Brand Name
Recarbrio
Generic Name
Cilastatin
View Brand Information FDA approval date: January 06, 2020
Classification: Penem Antibacterial
Form: Injection
What is Recarbrio (Cilastatin)?
RECARBRIO is a combination of imipenem, a penem antibacterial, cilastatin, a renal dehydropeptidase inhibitor, and relebactam, a beta-lactamase inhibitor, indicated in patients 18 years of age and older for the treatment of the following infections caused by susceptible gram-negative microorganisms: Hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia .
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Brand Information
RECARBRIO (imipenem anhydrous, cilastatin, and relebactam anhydrous)
1DOSAGE FORMS AND STRENGTHS
RECARBRIO (imipenem, cilastatin, and relebactam) for injection, 1.25 grams is supplied as a white to light yellow sterile powder for constitution in a single-dose glass vial containing imipenem 500 mg (equivalent to 530 mg imipenem monohydrate), cilastatin 500 mg (equivalent to 531 mg cilastatin sodium), and relebactam 250 mg (equivalent to 263 mg relebactam monohydrate).
2CONTRAINDICATIONS
RECARBRIO is contraindicated in patients with a history of known severe hypersensitivity (severe systemic allergic reaction such as anaphylaxis) to any component of RECARBRIO.
3ADVERSE REACTIONS
The following serious adverse reactions are described in greater detail in the Warnings and Precautions section.
- Hypersensitivity Reactions
- Seizures and Other Central Nervous System Adverse Reactions
- Increased Seizure Potential Due to Interaction with Valproic Acid
- Clostridioides difficile-Associated Diarrhea (CDAD) [see
3.1Clinical 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.
4OVERDOSAGE
In the event of overdose, discontinue RECARBRIO, treat symptomatically, and institute general supportive treatment. Imipenem, cilastatin, and relebactam can be removed by hemodialysis
5DESCRIPTION
RECARBRIO (imipenem, cilastatin, and relebactam) for injection is an antibacterial combination product consisting of imipenem, a carbapenem antibacterial drug, cilastatin, a renal dehydropeptidase inhibitor, and relebactam, a diazabicyclooctane beta-lactamase inhibitor, for intravenous administration.
6HOW SUPPLIED/STORAGE AND HANDLING
RECARBRIO (imipenem, cilastatin, and relebactam) for injection, 1.25 grams is supplied as a white to light yellow sterile powder for constitution in a single-dose glass vial containing imipenem 500 mg (equivalent to 530 mg imipenem monohydrate), cilastatin 500 mg (equivalent to 531 mg cilastatin sodium), and relebactam 250 mg (equivalent to 263 mg relebactam monohydrate).
The vials are supplied as a single-dose glass vial (NDC 0006-3856-01) and in cartons containing 25 vials (NDC 0006-3856-02).
7PRINCIPAL DISPLAY PANEL - 1.25 g Vial Carton Label
NDC 0006-3856-02
Recarbrio™
(imipenem, cilastatin, and relebactam)
for Injection
1.25 g per vial*
(imipenem, cilastatin, and relebactam)
for Injection
1.25 g per vial*
Must be constituted and further diluted.
See enclosed package insert for preparation instructions.
See enclosed package insert for preparation instructions.
For Intravenous Infusion Only
*Each vial contains imipenem 500 mg (equivalent to 530 mg imipenem monohydrate), cilastatin 500 mg (equivalent
25 single-dose vials
Rx only
