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Product Name
:
CEFEPIME-ELSaad
Chemical Name
:
Cefepime (HCl)
Therapeutic Category
:
Antimicrobial
Pharmacologic Category
:
Antibiotic, Cephalosporin (Fourth Generation)
Pharmaceutical Form
:
Vial
Composition
:
Cefepime (HCl) 500mg / 1000mg / 2000mg
Monitoring Parameters
Dosing
 
Dosing: Adult
Brain abscess, postneurosurgical prevention (unlabeled use): I.V.: 2 g every 8 hours with vancomycin
Febrile neutropenia, monotherapy: I.V: 2 g every 8 hours for 7 days or until the neutropenia resolves
Intra-abdominal infections, complicated, severe (in combination with metronidazole): I.V.: 2 g every 12 hours for 7-10 days. Note: 2010 IDSA guidelines recommend 2 g every 8-12 hours for 4-7 days (provided source controlled). Not recommended for hospital-acquired intra-abdominal infections (IAI) associated with multidrug-resistant gram negative organisms or in mild-to-moderate community-acquired IAIs due to risk of toxicity and the development of resistant organisms (Solomkin, 2010).
Otitis externa, malignant (unlabeled use): I.V.: 2 g every 12 hours
Pneumonia: I.V.:
Nosocomial (HAP/VAP): 1-2 g every 8-12 hours; Note: Duration of therapy may vary considerably (7-21 days); usually longer courses are required if Pseudomonas. In absence of Pseudomonas, and if appropriate empiric treatment used and patient responsive, it may be clinically appropriate to reduce duration of therapy to 7-10 days (American Thoracic Society Guidelines, 2005).
Community-acquired (including pseudomonal): 1-2 g every 12 hours for 10 days
Septic lateral/cavernous sinus thrombosis (unlabeled use): I.V.: 2 g every 8-12 hours; with metronidazole for lateral
Skin and skin structure, uncomplicated: I.V.: 2 g every 12 hours for 10 days
Urinary tract infections, complicated and uncomplicated:
Mild-to-moderate: I.M., I.V.: 0.5-1 g every 12 hours for 7-10 days
Severe: I.V.: 2 g every 12 hours for 10 days

Dosing: Pediatric
Febrile neutropenia: I.V.: 50 mg/kg/dose every 8 hours for 7 days or until neutropenia resolves
Skin and skin structure infections (uncomplicated) and pneumonia: I.V.: 50 mg/kg/dose every 12 hours for 10 days
Urinary tract infections, complicated and uncomplicated: I.V., I.M.: 50 mg/kg/dose every 12 hours for 7-10 days; Note: I.M. may be considered for mild-to-moderate infection only.

Dosing: Geriatric

Refer to adult dosing.

Dosing: Renal Impairment
Cefepime Hydrochloride
Creatinine Clearance
(mL/minute)
Recommended Maintenance Schedule
>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
<11
250 mg every 24 hours
250 mg every 24 hours
500 mg every 24 hours
1 g every 24 hours

Note:

Consider higher dosage of 4 g/day if treating Pseudomonas or life-threatening infections in order to maximize time above MIC (Trotman, 2005). Dosage of 2 g every 8 hours may be needed for gram-negative rods with MIC ≥4 mg/L (Heintz, 2009).
Use
 
Treatment of uncomplicated and complicated urinary tract infections, including pyelonephritis caused by Escherichia coli, Klebsiella pneumoniae, or Proteus mirabilis; monotherapy for febrile neutropenia; uncomplicated skin and skin structure infections caused by Streptococcus pyogenes or methicillin-susceptible staphylococci; moderate-to-severe pneumonia caused by Streptococcus pneumoniae, Pseudomonas aeruginosa, Klebsiella pneumoniae, or Enterobacter species; complicated intra-abdominal infections (in combination with metronidazole) caused by E. coli, P. aeruginosa, K. pneumoniae, Enterobacter species, or Bacteroides fragilis against methicillin-susceptible staphylococci, Enterobacter sp, and many other gram-negative bacilli.
Children 2 months to 16 years: Empiric therapy of febrile neutropenia patients, uncomplicated skin/soft tissue infections, pneumonia, and uncomplicated/complicated urinary tract infections, including pyelonephritis.
Use - Unlabeled/Investigational
Brain abscess (postneurosurgical prevention); malignant otitis externa; septic lateral/cavernous sinus thrombosis
Adverse Reactions
 
Significant
>10%: Hematologic: Positive Coombs' test without hemolysis (16%)
1% to 10%:
Central nervous system: Fever (1%), headache (1%)
Dermatologic: Rash (1% to 4%), pruritus (1%)
Endocrine & metabolic: Hypophosphatemia (3%)
Gastrointestinal: Diarrhea (≤3%), nausea (≤2%), vomiting (≤1%)
Hematologic: Eosinophils (2%)
Hepatic: ALT increased (3%), AST increased (2%), PTT abnormal (2%), PT abnormal (1%)
Local: Inflammation, phlebitis, and pain (1%)
<1% (Limited to important or life-threatening): Agranulocytosis, alkaline phosphatase increased, anaphylactic shock, anaphylaxis, bilirubin increased, BUN increased, colitis, coma, confusion, creatinine increased, encephalopathy, hallucinations, hematocrit decreased, hypercalcemia, hyperkalemia, hyperphosphatemia, hypocalcemia, leucopenia, myoclonus, neutropenia, oral moniliasis, pseudomembranous colitis, seizure, stupor, thrombocytopenia, urticaria, vaginitis
Reactions reported with other cephalosporins: Aplastic anemia, erythema multiforme, hemolytic anemia, hemorrhage, pancytopenia, PT prolonged, renal dysfunction, Stevens-Johnson syndrome, superinfection, toxic epidermal necrolysis, toxic nephropathy, vaginitis
Contraindications
 
Hypersensitivity to cefepime, other cephalosporins, penicillins, other beta-lactam antibiotics, or any component of the formulation
Warnings / Precautions Drug
 
Concerns related to adverse effects:
• Elevated INR: May be associated with increased INR, especially in nutritionally-deficient patients, prolonged treatment, hepatic or renal disease.
• Penicillin allergy: Use with caution in patients with a history of penicillin allergy, especially IgE-mediated reactions (eg, anaphylaxis, angioedema, urticaria).
• Superinfection: Prolonged use may result in fungal or bacterial superinfection, including C. difficile-associated diarrhea (CDAD) and pseudomembranous colitis; CDAD has been observed >2 months postantibiotic treatment.
Disease-related concerns:
• Gastrointestinal disease: Use with caution in patients with a history of gastrointestinal disease, especially colitis.
• Renal impairment: Use with caution in patients with renal impairment (Clcr ≤60 mL/minute); dosage adjustments recommended. May increase risk of encephalopathy, myoclonus, and seizures.
• Seizure disorders: Use with caution in patients with a history of seizure disorder; high levels, particularly in the presence of renal impairment, may increase risk of seizures.
Interactions
 
BCG: Antibiotics may diminish the therapeutic effect of BCG. Risk X: Avoid combination
Probenecid: May increase the serum concentration of Cephalosporins. Risk C: Monitor therapy
Typhoid Vaccine: Antibiotics may diminish the therapeutic effect of Typhoid Vaccine. Only the live attenuated Ty21a strain is affected. Management: Vaccination with live attenuated typhoid vaccine (Ty21a) should be avoided in patients being treated with systemic antibacterial agents. Use of this vaccine should be postponed until at least 24 hours after cessation of antibacterial agents. Risk D: Consider therapy modification
Pregnancy
 
B
Pregnancy Implications
Teratogenic effects were not observed in animal studies; therefore, cefepime is classified as pregnancy category B. It is not known if cefepime crosses the human placenta.
Lactation
 
Enters breast milk/use caution
Breast-Feeding Considerations
Small amounts of cefepime are excreted in breast milk. The manufacturer recommends that caution be exercised when administering cefepime to nursing women. Nondose-related effects could include modification of bowel flora.
Mechanism of Action
 
Inhibits bacterial cell wall synthesis by binding to one or more of the penicillin-binding proteins (PBPs) which in turn inhibits the final transpeptidation step of peptidoglycan synthesis in bacterial cell walls, thus inhibiting cell wall biosynthesis. Bacteria eventually lyse due to ongoing activity of cell wall autolytic enzymes (autolysis and murein hydrolases) while cell wall assembly is arrested.
Pharmacodynamics / Kinetics
 
Absorption: I.M.: Rapid and complete
Distribution: Vd: Adults: 16-20 L; penetrates into inflammatory fluid at concentrations ~80% of serum levels and into bronchial mucosa at levels ~60% of those reached in the plasma; crosses blood-brain barrier
Protein binding, plasma: ~20%
Metabolism: Minimally hepatic
Half-life elimination: 2 hours
Time to peak: I.M.: 1-2 hours; I.V.: 0.5 hours
Excretion: Urine (85% as unchanged drug)
 
   
 
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