Younam

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Younam

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 Younam

Property Description
Active Ingredients Imipenem, Cilastatin (sodium)
Form Powder for solution for injection/infusion
Pharmacological Class Carbapenem (β-lactam antibiotic) / Renal Dehydropeptidase-I Inhibitor
General Purpose Antiinfective action against severe bacterial pathogens
Origin Semisynthetic

Younam: Defining the Drug Entity and Pharmacological Class

Younam is a prescription medicine formulated as a fixed-dose combination product, containing the antibiotic Imipenem and the enzyme inhibitor Cilastatin. Imipenem is classified as a semisynthetic β-lactam antibiotic belonging to the potent Carbapenems class, a group that is clinically recognized for its essential role in treating serious, complicated bacterial infections. This high-level classification underscores the product's design as a powerful antiinfective agent, typically reserved for situations where a broad spectrum of activity against various bacterial types is critical for therapeutic success.

Active Components and the Strategy of Combination

The combination includes Imipenem, the primary agent that is bactericidal by interfering with bacterial cell wall synthesis, and Cilastatin, the protective compound. Cilastatin acts as a renal dehydropeptidase-I inhibitor, preventing an enzyme in the kidney from rapidly breaking down the Imipenem molecule. This strategic pairing is universally utilized for this formulation, as the combined delivery enhances the duration and efficacy of Imipenem's antibacterial action. This protection is a unique and necessary feature distinguishing this formulation.

Physical Form and Administration Route

Younam is specifically supplied as a sterile powder to be mixed with liquid, typically packaged in vials of lyophilized powder suitable for hospital settings. This preparation must be reconstituted with a compatible vehicle before administration. The required parenteral route of administration—meaning delivery via Intravenous or Intramuscular injection—is critical to ensure rapid and complete systemic availability of the active ingredients, which is mandated for the effective management of severe bacterial infections.

Regulatory References

  1. NIH LiverTox: Imipenem-Cilastatin

What side effects are possible with Younam?

Possible side effects and safety information

The official safety profile for Younam (Imipenem and Cilastatin) classifies documented adverse reactions by frequency and the body systems they affect, based on regulatory standards.

Classification Examples of Officially Documented Adverse Reactions
Common Nausea, Vomiting, Diarrhea, Rash, Eosinophilia, Injection site reactions, and increased levels of liver enzymes.
Uncommon Seizures, Confusion, Hypotension, Thrombocytopenia, and other Central Nervous System (CNS) effects.
Rare Serious events including Pseudomembranous colitis, Acute renal failure, and Hepatic failure.

Serious reactions that are explicitly documented in regulatory sources include anaphylactic reactions and other severe hypersensitivity events, as well as seizures.

Population-Specific Safety Considerations

Official labeling indicates that individuals with impaired renal function or a history of CNS disorders have an increased risk for developing CNS adverse reactions, including seizures. This neurological risk is also noted to be higher with higher doses and in older adults, often linked to underlying reduced renal function. Pseudomembranous colitis is a documented safety concern that may manifest during or after the completion of treatment.

Safety-Related Restrictions or Limitations

The product is contraindicated in individuals with a documented hypersensitivity to imipenem, cilastatin, or any other beta-lactam antibacterial agent who have experienced a severe, immediate allergic reaction. This represents a critical safety constraint defined in the regulatory prescribing information.

Overdose and Emergency Response

The official regulatory profile for Younam (Imipenem and Cilastatin) defines overdose primarily through central nervous system (CNS) manifestations, which are linked to administration exceeding recommended dosages. Documented presentations include severe outcomes like seizures and convulsions, along with specific clinical signs such as focal tremors, myoclonic activity (involuntary muscle jerking), and confusional states.

Urgent medical help is explicitly required for life-threatening scenarios: if an individual has collapsed, had a seizure, has trouble breathing, or cannot be awakened, immediate emergency services must be called. Regulatory resources also advise contacting a Poison Control Center for guidance. The mandatory initial action in the event of overdosage is to discontinue the drug.

Management is strictly symptomatic and supportive, as no specific antidote is documented in the official prescribing information. While the drug is known to be cleared by hemodialysis, the clinical usefulness of this procedure in the overdosage setting is noted as questionable in some regulatory documents. Population-specific risk factors are cited in official labeling: the risk of seizure activity is heightened when recommended dosages are exceeded in patients with compromised renal function and those with pre-existing CNS disorders.

Therapeutic Uses of Younam

What Younam Treats: Main Uses and Benefits

Younam is considered relevant within therapeutic areas involving heightened responses to severe bacterial involvement, such as bacterial septicemia (bloodstream infection) and severe endocarditis. It is applicable within clinical settings that involve acute or disruptive symptom patterns and is considered relevant for a wide range of critical, systemic, and localized infections. It is often used during phases when symptoms become more noticeable and create noticeable physiological strain.

The medication is applied to help manage groups of symptoms associated with severe intra-abdominal, gynecologic, bone and joint, and complicated urinary tract infections. This use provides supportive relief when symptoms interfere with routine activities, and helps ease the overall symptom load in the affected organ system. Younam is relevant in clinical settings that involve acute or unstable symptom patterns, particularly when infections are caused by multi-drug resistant bacteria or when initial, standard treatments have failed. The primary therapeutic benefit is providing support that helps ease the overall symptom burden by supporting swift management of widespread infections, and assists with supporting a sense of stability when symptoms are more noticeable.


Quick Fact: Symptomatic Support for Acute Episodes Younam is typically reserved for managing the pronounced symptoms associated with complicated and systemic infections, which require supportive management due to intense manifestations.

Regulatory References

  1. U.S. Food and Drug Administration (FDA) official drug label

Eligibility and Restrictions for Use

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

Eligibility Scope Classification Population Group Regulatory Status
Allowed Adults and older adults with normal renal function Eligible
Allowed Pediatric patients ge 3 months of age Eligible for non-CNS infections
Contraindicated Patients with known hypersensitivity to Imipenem, Cilastatin, or any other beta-lactam antibiotic Prohibited
Not Recommended Infants under 3 months of age Safety/efficacy not established
Not Recommended Patients with severe renal impairment (CrCl le 5 mL/min) Prohibited unless hemodialysis is instituted within 48 hours
Restricted Use Patients with a history of CNS disorders (e.g., seizures) Use with Caution
Restricted Use Patients taking valproic acid or divalproex sodium Generally not recommended

Age-related Eligibility Rules: Use is not established for infants under 3 months. Pediatric patients must not be treated for CNS infections (meningitis) due to documented seizure risk.

Pregnancy and Lactation Eligibility Status: Use during pregnancy is permitted only if the potential benefit justifies the potential risk to the fetus. The medicine is generally not recommended for use while breastfeeding.

Connection to the overall eligibility profile: Regulatory documents define who can and cannot use this medicine by establishing absolute contraindications based on allergic history and imposing strict limitations based on the patient’s kidney function, neurological history, and age group. These rules create the formal population boundaries for the drug's use.

What should I know about interactions with other medicines?

Younam Interactions with Other Medicines and Products

This section outlines the officially documented interaction patterns for Younam (Imipenem and Cilastatin), based strictly on government regulatory information.

Restrictions on Concomitant Use

Certain combinations are subject to official restrictions due to documented effects on drug exposure or shared risks of adverse outcomes. These combinations are generally not recommended or require careful evaluation by a healthcare provider before use.

Interacting Medicine Regulatory Stance / Description
Valproic Acid / Divalproex Sodium Not Recommended: Imipenem/Cilastatin reduces the concentration of the anticonvulsant, increasing the risk of loss of seizure control.
Probenecid Not Recommended: Causes an increase in Imipenem's plasma level and half-life by reducing its renal clearance.
Ganciclovir Use Only If Benefit Outweighs Risk: Associated with increased risk of generalized seizures.

Official Interaction Mechanisms

  • Pharmacokinetic Effect (Clearance): Probenecid significantly increases Imipenem exposure by officially documented inhibition of renal tubular transport, thereby reducing Imipenem's clearance rate.
  • Pharmacodynamic Effect (CNS Risk): The co-administration of Ganciclovir or certain anticonvulsants is documented to increase the potential for central nervous system excitability, particularly seizures.

No clinically significant interactions with food, alcohol, or dietary supplements are explicitly documented in official regulatory prescribing information.

Mechanism of Action

The action of Younam, a combination of Imipenem and Cilastatin, is defined by a dual mechanism: microbial target inhibition and molecular preservation.

Direct Mechanism: Irreversible Blockade of Bacterial Cell Wall Synthesis

This core domain details how Imipenem acts by targeting and permanently inhibiting Penicillin-Binding Proteins (PBPs), the essential enzymes responsible for peptidoglycan cross-linking. This irreversible inhibition halts the microbe's structural construction, triggering an autolytic cascade that results in osmotic lysis and microbial cell death.


Protective Mechanism: Sustaining Active Imipenem Concentration

This protective component involves Cilastatin, which acts to prevent the breakdown of the primary drug by the human enzyme Renal Dehydropeptidase-I (DHP-I) in the kidney. By acting as a competitive inhibitor of DHP-I, Cilastatin ensures that a high, sustained concentration of active, non-metabolized Imipenem remains available in the systemic circulation. This protection acts to sustain the time above the minimum inhibitory concentration (T>MIC), which is correlated with the duration required for the bactericidal mechanism.


Mechanistic Constraints: Enzyme and Barrier Defenses

The mechanism is constrained when bacteria employ defenses, such as the production of inactivating enzymes called carbapenemases, or when they structurally prevent drug entry by reducing outer membrane permeability. These microbial strategies directly override Imipenem's PBP-targeting mechanism, resulting in the inhibition of the bactericidal cascade.

Dosage and Administration Information

Younam is a fixed-dose combination product containing Imipenem and Cilastatin, and its administration is strictly governed by prescribing requirements. The medicine is supplied as a sterile powder which must undergo reconstitution and subsequent dilution before use. The authorized way to deliver the medication is exclusively through Intravenous (IV) infusion in a supervised clinical setting.

The standard adult usage pattern involves a total daily dose typically ranging from 1 g up to a maximum of 4 g of the combination, administered in equally divided doses. For patients with typical kidney function, this regimen requires doses to be scheduled at regular fixed intervals, commonly every 6 hours or every 8 hours. The administration must follow a controlled speed requirement: doses of 500 mg or less are infused over 20 to 30 minutes, while larger doses are administered over a longer duration, generally 40 to 60 minutes.

A critical procedural rule mandates dose reduction for adult patients with renal impairment (creatinine clearance < 90 mL/min), based on specific adjustment protocols. For patients undergoing hemodialysis, the drug is administered only after the dialysis session to account for the clearance of the drug. The duration of the treatment course is generally short-term, typically ranging between 4 and 14 days, dependent on the clinical context.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Younam (Imipenem/Cilastatin)

The research evidence for Younam is derived from a body of clinical trials and observational studies that was studied for severe bacterial infections. These studies described patterns observed in specific patient populations under controlled conditions.

Evidence for Use in Complicated Intra-abdominal Infections (cIAI) and Complicated Urinary Tract Infections (cUTI)

Research has been conducted to evaluate Imipenem/Cilastatin in research contexts for severe, complicated infections inside the body, particularly in the abdomen and urinary tract. These include both Randomized Controlled Trials (RCTs) and various observational studies focused on hospitalized adults.

Research has explored outcomes related to clinical response and the microbiological clearance rate, which measured whether the target bacteria could be cleared from the infection site. Findings reported in the original evidence base describe patterns of short-term microbiological clearance in patients whose infections was observed for susceptible bacterial strains.

Evidence for Use in Systemic Infections and Sepsis

The medication was observed in research for patients experiencing severe, body-wide systemic infections, such as bacterial septicemia (a form of bloodstream infection). Research in this area relies more heavily on large observational cohort studies involving critically ill patients.

These studies primarily focused on intermediate-term measures, such as all-cause mortality tracked at 28 or 30 days after the start of therapy, and researchers also monitored the time to microbiological clearance. Findings were observed to be heterogeneous across the research landscape due to the different causes and the complexity of illness severity in the septic patient population.

What is Still Uncertain in the Research Landscape

While the original evidence base is substantial, certain areas of research remain uncertain. As bacterial resistance has grown, the role of the original two-component formula against some newly emerged Multi-Drug Resistant (MDR) strains is less clear. Furthermore, data are still emerging regarding the specific role of the Cilastatin component in protecting the kidneys, with studies often categorized as having low certainty due to size and heterogeneity.

Key Studies & References

  1. Imipenem/Cilastatin - LiverTox: Clinical and Research Information on Drug-Induced Liver Injury (NIH)
  2. Official Imipenem and Cilastatin for Injection Labeling - U.S. Food and Drug Administration (FDA)

Frequently Asked Questions (FAQ)

Common questions about Younam (FAQ)


Q: What is the key difference between Younam and other drugs in its therapeutic class?

Younam is the brand name for the fixed combination of two active ingredients: the antibiotic Imipenem and the enzyme inhibitor Cilastatin. The official prescribing information indicates that Cilastatin is included to prevent the body from rapidly breaking down Imipenem, thereby inhibiting breakdown of the antibiotic by a specific kidney enzyme.


Q: How does the action of Younam compare to older treatments for the same condition?

As a type of Carbapenem beta-lactam antibiotic, official information notes that Imipenem is often reserved for treating severe infections due to its high potency and broad spectrum of activity against many types of bacteria. This broad coverage can be a key difference compared to many older antibiotics that may target fewer types of bacteria.


Q: Is it typical to experience mild nausea or headache when first starting Younam?

Official regulatory documents list nausea, vomiting, and headache among the common adverse reactions reported in patients receiving Imipenem/Cilastatin. These effects are generally recognized side effects of the medicine.


Q: Is it safe to consume alcohol while undergoing treatment with Younam?

Official regulatory prescribing information does not specifically list alcohol as a documented, restricted interaction with Imipenem/Cilastatin. The potential for the medicine to cause CNS effects like dizziness means combining it with alcohol may require caution, although no specific interaction is officially documented.


Q: Is Younam generally considered suitable for use by people over the age of 65?

Official eligibility maps indicate that the medicine is authorized for use in older adults. However, the official label includes a warning that this population may have an increased risk for Central Nervous System (CNS) adverse reactions, such as seizures or tremors, particularly if kidney function is reduced.


Q: Can individuals with existing kidney or liver problems use Younam?

Use in patients with impaired kidney function involves restrictions and may require specialized dosing based on clinical evaluation. Use in patients with existing liver problems is documented as requiring precaution, as severe hepatotoxicity (liver injury) has been reported rarely.


Q: What are the common signs of an interaction between Younam and other medications?

Interactions documented in the regulatory label often relate to an increased risk of Central Nervous System (CNS) effects. Signs of potential interaction may include increased potential for seizures, sudden confusion, muscle twitching, or other uncontrolled movements.


Q: Is it described that Younam can cause changes in mood or anxiety?

Official product information notes that Central Nervous System (CNS) effects are possible, and specific symptoms like confusion are documented. Less common effects like anxiety or nervousness have also been reported, sometimes accompanying other documented CNS changes.


Q: Is Younam a generic drug or a brand-name medication?

Younam is a brand-name medication. The generic drug contained within it is the combination of Imipenem and Cilastatin.


Q: How long has Younam been officially approved by major regulatory bodies?

The Imipenem/Cilastatin combination was first approved for use by the U.S. FDA in 1985. The medicine has since been authorized for use for several decades.


Q: Is Younam used to manage symptoms or to address the underlying cause of a condition?

According to the mechanism of action described in official documents, Younam is primarily used to address the underlying cause of the condition. It works by having a bactericidal effect, meaning it directly kills the susceptible bacteria causing the infection.


Q: Are there any non-medicinal ingredients in Younam that commonly cause reactions?

The official product description lists ingredients such as sodium bicarbonate as a buffer, and the total sodium content is specified. The official label specifies this information for individuals with known sensitivities or dietary restrictions.


Q: Can Younam affect a person's energy levels or cause tiredness/fatigue?

Official safety information lists dizziness and unusual tiredness or weakness among the documented side effects of Imipenem/Cilastatin. These are documented Central Nervous System effects.


Q: How long does it usually take to notice the initial effects of Younam?

Pharmacological studies indicate that the active medicine reaches its peak concentration in the bloodstream very rapidly after intravenous infusion, typically within 20 to 60 minutes. However, a noticeable clinical improvement in symptoms will depend on the type and severity of the infection being treated.


Q: What is the typical timeline for reaching the full therapeutic effect of Younam?

Official dosage guidelines indicate that the full course of treatment usually ranges from 4 to 14 days, depending on the site and severity of the infection. The medicine is intended to be administered for the full prescribed duration to address the infection completely.


Q: Does official research data address the long-term safety of Younam?

Regulatory safety data primarily reflects the medicine's use during the short-term courses of therapy, which typically last less than two weeks. This medicine is generally used for acute, severe infections rather than long-term maintenance.


Q: Is Younam classified as a controlled substance in any major regions?

No, Imipenem/Cilastatin is classified by regulatory authorities as a Carbapenem beta-lactam antibiotic and is not categorized as a controlled substance.


Q: What is the expected experience if a dose of Younam is missed?

The official label addresses that skipping doses or discontinuing treatment early may reduce the medicine's effectiveness and increase the potential for drug-resistant bacteria to develop.


Q: Are there any specific safety warnings for operating machinery while taking Younam?

Due to the documented risk of Central Nervous System effects, including dizziness, confusion, or seizures, the official label advises caution regarding activities requiring mental alertness, such as driving or operating heavy machinery.


Q: Does Younam affect blood sugar levels or diabetes management?

The official product information does not document a general interaction with blood sugar levels. However, clinical studies have included the use of this medicine in patients with diabetes for treating complicated infections.

How should Younam be stored and disposed of?

Official Storage and Disposal Requirements for Younam

This section outlines the formal requirements for storing and disposing of Younam, based strictly on official regulatory labeling.

Requirement Area Official Instruction
Temperature & Protection Store below 25 C (or 30 C). Protect from light and moisture. Do not refrigerate or freeze.
Packaging & Handling Keep the medicine in the original, tightly closed container until use.
Child Safety Always keep this medicine out of the sight and reach of children.
Disposal Rules Do not dispose of unused or expired Younam in household waste or via wastewater (flushing). Return the product to a pharmacy or authorized collection point for proper disposal, as required by local pharmaceutical waste regulations.

These statements define the necessary environmental and handling conditions to maintain the product's stability and integrity throughout its shelf-life, and ensure safe management of unused medicine.

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

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