Last reviewed · How we verify
Primaxin (CILASTATIN)
Primaxin works by inhibiting the action of dehydropeptidase, an enzyme that breaks down certain antibiotics, thereby protecting them from degradation and allowing them to reach effective concentrations in the body.
Primaxin (Cilastatin) is a small molecule renal dehydropeptidase inhibitor developed by Merck, targeting dipeptidase 1. It is used to treat various bacterial infections, including pneumonia, septicemia, and urinary tract infections. Primaxin is a commercial product, still owned by Merck, and has been FDA-approved since 1985. Key safety considerations include its short half-life of 0.86 hours. As a branded product, its commercial status is patented.
At a glance
| Generic name | CILASTATIN |
|---|---|
| Sponsor | Merck & Co. |
| Drug class | Renal Dehydropeptidase Inhibitor |
| Target | Dipeptidase 1 |
| Modality | Small molecule |
| Therapeutic area | Metabolic |
| Phase | FDA-approved |
| First approval | 1985 |
Mechanism of action
Imipenem and cilastatin for injection is combination of imipenem and cilastatin. Imipenem is penem antibacterial drug [see Clinical Pharmacology (12.4)]. Cilastatin sodium is renal dehydropeptidase inhibitor that limits the renal metabolism of imipenem.
Approved indications
- Abdominal abscess
- Acute exacerbation of chronic bronchitis
- Bacterial endocarditis
- Bacterial infection due to Klebsiella pneumoniae
- Bacterial pneumonia
- Bacterial septicemia
- Bacterial urinary infection
- Diabetic Foot Infection
- Endometritis
- Enterobacter Pneumonia
- Female genital tract infection
- Gram-Negative Aerobic Bacillary Pneumonia
- Haemophilus influenzae pneumonia
- Infection caused by Acinetobacter spp resistant to carbapenem antimicrobial drugs
- Infection caused by Citrobacter spp resistant to carbapenem antimicrobial drugs
- Infection caused by Enterococcus spp resistant to carbapenem antimicrobial drugs
- Infection caused by Escherichia coli strain resistant to carbapenem antimicrobial drugs
- Infection caused by Klebsiella spp resistant to carbapenem antimicrobial drugs
- Infection caused by Pseudomonas aeruginosa strain resistant to carbapenem antimicrobial drugs
- Infection caused by Serratia spp resistant to carbapenem antimicrobial drugs
Common side effects
- Phlebitis/thrombophlebitis
- Nausea
- Diarrhea
- Vomiting
- Rash
- Pain at the injection site
- Erythema at the injection site
- Hypotension
- Fever
- Seizures
- Dizziness
- Somnolence
Key clinical trials
- Testing a Novel Combination Treatment (Arm D) Versus Standard of Care for Intensive Phase Treatment for Mycobacterium Abscessus Pulmonary Disease in People With or Without Cystic Fibrosis in the Finding the Optimal Regimen for Mycobacterium Abscessus Treatment (FORMaT) Adaptive Platform Trial (PHASE2)
- A Study of Oral Tebipenem Pivoxil Hydrobromide (TBP-PI-HBr) Compared to Intravenous Imipenem-cilastatin in Participants With Complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP) (PHASE3)
- Safety, Tolerability, Efficacy and Pharmacokinetics of Imipenem/Cilastatin/Relebactam (MK-7655A) in Pediatric Participants With Gram-negative Bacterial Infection (MK-7655A-021) (PHASE2,PHASE3)
- Percutaneous Transcatheter Genicular Embolization in Osteoarthritis (NA)
- Efficacy and Safety of Cefepime/Nacubactam or Aztreonam/Nacubactam Compared to Imipenem/Cilastatin in Subjects With Complicated Urinary Tract Infections or Acute Uncomplicated Pyelonephritis (PHASE3)
- Prevention of Nephrotoxin-Induced Acute Kidney Injury Using Cilastatin (PHASE2)
- Genicular Artery Embolization (GAE) vs inTra-articular Corticosteroid Injection for Osteoarthritic Knee Pain. (NA)
- A Double-blind Non Inferiority Clinical Trial to Compare the Nephroprotection of Cilastatn Versus Thiosulfate in Patients Undergoing Debulking Surgery With Intraoperative Hyperthermic Intraperitoneal Chemotherapy With Cisplatin. (PHASE2)
Patents
| Patent | Expiry | Type |
|---|---|---|
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 |
| FDA Orange Book | Patents + exclusivity |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Primaxin CI brief — competitive landscape report
- Primaxin updates RSS · CI watch RSS
- Merck & Co. portfolio CI