Bacqure

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Bacqure

Method of action: Bactericidal

Treatment option: Endocarditis

Medically reviewed

Marina Burgos

Last updated on 22/12/2025

This page provides general, reference-level information compiled from official medical sources. It is not a substitute for professional medical advice, diagnosis, or treatment. For decisions about your health, please consult a qualified healthcare professional.

Overview of Bacqure

What is Bacqure? Overview and Identity

Property Description
Active Ingredient Cilastatin (often as Sodium Cilastatin)
Form Injectable Powder (for reconstitution)
Pharmacological Class Enzyme Inhibitor (Renal Dehydropeptidase Inhibitor)
Common Role Therapeutic Adjunct (Co-formulation component)
Origin Synthetic Compound

Bacqure is a medicinal preparation whose functional identity is defined by its active component, Cilastatin, a synthetic compound classified as an Enzyme Inhibitor. The drug is typically supplied as an injectable powder intended for parenteral administration (intravenous infusion) after reconstitution.


The active substance, often formulated as Sodium Cilastatin, is a Renal Dehydropeptidase Inhibitor. Unlike most primary therapeutic agents, Cilastatin functions solely as a therapeutic adjunct or co-formulation component. This unique role means it is designed to support and protect a separate, co-administered medicine rather than providing the main curative effect itself. Its formulation as an injectable powder is characteristic of agents requiring rapid systemic distribution.

Cilastatin: Pharmacological Class and Purpose

Cilastatin belongs to the high-level pharmacological class of Dipeptidase Inhibitors because its sole mechanism of action involves blocking the kidney enzyme Dehydropeptidase-I (DHP-I). This inhibition is the defining characteristic of its classification, distinguishing it from primary therapeutic antibiotics.


This agent's purpose is not primary healing but rather biochemical protection. DHP-I is an enzyme located in the kidneys that rapidly breaks down certain co-administered beta-lactam antibiotics, severely limiting their concentration and efficacy. Cilastatin acts by directly inhibiting this destructive enzyme, thereby preventing the catabolism of the primary therapeutic medicine. This protective action ensures that the main medicine can work effectively before the body naturally clears it. The overall purpose of Bacqure is to act as a protector and stabilizer, guaranteeing that the primary medicine remains structurally intact, maximizing the therapeutic effectiveness of the combination treatment.

What side effects are possible with Bacqure?

Possible Side Effects and Safety Information

The safety profile for the co-formulation containing Cilastatin (Bacqure's active ingredient) is formally documented in government regulatory sources, classifying adverse reactions by frequency and the physiological system affected. The most frequently documented side effects, classified as Common, include nausea, vomiting, diarrhea, rash, and elevations in serum transaminases. Reactions classified as Uncommon include seizures (convulsions), dizziness, and confusion.


System-Organ Classifications and Serious Reactions

Adverse effects are formally grouped by System-Organ Class, affecting systems such as the Nervous System (seizures, myoclonic activity), Gastrointestinal Disorders (colitis, diarrhea), and Hepatobiliary Disorders (hepatic failure, jaundice). The label explicitly documents several serious adverse reactions, including life-threatening anaphylactic reactions (hypersensitivity), acute renal failure, and severe Clostridioides difficile-associated diarrhea (CDAD). Serious CNS effects like seizures are also highlighted.


Population-Specific Constraints

Regulatory documentation notes specific safety considerations for certain patient groups. Individuals with renal impairment or pre-existing central nervous system disorders have a documented elevated risk of CNS adverse reactions, including seizures. Additionally, Gastrointestinal effects such as colitis may occur not only during treatment but also up to several weeks following cessation of therapy. The product is strictly contraindicated in patients with a history of severe hypersensitivity to the active component or any other carbapenem antibacterial agent.

Overdose and Emergency Response

Overdose and when to seek help

The official regulatory profile for Bacqure, which contains Cilastatin, is derived from government-authorized prescribing information for the co-formulated product. Overexposure is primarily associated with the risk of severe Central Nervous System (CNS) adverse reactions.

Documented Overdose Manifestations and Risk

Clinical manifestations of overdose include officially documented CNS effects such as seizures (convulsions), myoclonia (muscle jerking), focal tremors, and confusional states. Less severe signs such as nausea and vomiting may also be present. The medication must be discontinued immediately if any of these focal tremors, myoclonus, or seizures are observed.

A critical risk factor noted in the official labeling is compromised renal function. Patients with impaired kidney function face an increased potential for severe CNS adverse reactions due to documented accumulation of the drug components.

Emergency Actions and Management

Urgent medical attention must be sought immediately or emergency services contacted if a seizure or any severe neurological symptom is observed, if the individual collapses, or has difficulty breathing. The severity classification in regulatory documents highlights the potential for severe CNS toxicity, underscoring the necessity of this immediate response.

Management Protocol:

  • No specific antidote is known for Bacqure overexposure.
  • Overdose management involves strictly symptomatic and supportive measures.
  • The components of the medicine can be removed from the circulation by haemodialysis.

Therapeutic Uses of Bacqure

What Bacqure Treats: Main Uses and Benefits

The combined medicine enabled by Bacqure's active ingredient, Cilastatin, is a key therapeutic agent primarily used in hospital settings to treat severe and complicated bacterial infections. Its approved indications outline its use in contexts requiring critical care and complex disease management. This treatment is generally applied across conditions presenting with acute episodes and significant symptomatic burden.

Therapeutic Scope and Benefits

This treatment is applied in clinical settings that involve acute or unstable symptom patterns, such as bacterial septicemia, endocarditis, severe lower respiratory tract infections, complex intra-abdominal infections, and difficult-to-treat infections of the urinary tract, bones, and skin. It directly supports the patient by providing an appropriate therapeutic approach to address the underlying bacterial cause of the illness, which helps support the reversal of severe systemic signs like high fever and hemodynamic instability.

The therapy is relevant in challenging scenarios where the infection may be caused by multi-drug resistant bacterial strains or in immunocompromised patients (e.g., those with neutropenic fever). Its use plays an important therapeutic role by contributing to the effectiveness of the primary antibiotic, which supports general well-being during symptomatic phases in patients with high-risk infections.

“This therapy is commonly used when symptoms intensify and supportive relief is needed, assisting in the management of the infection and contributing to easing the overall physical burden of the disease.”


Quick Fact: Support for Symptoms Related to Severe Infection

Quick Fact: Support for Symptoms Related to Severe Infection — The treatment supports patients during episodes of heightened discomfort by managing acute symptoms related to systemic imbalance (like high fever) and localized inflammatory states (like severe pain in affected tissues).

Eligibility and Restrictions for Use

Who Can and Cannot Use Bacqure?

The population eligibility for the Cilastatin-containing medicine (Bacqure) is strictly defined by regulatory documents, focusing on patient health status and age.

Eligibility Scope Official Regulatory Status
Contraindicated Populations Patients with a known hypersensitivity to Cilastatin, Imipenem, or any component of the formulation.
Age-Based Eligibility Approved for adults and pediatric patients 3 months of age for non-Central Nervous System (CNS) infections. Use is not established for pediatric CNS infections.
Severe Renal Impairment Not recommended for adult patients with Creatinine Clearance (CrCl) less than 15 mL/min unless hemodialysis is initiated promptly.
Other Restrictions Conditional use in patients with pre-existing CNS disorders (e.g., history of seizures) due to increased risk. Conditional use during pregnancy and lactation, requiring assessment of benefit versus risk due to insufficient data.

Regulatory criteria mandate absolute prohibition based on allergy and severe restriction based on organ function, with patients requiring dose adjustment for any degree of renal impairment. Use is also restricted in certain infections, such as meningitis, where the medicine is officially not indicated.

What should I know about interactions with other medicines?

Bacqure Interactions with other medicines and products

The official regulatory profile for Bacqure (Cilastatin co-formulation) defines specific drug-drug and substance interaction patterns based on pharmacokinetic and pharmacodynamic outcomes. Regulatory documents strictly define certain co-administrations as having significant risk.

Agents with Severe Interaction Risk

The co-administration of Ganciclovir or Valganciclovir is formally associated with an increased risk of generalized seizures, and concomitant use is often listed as not recommended. A similar restriction applies to Valproic Acid and Divalproex Sodium because regulatory documents cite that co-administration can lead to a significant reduction in Valproic Acid concentrations, potentially resulting in loss of seizure control.

Exposure-Altering Interactions

The use of Probenecid is discouraged because this agent causes a pharmacokinetic interaction resulting in increases in the plasma level and half-life of Cilastatin (and its co-formulation) through decreased renal clearance. Conversely, the official profile notes only minimal increases in plasma levels during co-administration with Cyclosporine.

Other Interaction Constraints

Bacqure may impair the expected effectiveness of live bacterial vaccines due to pharmacodynamic antagonism; postponement of the vaccine until the regimen is complete is a documented consideration. Furthermore, regulatory documents contain specific notes that elderly patients and individuals with compromised renal function are cited as having an increased susceptibility to CNS side effects due to drug accumulation or altered clearance profiles.

Mechanism of Action

How Bacqure works

Targeting the Bacterial Cell Wall for Bactericidal Effect

This drug's primary action focuses on the bacterial cell wall, where the active component, Imipenem, irreversibly inhibits bacterial Penicillin-Binding Proteins (PBPs) . These PBPs are enzymes essential for peptidoglycan cross-linking (structural support). The inactivation of these enzymes leads to the rapid disruption and lysis (death) of susceptible bacteria. This action results in bactericidal cell lysis.

Modulating Renal Metabolism for Enhanced Stability

The secondary component, Cilastatin, acts within the domain of renal drug metabolism. Cilastatin functions as a targeted inhibitor of the human kidney enzyme Dehydropeptidase-I (DHP-I) , an enzyme that catalyzes the hydrolysis of Imipenem. This pharmacokinetic synergy maintains higher, sustained concentrations of active Imipenem in the circulation, supporting the full expression of the antibacterial mechanism.

Dosage and Administration Information

How to Use Bacqure: Official Administration Guidelines

Bacqure, the Cilastatin component of its fixed-dose combination, is administered according to protocols that ensure the proper delivery of the combined medicine. Dosing information follows the guidelines for the Imipenem component.


Administration Scope

Feature Guideline
Route of Administration Primarily Intravenous (IV) Infusion. The sterile powder formulation is not approved for intramuscular use.
Dosing Schedule (Adults) Standard doses range from 500 mg to 1000 mg of the Imipenem component per dose. The maximum recommended total daily dose is 4 g.
Frequency Pattern Administered every 6 hours or 8 hours in equally divided doses.
Preparation Requirements Requires the reconstitution of the powder followed by mandatory dilution with an appropriate IV solution (e.g., 0.9% Sodium Chloride) before infusion.

Procedural Structure and Constraints

The full procedure for using the medicine is governed by specific constraints. The infusion rate is dependent on the dose: doses up to 500 mg are infused over 20–30 minutes, while the 1000 mg dose must be infused slowly over 40–60 minutes.

Additionally, a mandatory dose reduction must be implemented for patients with any degree of renal impairment (Creatinine Clearance < 90 mL/min) to prevent accumulation of the Imipenem component. For patients undergoing hemodialysis, the dose is timed to follow immediately after the session. Treatment must be maintained for the full prescribed duration (typically 4–14 days).

This protocol ensures a highly controlled method of product delivery, where the dose, frequency, and rate of administration are strictly tied to the patient's clinical and physiological status.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Bacqure

The research evidence for Bacqure is derived from the clinical evaluation of its co-formulated medicine, where Cilastatin, a component of the co-formulation, was included in the research for its specific role. Studies were evaluated in settings focusing on conditions involving periods of heightened symptoms and systemic imbalance. Research provides context but not individual predictions, and findings describe group patterns, not personal outcomes.


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

The evidence base includes multiple Randomized Controlled Trials (RCTs) and supporting Systematic Reviews studied alongside other established antibiotic regimens. Research examined outcomes related to physical discomfort, systemic imbalance, microbiological eradication, and clinical response. Studies explored non-inferiority against some comparator treatments, and all-cause mortality was monitored, with data showing patterns related to survival.

Evidence for Use in Severe Lower Respiratory Tract Infections

The medicine was studied for conditions associated with acute or disruptive episodes of lower respiratory tract infection, including Hospital-Acquired Bacterial Pneumonia (HABP) and Ventilator-Associated Bacterial Pneumonia (VABP) in critically ill adult patients. Data show patterns related to measured outcomes in these trials that were generally found to be in the same range as those receiving comparator treatments. Some research observed patterns where bacterial resistance was observed in some studies during the treatment period.

Evidence for Use in Complicated Urinary Tract Infections (cUTI) and Septicemia

The medicine was evaluated in RCTs focusing on complicated urinary tract infections, where studies monitored the successful eradication of bacteria and symptom resolution. Studies reported how symptoms evolved in the observed populations, and findings describe positive patterns related to the measured microbiological and clinical responses. Septicemia was observed in clinical trials, but certainty remains low for dedicated, large-scale findings specific only to that condition, as data are often derived from heterogeneous cohorts.


Long-Term Follow-up and Evidence in Special Patient Populations

Most available research focuses on short-term outcomes measured during therapy and within 30 days post-treatment. Follow-up durations were limited in many pivotal trials, and thus, there is limited information for long-term outcomes such as durability of response or recurrence rates. Data for certain groups remain insufficient; for instance, while the combination was studied for children older than three months, data for very young infants and individuals with multiple complex underlying diseases are less certain.

Frequently Asked Questions (FAQ)

Common questions about Bacqure (FAQ)


Q: What is Bacqure actually for?

Bacqure (Imipenem and Cilastatin) is indicated for treating serious bacterial infections caused by susceptible bacteria. Official documents state its use for conditions such as complicated infections of the abdomen, lower respiratory tract, and urinary tract. It is typically used in healthcare settings for systemic infections.


Q: Is Bacqure a type of [General Drug Class like Antibiotic or Antihistamine]?

According to official drug classifications, Bacqure is an antibacterial combination medicine. The Imipenem component belongs to the Carbapenem class of antibiotics. The Cilastatin component is classified separately as a renal enzyme inhibitor, included to protect the antibiotic component from being broken down too quickly.


Q: Is the purpose of Bacqure curative or managing symptoms?

The overall purpose of this medicine, as an antibacterial agent, is considered curative. The goal of the antibiotic component is to achieve the eradication of susceptible bacteria causing the infection. It is not intended for the long-term management of chronic symptoms.


Q: What does 'contraindicated' mean for Bacqure?

When a drug is 'contraindicated,' it means official medical guidance advises that the medicine must not be used in patients with certain conditions because the risk is too high. For Bacqure, this includes a history of severe allergic reaction (hypersensitivity) to the drug or other antibiotics in the same class.


Q: Why do official documents mention [Specific Safety Warning] for Bacqure?

Official documents include specific warnings to clearly communicate risks identified during clinical trials and post-market surveillance. For example, warnings are given for patients with pre-existing kidney issues or Central Nervous System (CNS) disorders because these groups have a documented increased susceptibility to certain adverse reactions.


Q: Is Bacqure safe for older adults?

The medicine is included in the eligibility criteria for adults, which encompasses older adults. Official warnings indicate that older adults may have an increased risk of Central Nervous System (CNS) side effects, especially if their kidney function is already reduced. No specific dose adjustment is required if kidney function is normal.


Q: Does Bacqure come in different strengths?

Yes, the medicine is officially supplied in specific fixed-dose strengths as a dry powder for injection. These strengths represent a balanced ratio of the Imipenem and Cilastatin components, such as 250 mg/250 mg or 500 mg/500 mg.


Q: Is Bacqure a new medicine?

No, the Imipenem/Cilastatin combination is an established medicine. Regulatory records show that the original formulation was first approved for marketing in the 1980s.


Q: Is there a generic version of Bacqure?

Yes, the original drug combination of Imipenem and Cilastatin has been approved for use by regulatory bodies as a generic medicine. It is available from multiple manufacturers.


Q: Is Bacqure addictive?

According to federal and international regulatory scheduling, Bacqure is not classified as a controlled substance. Official product information does not associate it with potential for abuse or physical dependence.


Q: Is Bacqure used for anything else besides its main purpose?

The official regulatory documentation only authorizes the use of the medicine for the specific medical indications listed in the product label. Its use is restricted to these documented conditions, and the label does not indicate other purposes.


Q: Are there any long-term side effects from Bacqure?

Official product information on adverse reactions focuses primarily on effects observed during treatment and the short period immediately following the final dose. Regulatory data on potential risks that extend years beyond the course of therapy are generally limited.


Q: How quickly does Bacqure start working?

Pharmacokinetic data indicates that the medicine reaches its maximum concentration in the bloodstream very shortly after the completion of the intravenous infusion. In clinical trials, patient therapeutic response is typically measured within the first 48 to 72 hours after starting treatment.


Q: How long do the effects of Bacqure last?

In patients with normal kidney function, the plasma elimination half-life for both the antibiotic and the inhibitor components is approximately one hour. This short half-life is a key factor in the prescribed dosing frequency.


Q: How long does it take for Bacqure to clear out of the system?

The medicine is rapidly cleared from the body, primarily by the kidneys. The elimination process is quick, consistent with its short half-life of approximately one hour in individuals with normal renal function.


Q: Can I drive after taking Bacqure?

Official warnings state that the medicine can cause Central Nervous System (CNS) side effects, including dizziness, confusion, and convulsions. The official product information notes that these potential effects may impair the ability to drive or operate machinery.


Q: Does Bacqure affect sleep?

Adverse reaction profiles document Central Nervous System (CNS) effects such as confusion and somnolence (drowsiness). These CNS effects can potentially affect sleep patterns. The safety information lists adverse reactions related to the nervous system.


Q: What happens if I stop taking Bacqure suddenly?

Official documents stress the importance of completing the full prescribed duration of therapy to support therapeutic effectiveness. The label notes that severe diarrhea, known as Clostridioides difficile-associated diarrhea (CDAD), can occur even after treatment has ended.


Q: Can people with [Common Pre-existing Condition, e.g., High Blood Pressure] use Bacqure?

Regulatory documentation only places prohibitions or restrictions on specific conditions, such as severe renal impairment, CNS disorders, or allergies. If a common condition is not explicitly mentioned as a contraindication or warning in the label, it is not officially restricted.


Q: Is Bacqure still being studied?

Yes. Like all approved medications, Bacqure is subject to continuous safety monitoring by regulatory authorities through post-marketing surveillance programs. This vigilance represents the ongoing study of the drug’s safety profile in the general population.


Q: Do I need a special diet while taking Bacqure?

The medicine is administered as an intravenous infusion, delivered directly into the bloodstream. Because of the route of administration, there are no special dietary restrictions or requirements noted in the official regulatory labeling.


Q: Can Bacqure be taken with food?

No, Bacqure is administered via intravenous infusion by a healthcare professional. Since it is delivered directly into the bloodstream and is not taken orally, taking it with food is not relevant.


Q: Is Bacqure a controlled substance?

No, the medicine is not listed on any federal controlled substance schedules. Its official classification is an antibacterial.


Q: Does Bacqure cause headaches?

Yes, official adverse reaction data documents headache as a commonly reported side effect for this medicine. Information on frequency is detailed in the official safety profile.


Q: Can Bacqure affect my mood?

Adverse reaction reporting includes the listing of Central Nervous System (CNS) effects such as confusion and 'psychic disturbances.' These types of documented effects may potentially include changes in mood or behavior.


Q: Why are there different warnings about Bacqure in different countries?

Differences in warnings, dosage, or indications across countries are common because regulatory agencies (such as the FDA, EMA, or TGA) operate independently. Each authority reviews evidence and authorizes product labeling specific to its own national jurisdiction.


How should Bacqure be stored and disposed of?

How to Store and Dispose of Bacqure

The storage and disposal of Bacqure (Imipenem and Cilastatin powder for injection) must comply strictly with official regulatory requirements to maintain product stability.

Storage Conditions

Product State Temperature and Protection Requirements
Dry Powder Must be stored below 25°C and protected from light. Do not freeze. Keep the vial in the original outer carton until use.
Reconstituted Solution Use within 4 hours at 25°C or within 24 hours under refrigeration (4°C).

All medicine must be stored out of the sight and reach of children.

Disposal Instructions

Any unused or expired product, including the remaining reconstituted solution, must be discarded immediately and must not be disposed of in drains or general household waste. Disposal must be conducted according to local pharmaceutical waste requirements, often by returning the medicine to a pharmacist or designated take-back program.

Attention! Always consult to a doctor or pharmacist before using pills or medicines.

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