Recarbrio
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Omid Afkhami Ardakani
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Overview
Recarbrio is an Antibacterial Combination that is FDA approved for the treatment of Complicated Urinary Tract Infections (cUTI), Complicated Intra-Abdominal Infections (cIAI), and Hospital-Acquired Bacterial Pneumonia and Ventilator-Associated Bacterial Pneumonia (HABP/VABP) in patients 18 years and older.. Common adverse reactions include Nausea, Diarrhea, Headache, Fever, and Elevated liver enzymes..
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
For Complicated Urinary Tract Infections (cUTI) Administer 1.25 grams (imipenem 500 mg, cilastatin 500 mg, relebactam 250 mg) intravenously every 6 hours. For Complicated Intra-Abdominal Infections (cIAI): Administer 1.25 grams intravenously every 6 hours. For HABP/VABP: Administer 1.25 grams intravenously every 6 hours.
Off-Label Use and Dosage (Adult)
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
The safety and effectiveness of Recarbrio in pediatric patients have not been established.
Off-Label Use and Dosage (Pediatric)
Contraindications
Patients with a history of severe hypersensitivity to any component of Recarbrio or other beta-lactam antibiotics.
Warnings
Hypersensitivity Reactions Seizures and Central Nervous System Adverse Reactions Clostridium difficile-Associated Diarrhea (CDAD)
Adverse Reactions
Clinical Trials Experience
Nausea, Diarrhea, Headache, Fever, and Elevated liver enzymes
Postmarketing Experience
Hypersensitivity reactions, Seizures, and Clostridium difficile-associated diarrhea.
Drug Interactions
Valproic Acid (may result in decreased valproic acid concentrations) Probenecid (May increase plasma concentrations of imipenem)
Use in Specific Populations
Pregnancy
Pregnancy Category (FDA):
Use only if the potential benefit justifies the potential risk to the fetus.
Pregnancy Category (AUS):
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Recarbrio in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Recarbrio during labor and delivery.
Nursing Mothers
Imipenem and cilastatin are excreted in human milk; caution should be exercised when administered to a nursing woman.
Pediatric Use
Safety and effectiveness have not been established in pediatric patients.
Geriatic Use
No overall differences in safety or effectiveness were observed between elderly and younger patients.
Gender
There is no FDA guidance on the use of Recarbrio with respect to specific gender populations.
Race
There is no FDA guidance on the use of Recarbrio with respect to specific racial populations.
Renal Impairment
Dosage adjustment is recommended for patients with renal impairment.
Hepatic Impairment
No dosage adjustment is necessary
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Recarbrio in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Recarbrio in patients who are immunocompromised.
Administration and Monitoring
Administration
Recarbrio is administered intravenously over 30 minutes.
Monitoring
Monitoring is advised for patients with renal impairment, particularly to adjust dosing and reduce the risk of CNS toxicity. Regular assessment of liver enzymes and signs of hypersensitivity is recommended during treatment.
IV Compatibility
Recarbrio should be administered intravenously over 30 minutes. It should not be mixed or co-administered with other medications through the same IV line unless compatibility is confirmed.
Overdosage
Symptoms of overdose may include seizures and other CNS adverse effects, especially in patients with renal impairment. Supportive treatment and careful monitoring of renal function are recommended in case of overdose.
Pharmacology
There is limited information regarding Recarbrio Pharmacology in the drug label.
Mechanism of Action
Recarbrio is a combination of imipenem, cilastatin, and relebactam:
Imipenem is a carbapenem antibiotic that disrupts bacterial cell wall synthesis. Cilastatin inhibits the renal metabolism of imipenem, enhancing its efficacy. Relebactam is a beta-lactamase inhibitor that protects imipenem from degradation by beta-lactamases produced by certain bacteria.
Structure
There is limited information regarding Recarbrio Structure in the drug label.
Pharmacodynamics
Recarbrio has broad-spectrum activity against Gram-negative bacteria, including carbapenem-resistant strains. The addition of relebactam extends its activity to beta-lactamase-producing bacteria.
Pharmacokinetics
After intravenous administration, peak plasma concentrations are achieved rapidly. Imipenem, cilastatin, and relebactam are primarily eliminated via the kidneys, and dose adjustment is required for patients with renal impairment.
Nonclinical Toxicology
There is limited information regarding Recarbrio Nonclinical Toxicology in the drug label.
Clinical Studies
There is limited information regarding Recarbrio Clinical Studies in the drug label.
How Supplied
Recarbrio is supplied in single-dose vials containing a fixed dose of imipenem 500 mg, cilastatin 500 mg, and relebactam 250 mg. It is available in cartons of 10 vials.
Storage
Recarbrio should be stored at 2°C to 8°C (36°F to 46°F) and protected from light. It should be used immediately after reconstitution or stored in a refrigerator if not used within one hour.
Images
Drug Images
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Package and Label Display Panel
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Patient Counseling Information
There is limited information regarding Recarbrio Patient Counseling Information in the drug label.
Precautions with Alcohol
Alcohol may exacerbate CNS side effects, so caution is advised.
Brand Names
Recarbrio
Look-Alike Drug Names
Care should be taken to avoid confusion with other carbapenem antibiotics like Invanz or Primaxin due to similar uses.
Drug Shortage Status
Price
References
The contents of this FDA label are provided by the National Library of Medicine.