CEFEPIME injection, powder, for solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

CEFEPIME HYDROCHLORIDE (UNII: I8X1O0607P) (CEFEPIME - UNII:807PW4VQE3)

Available from:

SAMSON MEDICAL TECHNOLOGIES LLC

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Cefepime is indicated in the treatment of pneumonia (moderate to severe) caused by susceptible strains of Streptococcus pneumoniae , including cases associated with concurrent bacteremia, Pseudomonas aeruginosa , Klebsiella pneumoniae , or Enterobacter species. 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 (14.1) ]. Cefepime is indicated in the treatment of uncomplicated and complicated urinary tract infections (including pyelonephritis) caused by susceptible isolates of 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 bacteria. Cefepime is indicated in the treatment of uncomplicated skin and skin structure infections caused by Staphylococcus aureus (methicillin-susceptible isolates only) or Streptococcus pyogenes . Cefepime is indicated in the treatment of complicated intra-abdominal infections (used in combination with metronidazole) in adults caused by susceptible isolates of Escherichia coli , viridans group streptococci, Pseudomonas aeruginosa, Klebsiella pneumoniae, Enterobacter species or Bacteroides fragilis .  [see Clinical Studies (14.2) ]. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Cefepime for Injection, USP and other antibacterial drugs, Cefepime for Injection, USP should be used only to treat 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. Cefepime for Injection, USP is contraindicated in patients who have shown immediate hypersensitivity reactions to cefepime or the cephalosporin class of antibiotics, penicillins or other beta-lactam antibiotics. Pregnancy Category B There are no adequate and well-controlled studies of cefepime use in pregnant women.  Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Cefepime was not teratogenic or embryocidal when administered during the period of organogenesis to rats at doses up to 1000 mg/kg/day (1.6 times the recommended human dose calculated on a body surface area basis) or to mice at doses up to 1200 mg/kg (approximately equal to the recommended maximum human dose calculated on a body surface area basis) or to rabbits at a dose level of 100 mg/kg (0.3 times the recommended maximum human dose calculated on a body surface area basis). Cefepime has not been studied for use during labor and delivery. Treatment should only be given if clearly indicated. Cefepime is excreted in human breast milk.  Caution should be exercised when cefepime is administered to a nursing woman [see Clinical Pharmacology (12.3) ]. Cefepime for Injection, Pharmacy Bulk Package bag SmartPak® should not be used in pediatric patients who require less than a 500 mg dose of cefepime. The safety and effectiveness of cefepime in the treatment of uncomplicated and complicated urinary tract infections (including pyelonephritis), uncomplicated skin and skin structure infections, pneumonia, and as empiric therapy for febrile neutropenic patients have been established in the age groups 2 months up to 16 years.  Use of cefepime in these age groups is supported by evidence from adequate and well-controlled studies of cefepime in adults with additional pharmacokinetic and safety data from pediatric trials [see Clinical Pharmacology (12.3) ]. Safety and effectiveness in pediatric patients below the age of 2 months have not been established.  There are insufficient clinical data to support the use of cefepime in pediatric patients for the treatment of serious infections in the pediatric population where the suspected or proven pathogen is H. influenzae type b.  In those patients in whom meningeal seeding from a distant infection site or in whom meningitis is suspected or documented, an alternate agent with demonstrated clinical efficacy in this setting should be used. Of the more than 6400 adults treated with cefepime in clinical studies, 35% were 65 years or older while 16% were 75 years or older.  When geriatric patients received the usual recommended adult dose, clinical efficacy and safety were comparable to clinical efficacy and safety in non-geriatric adult patients. Serious adverse events have occurred in geriatric patients with renal insufficiency given unadjusted doses of cefepime, including life-threatening or fatal occurrences of the following: encephalopathy, myoclonus, and seizures [ see Warnings and Precautions (5.2), Adverse Reactions (6.2) ]. This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function.  Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and renal function should be monitored [ see Clinical Pharmacology (12.3), Warnings and Precautions (5.2), Dosage and Administration (2.3) ]. Cefepime for Injection, Pharmacy Bulk Package bag SmartPak® should not be used in patients with renal impairment who require less than a 500 mg dose of cefepime. Adjust the dose of cefepime in patients with creatinine clearance less than or equal to 60 mL/min to compensate for the slower rate of renal elimination. [see Dosage Adjustments in Patients with Renal Impairment (2.3) ]

Product summary:

How Supplied Cefepime for Injection, USP in the dry state is a white to pale yellow powder.  Constituted solutions of Cefepime for Injection, USP can range in color from pale yellow to amber.   Cefepime for Injection, USP is  available in the following SmartPakPharmacy Bulk Package: 100 grams* (1 Pharmacy Bulk Package) Product No. 8100  NDC 66288-8100-1 sold in individual bags. *Each 100 gram Pharmacy Bulk Package contains sterile cefepime hydrochloride equivalent to 100 grams of cefepime and 70.7 grams of L-arginine. SmartPak® system components are not made with natural rubber latex. Storage and Handling Cefepime for Injection, USP in the dry state should be stored at 20 to 25°C (68 to 77°F) [see USP controlled room temperature.] and protected from light. The inner bag should be retained in the outer bag until time of use.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CEFEPIME- CEFEPIME INJECTION, POWDER, FOR SOLUTION
SAMSON MEDICAL TECHNOLOGIES LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
CEFEPIME FOR INJECTION
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR CEFEPIME
FOR INJECTION.
CEFEPIME FOR INJECTION, FOR INTRAVENOUS USE
PHARMACY BULK PACKAGE - NOT FOR DIRECT INFUSION
INITIAL U.S. APPROVAL: 1996
INDICATIONS AND USAGE
Cefepime for Injection, USP is a cephalosporin antibacterial indicated
for the treatment of the following
infections caused by susceptible strains of the designated
microorganisms:
Pneumonia. (1.1)
Empiric therapy for febrile neutropenic patients. (1.2)
Uncomplicated and complicated urinary tract infections (including
pyelonephritis). (1.3)
Uncomplicated skin and skin structure infections. (1.4)
Complicated intra-abdominal infections (used in combination with
metronidazole) in adults. (1.5)
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of cefepime and
other antibacterial drugs, cefepime should be used only to treat
infections that are proven or strongly
suspected to be caused by bacteria. (1.6)
DOSAGE AND ADMINISTRATION
For intravenous use only over approximately 30 minutes (2)
THIS IS A PHARMACY BULK PACKAGE - NOT FOR DIRECT INJECTION. CEFEPIME
FOR INJECTION, PHARMACY
BULK PACKAGE BAG SMARTPAK SHOULD NOT BE USED IN PATIENTS WHO REQUIRE
LESS THAN A 500
MG DOSE OF CEFEPIME.
For _Pseudomonas aeruginosa_, use 2 g IV every 8 hours. (2.1)
*Or until resolution of neutropenia. (2.1)
**Intramuscular route of administration is indicated only for mild to
moderate, uncomplicated or
complicated UTIs due to _E. coli_. (2.1)
RECOMMENDED DOSAGE IN ADULTS WITH CREATININE CLEARANCE (CRCL)
GREATER THAN 60 ML/MIN (2.1)
SITE AND TYPE OF INFECTION
DOSE
FREQUENCY
DURATION (DAYS)
Moderate to Severe Pneumonia
1 to 2 g IV
Every 8 to12 hours
10
Empiric Therapy for Febrile Neutropenic
Patients
2 g IV
Every 8 hours
7*
Mild to Moderate Uncomplicated or
Complicated