Label: Refrigerate.
Stability data:
|
| Drug |
Stability
Refrigerated |
Stability
Room Temp. |
Reconstituted
Vial/Powder |
Notes |
| Cefepime Powder |
Cefepime for Injection in ADD-Vantage vials are stable for 7 days in a refrigerator 2°C to 8°C (36°F to 46°F) |
Cefepime for Injection in the dry state should be stored at 20 to 25° C (68 to 77° F) and protected from light.
Cefepime for Injection in ADD-Vantage vials are stable for 24 hours at controlled room temperature 20°C to 25°C (68°F to 77°F) |
Powder |
As with other cephalosporins, the color of cefepime 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. |
| Cefepime Solution |
Store at or below –20°C (-4°F).
Thaw frozen container under refrigeration 5°C (41°F). Do not force thaw by immersion in water baths or by microwave irradiation.
The thawed solution remains stable for 7 days under refrigeration 5°C (41°F). Do not refreeze. |
Thaw frozen container at room temperature 25°C (77°F). Do not force thaw by immersion in water baths or by microwave irradiation.
The thawed solution remains stable for 24 hours at room temperature 25°C (77°F). Do not refreeze. |
Solution |
As with other cephalosporins, the color of Cefepime Injection tend to darken depending on storage conditions; however, when stored as recommended, the product potency is not adversely affected.
Handle frozen product containers with care. Product containers may be fragile in the frozen state. |
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.
Recommended Dosage Schedule for MAXIPIME in Patients with CrCL >60 mL/min.
| Site and Type of Infection |
Dose |
Frequency |
Duration
(days) |
| Adults |
| *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. |
| ***IM route of administration is indicated only for mild to moderate, uncomplicated or complicated UTI’s due to E. coli when the IM route is considered to be a more appropriate route of drug administration. |
| Moderate to Severe Pneumonia due to S. pneumoniae*, P. aeruginosa, K. pneumoniae, or Enterobacter species |
1-2 g IV |
q12h |
10 |
| Empiric therapy for febrile neutropenic patients |
2 g IV |
q8h |
7** |
| Mild to Moderate Uncomplicated or Complicated Urinary Tract Infections, including pyelonephritis, due to E. coli, K. pneumoniae, or P. mirabilis* |
0.5-1 g IV/IM*** |
q12h |
7-10 |
| Severe Uncomplicated or Complicated Urinary Tract Infections, including pyelonephritis, due to E. coli or K. pneumoniae* |
2 g IV |
q12h |
10 |
| Moderate to Severe Uncomplicated Skin and Skin Structure Infections due to S. aureus or S. pyogenes |
2 g IV |
q12h |
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. |
2 g IV |
q12h |
7-10 |
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/kg/dose, administered q12h (50 mg/kg/dose, q8h for febrile neutropenic patients), for durations as given above. |
Impaired Hepatic Function
No adjustment is necessary for patients with impaired hepatic function.
Impaired Renal Function
In patients with impaired renal function (creatinine clearance ≤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.
Recommended Dosing Schedule for MAXIPIME in Adult Patients (Normal Renal Function, Renal Insufficiency, and Hemodialysis)
Creatinine
Clearance (mL/min) |
Recommended Maintenance Schedule |
| *On hemodialysis days, cefepime should be administered following hemodialysis. Whenever possible, cefepime should be administered at the same time each day. |
>60 Normal
recommended
dosing schedule |
500 mg q12h |
1 g q12h |
2 g q12h |
2 g q8h |
| 30-60 |
500 mg q24h |
1 g q24h |
2 g q24h |
2 g q12h |
| 11-29 |
500 mg q24h |
500 mg q24h |
1 g q24h |
2 g q24h |
| <11 |
250 mg q24h |
250 mg q24h |
500 mg q24h |
1 g q24h |
| CAPD |
500 mg q48h |
1 g q48h |
2 g q48h |
2g q48h |
| Hemodialysis* |
1 g on day 1, then 500 mg q24h thereafter |
1 g q24h |
Administration
For Intravenous Infusion, constitute the 1 g or 2 g piggyback (100 mL) bottle with 50 or 100 mL of a compatible IV fluid listed in the Compatibility and Stability subsection. Alternatively, constitute the 500 mg, 1 g, or 2 g vial, and add an appropriate quantity of the resulting solution to an IV container with one of the compatible IV fluids. THE RESULTING SOLUTION SHOULD BE ADMINISTERED OVER APPROXIMATELY 30 MINUTES.
Intermittent IV 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 or 100 mL of 5% Dextrose Injection or 0.9% Sodium Chloride Injection in Abbott ADD-Vantage® flexible diluent containers. (See ADD-Vantage® Vial Instructions for Use.)
Intramuscular Administration: For IM 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 1.0% Lidocaine Hydrochloride, or Sterile Bacteriostatic Water for Injection with Parabens or Benzyl Alcohol .
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)
500 mg (IM)
1 g (IV)
1 g (IM)
2 g (IV) |
5.0
1.3
10.0
2.4
10.0 |
5.6
1.8
11.3
3.6
12.5 |
100
280
100
280
160 |
Piggyback (100 mL)
1 g bottle
1 g bottle
2 g bottle
2 g bottle |
50
100
50
100 |
50
100
50
100 |
20
10
40
20 |
ADD-Vantage®
1 g vial
1 g vial
2 g vial
2 g vial |
50
100
50
100 |
50
100
50
100 |
20
10
40
20 |
Compatibility and Stability
---- Storage/Stability ----
Intravenous: MAXIPIME is compatible at concentrations between 1 and 40 mg/mL with the following IV 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°–25° C (68°–77° F) or 7 days in a refrigerator 2°–8° C (36°–46° F). MAXIPIME in ADD-Vantage® vials is stable at concentrations of 10–40 mg/mL in 5% Dextrose Injection or 0.9% Sodium Chloride Injection for 24 hours at controlled room temperature 20°–25° C or 7 days in a refrigerator 2°–8° C.
MAXIPIME admixture compatibility information is summarized below:
|
Stability Time for |
MAXIPIME
Concentration |
Admixture and
Concentration |
IV Infusion
Solutions |
RT/L
(20°-25° C) |
Refrigeration
(2°-8° C) |
| NS = 0.9% Sodium Chloride Injection |
| D5W = 5% Dextrose Injection |
| na = not applicable |
| RT/L = Ambient room temperature and light |
| 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 |
| 4-40 mg/mL |
Clindamycin
Phosphate
0.25-6 mg/mL |
NS or D5W |
24 hours |
7 days |
| 4 mg/mL |
Heparin
10-50 units/mL |
NS or D5W |
24 hours |
7 days |
| 4 mg/mL |
Potassium Chloride
10-40 mEq/L |
NS or D5W |
24 hours |
7 days |
| 4 mg/mL |
Theophylline
0.8 mg/mL |
D5W |
24 hours |
7 days |
| 1-4 mg/mL |
na |
Aminosyn® II
4.25% with
electrolytes and
calcium |
8 hours |
3 days |
| 0.125-0.25 mg/mL |
na |
Inpersol™ with
4.25% dextrose |
24 hours |
7 days |
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/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°–25° C (68°–77° F) or for 7 days in a refrigerator 2°–8° C (36°–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.
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.
HOW SUPPLIED
MAXIPIME® (cefepime hydrochloride, USP) for Injection is supplied as follows:
*Based on cefepime activity
500 mg* 15 mL vial (tray of 10) NDC 51479-053-10
1 g* Piggyback bottle 100 mL (tray of 10) NDC 51479-054-10
1 g* ADD-Vantage® vial (tray of 10) NDC 51479-054-20
1 g* 15 mL vial (tray of 10) NDC 51479-054-30
2 g* Piggyback bottle 100 mL (tray of 10) NDC 51479-055-20
2 g* ADD-Vantage® vial (tray of 10) NDC 51479-055-10
2 g* 20 mL vial (tray of 10) NDC 51479-055-30
Storage
MAXIPIME IN THE DRY STATE SHOULD BE STORED BETWEEN 2°–25° C (36°–77° F) AND PROTECTED FROM LIGHT.
Manufactured by
Bristol-Myers Squibb Company
Princeton, NJ 08543 USA
Distributed by
Elan Biopharmaceuticals, a business unit of Elan Pharmaceuticals, Inc (EPI),
a member of the Elan Group, San Diego, CA 92121 USA
0055DIM-08
6001123
1095225A7
Rev December 2003 |
