Inem

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Inem

Method of action: Bactericidal

Treatment option: Endocarditis

Medically reviewed

Rosario Oropesa

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 Inem

What is Inem? Quick Facts and Identity

Property Description
Active ingredients Imipenem and Cilastatin sodium
Form Sterile powder for reconstitution (injection)
Pharmacological class Carbapenem Antibiotic and DHP-I Inhibitor
General purpose Potent anti-infective for severe bacterial infections
Origin Semisynthetic (Imipenem component)

The Combination Drug and Its Core Composition

Inem refers to a fixed-dose combination product containing the two active substances, Imipenem and Cilastatin sodium. The primary component, Imipenem, is a highly potent semisynthetic Carbapenem antibiotic, a class within the larger family of beta-lactam antibacterials. The fixed combination is a specialized therapeutic approach, distinguishing it from single-agent formulations.

The second component, Cilastatin, functions as a Renal Dehydropeptidase Inhibitor; it has no direct antimicrobial effect but is intended for maximizing Imipenem's therapeutic efficacy. Cilastatin works by preventing the breakdown of Imipenem by the specific enzyme Dehydropeptidase I in the kidneys. This protective mechanism is designed to ensure that sufficient concentrations of the active antibiotic are maintained to fight the target pathogens throughout the body.

Form and General Therapeutic Purpose

The drug is supplied as a sterile powder mixture for reconstitution, intended for parenteral administration (intravenous or intramuscular injection). This specialized dosage form and route of administration are utilized for powerful, hospital-grade antibiotics. The general therapeutic purpose of this combination is to provide a reliable and potent option for addressing severe bacterial infections, such as those that might complicate complex surgical procedures.

The fixed-ratio formulation is noted for its efficacy against a wide variety of resistant microorganisms, a unique aspect that makes it a tool in infectious disease management. The Imipenem and Cilastatin combination is categorized as an essential medicine, signifying its role in managing life-threatening bacterial infections globally.

Regulatory References

  1. WHO Essential Medicines List entry for Imipenem + Cilastatin

What side effects are possible with Inem?

Possible Side Effects and Safety Information

The safety profile of Inem is based on official data from government regulatory agencies, detailing adverse reactions and necessary usage restrictions.

Key Adverse Reactions

Adverse reactions are classified by how often they occurred in clinical studies:

  • Very Common (Affecting 1 in 10 people or more): Infusion-related reactions (e.g., headache, fever, nausea, chills).
  • Common (Affecting up to 1 in 10 people): Infections (such as urinary tract infection, nasopharyngitis), neutropenia (a reduction in a type of white blood cell), and back pain.

Serious and Clinically Significant Safety Information

Regulatory documents highlight several serious and clinically significant risks:

  • Serious Infections: Inem can increase the risk of serious infections, including opportunistic infections and the reactivation of viral infections like Hepatitis B Virus (HBV) and Progressive Multifocal Leukoencephalopathy (PML), a rare but serious brain infection. Screening for HBV and Tuberculosis ( TB) is required before starting treatment.
  • Hypogammaglobulinemia: Prolonged use may lead to a progressive and sustained decrease in immunoglobulin (antibody) levels, which can further increase the risk of infection.
  • Serious Infusion Reactions: While most infusion reactions are manageable, severe reactions, including anaphylaxis, can occur.

Mandatory Safety Restrictions

Inem must not be used (Contraindications) in patients who have:

  • A history of a life-threatening allergic or infusion-related reaction to Inem.
  • Active HBV infection.
  • Active or untreated latent TB.

Population-Specific Risk: Based on non-human data, Inem has the potential to cause fetal harm, and regulatory information notes this risk for females of reproductive potential.

Overdose and Emergency Response

Overdose and when to seek help

The official regulatory documentation for Inem (Imipenem/Cilastatin) defines the overdose profile primarily through its potential for severe neurological toxicity, particularly when recommended dosages are exceeded.

Documented Overdose Manifestations

Overdose may present with severe Central Nervous System (CNS) adverse reactions. These regulator-documented signs and symptoms include seizures (convulsions), myoclonic activity, focal tremors, and confusional states. These effects are reported especially when the dosage schedules, based on renal function, have been exceeded.

When to Seek Immediate Medical Help

Urgent medical intervention is required for any suspected overdose or if the individual experiences severe manifestations such as collapse, seizures, breathing difficulty, or inability to be awakened. Immediate attention is necessary for these severe, life-threatening outcomes.

Emergency Response and Population-Specific Risk

If overdose is suspected, official guidance mandates discontinuation of the drug and immediate neurological evaluation. Anticonvulsant therapy should be instituted if tremors or seizures occur. The risk of accumulation and severe CNS symptoms is notably higher in patients with compromised renal function or pre-existing CNS disorders. There is no specific antidote known for Imipenem/Cilastatin overdose, and the utility of hemodialysis in managing this situation is officially documented as questionable.

Therapeutic Uses of Inem

What Inem Treats: Main Uses and Benefits

The Imipenem/Cilastatin combination (Inem) is an established anti-infective treatment reserved for the management of severe bacterial infections. Its use is relevant in clinical settings that involve acute or unstable symptom patterns.

The medication is commonly used for conditions presenting with systemic or localized discomfort, such as bacterial sepsis (septicemia), where symptoms related to systemic imbalance are present. It is utilized for serious infections, including complicated hospital-acquired pneumonia, severe intra-abdominal abscesses, deep-seated skin and soft tissue infections, and conditions in immunocompromised patients like febrile neutropenia.

In these contexts, Inem plays a role in managing severe systemic infections. It is relevant for addressing symptoms related to systemic imbalance, which is associated with maintaining clinical stability when symptoms are more noticeable. It is also intended to help manage symptoms that create noticeable physiological strain in deep-seated locations.

Quick Fact: Relief for Acute Systemic Symptoms
This treatment supports patients during difficult episodes by addressing distress related to systemic imbalance, such as persistent high fever and signs of overwhelming infection.

Regulatory References

  1. NIH DailyMed drug information

Eligibility and Restrictions for Use

Who can and cannot use Inem?

The eligibility for using Inem (Imipenem and Cilastatin) is strictly defined by regulatory authorities based on population characteristics and underlying medical conditions.


Absolute Non-Eligibility (Contraindicated)

Use is contraindicated in patients with a known hypersensitivity to Imipenem, Cilastatin, or any component of the product. This prohibition extends to individuals with documented severe hypersensitivity to other beta-lactam antibacterials, such as Penicillins or other Carbapenems.


Conditional and Restricted Use

Use is established in the adult population. However, use is conditional in patients with impaired renal function, which requires specific consideration as per labeled instructions. Caution is also required for patients with pre-existing CNS disorders or a history of seizures.


Special Populations and Limitations

  • Pediatrics: Use is not recommended in children with CNS infections or in those weighing less than 30 kg who also have impaired kidney function. Efficacy and safety have not been established for the treatment of meningitis.
  • Pregnancy and Lactation: Use is contingent on a regulatory risk/benefit assessment, as the drug is known to be excreted into human milk.

What should I know about interactions with other medicines?

Interactions with other medicines and products

This section describes officially documented interaction patterns for Imipenem and Cilastatin (Inem) as stated in government regulatory labeling.

Documented Pharmacokinetic and Pharmacodynamic Constraints

The regulatory profile establishes strong restrictions against co-administration with several specific agents due to the potential for clinically significant effects on drug exposure or systemic toxicity.

Interacting Medicine Official Interaction Pattern & Outcome Regulatory Status
Valproic acid / Divalproex sodium Results in a reduction in valproic acid concentrations, leading to an increased risk of breakthrough seizures. Generally not recommended
Probenecid Results in increases in the plasma level and half-life of imipenem by inhibiting renal clearance. Not recommended
Ganciclovir Associated with reports of generalized seizures upon co-administration. Do not co-administer unless benefit outweighs risk

Official Regulatory Profile

The primary constraints are directed at preventing the documented reduction in anticonvulsant efficacy and mitigating the potential for serious toxicodynamic effects, such as seizures. The regulatory basis for the restrictions against co-administration with Probenecid is a pharmacokinetic interaction involving the inhibition of Imipenem's renal tubular clearance. There are no official, outcome-defining interactions documented with food, alcohol, or herbal products in the primary regulatory warnings.

Mechanism of Action

Inem functions as a highly selective competitive antagonist at the P2Y12 purinergic receptor found primarily on the surface of platelets. Following absorption, Inem binds rapidly and reversibly to the P2Y12 receptor, preventing the binding of its endogenous ligand, adenosine diphosphate (ADP).

This antagonistic action blocks the ADP-mediated activation of the GP IIb/IIIa receptor complex (also known as integrin alpha IIbbeta3), a crucial step in platelet signal transduction. By preventing P2Y12 signaling, Inem inhibits the intracellular cascade required for platelet shape change and, most importantly, limits the conformational change necessary for GP IIb/IIIa receptor activation.

Functionally, this molecular intervention results in the inhibition of platelet aggregation and the subsequent reduction in thrombus formation potential within the systemic circulation. This systemic physiological modulation is a direct consequence of the drug's interaction at the platelet receptor level.

Dosage and Administration Information

How Inem is Used: Official Administration Guidelines

Inem (Imipenem and Cilastatin) is a combination anti-infective administered according to established procedures, reflecting its use as a potent, hospital-grade medicine. The administration protocol is intended to ensure the drug is delivered correctly to maximize its effect.


Administration Scope and Preparation

Instruction Category Detail
Route of Administration Primarily Intravenous (IV) Infusion for the severe infections it is indicated to treat.
Preparation Requirements Supplied as a sterile powder that must be reconstituted and diluted using specific solutions (e.g., 0.9% Sodium Chloride Injection) before administration. It must not be mixed with other drug products in the infusion container.
Infusion Rate Fixed infusion times apply: doses up to 500 mg are infused over 20–30 minutes, while doses exceeding 500 mg are infused over 40–60 minutes.

Standard Dosing and Population Adjustments

In adult patients with normal kidney function, doses are based on the Imipenem component and typically range from 500 mg to 1000 mg (1 gram). This total daily amount is divided and administered in equally spaced intervals, usually every 6 hours or every 8 hours.

Special Population Rule Clinical Requirement
Renal Impairment Dose reduction is required for adult patients with reduced kidney function (Creatinine Clearance < 90 mL/min), requiring adherence to specific dosage adjustments.
Pediatric Patients Dosing for children 1 year and older is calculated on a weight-basis (mg/kg) and administered every 6 hours.
Hemodialysis Doses are administered after the hemodialysis session is completed, as the treatment removes the drug from the body.

The treatment duration, which may span a full course (e.g., 4 to 7 days or more), is maintained on a regular schedule as determined by clinical oversight.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Inem

The research base for Inem (Imipenem/Cilastatin) consists primarily of Randomized Controlled Trials (RCTs) and Systematic Reviews that compare study outcomes with other established antibiotics. These studies, which follow rigorous standards set by regulators, provide details regarding the specific types of severe bacterial infections the combination was studied for and what outcomes were monitored during the trials.


Evidence for Complicated Intra-Abdominal Infections (cIAI) and Abscesses

Research exploring the use of Inem for patients diagnosed with serious, deep-seated abdominal infections involved short-term RCTs. The study populations were typically adults hospitalized with high initial illness severity. Studies monitored for two main types of outcomes: Clinical Success (measurement of signs and symptoms like fever) and Bacteriological Eradication (monitoring for the clearance of specific bacteria). Findings observed in the studies described patterns of success that were described in relation to those measured for other comparator drugs used for cIAI. The results apply only to the populations studied, and follow-up durations were generally limited.


Evidence for Hospital-Acquired Pneumonia (HAP) and Septicemia

Research has examined the use of Inem in severe lung infections, including those that develop in a hospital setting (HAP) or those related to mechanical ventilation (VAP). Studies also explored systemic bloodstream infections (septicemia), often relying on subgroup analyses from larger trials where septicemia was an observed factor. Researchers monitored critical outcomes such as All-Cause Mortality and the rate of Favorable Clinical Response. The combination was evaluated in research covering other infections, including severe complicated Urinary Tract Infections and deep-seated Skin and Soft Tissue Infections.


Long-Term Evidence and Research Uncertainties

The research for Inem primarily focused on acute infection management. Most follow-up durations were limited to the period during and immediately after the treatment course. Long-term effects are not fully established, and there is limited information for outcomes such as measured quality of life several months after the acute infection period. Studies have examined the use in pediatric populations and critically ill adults. However, comparative evidence is lacking for some of the newly emerging multidrug-resistant (MDR) organisms. While the research provides context, it does not determine whether an individual will respond similarly; findings describe group patterns, not personal outcomes.

Key Studies & References

  1. Imipenem and Cilastatin for Injection: Labeling and Drug Information

Frequently Asked Questions (FAQ)

Common questions about Inem (FAQ)


Q: Is Inem a medication intended for long-term or short-term use?

The treatment duration is determined by the acute nature of the severe bacterial infections the drug is designed to treat. Therefore, official guidance indicates it is typically intended for a short course of treatment, often ranging from a few days up to two weeks, based on the required course of therapy.


Q: Is Inem available in generic form?

Official documents state that the fixed-dose combination of Imipenem and Cilastatin is available in generic formulations. This means the medicine can be dispensed under its non-brand name, which may affect its cost or availability.


Q: Does Inem carry a specific warning, like a Black Box Warning, in the official regulatory documents?

The official Prescribing Information includes a detailed Warnings and Precautions section that lists several serious risks, such as the potential for seizures and hypersensitivity reactions. However, the product information reviewed does not use the specific regulatory term 'Boxed Warning' to describe these warnings.


Q: Can Inem affect a person's ability to drive or operate machinery?

Official regulatory sources note that certain side effects of this medicine can affect the central nervous system (CNS), potentially including dizziness, confusion, or seizures. Because of these potential effects, these risks are noted as potentially affecting the ability to drive or operate machinery.


Q: Can individuals with existing liver conditions safely use Inem?

The medicine is primarily cleared from the body by the kidneys, and official regulatory guidance does not generally require specific dose adjustments for individuals with hepatic (liver) impairment. However, regulatory documents mention that liver function may be monitored in certain clinical settings.


Q: What is the official guidance regarding alcohol consumption while using Inem?

The primary regulatory warnings do not explicitly detail a pharmacological interaction with alcohol, food, or herbal products. However, the medicine's formulation contains sodium. The label discloses this sodium content as a consideration for individuals with conditions requiring sodium restriction, such as congestive heart failure or hypertension.


Q: How quickly does Inem typically start to produce a noticeable effect?

As a medicine administered directly into the bloodstream through an intravenous (IV) infusion, the drug is introduced systemically almost immediately. This means the medicine begins working throughout the body shortly after the infusion starts.


Q: What is the expected duration of the effects of one dose of Inem?

The active component, Imipenem, is eliminated from the body relatively quickly, with an elimination half-life of approximately one hour. Due to this rapid elimination, the administration schedule is typically set for multiple doses every six to eight hours to maintain therapeutic drug concentrations.


Q: Does the effectiveness of Inem typically diminish over time (tolerance)?

Official labeling notes that using any antibiotic when a bacterial infection is not proven or strongly suspected can increase the risk of developing drug-resistant bacteria. This risk is a standard regulatory warning regarding antibiotic misuse, but it does not refer to the development of patient tolerance.


Q: Is Inem considered appropriate for use in older adults (geriatric population)?

The medicine is considered appropriate for use in the older adult population. However, since the drug is mostly cleared by the kidneys and renal function may naturally decline with age, regulatory information indicates that dose selection and monitoring of kidney function must reflect the patient's individual status.


Q: What is the official guidance on using Inem during pregnancy and breastfeeding?

Regulatory information states that use during pregnancy is conditional due to findings of potential risk in animal studies. Therefore, it is used only when the required assessment determines that the benefit outweighs the risk. The medicine is known to be excreted into human milk in small amounts, and official guidance on breastfeeding varies.


Q: Can people with a history of seizures or convulsions use Inem?

Official documents state that use is generally restricted for people who have a history of Central Nervous System (CNS) disorders or seizures. This is due to an increased risk of CNS adverse events, and a patient's pre-existing anticonvulsant therapy is an important consideration that requires regulatory guidance during the administration of the medicine.


How should Inem be stored and disposed of?

The storage and disposal of Imipenem and Cilastatin must strictly follow conditions mandated by regulatory labeling.

Storage Conditions

Product State Requirement
Unopened Powder Store at 20 C to 25 C (68 F to 77 F) and protect from moisture by keeping it in the original container.
Prepared Solution Do not freeze. The solution is stable for 24 hours when refrigerated (2 C to 8 C), or 2 hours at room temperature.

The medication must be kept out of the sight and reach of children.

Disposal Instructions

Disposal of unused or expired product must be managed according to local requirements for pharmaceutical waste. Medicines must not be thrown away via wastewater or standard household trash to prevent environmental release.

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

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