Table 8: Mean Pharmacokinetic Parameters for Cefepime (±SD), Intramuscular Administration. Use of Cefepime for injection 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)]. It is a potent (IC 50 = 36nM) inhibitor of phosphodiesterase-II. Patients with myeloproliferative conditions are known to have a very slow and somewhat variable course of marrow fibrosis increase. Pharmacokinetic parameters for Cefepime following a single intramuscular injection are summarized in Table 8. The word epinephrine derives from epi, meaning above, and nephros, the root word for kidney, because the gland sits atop the kidney.Epinephrine is also called adrenaline, derived from the name of its gland.For this reason, receptors for both epinephrine … Table 6: Adverse Laboratory Changes in Cefepime Multiple-Dose Dosing Regimens Clinical Trials in North America, Positive Coombs’ test (without hemolysis) (16.2%); decreased phosphorus (2.8%); increased Alanine Transaminase (ALT) (2.8%), Aspartate Transaminase (AST) (2.4%), eosinophils (1.7%); abnormal PTT (1.6%), Prothrombin Time (PT) (1.4%), Increased alkaline phosphatase, Blood Urea Nitrogen (BUN), calcium, creatinine, phosphorus, potassium, total bilirubin; decreased calcium*, hematocrit, neutrophils, platelets, White Blood Cells (WBC). Mechanism of Action. Cefepime pharmacokinetics have been investigated in elderly (65 years of age and older) men (n=12) and women (n=12) whose mean (SD) creatinine clearance was 74 (±15) mL/min. Most cases occurred in patients with renal impairment who did not receive appropriate dosage adjustment.  The exact mechanism of action is unclear, although it is known to be a phosphodiesterase inhibitor. Cefepime is excreted in human milk at a concentration of 0.5 mcg/mL. Many cephalosporins, including Cefepime, have been associated with a fall in prothrombin activity. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated. Positive direct Coombs’ tests have been reported during treatment with Cefepime for injection. The mechanism(s) whereby Fluothane (halothane) and other substances induce general anesthesia is … 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)]. lwoffii. Direct vasodilator; dilates arterioles with little effect on vein; decreases systemic resistance, which subsequently decreases blood pressure. Pregnancy and breastfeeding safety information are provided. The absolute bioavailability of Cefepime after an intramuscular dose of 50 mg per kg was 82.3 (±15)% in eight patients. If particulate matter is evident in reconstituted fluids, the drug solution should be discarded. Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including Cefepime for injection, and may range in severity from mild diarrhea to fatal colitis. The following (Table 6) adverse laboratory changes, with Cefepime, were seen during clinical trials conducted in North America. Patients hospitalized with complicated intra-abdominal infections participated in a randomized, double-blind, multicenter trial comparing the combination of Cefepime (2 g every 12 hours) plus intravenous metronidazole (500 mg every 6 hours) versus imipenem/cilastatin (500 mg every 6 hours) for a maximum duration of 14 days of therapy. Cefepime pharmacokinetics have been investigated in patients with various degrees of renal impairment (n=30). Following a single intravenous dose, total body clearance and the steady-state volume of distribution averaged 3.3 (±1) mL/min/kg and 0.3 (±0.1) L/kg, respectively. Dosage Form: injection, powder, lyophilized, for solution. [see Warnings and Precautions (5.2)]. Cefepime for injection 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. The following adverse reactions (Table 5) were identified in clinical trials conducted in North America (n=3,125 Cefepime-treated patients). Urinary Tract Infections, including pyelonephritis, Severe Uncomplicated or Complicated Urinary C. difficile produces toxins A and B, which contribute to the development of CDAD. Table 12: Demographics of Evaluable Patients (First Episodes Only), ANC = absolute neutrophil count; SBP = systolic blood pressure. In other in vitro assays (bacterial and mammalian cell mutation, DNA repair in primary rat hepatocytes, and sister chromatid exchange in human lymphocytes), Cefepime was negative for genotoxic effects. Cefepime was not teratogenic or embryocidal when administered during the period of organogenesis to rats at doses up to 1,000 mg/kg/day (1.6 times the recommended maximum human dose calculated on a body surface area basis) or to mice at doses up to 1,200 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). The observed differences in efficacy may have been due to a greater proportion of patients with high APACHE II scores in the imipenem/cilastatin group. The primary analyses were conducted on the population consisting of those with a surgically confirmed complicated infection, at least one pathogen isolated pretreatment, at least 5 days of treatment, and a 4 to 6 week follow-up assessment for cured patients. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Mechanism of action. 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. Amide formation between the newly formed imide and the ester would then serve to form the imidazolone ring, whatever the details of the sequence, there is obtained anagrelide (5). For specific information regarding susceptibility test interpretive criteria and associated test methods and quality control standards recognized by FDA for this drug, please see: https://www.fda.gov/STIC. As with other cephalosporins, the color of Cefepime for injection 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. Cefepime total body clearance decreased proportionally with creatinine clearance in patients with abnormal renal function, which serves as the basis for dosage adjustment recommendations in this group of patients [see Dosage and Administration (2.3)]. Following intramuscular (IM) administration, Cefepime is completely absorbed.  Essential thrombocytosis patients who are suitable for anagrelide often meet one or more of the following factors:. The recommended adult dosages and routes of administration are outlined in Table 1 below for patients with creatinine clearance greater than 60 mL/min. When only serum creatinine is available, the following formula (Cockcroft and Gault equation)1 may be used to estimate creatinine clearance. Cefepime for Injection Admixture Incompatibility. However, the incidence of discontinuation due to rash increased with the higher recommended doses. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. Life threatening hyperkalaemia (> 7.0 mmol/l ) is commonly associated with acute renal failure. It works by … Cefepime for Injection, USP is a sterile, dry mixture of Cefepime hydrochloride and L-arginine. Synthesis In these patients, the recommended initial dose of Cefepime for injection should be the same as in patients with CrCL greater than 60 mL/min except in patients undergoing hemodialysis. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. Addition of the aliphatic would then lead to formation of the quinazoline ring (4). Constituted solution of Cefepime for Injection, USP can range in color from pale yellow to amber. CDAD must be considered in all patients who present with diarrhea following antibacterial drug use. Thus, patients on anagrelide may need to be monitored on a periodic basis for marrow reticulin scores, especially if anemia develops, or becomes more pronounced if present initially.. Duration: 10 min. Medically reviewed by Drugs.com. During the first Match Day celebration of its kind, the UCSF School of Medicine class of 2020 logged onto their computers the morning of Friday, March 20 to be greeted by a video from Catherine Lucey, MD, MACP, Executive … Absorption. The i.v. Cefepime for injection as monotherapy is indicated for empiric treatment of febrile neutropenic patients. Time to peak effect: ~15 min. Absorption. Less than 1% of the administered dose is recovered from urine as NMP, 6.8% as NMP-N-oxide, and 2.5% as an epimer of Cefepime. [A180310,L7153] One major hypothesis is that carbamazepine inhibits sodium channel firing, treating seizure activity. Pharmacokinetic parameters for Cefepime in healthy adult male volunteers (n=9) following single 30‑minute infusions (IV) of Cefepime 500 mg, 1 g, and 2 g are summarized in Table 7. The administration of Cefepime may result in a false-positive reaction for glucose in the urine when using some methods (e.g. Cefepime for injection 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. Select one or more newsletters to continue.  It inhibits PDE-3 and phospholipase A2.. After oral administration, Lithium is reported to be completely absorbed in the upper gastrointestinal tract. Cefepime for injection is indicated in the treatment of uncomplicated skin and skin structure infections caused by Staphylococcus aureus (methicillin-susceptible isolates only) or Streptococcus pyogenes. Discard unused portion. 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