INDICATIONS AND USAGE
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.
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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) |
|---|
| 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. |
| ***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. |
| Moderate to Severe Pneumonia due to S. pneumoniae *, P. aeruginosa, K. pneumoniae, or Enterobacter species | 1–2 g IV | Every 12 hours | 10 |
| 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 * | 0.5–1 g IV/IM*** | Every 12 hours | 7–10 |
| 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 | 7–10 |
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. |
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: Creatinine Clearance (mL/min) = Weight (kg) × (140–age)
——————————————
72× serum creatinine (mg/dL)
Females: 0.85 × above value
Table 13: Recommended Dosing Schedule for MAXIPIME in Adult Patients (Normal Renal Function, Renal Impairment, 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. |
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 |
| 30–60 | 500 mg
every 24 hours | 1 g
every 24 hours | 2 g
every 24 hours | 2 g
every 12 hours |
| 11–29 | 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 | 2g
every 48 hours |
| Hemodialysis* | 1 g on day 1, then 500 mg every 24 hours thereafter | 1 g
every 24 hours |
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.
Administration
For 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 Abbott 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 1.0% 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)
500 mg (IM)
1 g (IV)
1 g (IM)
2 g (IV) |
5
1.3
10
2.4
10 |
5.6
1.8
11.3
3.6
12.5 |
100
280
100
280
160 |
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
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°–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 per 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 in Table 15.
Table 15: Cefepime Admixture Stability | | 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 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°–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.
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