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Cefotaxime (cefotaxime for injection) for Injection USP and Dextrose Injection is indicated for the treatment of patients with serious infections caused by susceptible strains of the designated microorganisms in the diseases listed below.
- Lower respiratory tract infections, including pneumonia, caused by Streptococcus pneumoniae, Streptococcus pyogenes* (Group A streptococci) and other streptococci (excluding enterococci, e.g., Enterococcus faecalis), Staphylococcus aureus (penicillinase and non-penicillinase producing), Escherichia coli, Klebsiella species, Haemophilus influenzae (including ampicillin resistant strains), Haemophilus parainfluenzae, Proteus mirabilis, Serratia marcescens*, Enterobacter species, indole positive Proteus and Pseudomonas species (including P. aeruginosa).
- Genitourinary infections. Urinary tract infections caused by Enterococcus species, Staphylococcus epidermidis, Staphylococcus aureus* (penicillinase and non-penicillinase producing), Citrobacter species, Enterobacter species, Escherichia coli, Klebsiella species, Proteus mirabilis, Proteus vulgaris*, Providencia stuartii, Morganella morganii*, Providencia rettgeri*, Serratia marcescens and Pseudomonas species (including P. aeruginosa).
- Gynecologic infections, including pelvic inflammatory disease, endometritis
and pelvic cellulitis caused by Staphylococcus epidermidis, Streptococcus
species, Enterococcus species, Enterobacter species*, Klebsiella species*,
Escherichia coli, Proteus mirabilis, Bacteroides species (including Bacteroides
fragilis*), Clostridium species, and anaerobic cocci (including
Peptostreptococcus species and Peptococcus species) and Fusobacterium
species (including F. nucleatum*).
Cefotaxime (cefotaxime for injection) , like other cephalosporins, has no activity against Chlamydia trachomatis. Therefore, when cephalosporins are used in the treatment of patients with pelvic inflammatory disease and C. trachomatis is one of the suspected pathogens, appropriate anti-chlamydial coverage should be added.
- Bacteremia/Septicemia caused by Escherichia coli, Klebsiella species, and Serratia marcescens, Staphylococcus aureus and Streptococcus species (including S. pneumoniae).
- Skin and skin structure infections caused by Staphylococcus aureus (penicillinase and non-penicillinase producing), Staphylococcus epidermidis, Streptococcus pyogenes (Group A streptococci) and other streptococci, Enterococcus species, Acinetobacter species*, Escherichia coli, Citrobacter species (including C. freundii*), Enterobacter species, Klebsiella species, Proteus mirabilis, Proteus vulgaris*, Morganella morganii, Providencia rettgeri*, Pseudomonas species, Serratia marcescens, Bacteroides species, and anaerobic cocci (including Peptostreptococcus* species and Peptococcus species).
- Intra-abdominal infections including peritonitis caused by Streptococcus species*, Escherichia coli, Klebsiella species, Bacteroides species, and anaerobic cocci (including Peptostreptococcus* species and Peptococcus* species) Proteus mirabilis*, and Clostridium species*.
- Bone and/or joint infections caused by Staphylococcus aureus (penicillinase and non-penicillinase producing strains), Streptococcus species (including S. pyogenes*), Pseudomonas species (including P. aeruginosa*), and Proteus mirabilis*.
- Central nervous system infections, e.g., meningitis and ventriculitis, caused by Neisseria meningitidis, Haemophilus influenzae, Streptococcus pneumoniae, Klebsiella pneumoniae* and Escherichia coli*.
(*) Efficacy for this organism, in this organ system, has been studied in fewer than 10 infections.
Although many strains of enterococci (e.g., E. faecalis) and Pseudomonas species are resistant to cefotaxime (cefotaxime for injection) sodium in vitro, cefotaxime (cefotaxime for injection) has been used successfully in treating patients with infections caused by susceptible organisms.
Specimens for bacteriologic culture should be obtained prior to therapy in order to isolate and identify causative organisms and to determine their susceptibilities to cefotaxime (cefotaxime for injection) . 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 certain 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, cefotaxime (cefotaxime for injection) may be used concomitantly with an aminoglycoside. 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. Renal function should be carefully monitored, especially if higher dosages of the aminoglycosides are to be administered or if therapy is prolonged, because of the potential nephrotoxicity and ototoxicity of aminoglycoside antibiotics. It is possible that nephrotoxicity may be potentiated if cefotaxime (cefotaxime for injection) is used concomitantly with an aminoglycoside.
The administration of cefotaxime (cefotaxime for injection) preoperatively reduces the incidence of certain infections in patients undergoing surgical procedures (e.g., abdominal or vaginal hysterectomy, gastrointestinal and genitourinary tract surgery) that may be classified as contaminated or potentially contaminated.
In patients undergoing cesarean section, intraoperative (after clamping the umbilical cord) and postoperative use of cefotaxime (cefotaxime for injection) may also reduce the incidence of certain postoperative infections. See DOSAGE AND ADMINISTRATION section.
Effective use for elective surgery depends on the time of administration. To achieve effective tissue levels, cefotaxime (cefotaxime for injection) should be given 1/2 or 1 1/2 hours before surgery. See DOSAGE AND ADMINISTRATION section.
For patients undergoing gastrointestinal surgery, preoperative bowel preparation by mechanical cleansing as well as with a non-absorbable antibiotic (e.g., neomycin) is recommended.
If there are signs of infection, specimens for culture should be obtained for identification of the causative organism so that appropriate therapy may be instituted.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Cefotaxime (cefotaxime for injection) for Injection USP and Dextrose Injection and other antibacterial drugs, Cefotaxime (cefotaxime for injection) for Injection USP and Dextrose Injection 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 antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
DOSAGE AND ADMINISTRATION
This product is intended for intravenous administration only.
This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function (see PRECAUTIONS, General and PRECAUTIONS, Geriatric Use).
Dosage and route of administration should be determined by susceptibility of the causative organisms, severity of the infection, and the condition of the patient (see table for dosage guideline). Cefotaxime (cefotaxime for injection) for Injection USP and Dextrose Injection is intended for IV administration after reconstitution. The maximum daily dosage should not exceed 12 grams.
GUIDELINES FOR DOSAGE OF CEFOTAXIME (cefotaxime for injection) FOR INJECTION USP AND DEXTROSE INJECTION
|Type of Infection||Daily Dose (grams)||Frequency|
|Uncomplicated infections||2||1 gram every 12 hours|
|Moderate to severe infections||3-6||1-2 grams every 8 hours|
|Infections commonly needing antibiotics in higher dosage (e.g., septicemia)||6-8||2 grams every 6-8 hours|
|Life-threatening infections||up to 12||2 grams every 4 hours|
To prevent postoperative infection in contaminated or potentially contaminated surgery, the recommended dose is a single 1 gram IV administered 30 to 90 minutes prior to start of surgery.
Cesarean Section Patients
The first dose of 1 gram is administered intravenously as soon as the umbilical cord is clamped. The second and third doses should be given as 1 gram intravenously at 6 and 12 hours after the first dose.
For body weights less than 50 kg, the recommended daily dose is 50 to 180 mg/kg body weight divided into four to six equal doses. The higher dosages should be used for more severe or serious infections, including meningitis. For body weights 50 kg or more, the usual adult dosage should be used; the maximum daily dosage should not exceed 12 grams.
Cefotaxime (cefotaxime for injection) for Injection USP and Dextrose Injection in the DUPLEX® Container is designed to deliver 1 g or 2 g dose of cefotaxime (cefotaxime for injection) . To prevent unintentional overdose, this product should not be used in pediatric patients who require less than the full adult dose of cefotaxime (cefotaxime for injection) .
Impaired Renal Function
see PRECAUTIONS section.
NOTE: As with antibiotic therapy in general, administration of cefotaxime (cefotaxime for injection) should be continued for a minimum of 48 to 72 hours after the patient defervesces or after evidence of bacterial eradication has been obtained; a minimum of 10 days of treatment is recommended for infections caused by Group A beta-hemolytic streptococci in order to guard against the risk of rheumatic fever or glomerulonephritis; frequent bacteriologic and clinical appraisal is necessary during therapy of chronic urinary tract infection and may be required for several months after therapy has been completed; persistent infections may require treatment of several weeks and doses smaller than those indicated above should not be used.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
DUPLEX® Drug Delivery System Directions for Use Removal from Multi-Pack Tray
- Tear tape strips from one or both sides of the tray. Remove top tray.
- To avoid inadvertent activation, DUPLEX Container should remain in th 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 labe
- 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 30 days, but not beyond the labeled expiration date.
- The product should be re-folded and the side tab latched until ready to activate.
- 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.
- 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, remove the set port cover from the set port and attach sterile administration set.
- Refer to Directions for Use accompanying the administration set.
- As with other cephalosporins, reconstituted Cefotaxime (cefotaxime for injection) for Injection USP and Dextrose Injection 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.
Cefotaxime (cefotaxime for injection) for Injection USP and Dextrose Injection in the DUPLEX Drug Delivery System is a flexible dual chamber container supplied in two concentrations. After reconstitution, the concentrations are equivalent to 1 g and 2 g cefotaxime. The diluent chamber contains approximately 50 mL of Dextrose Injection. Dextrose Injection has been adjusted to 3.9% and 2.4% for the 1 g and 2 g doses, respectively, such that the reconstituted solution is iso-osmotic.
Cefotaxime (cefotaxime for injection) for Injection USP and Dextrose Injection is supplied sterile and nonpyrogenic in the DUPLEX Drug Delivery System Containers packaged 12 units per tray, 2 trays per case.
|Cefotaxime for Injection USP and Dextrose Injection|
|0264-3133-11||3133-11||1 g||50 mL|
|Cefotaxime for Injection USP and Dextrose Injection|
|0264-3135-11||3135-11||2 g||50 mL|
Store the unactivated unit at 20-25°C (68-77°F). Excursions permitted to 15-30°C (59-86°F).
DUPLEX® is a registered trademark of B. Braun Medical Inc. U.S. Patent Nos. D388,168, D397,789, D402,366, D407,816, 5,944,709, and 6,165,161; additional patents pending. Made in USA Revised: January 2007 Braun Medical Inc. Irvine, CA USA 92614-5895. FDA Rev date: 9/10/2007This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 10/3/2007
Additional Cefotaxime Information
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