Recarbrio Approval History
Reviewed by J.Stewart BPharm Last updated on Jul 21, 2019.
FDA Approved: Yes (First approved July 16, 2019)
Brand name: Recarbrio
Generic name: imipenem, cilastatin, and relebactam
Dosage form: for Injection
Treatment for: Urinary Tract Infection, Intraabdominal Infection
Recarbrio (imipenem, cilastatin, and relebactam) is a combination of imipenem, a penem antibacterial, cilastatin, a renal dehydropeptidase inhibitor, and relebactam, a betalactamase inhibitor, indicated for the treatment of complicated urinary tract infections and complicated intra-abdominal infections (cIAI).
- The imipenem and cilastatin combination has been available for decades, and the addition of relebactam to the mix protects imipenem from degradation by certain serine beta lactamases, potentially overcoming antimicrobial resistance and extending the spectrum of activity of the antibiotic.
- Recarbrio is administered via intravenous (IV) infusion over 30 minutes every 6 hours.
- Patients receiving Recarbrio should be made aware of the potential for hypersensitivity reactions, seizures and central nervous system reactions, an increased risk of seizures due to the drug interaction between Recarbrio and valproic acid or divalproex sodium, and the possibility of watery or bloody diarrhea as a result of Clostridium difficile infection.
- Common side effects include diarrhea, nausea, headache, vomiting, increased liver enzymes, infusion site reactions, fever, and hypertension.
Development History and FDA Approval Process for Recarbrio
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