"The US Food and Drug Administration (FDA) today issued detailed guidance on deferring blood donations from individuals who may harbor the Zika virus, strongly suspected of causing congenital microcephaly and Guillain-BarrĂ© syndrome.
MAXIPIME is indicated in the treatment of the following infections caused by susceptible strains of the designated microorganisms (see also PRECAUTIONS: Pediatric Use and DOSAGE AND ADMINISTRATION):
Pneumonia (moderate to severe) caused by Streptococcus pneumoniae, including cases associated with concurrent bacteremia, Pseudomonas aeruginosa, Klebsiella pneumoniae, or Enterobacter species.
Empiric Therapy for Febrile Neutropenic Patients. Cefepime as monotherapy is indicated for empiric treatment of febrile neutropenic patients. In patients at high risk for severe infection (including patients with a history of recent bone marrow transplantation, with hypotension at presentation, with an underlying hematologic malignancy, or with severe or prolonged neutropenia), antimicrobial monotherapy may not be appropriate. Insufficient data exist to support the efficacy of cefepime monotherapy in such patients. (See Clinical Studies.)
Uncomplicated and Complicated Urinary Tract Infections (including pyelonephritis) caused by Escherichia coli or Klebsiella pneumoniae, when the infection is severe, or caused by Escherichia coli, Klebsiella pneumoniae, or Proteus mirabilis, when the infection is mild to moderate, including cases associated with concurrent bacteremia with these microorganisms.
Uncomplicated Skin and Skin Structure Infections caused by Staphylococcus aureus (methicillin-susceptible strains only) or Streptococcus pyogenes.
Complicated Intra-abdominal Infections (used in combination with metronidazole) caused by Escherichia coli, viridans group streptococci, Pseudomonas aeruginosa, Klebsiella pneumoniae, Enterobacter species, or Bacteroides fragilis. (See Clinical Studies.)
To reduce the development of drug-resistant bacteria and maintain the effectiveness of MAXIPIME and other antibacterial drugs, MAXIPIME 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
The recommended adult and pediatric dosages and routes of administration are outlined in the following table. MAXIPIME should be administered intravenously over approximately 30 minutes.
Table 12: Recommended Dosage Schedule for MAXIPIME in
Patients with CrCL Greater Than 60 mL/min
|Site and Type of Infection||Dose||Frequency||Duration (days)|
|Moderate to Severe Pneumonia due to S. pneumoniae*, P.||1 to 2 g IV||Every 12 hours||10|
|aeruginosa, K. pneumoniae, or Enterobacter species|
|Empiric therapy for febrile neutropenic patients (See INDICATIONS AND USAGE and Clinical Studies.)||2 g IV||Every 8 hours||7**|
|Mild to Moderate Uncomplicated or Complicated Urinary Tract Infections, including pyelonephritis, due to E. coli, K.pneumoniae, or P. mirabilis*||0.5 to 1 g IV/IM***||Every 12 hours||7 to 10|
|Severe Uncomplicated or Complicated Urinary Tract Infections, including pyelonephritis, due to E. coli or K. pneumoniae*||2 g IV||Every 12 hours||10|
|Moderate to Severe Uncomplicated Skin and Skin Structure Infections due to S. aureus or S. pyogenes||2 g IV||Every 12 hours||10|
|Complicated Intra-abdominal Infections (used in combination with metronidazole) caused by E. coli, viridans group streptococci, P. aeruginosa, K. pneumoniae, Enterobacter species, or B. fragilis. (See Clinical Studies.)||2 g IV||Every 12 hours||7 to 10|
|Pediatric Patients (2 months up to 16 years)
The maximum dose for pediatric patients should not exceed the recommended adult dose. The usual recommended dosage in pediatric patients up to 40 kg in weight for uncomplicated and complicated urinary tract infections (including pyelonephritis), uncomplicated skin and skin structure infections, and pneumonia is 50 mg per kg per dose, administered every 12 hours (50 mg per kg per dose, every 8 hours for febrile neutropenic patients), for durations as given above.
*including cases associated with concurrent bacteremia **or until resolution of neutropenia. In patients whose fever resolves but who remain neutropenic for more than 7 days, the need for continued antimicrobial therapy should be re-evaluated frequently.
***Intramuscular route of administration is indicated only for mild to moderate, uncomplicated or complicated UTIs due to E. coli when the intramuscular route is considered to be a more appropriate route of drug administration.
Patients with Hepatic Impairment
No adjustment is necessary for patients with hepatic impairment.
Patients with Renal Impairment
In patients with creatinine clearance less than or equal to 60 mL/min, the dose of MAXIPIME should be adjusted to compensate for the slower rate of renal elimination. The recommended initial dose of MAXIPIME should be the same as in patients with normal renal function except in patients undergoing hemodialysis. The recommended doses of MAXIPIME in patients with renal impairment are presented in Table 13.
When only serum creatinine is available, the following formula (Cockcroft and Gault equation)3 may be used to estimate creatinine clearance. The serum creatinine should represent a steady state of renal function:
|Males:||(weight in kg) x (140 – age)|
|(72) x serum creatinine (mg/100 mL)|
|Females||(0.85) x (above value)|
Table 13: Recommended Dosing Schedule for MAXIPIME in
Adult Patients (Normal Renal Function, Renal Impairment, and Hemodialysis)
|Creatinine Clearance (mL/min)||Recommended Mantenance Schedule|
|Greater than 60 Normal recommended dosing schedule||500 mg every 12 hours||1 g every 12 hours||2 g every 12 hours||2 g every 8 hours|
|30 to 60||500 mg every 24 hours||1 g every 24 hours||2 g every 24 hours||2 g every 12 hours|
|11 to 29||500 mg every 24 hours||500 mg every 24 hours||1 g every 24 hours||2 g every 24 hours|
|Less than 11||250 mg every 24 hours||250 mg every 24 hours||500 mg every 24 hours||1 g every 24 hours|
|CAPD||500 mg every 48 hours||1 g every 48 hours||2 g every 48 hours||2 g every 48 hours|
|Hemodialysis*||1 g on day 1, then 500 mg every 24 hours thereafter||1 g every 24 hours|
|*On hemodialysis days, cefepime should be administered following hemodialysis. Whenever possible, cefepime should be administered at the same time each day.|
In patients undergoing continuous ambulatory peritoneal dialysis, MAXIPIME may be administered at normally recommended doses at a dosage interval of every 48 hours (see Table 13).
In patients undergoing hemodialysis, approximately 68% of the total amount of cefepime present in the body at the start of dialysis will be removed during a 3-hour dialysis period. The dosage of MAXIPIME for hemodialysis patients is 1 g on Day 1 followed by 500 mg every 24 hours for the treatment of all infections except febrile neutropenia, which is 1 g every 24 hours.
MAXIPIME should be administered at the same time each day and following the completion of hemodialysis on hemodialysis days (see Table 13).
Data in pediatric patients with impaired renal function are not available; however, since cefepime pharmacokinetics are similar in adults and pediatric patients (see CLINICAL PHARMACOLOGY), changes in the dosing regimen proportional to those in adults (see Tables 12 and 13) are recommended for pediatric patients.
For Intravenous Infusion, Dilute with a suitable parenteral vehicle prior to intravenous infusion. Constitute the 500 mg, 1 g, or 2 g vial, and add an appropriate quantity of the resulting solution to an intravenous container with one of the compatible intravenous fluids listed in the Compatibility and Stability subsection. THE RESULTING SOLUTION SHOULD BE ADMINISTERED OVER APPROXIMATELY 30 MINUTES.
Intermittent intravenous infusion with a Y-type administration set can be accomplished with compatible solutions. However, during infusion of a solution containing cefepime, it is desirable to discontinue the other solution.
ADD-Vantage™ vials are to be constituted only with 50 mL or 100 mL of 5% Dextrose Injection or 0.9% Sodium Chloride Injection in ADD-Vantage flexible diluent containers. (See ADD-Vantage Vial Instructions for Use.)
Intramuscular Administration: For intramuscular administration, MAXIPIME (cefepime hydrochloride) should be constituted with one of the following diluents: Sterile Water for Injection, 0.9% Sodium Chloride, 5% Dextrose Injection, 0.5% or 1 % Lidocaine Hydrochloride, or Sterile Bacteriostatic Water for Injection with Parabens or Benzyl Alcohol (refer to Table 14).
Preparation of MAXIPIME solutions is summarized in Table 14.
Table 14: Preparation of Solutions of MAXIPIME
|Single-Dose Vials for Intravenous/Intramuscular Administration||Amount of Diluent to be added (mL)||Approximate Available Volume (mL)||Approximate Cefepime Concentration (mg/mL)|
|cefepime vial content|
|500 mg (IV)||5||5.6||100|
|500 mg (IM)||1.3||1.8||280|
|1 g (IV)||10||11.3||100|
|1 g (IM)||2.4||3.6||280|
|2 g (IV)||10||12.5||160|
|1 g vial||50||50||20|
|1 g vial||100||100||10|
|2 g vial||50||50||40|
|2 g vial||100||100||20|
Compatibility and Stability
Intravenous: MAXIPIME is compatible at concentrations between 1 mg per mL and 40 mg per mL with the following intravenous infusion fluids: 0.9% Sodium Chloride Injection, 5% and 10% Dextrose Injection, M/6 Sodium Lactate Injection, 5% Dextrose and 0.9% Sodium Chloride Injection, Lactated Ringers and 5% Dextrose Injection, Normosol™-R, and Normosol™-M in 5% Dextrose Injection. These solutions may be stored up to 24 hours at controlled room temperature 20°C to 25°C (68°F to 77°F) or 7 days in a refrigerator 2°C to 8°C (36°F to 46°F). MAXIPIME in ADD-Vantage vials is stable at concentrations of 10 to 40 mg per mL in 5% Dextrose Injection or 0.9% Sodium Chloride Injection for 24 hours at controlled room temperature 20°C to 25°C or 7 days in a refrigerator 2°C to 8°C.
MAXIPIME admixture compatibility information is summarized in Table 15.
Table 15: Cefepime Admixture Stability
|MAXIPIME Concentration||Admixture and Concentration||IV Infusion Solutions||Stability Time for RT/L (20° to 25°C)||Refrigeration (2° to 8°C)|
|40 mg/mL||Amikacin 6 mg/mL||NS or D5W||24 hours||7 days|
|40 mg/mL||Ampicillin 1 mg/mL||D5W||8 hours||8 hours|
|40 mg/mL||Ampicillin 10 mg/mL||D5W||2 hours||8 hours|
|40 mg/mL||Ampicillin 1 mg/mL||NS||24 hours||48 hours|
|40 mg/mL||Ampicillin 10 mg/mL||NS||8 hours||48 hours|
|4 mg/mL||Ampicillin 40 mg/mL||NS||8 hours||8 hours|
|4 to 40 mg/mL||Clindamycin Phosphate 0.25 to 6 mg/mL||NS or D5W||24 hours||7 days|
|4 mg/mL||Heparin 10 to 50 units/mL||NS or D5W||24 hours||7 days|
|4 mg/mL||Potassium Chloride 10 to 40 mEq/L||NS or D5W||24 hours||7 days|
|4 mg/mL||Theophylline 0.8 mg/mL||D5W||24 hours||7 days|
|1 to 4 mg/mL||na||Aminosyn™ II 4.25% with electrolytes and calcium||8 hours||3 days|
|0.125 to 0.25 mg/mL||na||Inpersol™ with 4.25% dextrose||24 hours||7 days|
|NS = 0.9% Sodium Chloride Injection
D5W = 5% Dextrose Injection
na = not applicable
RT/L = Ambient room temperature and light
Solutions of MAXIPIME, like those of most beta-lactam antibiotics, should not be added to solutions of ampicillin at a concentration greater than 40 mg per mL, and should not be added to metronidazole, vancomycin, gentamicin, tobramycin, netilmicin sulfate, or aminophylline because of potential interaction. However, if concurrent therapy with MAXIPIME is indicated, each of these antibiotics can be administered separately.
Intramuscular: MAXIPIME (cefepime hydrochloride) constituted as directed is stable for 24 hours at controlled room temperature 20°C to 25°C (68°F to 77°F) or for 7 days in a refrigerator 2°C to 8°C (36°F to 46°F) with the following diluents: Sterile Water for Injection, 0.9% Sodium Chloride Injection, 5% Dextrose Injection, Sterile Bacteriostatic Water for Injection with Parabens or Benzyl Alcohol, or 0.5% or 1% Lidocaine Hydrochloride.
NOTE: PARENTERAL DRUGS SHOULD BE INSPECTED VISUALLY FOR PARTICULATE MATTER BEFORE ADMINISTRATION. IF PARTICULATE MATTER IS EVIDENT IN RECONSTITUTED FLUIDS, THE DRUG SOLUTION SHOULD BE DISCARDED.
As with other cephalosporins, the color of MAXIPIME powder, as well as its solutions, tend to darken depending on storage conditions; however, when stored as recommended, the product potency is not adversely affected.
Instructions For Use
These instructions for use should be made available to the individuals who perform the reconstitution steps.
Peel overwrap at corner and remove solution container. Some opacity of the plastic 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 three 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 1/2 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 Reconstitute the Drug
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.
5. Look through the bottom of the vial to verify that the stopper has been removed and complete mixing has occurred. (SEE FIGURE 7.)
If the rubber stopper is not removed from the vial and medication is not released on the first attempt, the inner cap may be manipulated back into the rubber stopper without removing the drug vial from the diluent container. Repeat steps 3 through 5.
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 two 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.
3. Cockcroft DW, Gault MH. Prediction of creatinine clearance from serum creatinine. Nephron. 1976; 16:31-41.
MAXIPIME (cefepime hydrochloride, USP) for Injection is supplied as follows: MAXIPIME (cefepime hydrochloride, USP) for Injection in the dry state, is a white to pale yellow powder. Constituted solution of MAXIPIME can range in color from pale yellow to amber.
500 mg* (carton of 10) NDC 0409-0221-01
1 g* (carton of 10) NDC 0409-0219-01
2 g* (carton of 10) NDC 0409-0220-01
1 g* ADD-Vantage (carton of 25) NDC 0409-0217-01
2 g* ADD-Vantage (carton of 25) NDC 0409-0218-01
*Based on cefepime activity
IN THE DRY STATE STORE AT 20 TO 25°C (68 TO 77°F) [SEE USP CONTROLLED ROOM TEMPERATURE.] PROTECT FROM LIGHT.
Hospira, Inc Lake Forest, IL 60045, USA. Revised: 06/2012This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 9/20/2012
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