What Recrea Treats: Main Uses and Benefits

This medication is generally used to treat conditions associated with acute, life-threatening bacterial infections, primarily acquired in a hospital setting. Its application is highly relevant in clinical settings that involve acute or unstable symptom patterns driven by difficult-to-treat Gram-negative pathogens.

The core use of Recrea is to provide supportive management for conditions that involve infections of the lungs (such as severe hospital-acquired pneumonia), complicated infections of the urinary tract, and complicated infections within the abdominal cavity. This treatment is applied when dealing with highly resistant bacteria, such as MDR Pseudomonas aeruginosa, when a different symptomatic approach is appropriate. This supports the patient during difficult episodes by easing distress when symptoms create noticeable physiological strain.

“The medication is generally used to help address symptom clusters that may become intense or disruptive in vulnerable patients.”

Quick Fact: Supportive Management for Acute Symptoms

Recrea is relevant for easing symptoms related to systemic imbalance and severe inflammatory states often associated with uncontrolled infection, supporting the patient toward functional stability in critical care settings.

Eligibility Map: Who can and cannot use Recrea — official regulatory information

Eligibility scope

Populations for whom use is allowed (as stated in label):

• Use is typically allowed for adults 18 years of age and older who meet the specified medical indications, unless otherwise restricted by other eligibility criteria.

Populations for whom use is contraindicated:

• Individuals with a documented hypersensitivity or severe allergic reaction to Recrea, its active ingredients, or any of its inactive components.

Populations for whom use is not recommended or requires special consideration:

• Severe organ impairment (e.g., severe hepatic or renal impairment): Use may be restricted, or a significant dosage reduction may be necessary due to reduced drug clearance.
• Patients taking certain interacting medicines: Use is often restricted or not recommended when taking potent inhibitors or inducers of specific liver enzymes.

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Age-related and physiological rules

Age-related eligibility rules:

• Pediatric Use: Safety and effectiveness in patients under 18 years of age are typically not established, or the medicine may be specifically contraindicated in this population.
• Geriatric Use: Patients 65 years of age and older may require careful dose selection, often starting at the low end of the dosing range, due to a higher frequency of decreased organ function or co-existing conditions.

Pregnancy and lactation eligibility status:

• Pregnancy: Use is generally categorized based on the potential for fetal harm (e.g., an eligibility concern), and use is typically only permitted if the potential benefit justifies the potential risk.
• Lactation: It is generally not recommended to breastfeed during treatment, or for a defined period after the final dose, as the medicine may be excreted in human milk.

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Connection to the overall eligibility profile

Official regulatory documents define strict boundaries regarding who can and cannot use Recrea. The most absolute restriction is a contraindication for individuals with a known allergy to the product. Use is further limited by age, typically restricted to adults, and requires careful consideration and potential dose changes in patients with impaired liver or kidney function. These regulatory statements provide the definitive parameters for safe and effective prescribing.

Interactions with other medicines and products — Official Regulatory Information

The interaction profile for this medication, which contains Relebactam, is based strictly on governmental regulatory findings for the combination product. These official documents specify certain restrictions on co-administration with other medicines, largely due to pharmacokinetic and pharmacodynamic effects.

Category	Documented Interacting Substances
Contraindicated Combinations	Valproic Acid and Divalproex Sodium are restricted due to the official finding that co-administration reduces their serum concentration, increasing the risk of breakthrough seizures. Probenecid is restricted due to significant changes in drug levels.
Exposure-Altering Interactions	Probenecid increases the plasma level and half-life of the imipenem component by inhibiting its renal tubular secretion, an officially stated pharmacokinetic effect.
Pharmacodynamic Interactions	Ganciclovir co-administration is associated with an increased risk of generalized seizures. Live biological products, such as BCG live and the Cholera vaccine, live, may have their therapeutic effect decreased.
Timing Requirements	For patients on hemodialysis, the medication must be administered after the hemodialysis session is completed, an official instruction tied to the product’s renal clearance.

Population-Specific Notes: This interaction profile carries a heightened risk in patients with a history of seizures and requires attention to dosage adjustment in the presence of renal impairment, a condition that officially increases drug exposure (AUC) of all three components.

Neutralizing Bacterial Defense Enzymes

This core mechanism involves Relebactam binding to and inhibiting key Serine beta-lactamase enzymes (e.g., KPC and AmpC), which catalyze the hydrolysis of the antibiotic. By neutralizing these molecular defenses, Relebactam enables the activity of the active drug. This action functionally allows the subsequent bactericidal process to occur.

Inhibiting Cell Wall Construction

The primary bactericidal process is executed by Imipenem, which covalently inhibits bacterial Penicillin-Binding Proteins (PBPs), the enzymes responsible for linking the cell wall's peptidoglycan structure. This targeted inhibition arrests cell wall formation. This loss of structural integrity causes the bacterium to lyse (rupture) due to osmotic pressure.

Sustaining Active Drug Concentrations

The third mechanistic domain maintains the necessary pharmacological conditions for the process. Cilastatin acts by inhibiting the human kidney enzyme, Renal Dipeptidase-1, which otherwise rapidly degrades Imipenem. This mechanism of pharmacokinetic protection maintains sufficiently high and stable systemic concentrations of the active antibiotic, which allows it to reach and sustain its inhibitory action on the PBPs.

How to Use Recrea: Administration Guidelines

Recrea, the active component relebactam, is administered solely as part of a fixed-dose combination product (imipenem/cilastatin/relebactam). The following describes the standardized administration protocol.

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Administration Protocol

The medicine is designed for Intravenous (IV) Infusion only. It is supplied as a sterile powder that must undergo reconstitution and further dilution using aseptic technique with an appropriate intravenous solution prior to administration. Each dose must be infused over a fixed duration of 30 minutes.

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Dosage and Scheduling

The standard adult dose is 1.25 grams of the combination (imipenem 500 mg / cilastatin 500 mg / relebactam 250 mg) and is typically administered Every 6 hours (q6h). The total course of treatment typically lasts between 4 and 14 days, depending on the specific clinical scenario.

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Dosage Adjustment Requirements

Patient Status	Administration Principle
Renal Function ( CLcr < 90 mL/min)	Dose adjustment is mandatory and required for patients with reduced kidney function; specific reduced doses are prescribed based on creatinine clearance ranges.
Hepatic Function	No dose adjustment is typically required based on liver function.
Hemodialysis Patients	Doses should be timed to be administered after the hemodialysis session.
Pediatric Use	Safety and efficacy have not been established in children and adolescents under 18 years of age.

These instructions describe the administration as a standardized, fixed-frequency procedure that is tailored specifically to the patient's renal function, ensuring correct procedural use throughout the course of therapy.

Research Evidence / Overview of Studies for Recrea

Evidence for Use in Complicated Intra-abdominal Infections (cIAI)

The clinical evaluation for the relebactam combination was studied for complicated intra-abdominal infections (cIAI) in key Phase 3 Randomized Controlled Trials (RCTs). These studies were used to compare the combination to other standard antibiotic regimens already established for these serious infections. The research examined core outcomes, including measuring clinical response (outcomes related to systemic or functional imbalance) and microbiological eradication (studies monitored the elimination of targeted bacteria).

Key studies report that the rates of clinical response measured for the relebactam combination were observed to be similar to the response rates measured for the comparator antibiotic regimens in the study population. Trials were primarily designed to assess non-inferiority. Long-term patient outcomes beyond the immediate post-treatment follow-up are not well characterized by the available RCTs.

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Evidence for Use in Specific Drug-Resistant Bacterial Infections

The relebactam combination was studied for use in specific, imipenem-non-susceptible (resistant) Gram-negative infections where patients had few alternative options. Research included Phase 3 RCTs focusing on critically ill patients with confirmed resistance patterns, such as K. pneumoniae or P. aeruginosa.

The research examined overall response (a composite endpoint of outcomes related to physical discomfort and the microbiological status), alongside 30-day all-cause mortality. Findings indicated that the combination was studied for specific types of bacterial resistance and findings indicated a limited observation of activity against others, such as the OXA-48 carbapenemase family. This evidence contributes to the broader evidence landscape but confirms limitations in the range of bacteria covered.

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What is Still Uncertain About the Research for Recrea

One key limitation is that the initial resistant infection RCTs were conducted with modest sample sizes; the results apply only to the populations studied. Data for certain groups remain insufficient, especially concerning very specific or highly complex special populations. The follow-up durations were limited, meaning there is limited information for long-term outcomes regarding the extended duration of the effects.

Key Studies & References

1. Study of Imipenem/Cilastatin-Relebactam vs Imipenem/Cilastatin Alone in Patients With Imipenem-Non-Susceptible Bacterial Infections (RESTORE-IMI 1)
2. Study of Imipenem/Cilastatin-Relebactam vs Piperacillin/Tazobactam for Hospital-Acquired/Ventilator-Associated Bacterial Pneumonia (RESTORE-IMI 2)
3. WHO ATC/DDD Index 2024: J01DH56 Imipenem and beta-lactamase inhibitor

Common questions about Recrea (FAQ)

Q: How quickly does Recrea typically start working?

A: Studies on the drug’s behavior in the body, known as pharmacokinetics, indicate that the active component, relebactam, reaches its maximum concentration in the plasma approximately 30 minutes after the end of the intravenous infusion. The half-life, which tells you how quickly the body removes the medicine, is approximately 1.2 hours. This rapid clearance profile is a factor in the fixed, frequent dosing schedule as defined by regulatory guidance.

Q: Are there any major diet restrictions when taking Recrea?

A: Official regulatory documents primarily focus on potential drug-to-drug interactions. They do not typically list major restrictions regarding specific foods or dietary supplements. General regulatory information suggests that patients should consult with a healthcare professional regarding the use of any food, alcohol, or tobacco during treatment.

Q: Does alcohol interact negatively with Recrea?

A: Yes, the official drug interaction profile does include a specific note on potential negative alcohol interactions with the combination product containing Recrea. Official patient information indicates that patients should consult with their prescribing healthcare professional regarding the use of alcohol.

Q: Is it true that Recrea can affect sleep patterns?

A: Official documentation for the combination product lists insomnia, or difficulty sleeping, as a common adverse reaction. This means it is among the side effects that may occur in up to 1 in 10 patients.

Q: Does Recrea affect driving or operating machinery?

A: The official label notes that this medication may cause central nervous system (CNS) adverse reactions, such as dizziness and confusion, and in uncommon cases, seizures. Regulatory guidance states that caution should be exercised when performing activities that require mental alertness, such as driving or operating machinery.

Q: How should Recrea generally be stored?

A: Unopened vials of the powder are required by regulation to be stored at a Controlled Room Temperature (typically 20 °C to 25 °C) and must be kept in the original carton for protection from light. The prepared solution has limited stability and must not be frozen.

Q: What happens if Recrea is accidentally taken too much?

A: In the event of accidental exposure exceeding the prescribed amount, official information states that the drug combination can be removed from the body by hemodialysis (a process used to purify the blood). Official information states that immediate medical attention is necessary in cases of overdosage.

Q: Is Recrea the same type of medicine as [similar drug name]? (Note: Placeholder [similar drug name] is okay)

A: Recrea, which is the active ingredient relebactam, is officially classified as a Beta-Lactamase Inhibitor (BLI). It is considered an antibiotic enhancer, meaning its primary purpose is to protect a co-administered antibiotic (imipenem) from being broken down by bacterial defense enzymes. This function makes it distinct from traditional single-agent antibiotics, which directly attack the bacterial structure.

Q: How long does Recrea stay in your system after taking it?

A: The duration the medicine remains in your system is related to its half-life, which is approximately 1.2 hours for relebactam. This measurement describes the time it takes for the concentration of the medicine in the blood plasma to reduce by half.

Q: Are there generic versions of Recrea available?

A: The medication is currently available under a single brand name as a fixed-dose combination product. While regulatory agencies may assess the possibility of future generic versions, the primary product is currently branded.

Q: What is the list of ingredients in Recrea, besides the main active component?

A: The drug contains three active components: relebactam, the antibiotic imipenem, and the protective agent cilastatin. Official regulatory documents, such as the full prescribing information, also list the inactive ingredients, or excipients, required to form the sterile powder for injection.

Q: When was Recrea first approved by regulatory bodies?

A: The relebactam combination product received its initial regulatory approval from the U.S. Food and Drug Administration (FDA) on July 17, 2019. It has since been approved by other major health authorities globally.

Q: Does Recrea need to be taken consistently every day?

A: Yes. Regulatory guidance establishes a fixed, frequent dosing schedule, typically administered every 6 hours, over the total course of treatment. Consistent administration on this schedule is required to maintain the necessary drug concentrations to counter bacterial resistance throughout the course of therapy.

Q: How do the effects of Recrea compare between different age groups?

A: Official documents note that geriatric patients (aged 65 and older) may require careful dose selection, often starting at a lower dose. This caution is generally related to the higher frequency of decreased kidney function in this age group, which can alter how the drug is cleared from the body.

Q: Are there any long-term health concerns associated with Recrea?

A: Research evidence for the combination product is primarily from short-term clinical trials. Official summaries state that long-term patient outcomes beyond immediate follow-up are not well characterized by the currently available data.

Q: Does Recrea contain gluten or common allergens?

A: A complete list of inactive ingredients (excipients) is detailed in the official regulatory labeling for the product. Patients with concerns about specific allergens, such as gluten, should consult the full excipient list with a healthcare provider, as this information is important for managing allergies.

Q: Are there official patient support programs for Recrea?

A: The manufacturer of the combination product offers official patient assistance or support programs to help patients access the medicine. Information regarding eligibility and enrollment for these programs is available from the manufacturer.

Q: Can Recrea be split or crushed?

A: No. The product is manufactured as a sterile powder that must be reconstituted and administered solely through a precise intravenous (IV) infusion in a healthcare setting. Physical alteration methods like splitting or crushing are not applicable to this form of medicine.

Q: Why is Recrea not recommended for certain populations?

A: Use is officially restricted in certain groups because of specific safety concerns. For example, it is not recommended for children under 18 because safety and effectiveness in this group are not established. Furthermore, special consideration and dose adjustments are required for patients with reduced kidney function due to the potential for increased adverse reactions.

The storage and disposal of Recrea (relebactam, as part of the combination product Recarbrio) are strictly defined by regulatory labeling to maintain quality and safety.

Official Storage Requirements

Condition	Requirement
Unopened Vials	Store at Controlled Room Temperature (20 °C to 25 °C).
Protection	Keep vials in the original outer carton to protect the powder from light.
Freezing	Do not freeze the constituted or diluted solution.
Child Safety	Keep this medicine out of the sight and reach of children.

Stability and Disposal

Once the product is prepared (diluted), its stability is limited to 2 hours at room temperature or up to 24 hours when refrigerated (2 °C to 8 °C). Unused or expired medication must not be disposed of via wastewater or household waste. Disposal must follow local regulatory procedures, typically by returning the product to a pharmacist or designated collection point.