pneumoniae, Peptococcus niger1, Peptostreptococcus species.
Gynecologic Infections caused by Staphylococcus aureus (including penicillinase- and nonpenicillinase-producing strains), Staphylococcus epidermidis, Streptococcus species (excluding enterococci), Streptococcus agalactiae, E. coli, Proteus mirabilis, Neisseria gonorrhoeae, Bacteroides species (excluding B. distasonis, B. ovatus, B. thetaiotaomicron), Fusobacterium species1, and gram-positive anaerobic cocci (including Peptococcus niger and Peptostreptococcus species).
Cefotetan, like other cephalosporins, has no activity against Chlamydia trachomatis. Therefore, when cephalosporins are used in the treatment of pelvic inflammatory disease, and C. trachomatis is one of the suspected pathogens, appropriate antichlamydial coverage should be added.
Intra-abdominal Infections caused by E. coli, Klebsiella species (including K. pneumoniae), Streptococcus species (excluding enterococci), Bacteroides species (excluding B. distasonis, B. ovatus, B. thetaiotaomicron) and Clostridium species1.
Bone and Joint Infections caused by Staphylococcus aureus1.
Specimens for bacteriological examination should be obtained in order to isolate and identify causative organisms and to determine their susceptibilities to cefotetan. Therapy may be instituted before results of susceptibility studies are known; however, once these results become available, the antibiotic treatment should be adjusted accordingly.
In cases of confirmed or suspected gram-positive or gram-negative sepsis or in patients with other serious infections in which the causative organism has not been identified, it is possible to use Cefotetan for Injection USP and Dextrose Injection USP concomitantly with an aminoglycoside. Cefotetan combinations with aminoglycosides have been shown to be synergistic in vitro against many Enterobacteriaceae and also some other gram-negative bacteria. The dosage recommended in the labeling of both antibiotics may be given and depends on the severity of the infection and the patient's condition.
NOTE: Increases in serum creatinine have occurred when cefotetan was given alone. If Cefotetan for Injection USP and Dextrose Injection USP and an aminoglycoside are used concomitantly, renal function should be carefully monitored, because nephrotoxicity may be potentiated.
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- Efficacy for this organism in this organ system was studied in fewer than ten infections.
The preoperative administration of Cefotetan for Injection USP and Dextrose Injection USP may reduce the incidence of certain postoperative infections in patients undergoing surgical procedures that are classified as clean, contaminated or potentially contaminated (e.g., cesarean section, abdominal or vaginal hysterectomy, transurethral surgery, biliary tract surgery, and gastrointestinal surgery).
If there are signs and symptoms of infection, specimens for culture should be obtained for identification of the causative organism so that appropriate therapeutic measures may be initiated.
History
There is currently no drug history available for this drug.
Other Information
Cefotetan for Injection USP and Dextrose Injection USP in the DUPLEX® container is supplied as a sterile, nonpyrogenic, single use packaged combination of cefotetan disodium and dextrose injection (diluent) in the DUPLEX® sterile container. The DUPLEX® container is a flexible dual chamber container.
The drug chamber is filled with cefotetan disodium, a sterile, semisynthetic, broad-spectrum, beta-lactamase resistant, cephalosporin (cephamycin) antibiotic for intravenous administration. Cefotetan disodium is the disodium salt of [6R-(6alpha,7alpha)]-7-[[[4-(2-amino-1-carboxy-2-oxoethylidene)-1,3-dithietan-2-yl]carbonyl]amino]-7-methoxy-3-[[(1-methyl-1H-tetrazol-5-yl)thio]methyl]-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid.
Cefotetan disodium has the following structural formula:
The molecular formula of cefotetan disodium is C17H15N7Na2O8S4 with a molecular weight of 619.59.
Cefotetan disodium is supplied as a dry powder form equivalent to either 1 g or 2 g of cefotetan. Cefotetan disodium is a white to pale yellow powder which is readily soluble in dextrose injection diluent provided in the DUPLEX® container. The pH of freshly reconstituted solution is between 4 to 6.5. The color of reconstituted solutions ranges from colorless to yellow depending on the length of storage and concentration. Cefotetan for Injection USP and Dextrose Injection USP contains approximately 80 mg (3.5 mEq) of sodium per gram of cefotetan activity.
The diluent chamber contains dextrose injection. The concentration of Hydrous Dextrose in Water for Injection USP has been adjusted to render the reconstituted drug product iso-osmotic. Dextrose USP has been added to adjust the osmolality to approximately 290 mOsmol/kg (approximately 1.79 g [3.58% w/v] and 1.04 g [2.08% w/v] to the 1 g and 2 g dosages, respectively). Dextrose injection USP is sterile, nonpyrogenic, and contains no bacteriostatic or antimicrobial agents.
Hydrous Dextrose USP has the following structural (molecular) formula:
The molecular weight of Hydrous Dextrose USP is 198.17.
After removing the peelable foil strip, activating the seals, and thoroughly mixing, the reconstituted drug product is intended for single intravenous use. When reconstituted according to instructions in the product labeling, the approximate osmolality of the reconstituted solution of Cefotetan for Injection USP and Dextrose Injection USP is about 290 mOsmol/kg.
The DUPLEX® Container is Latex-free, PVC-free, and Di(2-ethylhexyl)phthalate (DEHP)-free.
The DUPLEX® dual chamber container is made from a specially formulated material. The product (diluent and drug) contact layer is a mixture of thermoplastic rubber and a polypropylene ethylene copolymer that contains no plasticizers. The safety of the container system is supported by USP biological evaluation procedures.
Sources
Cefotetan And Dextrose Manufacturers
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B. Braun Medical Inc.
![Cefotetan And Dextrose Injection, Solution [B. Braun Medical Inc.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Cefotetan And Dextrose | B. Braun Medical Inc.
Cefotetan for Injection USP and Dextrose Injection USP in the DUPLEX® Container is intended for intravenous use only.
TreatmentThe 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. Proper dosage should be determined by the condition of the patient, severity of the infection, and susceptibility of the causative organism.
General Guidelines for Dosage of Cefotetan for Injection USP and Dextrose Injection USP Type of Infection Daily Dose Frequency and Route * Klebsiella pneumoniae skin and skin structure infections should be treated with 1 or 2 grams every 12 hours IV. † Maximum daily dosage should not exceed 6 grams. Urinary Tract 1–4 grams 500 mg every 12 hours IV 1 or 2 g every 24 hours IV 1 or 2 g every 12 hours IV Skin & Skin Structure Mild – Moderate* 2 grams 2 g every 24 hours IV 1 g every 12 hours IV Severe 4 grams 2 g every 12 hours IV Other Sites 2–4 grams 1 or 2 g every 12 hours IV Severe 4 grams 2 g every 12 hours IV Life-Threatening 6 grams† 3 g every 12 hours IVIf Chlamydia trachomatis is a suspected pathogen in gynecologic infections, appropriate antichlamydial coverage should be added, since cefotetan has no activity against this organism.
ProphylaxisTo prevent postoperative infection in clean, contaminated, or potentially contaminated surgery in adults, the recommended dosage is 1 or 2 g of Cefotetan for Injection USP and Dextrose 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 FunctionWhen 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 * Dose determined by the type and severity of infection, and susceptibility of the causative organism. > 30 Usual Recommended Dosage* Every 12 hours 10 – 30 Usual Recommended Dosage* Every 24 hours < 10 Usual Recommended Dosage* Every 48 hoursAlternatively, 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) × (140 - age) 72 × serum creatinine (mg/100 mL) Females: 0.9 × value for malesCefotetan 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.
Intravenous AdministrationThe 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, 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. Butterfly or scalp vein-type needles are preferred for this type of infusion. However, during infusion of the solution containing Cefotetan for Injection USP and Dextrose Injection USP, it is advisable to discontinue temporarily the administration of other solutions at the same site.
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.
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.
NOTE: Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration.
DUPLEX® Drug Delivery System Directions for Use To avoid inadvertent activation, DUPLEX® Container should remain in the folded position until activation is intended.Patient Labeling and Drug Powder/Diluent Inspection
Apply patient-specific label on foil side of container. USE CARE to avoid activation. 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 container and seals are intact. To inspect the drug powder for foreign matter or discoloration, peel foil strip from drug chamber. (See Diagram 2.) Protect from light after removal of foil strip.
Note: 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 use directly after storage by refrigeration, allow the product to equilibrate to room temperature before patient use. Unfold the DUPLEX® Container and point the set port in a downward direction. 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.
Note: 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 container firmly. If leaks are found, discard container and solution as sterility may be impaired. Using aseptic technique, peel foil cover from the set port and attach sterile administration set. (See Diagram 5.) Refer to Directions for Use accompanying the administration set.Precautions
As with other cephalosporins, reconstituted Cefotetan for Injection USP and Dextrose Injection USP tends to darken depending on storage conditions, within the stated recommendations. However, product potency is not adversely affected. Use only if prepared solution is clear and free from particulate matter. Do not use in series connection. Do not introduce additives into the DUPLEX® Container. Do not freeze.
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