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Cefuroxime Injection
for Injection USP and Dextrose Injection USP
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Cefuroxime (cefuroxime (cefuroxime injection) injection) for Injection USP and Dextrose Injection USP and other antibacterial drugs, Cefuroxime (cefuroxime (cefuroxime injection) injection) 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 bacteria.
Cefuroxime (cefuroxime (cefuroxime injection) injection) for Injection USP and Dextrose Injection USP is a sterile, nonpyrogenic, single use, packaged combination of Cefuroxime Sodium USP (crystalline) and Dextrose Injection USP (diluent) in the DUPLEX sterile container. The DUPLEX Container is a flexible dual chamber container.
The drug chamber is filled with sterile crystalline Cefuroxime (cefuroxime (cefuroxime injection) injection) for Injection USP, a semisynthetic, broad-spectrum, cephalosporin antibiotic for parenteral administration. It is the sodium salt of (6R,7R)-7-[2-(2-furyl)glyoxylamido]-3-(hydroxymethyl)-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylate, 72-(Z)-(O-methyloxime), carbamate (ester).
Cefuroxime (cefuroxime (cefuroxime injection) injection) Sodium USP has the following structural formula:
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The empirical formula is C16H15N4NaO8S, representing a molecular weight of 446.4.
Cefuroxime (cefuroxime (cefuroxime injection) injection) contains approximately 54.2 mg (2.4 mEq) of sodium per gram of cefuroxime (cefuroxime (cefuroxime injection) injection) activity.
The diluent chamber contains Dextrose Injection USP. The concentration of Hydrous Dextrose USP has been adjusted to render the reconstituted drug product iso-osmotic. Dextrose Injection USP is sterile, nonpyrogenic, and contains no bacteriostatic or antimicrobial agents.
Hydrous Dextrose USP has the following structural (molecular) formula:
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The molecular weight of Hydrous Dextrose USP is 198.17.
Dextrose hydrous USP has been added to the diluent to adjust osmolality (approximately 1.45 g and 2.05 g to 750 mg and 1.5 g dosages, respectively).
After removing the peelable foil strip, activating the seals, and thoroughly mixing, the reconstituted drug product is intended for single intravenous use. When reconstituted, the approximate osmolality of the reconstituted solution for Cefuroxime (cefuroxime (cefuroxime injection) injection) for Injection USP and Dextrose Injection USP is 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.
Cefuroxime (cefuroxime (cefuroxime injection) injection) for Injection USP and Dextrose Injection USP is indicated for the treatment of patients with infections caused by susceptible strains of the designated organisms in the following diseases:
Clinical microbiological studies in skin and skin-structure infections frequently reveal the growth of susceptible strains of both aerobic and anaerobic organisms. Cefuroxime (cefuroxime (cefuroxime injection) injection) has been used successfully in these mixed infections in which several organisms have been isolated.
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, cefuroxime (cefuroxime (cefuroxime injection) injection) may be used concomitantly with an aminoglycoside (see PRECAUTIONS). The recommended doses of both antibiotics may be given depending on the severity of the infection and the patient's condition.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Cefuroxime (cefuroxime (cefuroxime injection) injection) for Injection USP and Dextrose Injection USP and other antibacterial drugs, Cefuroxime (cefuroxime (cefuroxime injection) injection) 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 antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
Prevention: The preoperative prophylactic administration of Cefuroxime (cefuroxime (cefuroxime injection) injection) for Injection USP and Dextrose Injection USP may prevent the growth of susceptible disease-causing bacteria and thereby may reduce the incidence of certain postoperative infections in patients undergoing surgical procedures (e.g., vaginal hysterectomy) that are classified as clean-contaminated or potentially contaminated procedures. Effective prophylactic use of antibiotics in surgery depends on the time of administration. Cefuroxime (cefuroxime (cefuroxime injection) injection) for Injection USP and Dextrose Injection USP should usually be given one-half to 1 hour before the operation to allow sufficient time to achieve effective antibiotic concentrations in the wound tissues during the procedure. The dose should be repeated intraoperatively if the surgical procedure is lengthy.
Prophylactic administration is usually not required after the surgical procedure ends and should be stopped within 24 hours. In the majority of surgical procedures, continuing prophylactic administration of any antibiotic does not reduce the incidence of subsequent infections but will increase the possibility of adverse reactions and the development of bacterial resistance.
The perioperative use of Cefuroxime (cefuroxime (cefuroxime injection) injection) for Injection USP and Dextrose Injection USP has also been effective during open heart surgery for surgical patients in whom infections at the operative site would present a serious risk. For these patients it is recommended that cefuroxime (cefuroxime (cefuroxime injection) injection) therapy be continued for at least 48 hours after the surgical procedure ends. If an infection is present, specimens for culture should be obtained for the identification of the causative organism, and appropriate antimicrobial therapy should be instituted.
This product is intended for intravenous administration only.
Dosage: Adults: The usual adult dosage range for cefuroxime (cefuroxime (cefuroxime injection) injection) is 750 mg to 1.5 grams every 8 hours, usually for 5 to 10 days. In uncomplicated urinary tract infections, skin and skin-structure infections, disseminated gonococcal infections, and uncomplicated pneumonia, a 750 mg dose every 8 hours is recommended. In severe or complicated infections, a 1.5 gram dose every 8 hours is recommended.
In bone and joint infections, a 1.5 gram dose every 8 hours is recommended. In clinical trials, surgical intervention was performed when indicated as an adjunct to cefuroxime (cefuroxime (cefuroxime injection) injection) therapy. A course of oral antibiotics was administered when appropriate following the completion of parenteral administration of cefuroxime (cefuroxime (cefuroxime injection) injection) .
In life-threatening infections or infections due to less susceptible organisms, 1.5 grams every 6 hours may be required. In bacterial meningitis, the dosage should not exceed 3 grams every 8 hours. For preventive use for clean-contaminated or potentially contaminated surgical procedures, a 1.5 gram dose administered intravenously just before surgery (approximately one-half to 1 hour before the initial incision) is recommended. Thereafter, give 750 mg intravenously every 8 hours when the procedure is prolonged.
For preventive use during open heart surgery, a 1.5 gram dose administered intravenously at the induction of anesthesia and every 12 hours thereafter for a total of 6 grams is recommended.
Impaired Renal Function: A reduced dosage must be employed when renal function is impaired. Dosage should be determined by the degree of renal impairment and the susceptibility of the causative organism (see Table 2).
Table 2: Dosage of Cefuroxime (cefuroxime (cefuroxime injection) injection) in Adults with Reduced Renal
Function
| Creatinine Clearance (mL/min) | Dose | Frequency |
| >20 | 750 mg-1.5 grams | q8h |
| 10-20 | 750 mg | q12h |
