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Cefuroxime

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Cefuroxime

Indications
Dosage
How Supplied

INDICATIONS

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:

  1. Lower Respiratory Tract Infections, including pneumonia, caused by Streptococcus pneumoniae, Haemophilus influenzae (including ampicillin-resistant strains), Klebsiella spp., Staphylococcus aureus (penicillinase- and non-penicillinase-producing strains), Streptococcus pyogenes, and Escherichia coli.
  2. Urinary Tract Infections caused by Escherichia coli and Klebsiella spp.
  3. Skin and Skin-Structure Infections caused by Staphylococcus aureus (penicillinase- and non-penicillinase-producing strains), Streptococcus pyogenes, Escherichia coli, Klebsiella spp., and Enterobacter spp.
  4. Septicemia caused by Staphylococcus aureus (penicillinase- and non-penicillinase-producing strains), Streptococcus pneumoniae, Escherichia coli, Haemophilus influenzae (including ampicillin-resistant strains), and Klebsiella spp.
  5. Meningitis caused by Streptococcus pneumoniae, Haemophilus influenzae (including ampicillin-resistant strains), Neisseria meningitidis, and Staphylococcus aureus (penicillinase- and non-penicillinase-producing strains).
  6. Gonorrhea: Uncomplicated and disseminated gonococcal infections due to Neisseria gonorrhoeae (penicillinase- and non-penicillinase-producing strains) in both males and females.
  7. Bone and Joint Infections caused by Staphylococcus aureus (penicillinase- and non-penicillinase producing strains).

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.

DOSAGE AND ADMINISTRATION

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
<10 750 mg q24h*

*Since cefuroxime (cefuroxime (cefuroxime injection) injection) is dialyzable, patients on hemodialysis should be given a further dose at the end of the dialysis.

When only serum creatinine is available, the following formula2 (based on sex, weight, and age of the patient) may be used to convert this value into creatinine clearance. The serum creatinine should represent a steady state of renal function.

Males: Creatinine clearance (mL/min) = Weight (kg) x (140 - age)
72 x serum creatinine (mg/dL)

Females: 0.85 x male value

Note: As with antibiotic therapy in general, administration of Cefuroxime (cefuroxime (cefuroxime injection) injection) for Injection USP and Dextrose Injection USP should be continued for a minimum of 48 to 72 hours after the patient becomes asymptomatic or after evidence of bacterial eradication has been obtained; a minimum of 10 days of treatment is recommended in infections caused by Streptococcus pyogenes 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 for several weeks; and doses smaller than those indicated above should not be used. In staphylococcal and other infections involving a collection of pus, surgical drainage should be carried out where indicated.

Pediatric Patients Above 3 Months of Age: Administration of 50 to 100 mg/kg/day in equally divided doses every 6 to 8 hours has been successful for most infections susceptible to cefuroxime (cefuroxime (cefuroxime injection) injection) . The higher dosage of 100 mg/kg/day (not to exceed the maximum adult dosage) should be used for the more severe or serious infections.

In bone and joint infections, 150 mg/kg/day (not to exceed the maximum adult dosage) is recommended in equally divided doses every 8 hours. In clinical trials, a course of oral antibiotics was administered to pediatric patients following the completion of parenteral administration of cefuroxime (cefuroxime (cefuroxime injection) injection) .

In cases of bacterial meningitis, a larger dosage of cefuroxime (cefuroxime (cefuroxime injection) injection) is recommended, 200 to 240 mg/kg/day intravenously in divided doses every 6 to 8 hours.

In pediatric patients with renal insufficiency, the frequency of dosing should be modified consistent with the recommendations for adults.

Cefuroxime (cefuroxime (cefuroxime injection) injection) for Injection USP and Dextrose for Injection USP in the DUPLEX® Container is designed to deliver a 750 mg or 1.5 g dose of cefuroxime (cefuroxime (cefuroxime injection) injection) . To prevent unintentional overdose, this product should not be used in pediatric patients who require less than the full adult dose.

For intermittent IV infusion with a Y-type administration set, dosing can be accomplished through the tubing system by which the patient may be receiving other IV solutions. However, during infusion of the solution containing Cefuroxime (cefuroxime (cefuroxime injection) injection) , it is advisable to temporarily discontinue administration of any other solutions at the same site.

Solutions of cefuroxime (cefuroxime (cefuroxime injection) injection) , like those of most beta-lactam antibiotics, should not be added to solutions of aminoglycoside antibiotics because of potential interaction.

However, if concurrent therapy with cefuroxime (cefuroxime (cefuroxime injection) injection) and an aminoglycoside is indicated, each of these antibiotics can be administered separately to the same patient.

Use sterile equipment.

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.

DUPLEX® Drug Delivery System Directions for Use

Removal from Multi-Pack Tray

  • Tear tape strips from one or both sides of the trays. Remove top tray.
  • 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.)
  • Patient Labeling and Drug Powder/Diluent Inspection - illustration 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.)
  • Patient Labeling and Drug Powder/Diluent Inspection - illustration 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.

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.)
  • Reconstitution - illustration

  • Agitate the liquid-powder mixture until the drug powder is completely dissolved.

Note: Following reconstitution (activation), product must be used within 24 hours if stored at room temperature or within 7 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.)
  • Administration - illustration

  • 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.

Precautions

  • As with other cephalosporins, reconstituted Cefuroxime (cefuroxime (cefuroxime injection) injection) 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.

HOW SUPPLIED

Cefuroxime (cefuroxime (cefuroxime injection) injection) for Injection USP and Dextrose Injection USP in the DUPLEX Drug Delivery System is a flexible dual chamber container supplied in two concentrations. After reconstitution, the concentrations are equivalent to 750 mg and 1.5 g cefuroxime (cefuroxime (cefuroxime injection) injection) . The diluent chamber contains approximately 50 mL of Dextrose Injection USP. Dextrose Injection USP has been adjusted to 4.1% and 2.9% for the 750 mg and 1.5 g doses, respectively, such that the reconstituted solution is iso-osmotic.

Cefuroxime (cefuroxime (cefuroxime injection) injection) for Injection USP and Dextrose Injection USP is supplied sterile and nonpyrogenic in the DUPLEX Drug Delivery System containers packaged 12 units per tray, 2 trays per case.

NDC Cat. No. Dose Volume
Cefuroxime for Injection USP and Dextrose Injection USP
0264-3112-11 3112-11 750 mg 50 mL
Cefuroxime for Injection USP and Dextrose Injection USP
0264-3114-11 3114-11 1.5 g 50 mL

Store the unactivated unit at 20-25°C (68-77°F). Excursions permitted to 15-30°C (59-86°F).

REFERENCES

2.Cockcroft, DW., and Gault MH.: Prediction of creatinine clearance from serum creatinine. Nephron. 16:31-41, 1976.

DUPLEX® is a registered trademark of B. Braun Medical Inc., Clinitest® is a registered trademark of Ames Division, Miles Laboratories, Inc., Made in USA. Revised: January 2007, B. Braun Medical Inc., Irvine, CA USA 92614-5895. FDA revision date: 9/10/2007

Last reviewed on RxList: 4/10/2008
This monograph has been modified to include the generic and brand name in many instances.

Indications
Dosage
How Supplied
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