Maxipime® (cefepime hydrochloride) for Injection
| Product (generic name) | MAXIPIME® (cefepime hydrochloride) for Injection |
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| Indication | MAXIPIME® (cefepime hydrochloride) for Injection is indicated for the treatment of the following infections:
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| Therapeutic Focus Area | Infectious Diseases - intravenous antibiotic |
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| Product Description | MAXIPIME® (cefepime hydrochloride) for Injection is a semi-synthetic, broad-spectrum, cephalosporin antibiotic for parenteral administration. MAXIPIME is a fourth-generation injectable cephalosporin antibiotic used by pulmonologists, infectious disease specialists, internal medicine physicians, hematologists and oncologists to treat patients with serious and/or potentially life-threatening infections. |
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| Dosage Strengths | 500 mg, 1 g and 2 g of cefepime |
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| Mode of Administration | Injectable for IV/IM use. |
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| Clinical Efficacy | Please see full Prescribing Information |
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| Important Safety Information | In North American clinical trials of MAXIPIME® (cefepime hydrochloride) for Injection at a dose of 0.5 to 2 g q12h, the most common adverse events were local reactions (3%), including phlebitis (1.3%), pain and/or inflammation (0.6%); rash (1.1%). MAXIPIME is contraindicated in patients who have had an immediate hypersensitivity reaction to MAXIPIME, a cephalosporin, a penicillin, or any other ß-lactam antibiotic. Clostridium difficile associated diarrhea (CDAD) occurs with use of nearly all antibacterial agents, including MAXIPIME®, and severity ranges from mild diarrhea to fatal colitis. Antibacterial agent use alters the normal flora of the colon leading to overgrowth of C. difficile. Consider CDAD in all patients presenting with diarrhea following antibiotic use. If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. |
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| Size of Market | The global antibacterial drugs market was worth $25.2 billion in 2001 and is forecast to reach $27.6 billion in 2007. The injectable antibiotic market is $2.8 billion. The competitive cephalosporin market is estimated at $1.2 billion. |
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| Publications | Cefepime References Ambrose PG, Richerson MA, Stanton M-E, Bui K, Nicolau DP, Nightingale CH et al. Cost-effectiveness analysis of cefepime compared with ceftazidime in intensive care unit patients with hospital-acquired pneumonia. Infect Dis Clin Practice 1999; 8(5):245-251. Ambrose PG, Owens RC, Garvey MJ, Jones RN. Pharmacodynamic considerations in the treatment of moderate to severe pseudomonal infections with cefepime. J Antimicrob Chemother 2002; 49(3):445-453. Chandrasekar PH, Arnow PM. Cefepime versus ceftazidime as empiric therapy for fever in neutropenic patients with cancer. Ann Pharmacother 2000; 34(9):989-995. Fritsche TR, Sader HS, Jones RN. Comparative activity and spectrum of broad-spectrum ß-lactams (cefepime, ceftazidime, ceftriaxone, piperacillin/tazobactam) tested against 12,295 staphylococci and streptococci: Report from the SENTRY Antimicrobial Surveillance Program (North America: 2001-2002). Diagn Microbiol Infect Dis 2003; 47:435-440. Gouin F, Papazian L, Martin C, Albanese J, Durbec O, Domart Y et al. A non-comparative study of the efficacy and tolerance of cefepime in combination with amikacin in the treatment of severe infections in patients in intensive care. J Antimicrob Chemother 1993; 32;(suppl B)(suppl B):205-214. Hughes WT, Armstrong D, Bodey GP, Bow EJ, Brown AE, Calandra T et al. 2002 guidelines for the use of antimicrobial agents in neutropenic patients with cancer. Clin Infect Dis 2002; 34(6):730-751. Jones RN, Pfaller MA, Doern GV, Erwin ME, Hollis RJ. Antimicrobial activity and spectrum investigation of eight broad-spectrum beta-lactam drugs: a 1997 surveillance trial in 102 medical centers in the United States. Diagn Microbiol Infect Dis 1998; 30(3):215-228. Jones RN, Varnam DJ. Antimicrobial activity of broad-spectrum agents tested against gram-negative bacilli resistant to ceftazidime: Report from the SENTRY Antimicrobial Surveillance Program (North America, 2001). Diagn Microbiol Infect Dis 2002; 44:379-382. Raad II, Escalante C, Hachem RY, et al. Treatment of febrile neutropenic patients with cancer who require hospitalization: A prospective randomized study comparing imipenem and cefepime. Cancer 2003; 98:1039-1047. Sader HS, Biedenbach DJ, Jones RN. Global Patterns of susceptibility for 21 commonly utilized antimicrobial agents tested against 48,440 Enterobacteriaceae in the SENTRY Antimicrobial Surveillance Program (1997-2001). Diagn Microbiol Infect Dis 2003; 47:361-364. Yamamura D, Gucalp R, Carlisle P, Cimino M, Roberts J, Rotstein C. Open randomized study of cefepime versus piperacillin-gentamicin for treatment of febrile neutropenic cancer patients. Antimicrob Agents Chemother 1997; 41(8):1704-1708. |
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| Medical Inquiries | Medical Information Services can be reached at: Toll-Free Phone: 1-888-638-7605 An Elan Medical Information Services representative is available to answer medical information inquiries from 9:00 am–7:00 pm EST Monday through Friday. |
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Last Updated: 02/20/04