Cefepime Hydrochloride 2 g/1
Cefepime Hydrochloride · INJECTION, POWDER, FOR SOLUTION · Hikma Pharmaceuticals USA Inc.
Cefepime Hydrochloride is a injection, powder, for solution containing cefepime hydrochloride at 2 g/1, taken intravenous. Manufactured by Hikma Pharmaceuticals USA Inc..
Key Facts
- Brand Name
- Cefepime Hydrochloride
- Generic Name
- Cefepime Hydrochloride
- NDC Code (Product)
0143-9383- Manufacturer
- Hikma Pharmaceuticals USA Inc.
- Strength
- 2 g/1
- Dosage Form
- INJECTION, POWDER, FOR SOLUTION
- Route
- INTRAVENOUS
- Marketing Status
- Application #
- ANDA214402
- Marketing Start
- 09/22/2025
Recall History
No Recall HistorySide 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 and Dextrose Injection is a cephalosporin antibacterial indicated in 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 ( 1.3 ) Uncomplicated skin and skin structure infections ( 1.4 ) Complicated intra-abdominal infections (used in combination with metronidazole) ( 1.5 ) To reduce the development of drug-resistant bacteria and maintain the effectiveness of Cefepime for Injection and Dextrose Injection and other antibacterial drugs, Cefepime for Injection and Dextrose 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 and Dextrose Injection is indicated for the treatment of pneumonia (moderate to severe) caused by 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 Injec…
Dosage & Administration
2 DOSAGE AND ADMINISTRATION For intravenous use only administered over approximately 30 minutes. ( 2 ) Use this formulation of cefepime only in adult and pediatric patients who require the entire 1 or 2 gram dose and not any fraction thereof. ( 2.1 , 2.2 ) Recommended Dosing Schedule in Adult Patients with CrCL Greater than 60 mL/min ( 2.1 ) * Site and Type of Infection Dose Frequency Duration (days) Moderate to severe pneumonia For Pseudomonas aeruginosa , use 2 g IV every 8 hours ( 2.1 ) 1 or 2 g IV Every 8-12 hours 10 days Empiric therapy for febrile neutropenic patients 2 g IV Every 8 hours 7 days Or until resolution of neutropenia. ( 2.1 ) Mild to moderate uncomplicated or complicated urinary tract infections 0.5 or 1 g IV Every 12 hours 7-10 days Severe uncomplicated or complicated urinary tract infections 2 g IV Every 12 hours 10 days Moderate to severe uncomplicated skin and skin structure infections 2 g IV Every 12 hours 10 days Complicated intra-abdominal infections (used in combination with metronidazole) 2 g IV Every 8-12 hours 7-10 days Pediatric Patients (2 months to 16 years): Recommended Dosage in pediatric patients with CrCl greater than 60 mL/min. ( 2.2 ) The usua…
Contraindications
4 CONTRAINDICATIONS Patients with known immediate hypersensitivity reactions to cefepime or other cephalosporins, penicillins or other beta-lactam antibacterial drugs. ( 4 ) 4.1 Hypersensitivity to Cefepime or the Cephalosporin Class of Antibacterials, Penicillins, or Other Beta-lactam Antibacterials Cefepime for Injection and Dextrose 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 antibacterials. 4.2 Hypersensitivity to Corn Products Solutions containing dextrose may be contraindicated in patients with hypersensitivity to corn products.
Drug Interactions
7 DRUG INTERACTIONS Aminoglycosides: Increased potential of nephrotoxicity and ototoxicity. ( 7.2 ) Diuretics: Nephrotoxicity has been reported with concomitant administration of cephalosporins with potent diuretics such as furosemide. Monitor renal function. ( 7.3 ) 7.1 Drug/Laboratory Test Interactions The administration of Cefepime for Injection and Dextrose Injection 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 and Dextrose Injection because of the increased potential of nephrotoxicity and ototoxicity of aminoglycoside antibacterials. 7.3 Diuretics Nephrotoxicity has been reported following concomitant administration of 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 other sections of the labeling: 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 B. Braun Medical Inc. at 1-833-425-1464 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 the 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 …
Frequently Asked Questions
What is Cefepime Hydrochloride used for?
Cefepime Hydrochloride contains Cefepime Hydrochloride. It is a injection, powder, for solution taken intravenous. Consult your doctor for specific uses.
Is Cefepime Hydrochloride a controlled substance?
Cefepime Hydrochloride is not classified as a controlled substance by the DEA.
What is the generic name for Cefepime Hydrochloride?
The generic name for Cefepime Hydrochloride is Cefepime Hydrochloride. There are 7 other brand versions of Cefepime Hydrochloride.
What is the NDC code for Cefepime Hydrochloride 2 g/1?
The NDC (National Drug Code) for Cefepime Hydrochloride 2 g/1 is 0143-9383, listed by Hikma Pharmaceuticals USA Inc..