Cefepime 2 g/20mL
Cefepime · INJECTION, POWDER, FOR SOLUTION · WG Critical Care, LLC
Cefepime is a injection, powder, for solution containing cefepime at 2 g/20mL, taken intravenous. Manufactured by WG Critical Care, LLC.
Key Facts
- Brand Name
- Cefepime
- Generic Name
- Cefepime
- NDC Code (Product)
44567-131- Manufacturer
- WG Critical Care, LLC
- Strength
- 2 g/20mL
- Dosage Form
- INJECTION, POWDER, FOR SOLUTION
- Route
- INTRAVENOUS
- Marketing Status
- Application #
- ANDA065441
- Marketing Start
- 03/31/2021
Recall History
Sentara Infusion Services
Lack of sterility assurance
Lincare, Inc.
Lack of Assurance of Sterility: Sterility of product is not assured
B. Braun Medical Inc
Presence of Particulate Matter: The 1g Cefepime for Injection USP and Dextrose Injection USP lot has been found to contain visible organic particulate matter in a reserve sample unit.
B. Braun Medical Inc
Presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products due to visible particulate matter found in reserve sample units.
Franck's Lab Inc dba Trinity Care Solutions
Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. This recall is initiated due to concerns associated with quality control procedures observed during a recent FDA inspection.
Astral SteriTech Private Ltd.
Lack of Assurance of Sterility
Astral SteriTech Private Ltd.
Lack of Assurance of Sterility
Astral SteriTech Private Ltd.
Lack of Assurance of Sterility
Astral SteriTech Private Ltd.
Lack of Assurance of Sterility
Astral SteriTech Private Ltd.
Lack of Assurance of Sterility
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE Cefepime for Injection is a cephalosporin antibacterial indicated for the treatment of the following infections caused by susceptible strains of the designated microorganisms: • Pneumonia. ( 1.1 ) • Empiric therapy for febrile neutropenic patients. ( 1.2 ) • Uncomplicated and complicated urinary tract infections (including pyelonephritis). ( 1.3 ) • Uncomplicated skin and skin structure infections. ( 1.4 ) • Complicated intra-abdominal infections (used in combination with metronidazole) in adults. ( 1.5 ) 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. ( 1.6 ) 1.1 Pneumonia 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. 1.2 Empiric Therapy for Febrile Neutropenic Patients Cefepime for Injection as monothera…
Dosage & Administration
2 DOSAGE AND ADMINISTRATION § For Pseudomonas aeruginosa , use 2 g IV every 8 hours. ( 2.1 ) *Or until resolution of neutropenia. ( 2.1 ) **Intramuscular route of administration is indicated only for mild to moderate, uncomplicated or complicated UTIs due to E. coli . ( 2.1 ) Recommended Dosage in Adults with Creatinine Clearance (CrCL) Greater Than 60 mL/min ( 2.1 ) Site and Type of Infection Dose Frequency Duration (days) Moderate to Severe Pneumonia § 1-2 g IV Every 8-12 hours 10 Empiric Therapy for Febrile Neutropenic Patients 2 g IV Every 8 hours 7* Mild to Moderate Uncomplicated or Complicated Urinary Tract Infections 0.5-1 g IV/IM** Every 12 hours 7-10 Severe Uncomplicated or Complicated Urinary Tract Infections 2 g IV Every 12 hours 10 Moderate to Severe Uncomplicated Skin and Skin Structure Infections 2 g IV Every 12 hours 10 Complicated Intra-abdominal Infections § (used in combination with metronidazole) 2 g IV Every 12 hours 7-10 Pediatric Patients (2 months to 16 years) Recommended dosage in pediatric with CrCL greater than 60 mL/min. ( 2.2 ) • The usual recommended dosage in pediatric patients is 50 mg per kg per dose administered every 12 hours (every 8 hours for feb…
Contraindications
4 CONTRAINDICATIONS Cefepime for Injection is contraindicated in patients who have shown immediate hypersensitivity reactions to cefepime or the cephalosporin class of antibacterial drugs, penicillins or other beta-lactam antibacterial drugs. Patients with known immediate hypersensitivity reactions to cefepime or other cephalosporins, penicillins or other beta-lactam antibacterial drugs. ( 4 )
Drug Interactions
7 DRUG INTERACTIONS • Aminoglycosides: increased potential of nephrotoxicity and ototoxicity. Monitor renal function. ( 7.2 ) • Diuretics: nephrotoxicity has been reported following concomitant administration of other cephalosporins with potent diuretics such as furosemide. Monitor renal function. ( 7.3 ) 7.1 Drug/Laboratory Test Interactions The administration of cefepime may result in a false-positive reaction for glucose in the urine with certain methods. It is recommended that glucose tests based on enzymatic glucose oxidase reactions be used. 7.2 Aminoglycosides Monitor renal function if aminoglycosides are to be administered with Cefepime for Injection because of the increased potential of nephrotoxicity and ototoxicity of aminoglycoside antibacterial drugs. 7.3 Diuretics Nephrotoxicity has been reported following concomitant administration of other cephalosporins with potent diuretics such as furosemide. Monitor renal function when cefepime is concomitantly administered with potent diuretics.
Adverse Reactions
6 ADVERSE REACTIONS The following adverse reactions are discussed in the Warnings and Precautions section and below: • Hypersensitivity Reactions [ see Warnings and Precautions (5.1) ] • Neurotoxicity [ see Warnings and Precautions (5.2) ] • Clostridioides difficile -Associated Diarrhea [ see Warnings and Precautions (5.3) ] •The most common adverse reactions (incidence ≥ 1%) were local reactions, positive Coombs’ test, decreased phosphorous, increased ALT and AST, increased PT and PTT and rash. ( 6.1 ) •At the highest dose (2 g every 8 hours), incidence of adverse reactions was ≥1% for rash, diarrhea, nausea, vomiting, pruritis, fever, and headache. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Apotex Corp. at 1-800-706-5575, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience 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 …
Frequently Asked Questions
What is Cefepime used for?
Cefepime contains Cefepime. It is a injection, powder, for solution taken intravenous. Consult your doctor for specific uses.
Is Cefepime a controlled substance?
Cefepime is not classified as a controlled substance by the DEA.
What is the generic name for Cefepime?
The generic name for Cefepime is Cefepime. There are 3 other brand versions of Cefepime.
What is the NDC code for Cefepime 2 g/20mL?
The NDC (National Drug Code) for Cefepime 2 g/20mL is 44567-131, listed by WG Critical Care, LLC.