Cefepime Uses

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What is Cefepime?

Cefepime injection is used to treat bacterial infections in many different parts of the body. It belongs to the class of medicines known as cephalosporin antibiotics. It works by killing bacteria or preventing their growth. However, Cefepime will not work for colds, flu, or other virus infections.

Cefepime is to be given only by or under the direct supervision of a doctor.

Cefepime indications

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Adults: Cefepime for injection is indicated in the treatment of the infections listed as follows when caused by susceptible bacteria.

Lower respiratory tract infections, including pneumonia and bronchitis; urinary tract infections, both complicated, including pyelonephritis, and uncomplicated infections; skin and skin structure infections; intra-abdominal infections, including peritonitis and biliary tract infections; gynaecological infections; septicaemia; empiric treatment in febrile neutropenic patients.

Cefepime for injection is also indicated for surgical prophylaxis in patients undergoing intra-abdominal surgery. In this indication it is essential that metronidazole also be administered.

Paediatrics: Cefepime for injection is indicated in paediatric patients over 2 months of age for the treatment of the infections listed as follows when caused by susceptible bacteria: Pneumonia; urinary tract infections, both complicated, including pyelonephritis, and uncomplicated infections; skin and skin structure infections; septicaemia; empiric treatment in febrile neutropenic patients.

Culture and susceptibility studies should be performed when appropriate to determine susceptibility of the causative organism(s) to Cefepime. Empiric therapy with Cefepime for injection may be instituted before results of susceptibility studies are known; however, once these results become available, the antibiotic treatment should be adjusted accordingly.

Because of its broad spectrum of bactericidal activity against gram-positive and gram-negative bacteria, Cefepime for injection can be used appropriately as monotherapy prior to identification of the causative organism(s). In the treatment of febrile neutropenia, consideration should be given to the need for other antibiotics in combination with Cefepime for injection. In patients who are at risk of mixed aerobic-anaerobic infection, including infections in which Bacterioides fragilis may be present, concurrent initial therapy with an anti-anaerobic agent is recommended before the causative organism(s) is known.

How should I use Cefepime?

Use Cefepime as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Ask your health care provider any questions you may have about how to use Cefepime.

Uses of Cefepime in details

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Cefepime is used to treat a wide variety of bacterial infections. This medication belongs to a class of drugs known as cephalosporin antibiotics. It works by stopping the growth of bacteria.

How to use Cefepime injection

This medication is given by injection into a muscle or vein as directed by your doctor. The dosage is based on your medical condition and response to treatment.

If you are using this medication at home, learn all preparation and usage instructions from your health care professional. Before using, check this product visually for particles or discoloration. If either is present, do not use the liquid. Learn how to store and discard medical supplies safely.

If you are using the frozen pre-mixed solution, thaw the bag at room temperature or in the refrigerator. If the bag is thawed in the refrigerator, let it sit at room temperature at least 1 hour before using. Do not thaw by putting in a water bath or microwaving. After thawing, shake well and squeeze the bag to check for leaks. Discard solution if the bag leaks. Do not re-freeze the solution after thawing.

Antibiotics work best when the amount of medicine in your body is kept at a constant level. Use this drug at evenly spaced intervals.

Continue to use this medication for the full time prescribed, even if symptoms disappear after a few days. Stopping the medication too early may result in a return of the infection.

Tell your doctor if your condition lasts or gets worse.

Cefepime description

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Each 20 mL vial contains either 1.914 g or 3.828 g of sterile Cefepime-L-arginine powder, which is equivalent to 1 g or 2 g of Cefepime and approximately 725 mg of arginine per gram of Cefepime. It contains no antimicrobial preservative and is for use in one patient only.

Cefepime is a semi-synthetic broad spectrum cephalosporin antibiotic for parenteral administration. The chemical name is pyrrolidinium, 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-methyl-, chloride, monohydrochloride, monohydrate, [6R-[6α, 7β(Z)]]. It has a molecular formula of C19H25N6O5S2·Cl·HCl·H2O and a molecular weight of 571.5.

Cefepime is a white to pale yellow powder. It is highly soluble in water. It has a pH of between 4.0 and 6.0.

Cefepime for injection is a sterile lyophilised powder for injection containing the inactive ingredient L-arginine to control the pH of the reconstituted solution at 4.0 to 6.0. Following reconstitution with water for injection as directed in labeling, it results in a pale yellow to amber coloured, clear solution.

Cefepime dosage

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Adults: Urinary Tract Infections: For the treatment of mild to moderate uncomplicated or complicated urinary tract infections (including those associated with pyelonephritis and/or with concurrent bacteremia), the usual adult dosage of Cefepime is 500-1,000 mg administered IV or IM every 12 hrs for 7-12 days, including cases associated with concurrent bacteremia.

Intramuscular route at administration is indicated only for mild to moderate, uncomplicated or complicated urinary tract infections caused by E. coli when the IM route is a more appropriate route of drug administration. For the treatment of severe uncomplicated or complicated urinary tract infections (including those associated with pyelonephritis and/or concurrent bacteremia), adults should receive Cefepime 2,000 mg IV every 12 hrs for 10 days.

Skin and Skin Structure Infections: Treatment of moderate to severe uncomplicated skin and skin infections caused by Staphylococcus aureus or Streptococcus pyogenes, the usual adult dosage of Cefepime is 2,000 mg IV every 12 hrs for 10 days.

Moderate to Severe Pneumonia: Treatment of moderate to severe pneumonia caused by Streptococcus pneumoniae (including those with concurrent bacteremia), the usual adult dosage of Cefepime is 1,000-2,000 mg every 12 hrs for 10 days.

Intra-Abdominal Infections: Treatment of complicated intra-abdominal infections (in combination with metronidazole IV), the usual adult dosage of Cefepime is 2,000 mg given IV every 12 hrs for 7-10 days.

Empiric Therapy in Febrile Neutropenic Patients: When Cefepime is used as monotherapy for empiric anti-infective therapy in febrile neutropenic patients, adults should receive a dosage of 2,000 mg IV every 8 hrs for 7 days or until neutropenia resolves. The need for continued antimicrobial therapy in patients whose fever resolves but who remain neutropenic for longer than 7 days should be frequently re-evaluated.

Children: Treatment of uncomplicated and complicated urinary tract infections (including pyelonephritis), uncomplicated skin and skin structure infections or pneumoniae, it is recommended that pediatric weighing <40 kg receive Cefepime in a dosage of 50 mg/kg given IV every 12 hrs. When Cefepime is used as a monotherapy for empiric anti-infective therapy in febrile neutropenic pediatric patients who weigh <40 kg, it is recommended that a dosage of 50 mg/kg given IV every 8 hrs. Pediatric dosage should not exceed the recommended adult dosage.

Renal and Hepatic Impairment: In patients with renal impairment [ie, creatinine clearance (CrCl) of ≤60 mL/min], doses and/or frequency of administration of Cefepime should be modified in response to the degree of renal impairment, severity of the infection and susceptibility of the causative organism. It is recommended that, patients with renal impairment receive the same initial dose of Cefepime recommended for patients with normal renal function. However, maintenance dosage of Cefepime should be based on the patients measured or estimated CrCl.

The patients CrCl can be estimated by the following formula: See equation.

(where age is in years, weight is in kg and serum creatinine is in mg/dL).

It is recommended that adults receive the following maintenance dosage based on the patient's renal function were normal: See Table 3.

Data regarding use of Cefepime in pediatric patients with impaired renal function are not available. Because the pharmacokinetics of Cefepime are similar in pediatric and adult patients, it is recommended that dosage modifications similar to those recommended for adults be used in pediatric patients with impaired renal function.

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-hr dialysis period.

Patients undergoing hemodialysis should receive a repeat-dose of Cefepime equivalent to the initial dose at the completion of each dialysis.

Patients undergoing continuous ambulatory peritoneal dialysis (CAPD) should receive the usual dose every 48 hrs. Since pharmacokinetics of Cefepime appear not to be altered with hepatic impairment, the dosage adjustments are not necessary in such patients.

Cefepime interactions

See also:
What other drugs will affect Cefepime?

Renal function should be monitored carefully if high doses of aminoglycosides are to be administered with Cefepime because of the increased potential of nephrotoxicity and ototoxicity of aminoglycoside antibiotics. Nephrotoxicity has been reported following concomitant administration of other cephalosporins with potent diuretics such as furosemide.

Drug/Laboratory Test Interactions

The administration of Cefepime may result in a false-positive reaction for glucose in the urine when using Clinitest™ tablets. It is recommended that glucose tests based on enzymatic glucose oxidase reactions (such as Clinistix™) be used.

Cefepime side effects

See also:
What are the possible side effects of Cefepime?

Clinical Trials

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.

In clinical trials using multiple doses of Cefepime, 4137 patients were treated with the recommended dosages of Cefepime (500 mg to 2 g intravenous every 12 hours). There were no deaths or permanent disabilities thought related to drug toxicity. 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. Thirty-three (51%) of these 64 patients who discontinued therapy did so because of rash. 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). However, the incidence of discontinuation due to rash increased with the higher recommended doses.

The following adverse events were thought to be probably related to Cefepime during evaluation of the drug in clinical trials conducted in North America (n=3125 Cefepime-treated patients).

Table 10: Adverse Reactions Cefepime Multiple-Dose Dosing Regimens Clinical Trials—North America

INCIDENCE EQUAL TO OR GREATER THAN 1% 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, fever, headache, nausea, oral moniliasis,pruritus,urticaria, vaginitis, vomiting
* Local reactions, irrespective of relationship to Cefepime in those patients who received intravenous infusion (n=3048).

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. They consisted of rash (4%), diarrhea (3%), nausea (2%), vomiting (1%), pruritus (1%), fever (1%), and headache (1%).

The following adverse laboratory changes, irrespective of relationship to therapy with Cefepime, were seen during clinical trials conducted in North America.

Table 11: Adverse Laboratory Changes Cefepime Multiple-Dose Dosing Regimens Clinical Trials—North America

INCIDENCE EQUAL TO OR GREATER THAN 1% 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%)
INCIDENCE LESS THAN 1% BUT GREATER THAN 0.1% Increased alkaline phosphatase, BUN, calcium, creatinine, phosphorus, potassium, total bilirubin; decreased calcium*, hematocrit, neutrophils, platelets, WBC
* Hypocalcemia was more common among elderly patients. Clinical consequences from changes in either calcium or phosphorus were not reported.

A similar safety profile was seen in clinical trials of pediatric patients.

Postmarketing Experience

In addition to the events reported during North American clinical trials with Cefepime, the following adverse experiences have been reported during worldwide postmarketing experience.

Encephalopathy (disturbance of consciousness including confusion, hallucinations, stupor, and coma), myoclonus, seizures, and nonconvulsive status epilepticus have been reported. Although most cases occurred in patients with renal impairment who received doses of Cefepime that exceeded the recommended dosage schedules, some cases of neurotoxicity occurred in patients receiving an appropriate dosage adjustment for their degree of renal impairment. If neurotoxicity associated with Cefepime therapy occurs, consider discontinuing Cefepime or making appropriate dosage adjustments in patients with renal impairment..

As with other cephalosporins, anaphylaxis including anaphylactic shock, transient leukopenia, neutropenia, agranulocytosis and thrombocytopenia have been reported.

Cephalosporin-Class Adverse Reactions

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 antibiotics:

Stevens-Johnson syndrome, erythema multiforme, toxic epidermal necrolysis, renal dysfunction, toxic nephropathy, aplastic anemia, hemolytic anemia, hemorrhage, hepatic dysfunction including cholestasis, and pancytopenia.

Cefepime contraindications

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What is the most important information I should know about Cefepime?

You should not use this medication if you are allergic to Cefepime or a similar antibiotic such as cefdinir (Omnicef), cefprozil (Cefzil), cefuroxime (Ceftin), cephalexin (Keflex), and others. Do not use Cefepime if you have ever had an allergic reaction to a penicillin antibiotic.

Before using Cefepime, tell your doctor if you are allergic to any drugs (especially penicillins), or if you have kidney disease, liver disease, or a stomach or intestinal disorder such as colitis.

Tell your doctor if you are also using any other injected antibiotics, or a diuretic (water pill).

Use this medicine for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared. Skipping doses may also increase your risk of further infection that is resistant to antibiotics. Cefepime will not treat a viral infection such as the common cold or flu.

Antibiotic medicines can cause diarrhea, which may be a sign of a new infection. If you have diarrhea that is watery or bloody, stop taking Cefepime and call your doctor. Do not use anti-diarrhea medicine unless your doctor tells you to.



Active ingredient matches for Cefepime:

Cefepime


Unit description / dosage (Manufacturer)Price, USD
Injectable; Subcutaneous; Cefepime Hydrochloride 1 g
Injectable; Subcutaneous; Cefepime Hydrochloride 2 g
Injectable; Subcutaneous; Cefepime Hydrochloride 500 mg
Injectable; Injection; Cefepime Hydrochloride 1 g
Injectable; Injection; Cefepime Hydrochloride 2 g
Maxipime 2 gram vial$ 43.04
Cefepime hcl 2 gram vial$ 40.36
Maxipime 1 gm piggyback vial$ 23.24
Maxipime 1 gram vial$ 21.70
Cefepime hcl 1 gm vial$ 20.33
Cefepime 2 gm injection$ 0.51
Cefepime injection, solution 1 g/50mL (Baxter Healthcare Corporation (US))
Cefepime injection 2 g/1 (Sandoz Inc (US))
Cefepime injection 500 mg/1 (Sandoz Inc (US))
Cefepime injection 1 g/1 (Sandoz Inc (US))

List of Cefepime substitutes (brand and generic names):

Cefepime Hexpharm / vial 1 g x 1's
Cefepime Hydrochloride and Dextrose injection, solution 1 g/50mL (B. Braun Medical Inc. (US))
Cefepime Hydrochloride and Dextrose injection, solution 2 g/50mL (B. Braun Medical Inc. (US))
Injectable; Injection; Cefepime Hydrochloride 20 mg / ml
Cefepime O-S 1 g x 1's
Cefepime O-S 2 g x 1's
Cefepime O-S 500 mg x 1's

References

  1. DailyMed. "CEFEPIME HYDROCHLORIDE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
  2. PubChem. "cefepime". https://pubchem.ncbi.nlm.nih.gov/com... (accessed September 17, 2018).
  3. DrugBank. "cefepime". http://www.drugbank.ca/drugs/DB01413 (accessed September 17, 2018).

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