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ZINACEF (cefuroxime) is indicated for the treatment of patients with infections caused by susceptible strains of the designated organisms in the following diseases:
- 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.
- Urinary Tract Infections caused by Escherichia coli and Klebsiella spp.
- Skin and Skin-Structure Infections caused by Staphylococcus aureus (penicillinase- and non-penicillinase-producing strains), Streptococcus pyogenes, Escherichia coli, Klebsiella spp., and Enterobacter spp.
- Septicemia caused by Staphylococcus aureus (penicillinase- and non-penicillmase-producing strains), Streptococcus pneumoniae, Escherichia coli, Haemophilus influenzae (including ampicillin-resistant strains), and Klebsiella spp.
- Meningitis caused by Streptococcus pneumoniae, Haemophilus influenzae (including ampicillin-resistant strains), Neisseria meningitidis, and Staphylococcus aureus (penicillinase- and non-penicillinase-producing strains).
- Gonorrhea: Uncomplicated and disseminated gonococcal infections due to Neisseria gonorrhoeae (penicillinase- and non-penicillinase-producing strains) in both males and females.
- 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. ZINACEF (cefuroxime) 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, ZINACEF (cefuroxime) 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 ZINACEF (cefuroxime) and other antibacterial drugs, ZINACEF (cefuroxime) 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 ZINACEF (cefuroxime) may prevent the growth of susceptible disease-causing bacteria and thereby may reduce the incidence of certain postoperative infections inpatients 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. ZINACEF (cefuroxime) 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 ZINACEF (cefuroxime) 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 therapy with ZINACEF (cefuroxime) 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
Dosage: Adults: The usual adult dosage range for ZINACEF (cefuroxime) 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 therapy with ZINACEF (cefuroxime) . A course of oral antibiotics was administered when appropriate following the completion of parenteral administration of ZINACEF (cefuroxime) .
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. The recommended dosage for uncomplicated gonococcal infection is 1.5 grams given intramuscularly as a single dose at 2 different sites together with 1 gram of oral probenecid. 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 or intramuscularly every 8 hours when the procedure is prolonged.
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 ZINACEF (cefuroxime) in Adults With Reduced Renal Function
|Creatinine Clearance mL/min)||Dose||Frequency|
|* Since ZINACEF 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.
|Weight (kg) x (140 - age)|
|Males: Creatinine clearance (mL/min)=||----------------------------------|
|72 x serum creatinine (mg/dL)|
Females: 0.85 x male value
Note: As with antibiotic therapy in general, administration of ZINACEF (cefuroxime) 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. 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 ZINACEF (cefuroxime) .
In cases of bacterial meningitis, a larger dosage of ZINACEF (cefuroxime) 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.
Preparation of Solution and Suspension: The directions for preparing ZINACEF (cefuroxime) for both IV and EVI use are summarized in Table 3.
For Intramuscular Use: Each 750-mg vial of ZINACEF (cefuroxime) should be constituted with 3.0 mL of Sterile Water for Injection. Shake gently to disperse and withdraw completely the resulting suspension for injection.
For Intravenous Use: Each 750-mg vial should be constituted with 8.3 mL of Sterile Water for Injection. Withdraw completely the resulting solution for injection.
Each 1.5-gram vial should be constituted with 16.0 mL of Sterile Water for Inj ection, and the solution should be completely withdrawn for injection.
The 7.5-gram pharmacy bulk vial should be constituted with 77 mL of Sterile Water for Injection; each 8 mL of the resulting solution contains 750 mg of cefuroxime.
Each 750-mg and 1.5-gram infusion pack should be constituted with 100 mL of Sterile Water for Injection, 5% Dextrose Injection, 0.9% Sodium Chloride Injection, or any of the solutions listed under the Intravenous portion of the COMPATIBILITY AND STABILITY section.
Table 3. Preparation of Solution and Suspension
|Strength|| Amount of Diluent
to Be Added
|750-mg Vial||3.0 (IM)||Total*||225|
|750-mg Vial||8.3 (IV)||Total||90|
|1.5-gram Vial||16.0 (IV)||Total||90|
|750-mg Infusion pack||100 (IV)||--||7.5|
|1.5-gram Infusion pack||100 (IV)||--||15|
|7.5-gram Pharmacy bulk package||77 (IV)||Amount Needed†||95|
| *Note: ZINACEF (cefuroxime) is a suspension at IM concentrations.
†8 mL of solution contains 750 mg of cefuroxime; 16 mL of solution contains 1.5 grams ofcefuroxime.
Administration: After constitution, ZINACEF (cefuroxime) may be given intravenously or by deep IM injection into a large muscle mass (such as the gluteus or lateral part of the thigh). Before injecting intramuscularly, aspiration is necessary to avoid inadvertent injection into a blood vessel.
Intravenous Administration: The IV route may be preferable for patients with bacterial septicemia or other severe or life-threatening infections or for patients who may be poor risks because of lowered resistance, particularly if shock is present or impending.
For direct intermittent IV administration, slowly inject the solution into a vein over a period of 3 to 5 minutes or give it through the tubing system by which the patient is also receiving other rv solutions.
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 ZINACEF (cefuroxime) , it is advisable to temporarily discontinue administration of any other solutions at the same site.
ADD-Vantage vials are to be constituted only with 50 or 100 mL of 5% Dextrose Injection, 0.9% Sodium Chloride Injection, or 0.45% Sodium Chloride Injection in Abbott ADD-Vantage flexible diluent containers (see Instructions for Constitution). ADD-Vantage vials that have been joined to Abbott ADD-Vantage diluent containers and activated to dissolve the drug are stable for 24 hours at room temperature or for 7 days under refrigeration. Joined vials that have not been activated may be used within a 14-day period; this period corresponds to that for use of Abbott ADD-Vantage containers following removal of the outer packaging (overwrap).
Freezing solutions of ZINACEF (cefuroxime) in the ADD-Vantage system is not recommended.
For continuous IVinfusion, a solution of ZINACEF (cefuroxime) may be added to an IV infusion pack containing one of the following fluids: 0.9% Sodium Chloride Injection; 5% Dextrose Injection; 10% Dextrose Injection; 5% Dextrose and 0.9% Sodium Chloride Injection; 5% Dextrose and 0.45% Sodium Chloride Injection; or 1/6 M Sodium Lactate Injection.
Solutions of ZINACEF (cefuroxime) , 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 ZINACEF (cefuroxime) and an aminoglycoside is indicated, each of these antibiotics can be administered separately to the same patient.
Directions for Use of ZINACEF (cefuroxime) Frozen in Galaxy® Plastic Containers: ZINACEF (cefuroxime) supplied as a frozen, sterile, iso-osmotic, nonpyrogenic solution in plastic containers is to be administered after thawing either as a continuous or intermittent IV infusion. The thawed solution of the premixed product is stable for 28 days if stored under refrigeration (5°C) or for 24 hours if stored at room temperature (25°C). Do not refreeze.
Thaw container at room temperature (25°C) or under refrigeration (5°C). Do not force thaw by immersion in water baths or by microwave irradiation. Components of the solution may precipitate in the frozen state and will dissolve upon reaching room temperature with little or no agitation. Potency is not affected. Mix after solution has reached room temperature. Check for minute leaks by squeezing bag firmly. Discard bag if leaks are found as sterility may be impaired. Do not add supplementary medication. Do not use unless solution is clear and seal is intact.
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.
Preparation for Administration:
- Suspend container from eyelet support.
- Remove protector from outlet port at bottom of container.
- Attach administration set. Refer to complete directions accompanying set.
Compatibility and Stability
Intramuscular: When constituted as directed with Sterile Water for Injection, suspensions of ZINACEF (cefuroxime) for PM injection maintain satisfactory potency for 24 hours at room temperature and for 48 hours under refrigeration (5°C).
After the periods mentioned above any unused suspensions should be discarded.
Intravenous: When the 750-mg, 1.5-g, and 7.5-g pharmacy bulk vials are constituted as directed with Sterile Water for Injection, the solutions of ZINACEF (cefuroxime) for IV administration maintain satisfactory potency for 24 hours at room temperature and for 48 hours (750-mg and 1.5-g vials) or for 7 days (7.5-g pharmacy bulk vial) under refrigeration (5°C). More dilute solutions, such as 750 mg or 1.5 g plus 100 mL of Sterile Water for Injection, 5% Dextrose Injection, or 0.9% Sodium Chloride Injection, also maintain satisfactory potency for 24 hours at room temperature and for 7 days under refrigeration.
These solutions may be further diluted to concentrations of between 1 and 30 mg/mL in the following solutions and will lose not more than 10% activity for 24 hours at room temperature or for at least 7 days under refrigeration: 0.9% Sodium Chloride Injection; 1/6 M Sodium Lactate Injection; Ringer's Injection, USP; Lactated Ringer's Injection, USP; 5% Dextrose and 0.9% Sodium Chloride Injection; 5%> Dextrose Injection; 5% Dextrose and 0.45% Sodium Chloride Injection; 5% Dextrose and 0.225% Sodium Chloride Injection; 10% Dextrose Injection; and 10%> Invert Sugar in Water for Injection.
Unused solutions should be discarded after the time periods mentioned above.
ZINACEF (cefuroxime) has also been found compatible for 24 hours at room temperature when admixed in IV infusion with heparin (10 and 50 U/mL) in 0.9% Sodium Chloride Injection and Potassium Chloride (10 and 40 mEq/L) in 0.9%) Sodium Chloride Injection. Sodium Bicarbonate Injection, USP is not recommended for the dilution of ZINACEF (cefuroxime) .
The 750-mg and 1.5-g ZINACEF (cefuroxime) ADD-Vantage vials, when diluted in 50 or 100 mL of 5% Dextrose Injection, 0.9%> Sodium Chloride Injection, or 0.45% Sodium Chloride Injection, may be stored for up to 24 hours at room temperature or for 7 days under refrigeration.
Frozen Stability: Constitute the 750-mg, 1.5-g, or 7.5-g vial as directed for IV administration in Table 3. Immediately withdraw the total contents of the 750-mg or 1.5-g vial or 8 or 16 mL from the 7.5-g bulk vial and add to a Baxter VIAFLEX® MINI-BAG™ containing 50 or 100 mL of 0.9%) Sodium Chloride Injection or 5%> Dextrose Injection and freeze. Frozen solutions are stable for 6 months when stored at -20°C. Frozen solutions should be thawed at room temperature and not refrozen. Do not force thaw by immersion in water baths or by microwave irradiation. Thawed solutions may be stored for up to 24 hours at room temperature or for 7 days in a refrigerator.
Note: Parenteral drug products should be inspected visually for particulate matter and discoloration before administration whenever solution and container permit.
As with other cephalosporins, ZINACEF (cefuroxime) powder as well as solutions and suspensions tend to darken, depending on storage conditions, without adversely affecting product potency.
Directions for Dispensing: Pharmacy Bulk Package--Not for Direct Infusion: The pharmacy bulk package is for use in a pharmacy admixture service only under a laminar flow hood. Entry into the vial must be made with a sterile transfer set or other sterile dispensing device, and the contents dispensed in aliquots using aseptic technique. The use of syringe and needle is not recommended as it may cause leakage (see DOSAGE AND ADMINISTRATION). AFTER INITIAL WITHDRAWAL USE ENTIRE CONTENTS OF VIAL PROMPTLY. ANY UNUSED PORTION MUST BE DISCARDED WITHIN 24 HOURS.
(cefuroxime for injection)
Instructions for Constitution of ADD-Vantage® Vials
To Open Diluent Container:
Peel the corner of the ADD-Vantage diluent overwrap and remove flexible diluent container. Some opacity of the plastic flexible container due to moisture absorption during the sterilization process may be observed. This is normal and does not affect the solution quality or safety. The opacity will diminish gradually.
To Assemble Vial and Flexible Diluent Container (Use Aseptic Technique):
1. Remove the protective covers from the top of the vial and the vial port on the diluent container as follows:
a. To remove the breakaway vial cap, swing the pull ring over the top of the vial and pull down far enough to start the opening (see Figure 1), then pull straight up to remove the cap (see Figure 2). Note: Once the breakaway cap has been removed, do not access vial with syringe.
b. To remove the vial port cover, grasp the tab on the pull ring, pull up to break the 3 tie strings, then pull back to remove the cover (see Figure 3).
2. Screw the vial into the vial port until it will go no further. THE VIAL MUST BE SCREWED IN TIGHTLY TO ASSURE A SEAL. This occurs approximately one-half turn (180°) after the first audible click (see Figure 4). The clicking sound does not assure a seal; the vial must be turned as far as it will go. Note: Once vial is seated, do not attempt to remove (see Figure 4).
3. Recheck the vial to assure that it is tight by trying to turn it further in the direction of assembly.
4. Label appropriately.
To Prepare Admixture:
1. Squeeze the bottom of the diluent container gently to inflate the portion of the container surrounding the end of the drug vial.
2. With the other hand, push the drug vial down into the container, telescoping the walls of the container. Grasp the inner cap of the vial through the walls of the container (see Figure 5).
3. Pull the inner cap from the drug vial (see Figure 6). Verify that the rubber stopper has been pulled out, allowing the drug and diluent to mix.
4. Mix container contents thoroughly and use within the specified time.
Preparation for Administration (Use Aseptic Technique):
- Confirm the activation and admixture of vial contents.
- Check for leaks by squeezing container firmly. If leaks are found, discard unit as sterility may be impaired.
- Close flow control clamp of administration set.
- Remove cover from outlet port at bottom of container.
- Insert piercing pin of administration set into port with a twisting motion until the pin is firmly seated. Note: See full directions on administration set carton.
- Lift the free end of the hanger loop on the bottom of the vial, breaking the 2 tie strings. Bend the loop outward to lock it in the upright position, then suspend container from hanger.
- Squeeze and release drip chamber to establish proper fluid level in chamber.
- Open flow control clamp and clear air from set. Close clamp.
- Attach set to venipuncture device. If device is not indwelling, prime and make venipuncture.
- Regulate rate of administration with flow control clamp.
WARNING: Do not use flexible container in series connections.
ZINACEF (cefuroxime) in the dry state should be stored between 15° and 30°C (59° and 86°F) and protected from light. ZINACEF (cefuroxime) is a dry, white to off-white powder supplied in vials and infusion packs as follows:
NDC 0173-0352-10 750-mg* Vial (Tray of 10)
NDC 0173-0354-10 1.5-g* Vial (Tray of 10)
NDC 0173-0353-32 750-mg* Infusion Pack (Tray of 10)
NDC 0173-0356-32 1.5-g* Infusion Pack (Tray of 10)
NDC 0173-0400-00 7.5-g* Pharmacy Bulk Package (Tray of 6)
NDC 0173-0436-00 750-mg ADD-Vantage Vial (Tray of 25)
NDC 0173-0437-00 1.5-g ADD-Vantage Vial (Tray of 10)
(The above ADD-Vantage vials are to be used only with Abbott ADD-Vantage diluent containers.)
ZINACEF frozen as a premixed solution of cefuroxime injection should not be stored above -20°C. ZINACEF (cefuroxime) is supplied frozen in 50-mL, single-dose, plastic containers as follows:
NDC 0173-0424-00 750-mg* Plastic Container (Carton of 24)
NDC 0173-0425-00 1.5-g* Plastic Container (Carton of 24) Equivalent to cefuroxime.
2. Cockcroft DW, Gault MH. Prediction of creatinine clearance from serum creatinine. Nephron. 1976;16:31-41.
ZINACEF® (cefuroxime for injection): GlaxoSmithKline Research
Triangle Park, NC 27709
ZINACEF® (cefuroxime injection): Manufactured for GlaxoSmithKline Research Triangle Park, NC 27709 by Baxter Healthcare Corporation, Deerfield, IL 60015 ZINACEF (cefuroxime) is a registered trademark of GlaxoSmithKline. ADD-Vantage is a registered trademark of Abbott Laboratories. CLINITEST is a registered trademark of Ames Division, Miles Laboratories, Inc. GALAXY and VIAFLEX are registered trademarks of Baxter International Inc. February 2007
FDA Rev date:
Last reviewed on RxList: 8/17/2007
This monograph has been modified to include the generic and brand name in many instances.
Additional Zinacef Information
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