Data from FDA - Curated by EPG Health - Last updated 22 December 2016
4 CONTRAINDICATIONS Hypersensitivity to cefepime or other cephalosporin class antibiotics, penicillins, or other beta-lactam antibiotics (4.1) Hypersensitivity to corn products (4.2) 4.1 Hypersensitivity to Cefepime or the Cephalosporin Class of Antibiotics, Penicillins, or Other Beta-lactam Antibiotics Cefepime for Injection USP and Dextrose Injection USP is contraindicated in patients who have a history of immediate hypersensitivity reactions (e.g., anaphylaxis, serious skin reactions) to cefepime or the cephalosporin class of antibiotics, penicillins, or other beta-lactam antibiotics [see Warnings and Precautions (5.1)].
4.2 Hypersensitivity to Corn Products Solutions containing dextrose may be contraindicated in patients with hypersensitivity to corn products.
(6.1) At the
(6.1) To report SUSPECTED
6.1 Clinical Trials Experience Because clinical trials are conducted under widely
In clinical trials using multiple doses of cefepime, 4137 patients were treated with the
Sixty-four (1.5 %)
Thirty-three (51 %) of
(3.0 %), including phlebitis (1.3 %), pain and/or inflammation (0.6 %); rash (1.1 %) Incidence less than 1 % but
Reactions included rash (4 %), diarrhea (3 %),
Clinical consequences from changes in either calcium or phosphorus were not reported., hematocrit, neutrophils, platelets, WBC 6.2 Postmarketing Experience The following
Because these reactions are reported voluntarily from
Anaphylaxis (including anaphylactic
Although most cases occurred in
If neurotoxicity associated with cefepime therapy occurs, consider
2 DOSAGE AND ADMINISTRATION For intravenous use only over approximately 30
(2) Use this formulation of cefepime only in
(2.2) Site and Type of
(2.1) Use this formulation of cefepime only in
(2.1) 2.1 Adult and Pediatric Population Cefepime for Injection USP and Dextrose Injection USP in the DUPLEX® Container should be used only in
Cefepime for Injection USP and Dextrose Injection USP should be administered intravenously (IV) over approximately 30
, K. pneumoniae, or Enterobacter species 1-2 g IV Every 8-12 hours 10 Empiric therapy for febrile neutropenic patients [see Indications and Usage (1) and Clinical Studies (14)] 2 g IV Every 8 hours 7Or until resolution of neutropenia.
In patients whose fever resolves but who remain neutropenic for more than 7 days, the
pneumoniae 2 g IV
[see Clinical Studies (14)] 2 g IV Every 8-12 hours 7-10 Pediatric Patients (2 months up to 16 years)
Cefepime for Injection USP and Dextrose Injection
USP in the DUPLEX®
Container is designed to deliver a 1 g or 2 g dose of cefepime.
Cefepime for Injection USP and Dextrose Injection USP in the DUPLEX® Container should be used only in
The serum creatinine should represent a
serum creatinine (mg/dL) Females: 0.85?
above value Table 2:
Cefepime for Injection USP and Dextrose Injection USP should be administered following hemodialysis.
Whenever possible, Cefepime for Injection USP and Dextrose Injection USP should be administered at the same time each day.
1 g on day 1, then 500 mg every 24 hours thereafter 1 g every 24 hours In patients undergoing continuous ambulatory peritoneal dialysis, Cefepime for Injection USP and Dextrose Injection USP may be administered at normally
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 Cefepime for Injection USP and Dextrose Injection USP for hemodialysis patients is 1 g on Day 1 followed by 500 mg every 24 hours for the treatment of all
Cefepime for Injection USP and Dextrose Injection USP should be administered at the same time each day and following the completion of hemodialysis on hemodialysis days (see Table 2).
2.3 Preparation for Use of Cefepime for Injection USP and Dextrose Injection USP in DUPLEX® Container This reconstituted solution is for intravenous use only.
Such use would result in air embolism due to residual air being drawn from the primary container before
If administration is controlled by a pumping device,
Parenteral drug products should be inspected visually for particulate matter and
Use only if
DUPLEX® Container Storage To avoid
Patient Labeling and Drug Powder/Diluent Inspection Apply patient-specific label on foil side of container.
Do not cover any portion of foil strip with patient label.
Unlatch side tab and unfold DUPLEX® Container (see Diagram 1).
Visually inspect diluent chamber for particulate matter.
Use only if
To inspect the drug powder for foreign matter or
If foil strip is removed, the container should be re-folded and the side tab latched until ready to activate.
The product must then be used within 7 days, but not beyond the labeled expiration date.
Diagram 1 Diagram 2 Reconstitution (Activation) Do not
Unfold the DUPLEX® container and point the set port in a
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.
Following reconstitution (activation), product must be used within 12 hours if stored at room temperature or within 5 days if stored under refrigeration.
Diagram 3 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).
Prior to attaching the IV set, check for minute leaks by squeezing
If leaks are found,
Using aseptic technique, peel foil cover from the set port and attach
Refer to directions for use accompanying the administration set.
Do not introduce additives into the DUPLEX® Container.
Administer Cefepime for Injection USP and Dextrose Injection USP intravenously over approximately 30
However, during infusion of Cefepime for Injection USP and Dextrose Injection USP, it is advisable to
However, if concurrent therapy with cefepime is indicated, each of these antibiotics can be administered separately.
8 USE IN SPECIFIC POPULATIONS Geriatric use: Serious
(8.4) 8.1 Pregnancy Pregnancy Category B Cefepime was not teratogenic or embryocidal when administered during the period of organogenesis to
There are, however,
Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.
8.2 Labor and Delivery Cefepime has not been studied for use during labor and delivery.
Treatment should only be given if clearly indicated.
8.3 Nursing Mothers Cefepime is excreted in human breast milk in
8.4 Pediatric Use The
Use of Cefepime for Injection USP and
8.5 Geriatric Use Of the more than 6400 adults treated with cefepime in clinical studies, 35 % were 65 years or older while 16 % were 75 years or
When geriatric patients received the usual
Because elderly patients are more likely to have
|Date Last Revised||05-11-2015|
|Type||HUMAN PRESCRIPTION DRUG|
|Marketing authorisation holder||B. Braun Medical Inc.|