Because high and prolonged serum cefepime concentrations can occur from usual dosages in patients with renal impairment, the cefepime dosage should be reduced when it is administered to such patients. However, if concurrent therapy with cefepime for injection is indicated, each of these antibiotics can be administered separately. It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. Solutions containing dextrose may be contraindicated in patients with known allergy or hypersensitivity to corn or corn products. Written by ASHP. (See DOSAGE AND ADMINISTRATION.). For non-prescription products, read the label or package ingredients carefully. aeruginosa. Cefepime for injection, USP is indicated in the treatment of the following infections caused by susceptible strains of the designated microorganisms (see also PRECAUTIONS: Pediatric Use and DOSAGE AND ADMINISTRATION): Pneumonia (moderate to severe) caused by Streptococcus pneumoniae, including cases associated with concurrent bacteremia, Pseudomonas aeruginosa, Klebsiellapneumoniae, or Enterobacter species. Local reactions (3%), including phlebitis (1.3%), pain and/or inflammation (0.6%)*; rash (1.1%), INCIDENCE LESS THAN 1% BUT GREATER THAN 0.1%, Colitis (including pseudomembranous colitis), diarrhea, erythema, fever, headache, nausea, oral moniliasis, pruritus, urticaria, vaginitis, vomiting, anemia. Safety and effectiveness in pediatric patients below the age of 2 months have not been established. More resistant to inactivation by chromosomally and plasmid-mediated -lactamases than most other cephalosporins; hydrolyzed by -lactamases at a slower rate than third generation cephalosporins. Moreover, in vivo assessments of cefepime in mice (2 chromosomal aberration and 2 micronucleus studies) were negative for clastogenicity. 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. Patients with renal impairment: Clearance decreased and plasma half-life prolonged. Administer the dose at the same time each day (given at completion of procedure on hemodialysis days). There are insufficient clinical data to support the use of cefepime for injection in pediatric patients under 2 months of age or for the treatment of serious infections in the pediatric population where the suspected or proven pathogen is Haemophilusinfluenzae type b. Caution should be exercised when cefepime is administered to a nursing woman. Terms of Use. Cefepime is an antibacterial agent belonging to the cephalosporin class of antibacterials with in vitroantibacterial activity against facultative Gram-positive and Gram-negative bacteria. In adults with normal renal function, 8082% of a single dose excreted unchanged in urine; < 1% of the dose eliminated as NMP, 6.8% as NMP-N-oxide, and 2.5% as an epimer of the drug. The percentage of cefepime-treated patients who discontinued study drug because of drug-related adverse events was very similar at daily doses of 500 mg, 1 g, and 2 g every 12 hours (0.8%, 1.1%, and 2%, respectively). Serious acute hypersensitivity reactions may require treatment with epinephrine and other emergency measures including oxygen, corticosteroids, intravenous fluids, intravenous antihistamines, pressor amines, and airway management, as clinically indicated. Patients who receive an overdose should be carefully observed and given supportive treatment. Constitute the 1 g, or 2 g vial, and add an appropriate quantity of the resulting solution to an intravenous container with one of the compatible intravenous fluids listed in the Compatibility and Stability subsection. In the absence of such data, consider local epidemiology and susceptibility patterns when selecting anti-infectives for empiric therapy. Commercially available cefepime preparations contain l-arginine to adjust pH. Administer by IV infusion or deep IM injection. 5705185. 10 12 hours--------------------------------ADVERSE----------------- REACTIONS-------------- Empiric therapy for febrile2 g Every neutropenic 7 patients 8 hoursMild to Moderate UncomplicatedEv ry. Importance of informing clinicians if an allergic reaction occurs. Cefepime for injection, USP is supplied as follows: Cefepime for injection, USP in the dry state, is a white to pale yellow powder. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. aeruginosa is known or suspected to be involved. For treatment of meningitis caused by Ps. Many cephalosporins, including cefepime, have been associated with a fall in prothrombin activity. Concentrations of cefepime achieved in specific tissues and body fluids are listed in Table 3. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. 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 maximum human dose calculated on a mg/m2 basis) or to mice at doses up to 1200 mg/kg (approximately equal to the recommended maximum human dose calculated on a mg/m2 basis) or to rabbits at a dose level of 100 mg/kg (0.3 times the recommended maximum human dose calculated on a mg/m2 basis). Possible emergence and overgrowth of nonsusceptible organisms with prolonged therapy. Symptoms of neurotoxicity generally were reversible and resolved after cefepime was discontinued and/or after hemodialysis. A nursing infant consuming approximately 1000 mL of human milk per day would receive approximately 0.5 mg of cefepime per day. Sandoz Inc. 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 or prevent infections that are proven or strongly suspected to be caused by bacteria. Chemical name: [6R-(6,7(Z)]]-1-[[7-[[(2-amino-4-thiazolyl)(methoxyimino)acetyl]amino]-2-carboxy-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-en-3-yl]methyl] -1-methylpyrrolidinium chloride monohydrochloride monohydrate The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Ask your pharmacist any questions you have about cefepime injection. Advise patients that skipping doses or not completing the full course of therapy may decrease effectiveness and increase the likelihood that bacteria will develop resistance and will not be treatable with cefepime or other antibacterials in the future. The recommended doses of cefepime for injection in patients with renal impairment are presented in Table 11. Insufficient data exist to support the efficacy of cefepime monotherapy in such patients. 1998-2023 Mayo Foundation for Medical Education and Research (MFMER). The UK is the first country to allow OTC access to Sanofi's tadalafil-based erectile dysfunction drug Cialis following a successful switch. Cefepime is used to treat a wide variety of bacterial infections. per dose 2 g), increased if necessary to 50 mg/kg every 8 hours (max. If refrigerated after reconstitution (see Storage under Stability), allow solution to reach room temperature prior to administration. SeizuresUse with caution. In case of overdose, call the poison control helpline at 1-800-222-1222. You may report side effects to the FDA at 1-800-FDA-1088. (See Renal Impairment under Dosage and Administration.). C. difficile produces toxins A and B which contribute to development of CDAD; hypertoxin-producing strains of C. difficile are associated with increased morbidity and mortality since they may be refractory to anti-infectives and colectomy may be required. Advise patients that neurologic adverse events can occur. 2. Cefepime pharmacokinetics are linear over the range 250 mg to 2 g. There is no evidence of accumulation in healthy adult male volunteers (n=7) receiving clinically relevant doses for a period of 9 days. 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. Adult (body-weight up to 41 kg) 50 mg/kg every 12 hours (max. These studies comprised 317 evaluable patients. Positive Coombs test (without hemolysis) (16.2%); decreased phosphorus (2.8%); increased ALT/SGPT (2.8%), AST/SGOT (2.4%), eosinophils (1.7%); abnormal PTT (1.6%), PT (1.4%), Increased alkaline phosphatase, BUN, calcium, creatinine, phosphorus, potassium, total bilirubin; decreased calcium*, hematocrit, neutrophils, platelets, WBC. This medication belongs to a class of drugs known as cephalosporin antibiotics. Half-life averages 4.9, 10.5, 13.5 hours in those with Clcr 3160, 1130, or <10 mL/minute, respectively. American Society of Health-System Pharmacists, Inc., 4500 East-West Highway, Suite 900, Bethesda, Maryland 20814. If you use such tests, talk with your health care provider. Strains of staphylococci resistant to penicillinase-resistant penicillins (oxacillin-resistant [methicillin-resistant] staphylococci) should be considered resistant to cefepime, although results of in vitro susceptibility tests may indicate that the organisms are susceptible to the drug. Cefepime for injection is contraindicated in patients who have shown immediate hypersensitivity reactions to cefepime or the cephalosporin class of antibiotics, penicillins or other beta-lactam antibiotics. It is important that you put your used needles and syringes in a special sharps container. Enterococci (e.g., Enterococcus faecalis), oxacillin-resistant (methicillin-resistant) staphylococci, and Listeria monocytogenes are resistant. Importance of completing full course of therapy, even if feeling better after a few days. Cefepime for injection should be administered at the same time each day and following the completion of hemodialysis on hemodialysis days (see Table 11). It may occur 2 months or more after you or your child stop using this medicine. You should begin to feel better during the first few days of treatment with cefepime injection. If your symptoms do not improve within a few days, or if they become worse, check with your doctor. (See WARNINGS and ADVERSE REACTIONS.) Continue multiple-drug regimen for 6 weeks; discontinue gentamicin after first 2 weeks. Patients should be advised of neurological adverse events that could occur with cefepime for injection use. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco. These MICs provide estimates of the susceptibility of bacteria to antimicrobial compounds. NOTE: This sheet is a summary. We do not endorse non-Cleveland Clinic products or services. It is important not to miss your dose. May make these conditions worse. 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. 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. This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions. (See Renal Impairment under Dosage and Administration.). For all outcome measures, cefepime was therapeutically equivalent to ceftazidime. Also tell them if you smoke, drink alcohol, or use illegal drugs. Information is for End User's use only and may not be sold, redistributed or otherwise used for commercial purposes. Careful observation of the patient is essential. Initiate appropriate supportive therapy (e.g., fluid and electrolyte management, protein supplementation), anti-infective therapy directed against C. difficile (e.g., metronidazole, vancomycin), and surgical evaluation as clinically indicated. Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria that Grow Aerobically; Approved Standard - Ninth Edition. You may report side effects to FDA at 1-800-FDA-1088. Treatment should only be given if clearly indicated. Cefepime has been shown to be active against most isolates of the following microorganisms, both in vitro and in clinical infections as described in the INDICATIONS AND USAGE section. In the presence of renal insufficiency, hemodialysis, not peritoneal dialysis, is recommended to aid in the removal of cefepime from the body. AHFS DI Essentials. 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. No animal carcinogenicity studies have been conducted with cefepime. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them: Other side effects not listed may also occur in some patients. It is also important information to carry with you in case of emergencies. 2.1 Dosage for Adults The recommended adult dosages and routes of administration are outlined in Table 1 below for patients with creatinine clearance greater than 60 mL/min. If CDAD is suspected or confirmed, discontinue anti-infectives not directed against C. difficile whenever possible. (See DOSAGE AND ADMINISTRATION.) Manufacturers caution that patients in whom meningeal seeding from a distant infection site or in whom meningitis is suspected or documented should receive an alternative anti-infective with demonstrated clinical efficacy in this setting. Adult dosage 2g IV every 8 hours for 7 days or until neutropenia resolves Pediatric dosage Older than 2 months, weighing less than 40 kg: 50 mg/kg IV every 8 hours for 7 days or until neutropenia resolves; not to exceed 2 g every 8 hours Urinary Tract Infections Adult dosage Partially metabolized in vivo to N-methylpyrrolidine (NMP), which is rapidly converted to the N-oxide (NMP-N-oxide). Consultation with an infectious disease expert knowledgeable about infections in immunocompromised patients also advised. Thirty-three (51%) of these 64 patients who discontinued therapy did so because of rash. Exercise caution if this product is to be given to penicillin-sensitive patients because cross-hypersensitivity among beta-lactam antibiotics has been clearly documented and may occur in up to 10% of patients with a history of penicillin allergy. Gram-positive aerobes: Active in vitro and in clinical infections against S. aureus, S. pneumoniae, S. pyogenes (group A -hemolytic streptococci), and viridans streptococci. 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. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. Cefepime for Injection and Dextrose Injection is indicated for uncomplicated and complicated urinary tract infections (including pyelonephritis) caused by 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, inclu. Protect from light. The clinical relevance of these data is uncertain at this time. Pharmacokinetics The dosage of cefepime for injection for hemodialysis patients is 1 g on Day 1 followed by 500 mg every 24 hours for the treatment of all infections except febrile neutropenia, which is 1 g every 24 hours. Brand name: Maxipime Also active in vitro against S. epidermidis (methicillin-susceptible [oxacillin-susceptible] strains only), S. saprophyticus, and S. agalactiae (group B streptococci). Cefepime is metabolized to N-methylpyrrolidine (NMP) which is rapidly converted to the N-oxide (NMP-N-oxide). Do not use cefepime available in Duplex containers or the cefepime premixed injection (frozen) in pediatric patients who require less than the entire 1- or 2-g dose in the container. 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. For initial treatment of life-threatening sepsis in adults, some clinicians suggest that a third or fourth generation cephalosporin (cefepime, cefotaxime, ceftriaxone, ceftazidime), the fixed combination of piperacillin and tazobactam, or a carbapenem (imipenem or meropenem) be used in conjunction with vancomycin; some also suggest including an aminoglycoside or fluoroquinolone during initial few days of treatment. Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs. They need to know if you have any of these conditions: stomach, intestinal problems like colitis, an unusual or allergic reaction to cefepime, other cephalosporin or penicillin antibiotics, imipenem, other foods, dyes or preservatives. Cefepime as monotherapy is indicated for empiric treatment of febrile neutropenic patients. Talk to your health care provider about the use of this drug in children. 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. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. C. difficile infection (CDI) and C. difficile-associated diarrhea and colitis (CDAD; also known as antibiotic-associated diarrhea and colitis or pseudomembranous colitis) have been reported with nearly all anti-infectives, including cefepime, and may range in severity from mild diarrhea to fatal colitis. Sixty-four (1.5%) patients discontinued medication due to adverse events thought by the investigators to be possibly, probably, or almost certainly related to drug toxicity. A precipitate may have formed in the frozen injection, but should dissolve with little or no agitation after reaching room temperature. Cefepime injection is used to treat bacterial infections in many different parts of the body. However, the incidence of discontinuation due to rash increased with the higher recommended doses. Importance of informing patients of other precautionary information. Children 2 months to 16 years of age weighing <40 kg: 50 mg/kg every 12 hours. It works by killing bacteria or preventing their growth. Dosing Modifications Adjust recommended maintenance dosages according to CrCl Recommended maintenance dosage 500 mg q12hr CrCl >60 mL/min: 500 mg q12hr CrCl 30-60 mL/min: 500 mg q24hr CrCl 11-29. Cefepime is a bactericidal agent that acts by inhibition of bacterial cell wall synthesis. This medicine is given as a shot into a muscle or into a vein. Do not use in series connections with other plastic containers; such use could result in air embolism from residual air being drawn from primary container before administration of fluid from secondary container is complete. Based on spectrum of activity, classified as a fourth generation cephalosporin. It is usually given every 8 or 12 hours for 7 to 10 days. Using antibiotics when they are not needed increases your risk of getting an infection later that resists antibiotic treatment. At the higher dose of 2 g every 8 hours, the incidence of probably-related adverse events was higher among the 795 patients who received this dose of cefepime. Constituted solution of cefepime for injection, USP can range in color from pale yellow to amber. Drug information provided by: Merative, Micromedex. CDAD must be considered in all patients who present with diarrhea following antibiotic use. It is highly soluble in water. In November 2007, FDA announced initiation of a cefepime safety review after a published meta-analysis described a higher risk of all-cause mortality in patients treated with cefepime compared with patients treated with comparator -lactams. They can happen weeks to months after starting the medicine. A similar safety profile was seen in clinical trials of pediatric patients (see PRECAUTIONS: Pediatric Use). Serious adverse events, including life-threatening or fatal encephalopathy (disturbance of consciousness including confusion, hallucinations, stupor, coma), myoclonus, and seizures reported rarely. aeruginosa, K. pneumoniae, or Enterobacter. Breastfeeding Contact your doctor if you have diarrhea that lasts more than 2 days or if the diarrhea is severe and watery. (See CLINICAL STUDIES.). If your symptoms do not improve or get worse, call your doctor. Data suggest that cefepime does cross the inflamed blood-brain barrier. PRODUCT MONOGRAPH Cefepime for Injection (cefepime hydrochloride) 1 g and 2 g cefepime per vial Orchid Standard Antibiotic Manufactured by: Orchid Healthcare (A Division of Orchid Chemicals & Pharmaceuticals Ltd.) Plot No: B3-B6 & B11-B14, SIPCOT Industrial Park, Irungattukottai- 602 105, Sriperumbudur P.O., Kancheepuram District, INDIA. If an allergic reaction occurs, discontinue cefepime and institute appropriate therapy as indicated (e.g., epinephrine, corticosteroids, and maintenance of an adequate airway and oxygen). 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 or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. Be sure that you understand these directions, and ask your healthcare provider if you have any questions. You may need a lower dose of this medicine, as this may increase risk of having seizures. A single copy of these materials may be reprinted for noncommercial personal use only. 19.79. Performance Standards for Antimicrobial Disk Diffusion Susceptibility Tests; Approved Standard Eleventh Edition. It works by killing bacteria or preventing their growth. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. If neurotoxicity associated with cefepime therapy occurs, consider discontinuing the drug or making dosage adjustment appropriate for patient's renal function. ANC = absolute neutrophil count; SBP = systolic blood pressure. 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. There were no deaths or permanent disabilities thought related to drug toxicity. While it may be prescribed for children as young as 2 months for selected conditions, precautions do apply. 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 injection can also be given intramuscularly (into a muscle). Reconstitute (activate) commercially available Duplex drug delivery system that contains 1 or 2 g of cefepime and 50 mL of 5% dextrose injection in separate chambers according to the manufacturer's directions. Substantially eliminated by kidneys; risk of toxicity may be greater in those with impaired renal function. Urinary tract infection, complicated and uncomplicated: Infants 2 months, Children, and Adolescents: Mild to moderate infection: IM, IV: 50 mg/kg/dose every 12 hours for 7 to 10 days; maximum dose: 1,000 mg/dose. If you will be receiving cefepime injection at home, your healthcare provider will show you how to use the medication. Before you or your child have any medical tests, tell the medical doctor in charge that you are receiving this medicine. Streptococcuspneumoniae non-meningitis isolates. The disc diffusion interpretive criteria are provided in Table 4. For empiric treatment of CAP in patients with risk factors for Ps. Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Side effects that you should report to your doctor or health care professional as soon as possible: Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome): This list may not describe all possible side effects. (See Solution Compatibility under Compatibility.). Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details. Medically reviewed by Drugs.com on Aug 25, 2022. (See DOSAGE AND ADMINISTRATION. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. The study was designed to demonstrate equivalence of the two therapies. Inactive against fungi and viruses. Compare Prices Specify your dosage and quantity to find out exactly how much you can save. NOTE: This medicine is only for you. There appeared to be a decrease in cefepime total body clearance as a function of creatinine clearance. Make sure you tell your doctor if you have any other medical problems, especially: A nurse or other trained health professional will give you or your child this medicine. Dosage adjustments necessary in patients with Clcr 60 mL/minute. Your doctor may need to change the doses of your medications or monitor you carefully for side effects. However, you should not flush this medication down the toilet. Cefepime for injection should be administered intravenously over approximately 30 minutes. Table 6 describes the characteristics of the evaluable patient population. This medicine can interfere with some urine glucose tests. Administer by IV infusion over approximately 30 minutes. What is NDC 60505-6147-0? Importance of immediately contacting a clinician if any neurologic signs and symptoms, including encephalopathy (disturbance of consciousness including confusion, hallucinations, stupor, coma), myoclonus, or seizures, occur since immediate treatment, dosage adjustment, or discontinuance of the drug is required. Patients should be counseled that antibacterial drugs including cefepime for injection should only be used to treat bacterial infections. lwoffii. 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). New drug approvals, alerts and updates or into a muscle or into muscle! 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