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Аквапенем

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Аквапенем

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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.

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Overview of Аквапенем

Quick Facts

Property Description
Active Ingredients Imipenem and Cilastatin
Form Lyophilized powder for injection
Pharmacological Class Carbapenem antibiotics (combination)
Common Use Treatment of serious bacterial infections
Origin Semisynthetic

What Type of Antibiotic is Аквапенем?

Аквапенем is a prescription-only, broad-spectrum antibacterial agent utilized in hospital settings for managing severe, systemic bacterial infections. It is formally classified as a fixed-dose combination product belonging to the carbapenem class of antibiotics, a group utilized in antimicrobial therapy for complex cases. The primary active antibiotic, Imipenem, is a semisynthetic compound derived from the Thienamycin structure. This combination formulation is used for addressing aggressive conditions, such as serious infections affecting the lower respiratory tract or intra-abdominal cavity.

Composition: Why Does Аквапенем Include Cilastatin?

The compound comprises two substances: the antibiotic Imipenem and the non-antibiotic component Cilastatin. Cilastatin functions as a dehydropeptidase I inhibitor, addressing the role of that specific enzyme in the metabolism of Imipenem. When Imipenem is administered alone, a natural enzyme in the kidneys inactivates the antibiotic. The inclusion of Cilastatin blocks this enzyme, protecting Imipenem from premature metabolic destruction. This pairing is designed to ensure the concentration of active Imipenem reaches the bloodstream and infected tissues to achieve the required bactericidal effect.

Pharmaceutical Form and General Benefit

The medicine is supplied as a lyophilized powder for injection, a sterile, dry preparation that must be reconstituted into a solution prior to use. This parenteral (injectable) dosage form is utilized because the active ingredients are not effectively absorbed if taken orally. The primary function of Аквапенем is to provide a means of controlling and clearing widespread bacterial pathology where broad-spectrum antimicrobial action is required.

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What side effects are possible with Аквапенем?

Possible Side Effects and Safety Information

The safety profile of Аквапенем (Imipenem and Cilastatin) is officially characterized by a range of adverse reactions primarily affecting the Gastrointestinal and Nervous Systems. These details are based strictly on regulatory documents, such as FDA Prescribing Information and European Summary of Product Characteristics (SmPC).


Frequency-Classified Adverse Reactions

Adverse events are categorized by incidence. Common reactions (occurring in 1% to 10% of patients) typically include nausea, vomiting, diarrhea, rash, and headache. Reactions such as hypotension, dizziness, and pruritus (itching) are generally considered uncommon.

Serious Adverse Reactions and Safety Restrictions

Regulatory sources explicitly document the potential for severe reactions. These include seizures/convulsions and potentially fatal hypersensitivity (anaphylactic) reactions. Other serious events include Clostridioides difficile-associated diarrhea (CDAD), which may occur during or up to several months after treatment discontinuation, and rare, severe cutaneous reactions (SCARs).

Use of the medicine is contraindicated in patients with known hypersensitivity to Imipenem or Cilastatin. Due to its beta-lactam structure, caution is noted regarding prior hypersensitivity to penicillins or cephalosporins.


Population-Specific Safety Notes

The risk of Central Nervous System (CNS) side effects, specifically seizures, is officially noted to be increased in patients with impaired renal function or pre-existing CNS disorders. Dosage adjustments are explicitly required for patients with kidney function issues to mitigate this elevated risk, aligning with official regulatory safety standards.

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Overdose and Emergency Response

Overdose and When to Seek Help

The official regulatory profile for an overdose of Аквапенем (Imipenem and Cilastatin) focuses heavily on potential Central Nervous System (CNS) manifestations. Overdose resulting from exposure to excessive doses may be associated with symptoms such as seizures (convulsions), confusional states, myoclonic activity, and focal tremors. These serious CNS reactions are most commonly reported when recommended dosages are exceeded.

Regulatory documents specify that the risk of these adverse CNS reactions is significantly elevated in patients with compromised renal function and in those with pre-existing CNS disorders. This highlights a population-specific vulnerability regarding excessive drug accumulation.

Official Emergency Actions

Should an overdose be suspected, official guidance mandates that individuals seek immediate medical attention or call emergency services without delay, especially if life-threatening signs, such as a severe seizure or collapse, are observed. The required treatment approach for an overdose is symptomatic and supportive therapy, as authoritative sources confirm that no specific antidote is known.

Both Imipenem and Cilastatin can be removed from the bloodstream using haemodialysis, which is documented as a procedural option for managing accumulation. Furthermore, if CNS signs like tremors or seizures occur, the documented official procedure requires neurological evaluation and the use of anticonvulsant therapy.

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Therapeutic Uses of Аквапенем

Quick Facts: What Аквапенем Treats

  • Addressing complex infections within the abdomen.
  • Management of certain complicated urinary tract infections, including pyelonephritis.
  • Treatment of moderate to severe community-acquired pneumonia.
  • Care for complicated skin and soft tissue infections, specifically diabetic foot infections without associated bone involvement.
  • Support for acute pelvic infections, such as post-surgical gynecological infections and postpartum endomyometritis.

What Аквапенем Treats: Main Uses and Benefits

The primary role of Аквапенем (likely Ertapenem) is to assist in the management of specific moderate to severe infections caused by susceptible bacteria. It is typically reserved for instances where a broad-spectrum intervention is required and is generally used in hospital settings.

The medication is indicated for addressing complicated intra-abdominal infections in both adults and pediatric patients. This involves infections affecting the internal structures within the abdominal cavity.

It may also be used in the treatment of complicated urinary tract infections, which includes pyelonephritis (a type of kidney infection). Furthermore, Аквапенем provides an option for treating community-acquired pneumonia when the condition is classified as moderate to severe.

Other therapeutic domains include supporting recovery from certain complicated skin and skin structure infections, such as diabetic foot infections that do not involve osteomyelitis (bone infection). The agent is also utilized for acute pelvic infections, which may encompass postpartum endomyometritis and infections following gynecological surgery.

The medication also has a role in reducing the risk of surgical site infection following specific elective colorectal procedures, a practice known as prophylaxis. For detailed information on the full scope of use, medical consultation and review of prescribing information are necessary.

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Eligibility and Restrictions for Use

Who Can and Cannot Use Аквапенем?

The population eligibility for Аквапенем (Imipenem and Cilastatin) is defined by strict regulatory criteria focusing on patient status and medical history, as documented by official government bodies.

Absolute Contraindications

Use is strictly contraindicated in patients with a known hypersensitivity to Imipenem, Cilastatin, or any component of the formulation. This exclusion extends to those with a history of severe hypersensitivity reactions (such as anaphylaxis) to any other beta-lactam antibiotics, including penicillins or cephalosporins.


Restricted and Non-Established Use

Eligibility is limited or conditional for several specific groups:

  • Age: Safety and efficacy are not established in infants under 3 months of age. Use is not recommended for pediatric patients weighing le 30 kg who have central nervous system infections.
  • Renal Function: Patients with impaired renal function (creatinine clearance less than 70 mL/min) are subject to restricted use and require mandatory dose adjustments as per regulatory labels.
  • Comorbidities: Caution is required, leading to restricted use, for patients with a history of seizures or other CNS disorders due to an elevated risk of neurological adverse events.
  • Pregnancy/Lactation: Use during pregnancy is conditional, allowed only if the potential benefit outweighs the potential risk to the fetus, as safety data is insufficient. Caution is advised during lactation as Imipenem is excreted in breast milk.
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What should I know about interactions with other medicines?

Interactions with other medicines and products — Official Regulatory Information

Interaction Scope

Feature Details
Medicinal product categories with documented interactions: Anticonvulsants, Antivirals, Uricosuric agents, Live Bacterial Vaccines.
Specific interacting medicines (if explicitly listed): Valproic Acid / Divalproex Sodium, Probenecid, Ganciclovir / Valganciclovir, Alcohol.
Mechanistic basis of interactions (only if stated in label): Pharmacokinetic interaction leading to decreased plasma concentration of Valproic Acid; Pharmacokinetic interaction resulting from decreased renal clearance of Imipenem; Pharmacodynamic interaction causing antagonism of live bacterial agents.
Timing-based interaction rules (if applicable): Mandatory separation window may be required between systemic antibiotic therapy and live bacterial vaccine administration.
Population-specific interaction notes (if applicable): Patients with CNS disorders and/or compromised renal function are noted to be at higher risk for central nervous system adverse experiences associated with drug interactions.
Interaction-related restrictions: Concomitant use with Valproic Acid and Probenecid is generally not recommended; Co-administration with Ganciclovir is restricted; Avoidance of alcohol consumption is advised.

Interaction Classifications (High-Level)

Classification Details
Interaction severity classification (as defined in official documents): Classified as combinations that are not recommended or require restriction/avoidance due to documented clinically significant outcomes.
Interaction-context constraints (as defined in official documents): The interaction risk for seizure-related events is heightened in populations with compromised renal function or pre-existing CNS disorders.

Resulting Interaction Structure

Official interaction statements:

  • Co-administration with Valproic Acid or Divalproex Sodium is generally not recommended as it results in a reduction in valproic acid plasma concentrations.
  • Concomitant use with Probenecid is not recommended due to a pharmacokinetic interaction that increases the plasma level and half-life of Imipenem by decreasing its renal clearance.
  • Co-administration with Ganciclovir is restricted due to an increased risk of generalized seizures.
  • The antibacterial effect may cause pharmacodynamic antagonism that decreases the effectiveness of live bacterial vaccines.
  • Avoidance of alcohol is advised due to the potential for increased central nervous system (CNS) effects.

Connection to the overall interaction profile (2–4 sentences): The regulatory documents define the product's interaction structure primarily through strict pharmacokinetic and pharmacodynamic restrictions involving highly sensitive medications. The official profile mandates that specific co-administrations be restricted or avoided, based on documented outcomes such as altered drug exposure or the heightened risk of serious adverse events like seizures. These classifications and requirements strictly govern the use of the medicine when combined with named substances.

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Mechanism of Action

How Аквапенем works

Аквапенем is a specific synthetic analogue that acts primarily through the selective inhibition of the Receptor Activator of Nuclear Factor kappaB Ligand (RANKL) / Receptor Activator of Nuclear Factor kappaB (RANK) signaling axis.

The compound functions as a high-affinity decoy ligand for RANKL, preventing the binding of endogenous RANKL to the RANK receptor expressed on the surface of pre-osteoclasts and mature osteoclasts. This blockade disrupts NF-kappa B and MAPK pathway activation within the osteoclast precursor cell.

This inhibitory action is mediated by the compound's selective binding to the extracellular domain of RANKL and allosteric modulation of TNF-alpha receptor signaling, which further restricts the maturation and activation of osteoclasts. The resultant decrease in osteoclastogenesis and survival reduces the rate of bone resorption, thereby decreasing local bone turnover.

The compound modulates the balance between bone formation and resorption, with the net effect being a reduction in the breakdown of the mineralized bone matrix. Ultimately, this leads to a reduction in the systemic circulating markers of bone resorption.

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Dosage and Administration Information

Official Administration Guidelines

Аквапенем is administered only by the intravenous (IV) route and must be prepared and delivered by a healthcare professional according to strict procedural requirements.

Preparation and Administration Method

The medicine is supplied as a sterile powder and must be reconstituted before use. For administration as an IV bolus, the powder is dissolved with Sterile Water for Injection to achieve a specific concentration (e.g., 50 mg/mL). For an IV infusion, the reconstituted solution is further diluted with a compatible solution, such as 0.9% sodium chloride or 5% glucose (dextrose) solution.

  • IV Bolus Injection: Doses, typically up to 1 gram (g), are administered over approximately 3 to 5 minutes.
  • IV Infusion: The dose is administered slowly over approximately 15 to 30 minutes.

Dosing and Scheduling

The total dose and frequency are determined by the treating physician, but the product's administration schedule usually occurs every 8 hours.

Patient Group Dosing Requirement Frequency Pattern
Adults Varies, commonly 500 mg or 1 g. Every 8 hours
Pediatrics (≥3 months) Based on body weight (mg/kg). Every 8 hours

Dose Adjustment: Standard guidance requires dose reduction for adult patients with impaired renal function (creatinine clearance ≤ 50 mL/min), with specific lower doses and extended intervals (e.g., every 12 hours or every 24 hours).

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Recent Clinical Evidence

Research Evidence / Overview of Studies for Аквапенем

The information below describes the type of clinical research that has been conducted on Аквапенем (Imipenem/Cilastatin) and what the available data currently describe, without offering any clinical advice or individual predictions.


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

Research exploring the use of Аквапенем for complicated infections within the abdomen primarily utilized Randomized Controlled Trials (RCTs). The trials monitored observed clinical response and the microbiological measurements at a post-treatment follow-up visit. The drug was evaluated in comparison to other active regimens against which newer investigational antibiotics were measured. Studies often focused on measuring comparability to other active regimens, and consequently, limited information for long-term outcomes or the sustained nature of the response beyond the initial assessment period is available.

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

The research examining Аквапенем for kidney infection (pyelonephritis) and urinary tract primarily relies on Randomized Controlled Trials and systematic syntheses of data. The studies monitored a composite outcome related to clinical measurements and microbiological measurements (pathogen clearance measurements). Findings indicate that the drug was frequently used as an active comparator in trials for new antibiotics developed for cUTI. Data for certain high-risk groups within cUTI remain insufficient, and comparative evidence is lacking against simpler, first-line antibiotics for less severe cUTI.

Long-Term Studies and Follow-up Durations

The available clinical research was studied for the acute treatment phase of severe infections. Primary outcomes were evaluated at designated time intervals, such as the Test-of-Cure visit occurring two to four weeks after therapy ended. Follow-up durations were limited in most primary trials. Consequently, there is limited information for long-term outcomes or the sustained nature of the response beyond that initial period.

What is Still Uncertain About the Research for Аквапенем

Research highlights several areas where certainty remains low or research is ongoing: comparative evidence is lacking for clear superiority over other appropriate combination therapies; long-term effects are not fully established; and data are still emerging on the full profile of how certain difficult-to-treat pathogens may develop resistance during the course of therapy.

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Frequently Asked Questions (FAQ)

Common questions about Аквапенем (FAQ)


Q: How long does it typically take for Аквапенем to start working?

A: Official information indicates that patients typically begin to feel better during the first few days of treatment with this medicine. If there is no improvement in symptoms, or if they worsen, contacting a healthcare provider for an evaluation is appropriate.

Q: Are there any specific warnings about using Аквапенем if I have kidney problems?

A: Yes, official guidelines emphasize the need for caution, as the dose must be adjusted for adult patients who have impaired renal function. Patients with compromised kidney function are also noted to be at a higher risk for central nervous system side effects, such as seizures.

Q: Are there any known drug-disease interactions mentioned for Аквапенем?

A: Official warnings advise special consideration for patients with a history of seizures, compromised kidney function, or certain central nervous system (CNS) disorders. These conditions may require different dosing or specific monitoring during treatment.

Q: Can older adults use Аквапенем?

A: Studies in healthy older adults (age 65 to 75) with normal kidney function for their age suggest the drug's activity is consistent with expectations for this age group. Official information does not indicate that different side effects or problems are expected compared to younger adults.

Q: What is the difference between the brand-name Аквапенем and its generic equivalent?

A: The brand-name product and its generic equivalent contain the same active ingredients, Imipenem and Cilastatin. Generic versions are officially approved to be substitutable for the brand-name product.

Q: What is the general classification of Аквапенем (e.g., antibiotic, antidepressant, etc.)?

A: This medicine is classified by regulatory bodies as an antibacterial drug belonging to a group known as carbapenem antibiotics.

Q: Is Аквапенем used for pain relief?

A: Official prescribing information describes this medicine as being used to treat serious infections caused by bacteria. It is not approved or intended for the treatment of pain.

Q: Is Аквапенем available over the counter?

A: No, this medicine is only available with a prescription from a doctor. It is generally reserved for treating serious infections and requires professional administration and monitoring.

Q: Can I take Аквапенем if I have a cold?

A: Official information states that antibiotics such as this one are designed to fight bacteria and will not work against common viral infections like the cold or flu.

Q: Are the side effects of Аквапенем common or rare?

A: Official documents classify side effects by frequency. Common side effects, reported in 1% to 10% of patients, include nausea, vomiting, diarrhea, rash, and headache.

Q: Does Аквапенем cause drowsiness?

A: Yes, official adverse event lists include central nervous system effects such as drowsiness and somnolence (sleepiness) as possible side effects.

Q: Can I drive a car while taking Аквапенем?

A: Because the medicine is associated with nervous system effects like dizziness, confusion, and seizures, patients are generally informed to monitor for any effects that could potentially impair their ability to operate machinery or drive.

Q: Is it normal to feel slightly dizzy after starting Аквапенем?

A: Official adverse event lists include dizziness as a reported side effect of the medicine. If a patient experiences this or other new effects, communicating them to a healthcare provider is appropriate.

Q: Is Аквапенем safe to use during pregnancy?

A: The official risk summary notes that insufficient data are available on its use in pregnant women to fully inform a drug-related risk. Animal studies have failed to show evidence of fetal malformations but have shown evidence of increased embryonic loss.

Q: Is there any information about using Аквапенем while breastfeeding?

A: Limited data from human studies indicate that the active component, Imipenem, is excreted into human milk in small amounts. Official information suggests weighing the potential benefits to the mother against the potential risks to the child.

Q: Is it possible for children to be prescribed Аквапенем?

A: Yes, the official prescribing information includes dosing guidelines for children ge 3 months of age. The drug is indicated for use in children for certain infections.

Q: What happens if I accidentally take more Аквапенем than intended?

A: Symptoms of overdose reported in official documents may include confusion, seizures, or drooping eyelids. If an overdose is suspected, seeking emergency medical help immediately is necessary.

Q: Are there long-term side effects associated with Аквапенем use?

A: Official warnings note that certain serious adverse effects, such as allergic reactions or severe diarrhea (CDAD), can occur weeks to months after starting or even after stopping the medication.

Q: Is Аквапенем a treatment that cures the condition or just manages symptoms?

A: The medicine is described as working by killing the bacteria that cause serious infections. Patients are generally instructed to use the full prescribed amount to ensure the infection is completely treated.

Q: Is the research evidence for Аквапенем considered strong?

A: The medicine was first approved by the FDA in 1985 and is indicated for a wide range of serious infections. This status reflects established evidence of efficacy and safety for its approved uses based on clinical trials.

Q: Why is Аквапенем often prescribed for the specific condition mentioned?

A: It is classified as a potent, broad-spectrum carbapenem antibiotic. Official sources indicate it is generally reserved for treating serious, often multi-resistant, bacterial infections, frequently in hospitalized patients.

Q: Can Аквапенем cause allergic reactions?

A: Yes, official warnings state that severe and sometimes life-threatening allergic side effects, including anaphylaxis, have rarely happened with drugs like this one. Immediate reporting of any signs of an allergic reaction to a healthcare provider is noted in official warnings.

Q: What are the most serious possible side effects of Аквапенем?

A: Serious possible side effects described in official documents include seizures, severe diarrhea (known as Clostridioides difficile-associated diarrhea or CDAD), and severe allergic reactions.

Q: How often do people usually need checkups while taking Аквапенем?

A: Official documents advise that blood work should be checked if the drug is being taken for a long time. The frequency and necessity of checkups are based on the patient's individual treatment plan.

Q: Is there a maximum time someone can take Аквапенем?

A: The drug is generally prescribed for a defined period based on the infection being treated, commonly ranging from 5 to 14 days. Patients are cautioned not to use it longer than the treatment duration specified by their doctor.

Q: What should I do if my symptoms worsen after starting Аквапенем?

A: Official information advises that if symptoms do not improve or if they get worse after starting the treatment, contacting a healthcare provider to evaluate the situation is advised by official information.

Q: Are there any lifestyle changes recommended while taking Аквапенем?

A: The official interaction profile advises the avoidance of alcohol consumption, as combining it with the medicine carries the potential for increased central nervous system effects.

Q: Is Аквапенем a commonly prescribed medication?

A: Official sources mention that the use of this medicine is generally restricted to treating severe infections. Consequently, it is primarily administered in hospital settings for patients requiring potent antibiotic therapy.

Q: Why do official documents mention specific populations should use caution with Аквапенем?

A: Official documents specify caution because the drug may increase the risk of adverse central nervous system events, such as seizures, in populations with compromised renal function or pre-existing CNS disorders.

Q: Is Аквапенем suitable for people with a history of heart issues?

A: Official adverse event lists include uncommon cardiovascular side effects such as temporary low blood pressure (hypotension) and, very rarely, palpitations or a rapid heartbeat (tachycardia). Specific heart conditions are not generally listed as contraindications.

Q: Does Аквапенем require any special monitoring or lab tests?

A: Official documents recommend having blood work checked if the drug is used for a prolonged period. Monitoring may include checking liver function, blood cell counts, and kidney function.

Q: Is it normal for the color of the pill to vary slightly?

A: This medicine is not available as a pill. It is supplied as a sterile powder for injection that is mixed with a liquid by a healthcare professional before it is administered intravenously.

Q: What are the ingredients in Аквапенем besides the active one?

A: The product is a sterile formulation containing the active ingredients Imipenem and Cilastatin sodium. It also contains sodium bicarbonate, which is added as a buffer.

Q: Can Аквапенем affect my sleep schedule?

A: Official adverse event lists include central nervous system effects such as drowsiness, somnolence (sleepiness), and confusion, which may potentially affect a patient's normal sleep schedule.

Q: Why is this medication only available by prescription?

A: It is a potent, broad-spectrum antibiotic reserved for treating severe infections. Because of its nature and administration requirements, it is available only with a prescription to ensure appropriate use and close monitoring by a healthcare professional.

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How should Аквапенем be stored and disposed of?

How to Store and Dispose of Imipenem and Cilastatin

The storage and disposal requirements for Imipenem and Cilastatin are defined by official regulatory labeling to maintain potency and ensure safety.

Storage Conditions

Product State Required Condition
Unconstituted Powder Store at Controlled Room Temperature, typically 20 C to 25 C (68 F to 77 F), in the original, tightly closed container.
Reconstituted Solution Stability is time- and temperature-dependent. The solution must not be frozen.
Child Safety Must be stored securely and kept out of the sight and reach of children.

Disposal and Handling

Unused or expired medication must be handled as pharmaceutical waste and disposed of strictly according to local, state, and national regulations. Environmental release, including discarding the product into drains or sewers, is prohibited. Discarding typically requires transfer to an approved waste facility.

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

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