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Primaxin (IMIPENEM)
Primaxin works by inhibiting bacterial cell wall synthesis, ultimately leading to bacterial cell death.
Primaxin (Imipenem) is a carbapenem antibiotic developed by Merck Sharp & Dohme B.V. and approved by the FDA in 1985. It is a small molecule that targets a wide range of bacterial infections, including those caused by Klebsiella pneumoniae. Primaxin is used to treat various infections such as abdominal abscess, bacterial endocarditis, and diabetic foot infections. The drug has a short half-life of 0.95 hours and low bioavailability of 1%. Primaxin is still owned by Merck Sharp & Dohme B.V. and its commercial status is not publicly disclosed.
At a glance
| Generic name | IMIPENEM |
|---|---|
| Sponsor | Merck Sharp & Dohme B.V. |
| Drug class | imipenem |
| Modality | Small molecule |
| Therapeutic area | Metabolic |
| Phase | FDA-approved |
| First approval | 1985 |
Mechanism of action
Imipenem and Cilastatin for Injection (I.V.) is combination of imipenem and cilastatin. Imipenem is penem antibacterial drug [see Microbiology 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 Pseudomonas aeruginosa strain resistant to carbapenem antimicrobial drugs
- Infection caused by Serratia spp resistant to carbapenem antimicrobial drugs
- Infection of bone
Common side effects
- Phlebitis/thrombophlebitis
- Nausea
- Diarrhea
- Vomiting
- Rash
- Intravenous Site Irritation
- Convulsions
- Tachycardia
- Oliguria/Anuria
- Pain at the injection site
- Erythema at the injection site
- Vein induration
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)
- Pivmecillinam as Oral Step-Down Treatment for Escherichia Coli Febrile Urinary Tract Infection Versus Standard of Care (PHASE4)
- Antimicrobial Treatment in Patients With Ventilator-associated Tracheobronchitis (PHASE4)
- Temocillin Versus a Carbapenem as Initial Intravenous Treatment for ESBL Related Urinary Tract Infections (PHASE3)
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 |