Data from FDA (Food and Drug Administration, USA) - Curated by EPG Health - Last updated 20 February 2017
PRECAUTIONS General Prescribing cefepime for injection in
As with other antimicrobials,
Repeated evaluation of the patient 's condition is essential.
Should superinfection occur during therapy,
Those at risk include patients with renal or hepatic
Prothrombin time should be monitored in patients at risk, and exogenous vitamin K administered as indicated.
In hematologic studies or in transfusion cross-matching procedures when antiglobulin tests are performed on the minor side or in Coombs ' testing of newborns whose mothers have received cephalosporin antibiotics before parturition, it should be recognized that a
Cefepime for injection should be prescribed with
Arginine has been shown to alter glucose metabolism and elevate serum potassium transiently when administered at 33 times the amount provided by the maximum
The effect of lower doses is not presently known.
Information for Patients Before therapy with cefepime for injection is instituted,
Patients should be counseled that antibacterial drugs including cefepime for injection should only be used to treat bacterial
They do not treat
When cefepime for injection is prescribed to treat a bacterial
Skipping doses or not completing the full course of therapy may (1)
Sometimes after starting treatment with antibiotics,
If this occurs, patients should contact their physician as soon as
Patients should be advised of neurological
Patients should be instructed to inform their healthcare provider at once of any neurological signs and symptoms, including encephalopathy (
Nephrotoxicity has been reported following
Drug/Laboratory Test Interactions The administration of cefepime may result in a false-positive reaction for glucose in the
In other in_vitro assays (bacterial and mammalian cell mutation, DNA repair in primary rat hepatocytes, and sister chromatid exchange in human lymphocytes),
Moreover, in_vivo assessments of cefepime in mice (2 chromosomal
Pregnancy Teratogenic Effects 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.
Nursing Mothers Cefepime is excreted in human breast milk in
Labor and Delivery Cefepime has not been studied for use during labor and delivery.
Treatment should only be given if clearly indicated.
Pediatric Use The
When geriatric patients received the usual
(See WARNINGS and
Because elderly patients are more likely to have
(See CLINICAL PHARMACOLOGY: Specific Populations, WARNINGS, and DOSAGE AND ADMINISTRATION.
In clinical trials using multiple doses of cefepime, 4137 patients were treated with the
Sixty-four (1.5 %)
Thirty-three (51 %) of
; rash (1.1 %) INCIDENCE LESS THAN 1 % BUT
They consisted of rash (4 %), diarrhea (3 %),
The following (Table 9)
Clinical consequences from changes in either calcium or phosphorus were not reported., hematocrit, neutrophils, platelets, WBC A similar
Although most cases occurred in
If neurotoxicity associated with cefepime therapy occurs, consider
) As with other cephalosporins, anaphylaxis including anaphylactic
Cefepime for injection should be administered intravenously over approximately 30
) 2 g IV Every 8 hours 7 or until resolution of neutropenia.
In patients whose fever resolves but who remain neutropenic for more than 7 days, the
Every 12 hours 7 to 10
(See CLINICAL STUDIES.
) 2 g IV Every 8 to 12 hours 7 to 10 Pediatric Patients (2 months up to 16 years)
The serum creatinine should represent a
serum creatinine (mg/dL) Females: 0.85?
above value Table 11:
Whenever possible, cefepime 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 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 for hemodialysis patients is 1 g on Day 1 followed by 500 mg every 24 hours for the treatment of all
Cefepime for injection should be administered at the same time each day and following the completion of hemodialysis on hemodialysis days (see Table 11).
Administration For Intravenous Infusion Dilute with a
Constitute the 1 g, or 2 g vial, and add an
THE RESULTING SOLUTION SHOULD BE ADMINISTERED OVER APPROXIMATELY
However, during infusion of a solution containing cefepime,
Intramuscular Administration For intramuscular administration, cefepime for injection 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 12).
Preparation of cefepime for injection solutions is summarized in Table 12.
Table 12: Preparation of Solutions of Cefepime for Injection Single-Dose Vials for Intravenous/Intramuscular Administration Amount of Diluent to be added (mL) Approximate
These solutions may be stored up to 24 hours at
Cefepime for injection admixture compatibility information is summarized in Table 13.
Table 13: Cefepime Admixture Stability Stability Time for Cefepime for Injection Concentration Admixture and Concentration IV Infusion Solutions 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
However, if concurrent therapy with cefepime for injection is indicated, each of these antibiotics can be administered separately.
Intramuscular Cefepime for injection constituted as directed is stable for 24 hours at
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 cefepime for injection powder, as well as its solutions, tend to
|Date Last Revised||16-04-2015|
|Type||HUMAN PRESCRIPTION DRUG|
|Storage and handling||Storage IN THE DRY STATE STORE AT 20° TO 25°C (68° TO 77°F) [SEE USP CONTROLLED ROOM TEMPERATURE]. PROTECT FROM LIGHT. RETAIN IN CARTON UNTIL TIME OF USE.|
|Marketing authorisation holder||Sandoz Inc|