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CEFEPIME HYDROCHLORIDE
Cefepime is a cephalosporin antibacterial drug.
Cefepime Hydrochloride is a marketed cephalosporin antibacterial drug primarily indicated for pneumonia. Its key strength lies in its established mechanism as a broad-spectrum antibiotic, positioning it effectively against a range of bacterial infections. The primary risk is the key composition patent expiry in 2028, which could lead to increased competition from generics.
At a glance
| Generic name | CEFEPIME HYDROCHLORIDE |
|---|---|
| Modality | Small molecule |
| Phase | FDA-approved |
| First approval | 1996 |
Approved indications
- Pneumonia
- Empiric Therapy for Febrile Neutropenic Patients
- Uncomplicated and Complicated Urinary Tract Infections
- Uncomplicated Skin and Skin Structure Infections
- Complicated Intra-abdominal Infections
Common side effects
- local reactions
- phlebitis
- pain and/or inflammation
- rash
- Positive Coombs' Test (without hemolysis)
- decreased phosphorus
- increased Alanine Transaminase (ALT)
- increased Aspartate Transaminase (AST)
- eosinophils
- abnormal PTT
- Prothrombin Time PT
Drug interactions
- Aminoglycosides
- Diuretics (e.g., furosemide)
Key clinical trials
- Optimization of Beta-lactam Dosing in Critically Ill Patients With Cystatin C (OPTIMIZE-GNI) (PHASE4)
- IO Vancomycin Spine (PHASE2, PHASE3)
- Early Versus Late Stopping of Antibiotics in Children With Cancer and High-risk Febrile Neutropenia (PHASE4)
- A Randomised Study to Compare the Efficacy and Safety of Extended and Intermittent Infusion of Beta-lactams in Critically Ill Paediatric Patients. (PHASE4)
- P3 Study to Assess Efficacy and Safety of Cefepime/Nacubactam and Aztreonam/Nacubactam Versus Best Available Therapy for Adults With Infection Due to Carbapenem Resistant Enterobacterales (PHASE3)
- Optimizing the Diagnostic Approach to Cephalosporin Allergy Testing (PHASE2)
- SYN-004 Safety and Tolerability in Allo-HCT Subjects (PHASE1, PHASE2)
- Gram-Negative Bloodstream Infection Oral Antibiotic Therapy Trial (NA)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- CEFEPIME HYDROCHLORIDE CI brief — competitive landscape report
- CEFEPIME HYDROCHLORIDE updates RSS · CI watch RSS