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Maxipime Indications, Dosage, Storage, Stability - Cefepime

Maxipime Indications, Dosage, Storage, Stability - Cefepime

INDICATIONS

MAXIPIME (cefepime hydrochloride) is indicated in the treatment of the following infections caused by susceptible strains of the designated microorganisms:

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)

Culture and susceptibility testing should be performed where appropriate to determine the susceptibility of the causative microorganism(s) to cefepime.

Therapy with MAXIPIME may be instituted before results of susceptibility studies are known; however, once these results become available, the antibiotic treatment should be adjusted accordingly.

DOSAGE AND ADMINISTRATION

The recommended adult 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

Site and Type of Infection	Dose	Frequency	Duration (days)
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 ( See INDICATIONS and CLINICAL STUDIES.)	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. (See CLINICAL STUDIES.)	2 g IV	q12h	7-10

*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.

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 (cefepime hydrochloride) 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. The recommended maintenance doses of MAXIPIME in patients with renal insufficiency are presented in Table 13.

TABLE 13
Recommended Maintenance Schedule in Adult Patients with Renal
Impairment Relative to Normal Recommended Dosing Schedule

Creatinine Clearance (mL/min)	Recommended Maintenance Schedule
> 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

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:

Weight (kg) x (140–age)

Males: Creatinine Clearance (mL/min)= __________________________

72 x serum creatinine (mg/dL)

Females: 0.85 x above value

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. A repeat dose, equivalent to the initial dose, should be given at the completion of each dialysis session.

In patients undergoing continuous ambulatory peritoneal dialysis, MAXIPIME may be administered at normally recommended doses at a dosage interval of every 48 hours.

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 (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)	5.0	5.6	100
500 mg (IM)	1.3	1.8	280
1 g (IV)	10.0	11.3	100
1 g (IM)	2.4	3.6	280
2 g (IV)	10.0	12.5	160
Piggyback (100 mL)
1 g bottle	50	50	20
1 g bottle	100	100	10
2 g bottle	50	50	40
2 g bottle	100	100	20
ADD-Vantage ®
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 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 in Table 15.

Table 15
Cefepime Admixture Stability

Maxipime Concentration	Admixture and Concentration	IV Infusion Solutions	Stability Time for
			RT/ L	Refrigeration
			(20°– 25°C)	(2°– 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– 40 mg/mL	Clindamycin Phosphate 0.25–6mg/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
0.125–0.25mg/ 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/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) for Injection is supplied as follows:

NDC 0003-7731-99	500 mg*	15 mL vial (tray of 10)
NDC 0003-7732-95	1 g*	Piggyback bottle 100 mL (tray of 10)
NDC 0003-7732-89	1 g*	ADD-Vantage® vial (tray of 10)
NDC 0003-7732-99	1 g*	15 mL vial (tray of 10)
NDC 0003-7733-95	2 g*	Piggyback bottle 100 mL (tray of 10)
NDC 0003-7733-89	2 g*	ADD-Vantage® vial (tray of 10)
NDC 0003-7733-99	2 g*	20 mL vial (tray of 10)
* Based on cefepime activity

Storage

MAXIPIME IN THE DRY STATE SHOULD BE STORED BETWEEN 2°– 25° C (36°– 77° F) AND PROTECTED FROM LIGHT.

REFERENCES

1. National Committee for Clinical Laboratory Standards. Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria that Grow Aerobically— Third Edition. Approved Standard NCCLS Document M7-A3, Vol. 13, No. 25, NCCLS, Villanova, PA, December, 1993.
2. National Committee for Clinical Laboratory Standards. Performance Standards for Antimicrobial Disk Susceptibility Tests— Fifth Edition. Approved Standard NCCLS Document M2-A5, Vol. 13, No. 24, NCCLS, Villanova, PA, December, 1993.
3. Cockcroft DW, Gault MH. Prediction of creatinine clearance from serum creatinine. Nephron. 1976; 16:31-41.

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