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)]. There are insufficient clinical data to support the use of Cefepime for injection in pediatric patients for the treatment of serious infections in the pediatric population where the suspected or proven pathogen is H. influenzae type b. i'm taking rinozal 5mg, suprax 400mg , lanzol 30mg and deltacortril 5mg decreasing dose from 40mg every second day ending at 5mg. Cefepime is used to treat a wide variety of bacterial infections. Retain in carton until time of use. 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. Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Cefepime injection is used in combination with metronidazole (Flagyl) to treat abdominal (stomach area) infections. The usual recommended dosage in pediatric patients up to 40 kg in weight for durations as given above for adults is: Adjust the dose of Cefepime for injection in patients with creatinine clearance less than or equal to 60 mL/min to compensate for the slower rate of renal elimination. Cefepime with NDC 44567-241 is a a human prescription drug product labeled by Wg Critical Care, Llc. Positive Coombs’ test may be observed in newborns whose mothers have received cephalosporin antibiotics before parturition. The clinical relevance of these data is uncertain at this time. Should superinfection occur during therapy, appropriate measures should be taken. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Cefepime for injection and other antibacterial drugs, Cefepime for injection should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. Tract Infections, including pyelonephritis, Moderate to Severe Uncomplicated Skin and Skin 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. The chemical name is 1-[[(6R,7R)-7-[2-(2-amino-4-thiazolyl)-glyoxylamido]-2-carboxy-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-en-3-yl]methyl]-1-methylpyrrolidinum chloride,72-(Z)-O-methyloxime), monohydrochloride, monohydrate, which corresponds to the following structural formula: Cefepime hydrochloride is a white to pale yellow powder. can i drink alcohol? Sixty-four (1.5%) patients discontinued medication due to adverse reactions. 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. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile. The pharmacokinetics of Cefepime are linear over the range of 500 mg to 2 g intramuscularly and do not vary with respect to treatment duration. In addition to the adverse reactions listed above that have been observed in patients treated with Cefepime, the following adverse reactions and altered laboratory tests have been reported for cephalosporin-class antibacterial drugs: Stevens-Johnson syndrome, erythema multiforme, toxic epidermal necrolysis, renal dysfunction, toxic nephropathy, aplastic anemia, hemolytic anemia, hemorrhage, hepatic dysfunction including cholestasis, and pancytopenia. Caution should be exercised when Cefepime is administered to a nursing woman [see Clinical Pharmacology (12.3)]. Cefepime is excreted in human breast milk. Hypertoxin-producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. The safety and efficacy of empiric Cefepime monotherapy of febrile neutropenic patients have been assessed in two multicenter, randomized trials comparing Cefepime monotherapy (at a dose of 2 g intravenously every 8 hours) to ceftazidime monotherapy (at a dose of 2 g intravenously every 8 hours). Cefepime for Injection Admixture Incompatibility. 1.1 PneumoniaCefepime 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.1.2 Empiric Therapy for Febrile Neutropenic PatientsCefepime for Injection as monotherapy is indicated for empiric treatment of febrile neutropenic patients. Moreover, in vivo assessments of Cefepime in mice (2 chromosomal aberration and 2 micronucleus studies) were negative for clastogenicity. Select one or more newsletters to continue. Any catheter-related infection signs like warmth, irritation, swelling, redness, and pain at the site must be brought to doctor’s notice 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. Cefepime is a cephalosporin (SEF a low spor in) antibiotic. Medically reviewed by Drugs.com. Limit to 1 drink or 1 glass of wine. Concentrations of Cefepime achieved in specific tissues and body fluids are listed in Table 9. For intramuscular or intravenous use after constitution. In addition to the adverse reactions reported during the North American clinical trials with Cefepime, the following adverse reactions have been reported during worldwide postmarketing experience. There are no adequate and well-controlled studies of Cefepime use in pregnant women. It works by stopping the growth of bacteria. DESCRIPTION. Griseofulvin. 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. Most cases occurred in patients with renal impairment who did not receive appropriate dosage adjustment. eHealthMe makes it possible for everyone to run personal clinical trial. If particulate matter is evident in reconstituted fluids, the drug solution should be discarded. 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. However, the pharmacokinetic/pharmacodynamics relationship for Cefepime has not been evaluated in patients. At least 90 percent of the following bacteria exhibit an in vitro minimum inhibitory concentration (MIC) less than or equal to the susceptible breakpoint for Cefepime against isolates of similar genus or organism group. The presence of other medical problems may affect the use of cefepime. Whenever possible, Cefepime should be administered at the same time each day. Last updated on Aug 1, 2020. Symptoms of overdose include encephalopathy (disturbance of consciousness including confusion, hallucinations, stupor, and coma), myoclonus, seizures, neuromuscular excitability, and nonconvulsive status epilepticus [see Warnings and Precautions (5.2), Adverse Reactions (6.2), Dosage and Administration (2.3)]. The following adverse reactions are discussed in the Warnings and Precautions section and below: Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. 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). 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. 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 invention belongs to the field of medical intermediate and particularly relates to a synthesis method of cefepime hydrochloride. *or until resolution of neutropenia. Pregnancy Category B Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. 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)]. Exercise caution if this product is to be given to penicillin-sensitive patients because cross-hypersensitivity among beta-lactam antibacterial drugs has been clearly documented and may occur in up to 10% of patients with a history of penicillin allergy. By using our website, you consent to our use of cookies. HealthTap uses cookies to enhance your site experience and for analytics and advertising purposes. Monitor renal function when Cefepime is concomitantly administered with potent diuretics. 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 . i have been struggling to cure my gonorhea these past 3 months, we have gone as far as using cefixime 400mg 1 pill a day for 5 days. Cefepime Accession Number DB01413 Description. The percentage of Cefepime-treated patients who discontinued study drug because of drug-related adverse reactions was similar at daily doses of 500 mg, 1 g, and 2 g every 12 hours (0.8%, 1.1%, and 2%, respectively). NOTE: Most isolates of enterococci, e.g., Enterococcus faecalis, and methicillin-resistant staphylococci are resistant to Cefepime. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. The following (Table 6) adverse laboratory changes, with Cefepime, were seen during clinical trials conducted in North America. » Cefepime for Injection is a sterile mixture of Cefepime Hydrochloride and Arginine. 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. Cefepime for Injection, USP is a sterile, dry mixture of Cefepime hydrochloride and L-arginine. Cefepime should be considered only in non-severe infections (eg, uncomplicated urinary tract infection) when the minimum inhibitory concentration (MIC) is 2 mg/L or less (1). Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of cefepime injection in the elderly. Insufficient data exist to support the efficacy of Cefepime monotherapy 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). The average half-life in patients requiring hemodialysis was 13.5 (±2.7) hours and in patients requiring continuous peritoneal dialysis was 19 (±2) hours. Alcohol is not recommended while taking medications regardless of dose. There were no significant effects of age or gender (25 male vs. 17 female) on total body clearance or volume of distribution, corrected for body weight. The study was designed to demonstrate equivalence of the two therapies. Dr. James Ferguson answered. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. It works by fighting bacteria in your body. Cefixime is an antibiotic in the cephalosporin class. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. Cefepime for injection admixture compatibility information is summarized in Table 4. 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. The likelihood of having an allergic reaction to cefixime is under 10%. If CDAD is suspected or confirmed, ongoing antibacterial drug use not directed against C. difficile may need to be discontinued. These studies comprised 317 evaluable patients. In chromosomal aberration studies, Cefepime was positive for clastogenicity in primary human lymphocytes, but negative in Chinese hamster ovary cells. For all outcome measures, Cefepime was therapeutically equivalent to ceftazidime. 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 . Cefepime and methadone do not interact with each other but you must not take grapefruit juice with methadone. Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Do not add solutions of Cefepime for injection, to solutions of ampicillin at a concentration greater than 40 mg per mL, or to metronidazole, vancomycin, gentamicin, tobramycin, netilmicin sulfate, or aminophylline because of potential interaction. A diagnosis of bacterial pneumonia in the year previous to enrolment was made in 33% of patients in the cefepime group and 18% in the cefotaxime group ( P = 0.04). Hope your query is … The urinary recovery of unchanged Cefepime was 60.4 (±30.4)% of the administered dose, and the average renal clearance was 2 (±1.1) mL/min/kg. To learn more, please visit our. Therefore, dosage administration of Cefepime in the elderly should be adjusted as appropriate if the patient’s creatinine clearance is 60 mL/min or less [see Dosage and Administration (2.3)]. Repeated evaluation of the patient’s condition is essential. Drinking alcohol while taking this medication can cause: flushing; excessive sweating; fast heartbeat Cefepime is active against Gram-positive and Gram-negative bacteria, with greater activity against both than third-generation antibiotics. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The product's dosage form is injection, powder, for solution and is administered via intravenous form. However, elderly patients are more likely to have age-related kidney problems, which may require caution and an adjustment in the dose for patients receiving cefepime injection. No animal carcinogenicity studies have been conducted with Cefepime. CEFEPIME (SEF e pim) is a cephalosporin antibiotic. 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. Make sure your partner is also treated. Cefepime belongs to a group of drugs called cephalosporin antibiotics, which work to stop the growth of bacteria in the body. When alcohol is consumned along with cefixime, it weakens the drug, in as much as it (cefixime) leaves your body earlier than intended.