Cefepime

What is Cefepime?

• Cefepime (Maxipime) is a cephalosporin antibacterial used to treat certain infections caused by bacteria including pneumonia, and skin, urinary tract, and kidney infections.
• Cefepime injection is used in combination with metronidazole to treat abdominal infections.
• It is also used to treat patients who have fever and are at high risk for infection because they have a low number of white blood cells.

Cefepime structure

Cefepime

Cefepime ball-and-stick

What are the uses of this medicine?

Cefepime (Maxipime) is used for the treatment of:

• Pneumonia.
• Empiric therapy for febrile neutropenic patients.
• Uncomplicated and complicated urinary tract infections (including pyelonephritis).
• Uncomplicated skin and skin structure infections.
• Complicated intra-abdominal infections (used in combination with metronidazole) in adults.

How does this medicine work?

• Cefepime is a cephalosporin antibacterial drug.
• Cefepime is a bactericidal drug that acts by inhibition of bacterial cell wall synthesis.
• Cefepime has a broad spectrum of in vitro activity that encompasses a wide range of Gram-positive and Gram-negative bacteria.
• Within bacterial cells, the molecular targets of cefepime are the penicillin binding proteins (PBP).

Cefepime has been shown to be active against most isolates of the following microorganisms: Gram-negative Bacteria:

• Enterobacter spp
• Escherichia coli
• Klebsiella pneumoniae
• Proteus mirabilis
• Pseudomonas aeruginosa

Gram-positive Bacteria:

• Staphylococcus aureus (methicillin-susceptible isolates only)
• Streptococcus pneumoniae
• Streptococcus pyogenes
• Viridans group streptococci

Who Should Not Use this medicine ?

This medicine cannot be used in patients who:

• have shown immediate hypersensitivity reactions to cefepime or the cephalosporin class of antibiotics, penicillins or other beta-lactam antibiotics.

What drug interactions can this medicine cause?

• Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Be sure to mention any of the following:

• amikacin, gentamicin, kanamycin, neomycin (Neo-Fradin), streptomycin, and tobramycin.

Is this medicine FDA approved?

• Cefepime was patented in 1982 by Bristol-Myers Squibb and approved for medical use in 1994.
• It is available as a generic drug and sold under a variety of trade names worldwide.

How should this medicine be used?

Recommended dosage: Recommended Dosage in Adults with Creatinine Clearance (CrCL) Greater Than 60 mL/min: Moderate to Severe Pneumonia:

• 1 to 2 g IV every 8 to 12 hours for 10 days.

Empiric Therapy for Febrile Neutropenic Patients:

• 2 g IV every 8 hours for 7 days.

Mild to Moderate Uncomplicated or Complicated Urinary Tract Infections:

• 0.5 to 1 g IV/IM every 12 hoursfor 7 to 10 days.

Severe Uncomplicated or Complicated Urinary Tract Infections:

• 2 g IV every 12 hours for 10 days.

Moderate to Severe Uncomplicated Skin and Skin Structure Infections:

• 2 g IV every 12 hours for 10 days.

Complicated Intra-abdominal Infections (used in combination with metronidazole):

• 2 g IV every 12 hours for 7 to 10 days.

Pediatric Patients (2 months to 16 years):

• Recommended dosage in pediatric with CrCL greater than 60 mL/min.
• The usual recommended dosage in pediatric patients is 50 mg per kg per dose administered every 12 hours (every 8 hours for febrile neutropenia).

Patients with Renal Impairment:

• Adjust dose in patients with CrCL less than or equal to 60 mL/min.

Administration:

• Cefepime injection comes as a powder to be mixed with liquid, or as a premixed product, to be injected intravenously over a period of 30 minutes.
• Cefepime injection can also be given intramuscularly.
• It is usually given every 8 or 12 hours for 7 to 10 days.
• You may receive cefepime injection in a hospital or you may administer the medication at home.
• If you will be receiving cefepime injection at home, your healthcare provider will show you how to use the medication.
• You should begin to feel better during the first few days of treatment with cefepime injection.
• Use cefepime injection until you finish the prescription, even if you feel better.
• If you stop using cefepime injection too soon or skip doses, your infection may not be completely treated and the bacteria may become resistant to antibiotics.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Cefepime for Injection is a sterile powder of cefepime in vials for reconstitution, available in the following strengths:
• 1 gram per vial and 2 grams per vial.

This medicine is available in fallowing brand namesː

• Maxipime

What side effects can this medication cause?

The most common side effects of this medicine include:

• local reactions, positive Coombs’ test, decreased phosphorous, increased ALT and AST, increased PT and PTT and rash.

• At the highest dose (2 g every 8 hours), incidence of adverse reactions are rash, diarrhea, nausea, vomiting, pruritis, fever, and headache.

Less common but serious side effects, may include:

• Hypersensitivity reactions
• Neurotoxicity
• Clostridioides difficile-associated diarrhea

What special precautions should I follow?

• Before therapy with cefepime for injection is instituted, careful inquiry should be made to determine whether the patient has had previous immediate hypersensitivity reactions to cefepime, cephalosporins, penicillins, or other beta-lactams. If an allergic reaction to cefepime for injection occurs, discontinue the drug and institute appropriate supportive measures.
• Serious adverse reactions have been reported including life-threatening or fatal occurrences of the following: encephalopathy (disturbance of consciousness including confusion, hallucinations, stupor, and coma), aphasia, myoclonus, seizures, and nonconvulsive status epilepticus. If neurotoxicity associated with cefepime therapy occurs, discontinue cefepime and institute appropriate supportive measures.
• 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. If CDAD is suspected or confirmed, ongoing antibacterial drug use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated.
• Prescribing cefepime for injection in the absence of a proven or strongly suspected bacterial infection is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.
• The administration of cefepime may result in a false-positive reaction for glucose in the urine when using some methods.
• Positive direct Coombs’ tests have been reported during treatment with cefepime for injection.
• Many cephalosporins, including cefepime, have been associated with a fall in prothrombin activity. Prothrombin time should be monitored in patients at risk, and exogenous vitamin K administered as indicated.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• encephalopathy (disturbance of consciousness including confusion, hallucinations, stupor, and coma), myoclonus, seizures, neuromuscular excitability and nonconvulsive status epilepticus

Management of overdosage:

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.
• Patients who receive an overdose should be carefully observed and given supportive treatment.
• In the presence of renal insufficiency, hemodialysis, not peritoneal dialysis, is recommended to aid in the removal of cefepime from the body.

Can this medicine be used in pregnancy?

• Pregnancy Category B.
• There are no adequate and well-controlled studies of cefepime use in pregnant women.
• Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Can this medicine be used in children?

• Safety and effectiveness in pediatric patients below the age of 2 months have not been established.

What are the active and inactive ingredients in this medicine?

Active ingredients:

• CEFEPIME HYDROCHLORIDE

Inactive ingredients:

• N2-(4-FLUOROBENZOYL)-L-ARGININE

Who manufactures and distributes this medicine?

Mfd. for:

• Piramal Critical Care
• Bethlehem, PA , USA
• Made in India

What should I know about storage and disposal of this medication?

• In the dry state store at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F).
• Protect from light.
• Retain in carton until time of use.
• Discard unused portion.

• Dailymed label info on Cefepime
• FDA Cefepime

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