Цефепим

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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 Цефепим

Quick Facts

Property Description
Active Ingredient Cefepime hydrochloride (INN)
Form Sterile powder for injection (requires mixing)
Pharmacological Class Fourth-Generation Cephalosporin (Antibiotic)
Common Purpose Treatment of severe bacterial infections
Origin Semi-synthetic (Man-made)

What Type of Medicine is Cefepime? (Definition & Classification)

Cefepime (Цефепим) is a potent, injectable medication classified as a fourth-generation cephalosporin antibiotic. It belongs to the broader beta-lactam class of antimicrobials, which are widely used to treat serious bacterial infections, primarily in hospital settings. The active ingredient is Cefepime hydrochloride.

Pharmacological studies have clinically recognized Cefepime for its robust activity against many problematic strains of bacteria, including those resistant to earlier cephalosporin drugs. Its broad-spectrum nature is highly effective against a variety of organisms, including those resistant to third-generation cephalosporins. Its primary clinical distinction lies in its use in cases where immediate, broad-spectrum coverage is essential, such as managing infections in high-risk patients.


How Does Cefepime Fight Bacteria? (High-Level Purpose)

Cefepime works by directly killing susceptible bacteria, making it a bactericidal antibiotic. It achieves this by disrupting the bacteria's ability to build and maintain its outer protective layer, known as the cell wall.

Cefepime rapidly targets and binds to specific proteins in the bacterial wall, causing the structure to fail. This leads directly to the breakdown and death of the cell. This medication is recognized for its critical antimicrobial activity. Its key advantage is its stability against common bacterial defense mechanisms, making it a preferred option for treating multidrug-resistant pathogens.


What is Cefepime Made Of and How is it Given? (Form & Composition)

Cefepime is supplied as a sterile, dry powder (Cefepime hydrochloride) that must be reconstituted with a sterile liquid before administration. This medication must be given by injection—either intravenously (into a vein) or intramuscularly (into a muscle). The injectable route is essential because the drug is poorly absorbed by the digestive system, which means it would not be effective if taken orally. The formulation, often including an excipient like L-arginine, ensures the powder dissolves rapidly and the resulting solution is suitable for injection.

What side effects are possible with Цефепим?

Possible Side Effects and Safety Information

This section summarizes adverse reactions and safety considerations for Cefepime as documented in official government regulatory sources.


Serious and Clinically Significant Risks

Cefepime carries documented warnings for several serious risks. Hypersensitivity reactions, including anaphylaxis (a life-threatening allergic reaction), are a critical concern, especially in patients with known allergies to penicillins or other beta-lactam antibiotics. Neurotoxicity, including encephalopathy, seizures, coma, and nonconvulsive status epilepticus, is a major risk, particularly in individuals with renal impairment (poor kidney function) who do not receive the necessary dose adjustment. Clostridioides difficile-associated diarrhea (CDAD), which can range from mild to life-threatening colitis, may occur during or after treatment.


Adverse Reactions by Frequency

Classification Examples of Reactions
Common (1% to <10%) Positive Coombs test, Diarrhea, Rash, Injection site reactions (pain/inflammation), Elevated liver enzymes (ALT/AST).
Uncommon (0.1% to <1%) Oral candidiasis, Vaginitis, Pruritus, Headache, Nausea, Vomiting, Fever, Neutropenia, Thrombocytopenia.
Rare (<0.1%) Anaphylactic reactions, Seizures, Angioedema.

Safety Restrictions and Monitoring

Dose adjustment is mandatory for patients with impaired renal function (kidney disease) to prevent the accumulation of Cefepime, which directly reduces the risk of serious neurotoxicity. Caution is required when the drug is co-administered with other nephrotoxic drugs (medicines toxic to the kidneys), such as aminoglycosides, due to a heightened risk of kidney damage. The medicine may also cause a false-positive direct Coombs test.

Overdose and Emergency Response

Overdose and When to Seek Help

Official regulatory documentation defines Cefepime overdose primarily by the risk of serious neurotoxicity due to drug accumulation. Manifestations of overdose may include central nervous system (CNS) effects such as encephalopathy (confusion, stupor, coma), myoclonus (involuntary muscle movements), and seizures, including nonconvulsive status epilepticus.


Required Emergency Actions

Action/Condition Official Regulatory Statement
When to Seek Help Seek immediate medical attention if neurological signs such as altered mental status or seizures are observed [FDA].
Initial Response Cefepime must be discontinued upon suspicion or confirmation of neurotoxicity [FDA/SmPC].
Supportive Management Management includes symptomatic and supportive treatment. Hemodialysis is documented as a procedure that aids in the removal of Cefepime from the body [FDA].

Population-Specific Considerations

The most frequent cause of severe neurotoxicity is Cefepime accumulation in patients with renal impairment who did not receive an appropriate dose adjustment. Geriatric patients are also at a higher risk for these severe neurological adverse reactions when concurrent renal insufficiency is present. No specific chemical antidote is known.

Therapeutic Uses of Цефепим

What Цефепим Treats: Main Uses and Benefits

Cefepime (Цефепим) is a fourth-generation cephalosporin antibiotic used in managing severe bacterial infections and is relevant for patients dealing with heightened systemic distress. Its use is considered relevant for managing serious diseases where broad antimicrobial action is appropriate. It is commonly applied when short-term symptomatic assistance is needed. It is considered relevant in clinical settings that involve acute or unstable symptom patterns, where additional symptomatic support is needed.

Cefepime is commonly used to treat severe infections of the lungs, skin, urinary tract, and abdomen.

Therapeutic Contexts and Symptom Management

Cefepime is relevant in the clinical context of managing systemic imbalance, such as sepsis and bacteremia, and conditions associated with acute or disruptive episodes, including severe pneumonia and complicated infections of the kidneys or abdominal cavity. It is applied across domains where additional symptomatic support is needed, particularly for immunocompromised patients with conditions marked by increased physiological stress, such as febrile neutropenia. The medication is commonly used across conditions presenting with acute episodes in both adults and pediatric patients (infants over two months).

This application helps address symptom clusters related to systemic imbalance, such as high fever and chills. It supports the patient during difficult episodes by easing distress and is considered relevant for managing infections caused by certain bacteria that exhibit resistance. This may assist with maintaining a sense of stability when symptoms are more noticeable, and contributes to easing the overall symptom load associated with these infections.


QuickFact Block

Quick Fact: Support for Symptoms Related to Systemic Imbalance Description
Symptom Cluster High, persistent fever and symptoms related to systemic imbalance
Common Scenarios Sepsis, severe pneumonia, febrile neutropenia
Symptomatic Benefit Contributes to easing the overall symptom load and supports the patient during episodes of heightened discomfort
Targeted Conditions Conditions characterized by periods of heightened symptoms

Regulatory References

  1. NIH MedlinePlus overview

Eligibility and Restrictions for Use

Eligibility Map: Who can and cannot use Цефепим — Official Regulatory Information


Eligibility Scope

Populations for whom use is allowed (as stated in label): Adults and children generally 2 months of age and older.

Populations for whom use is contraindicated: Цефепим is strictly contraindicated for patients with a documented history of immediate hypersensitivity reactions to Цефепим itself or to the cephalosporin class of antibiotics. It is also prohibited for those with a history of severe hypersensitivity (e.g., anaphylaxis) to any other beta-lactam antibacterial agents, such as penicillins or carbapenems.

Age-related eligibility rules: Safety and effectiveness have not been established in pediatric patients younger than 2 months of age. Older adult (geriatric) patients may use the medicine but often require dose consideration due to a higher likelihood of decreased kidney function.

Condition-specific eligibility rules:

  • Renal Impairment: Patients with impaired kidney function (Creatinine Clearance le 60 mL/min) must have their dose adjusted. Failure to do so significantly increases the risk of serious side effects, including neurotoxicity.
  • Pregnancy/Lactation: There are no adequate studies in pregnant women. Use is typically considered only if clearly needed and if the benefit to the mother outweighs the potential risk to the child. The drug is excreted in breast milk in low amounts, and caution is advised when administering to a nursing woman.

Connection to the Overall Eligibility Profile

The regulatory profile strictly defines who can and cannot use Цефепим primarily through absolute contraindications based on hypersensitivity to the drug or related antibiotic classes. Its use is further restricted by age (not established for infants under two months) and is highly constrained by kidney function. Patients with kidney impairment are required to have a mandatory dose adjustment to manage the risk of serious neurological events, establishing a clear line between eligible and restricted use based on clinical state.

What should I know about interactions with other medicines?

Interactions with Other Medicines and Products

This medication’s official interaction profile is structured around two key domains: the increased risk of toxicity when combined with certain drugs, and interference with specific laboratory tests.

Interacting Product Category Official Constraint / Risk Statement
Aminoglycosides (e.g., Amikacin) Concomitant use increases the potential for nephrotoxicity (kidney damage) and ototoxicity (auditory damage).
Potent Diuretics (e.g., Furosemide) Nephrotoxicity has been reported following the co-administration of other cephalosporins with potent diuretics.
Laboratory Glucose Tests The drug may cause a false-positive reaction for glucose in the urine when using copper-reduction methods (e.g., Clinitest tablets).

The regulatory documentation emphasizes that the co-administration of this drug with Aminoglycosides or potent Diuretics necessitates close monitoring of renal function due to the increased risk of organ-specific adverse effects. To avoid misleading test results, official labeling mandates a procedural restriction for urine glucose testing, requiring the use of methods based on enzymatic glucose oxidase reactions. The interaction information does not typically involve dose-timing or spacing requirements but focuses on the increased need for patient monitoring and procedural changes during combination therapy.

Mechanism of Action

Direct Inhibition of Bacterial Cell Wall Synthesis

Цефепим (Cefepime) works by acting on the cell's structure. Its mechanism centers on the irreversible inactivation of bacterial enzymes called Penicillin-Binding Proteins (PBPs), which are critical for the final, cross-linking step of peptidoglycan synthesis—the process that builds the rigid bacterial cell wall. Cefepime specifically blocks this step by forming a stable, covalent bond with the PBP active site, preventing the bacteria from completing or maintaining their protective outer structure.


Activation of Rapid Cellular Lysis

The inhibition of PBP activity immediately results in structural defects of the cell wall, preventing it from containing the high internal osmotic pressure. This structural failure causes the bacterial cell to rapidly swell and physically rupture, a process known as cell lysis. This defines the drug's mechanism as bactericidal, leading to the physical destruction of susceptible microbial cells.

Dosage and Administration Information

Cefepime is a powerful fourth-generation cephalosporin antibiotic administered only by injection, either intravenously (IV) or intramuscularly (IM), and is not available in oral form. It is typically administered by a healthcare professional in a hospital or clinic setting.

Administration and Dosage

The dosage of Cefepime depends on the specific type and severity of the infection, the patient's age and weight, and particularly their kidney function (Creatinine Clearance, or CrCL).

  • Intravenous (IV) Infusion: This is the most common route of administration. The drug is usually infused over approximately 30 minutes. In some severe infections or for specific types of bacteria like Pseudomonas aeruginosa, prolonged infusion times (e.g., 3 hours) may be used under a physician's guidance.
  • Intramuscular (IM) Injection: This route is generally reserved for mild to moderate uncomplicated or complicated urinary tract infections.

Common Adult Dosage Schedule (CrCL > 60 mL/min):

Type of Infection Dose (IV/IM) Frequency Duration (Days)
Moderate to Severe Pneumonia 1–2 g IV Every 8–12 hours 10
Empiric Therapy for Febrile Neutropenia 2 g IV Every 8 hours 7 (or until neutropenia resolves)
Complicated Intra-abdominal Infections (with metronidazole) 2 g IV Every 8–12 hours 7–10

Important Considerations

Finish the full course of therapy exactly as prescribed, even if symptoms improve quickly, to ensure the infection is fully treated and to prevent the development of drug-resistant bacteria. Do not stop or skip doses without consulting your doctor. Dosage adjustments are required for patients with renal impairment (CrCL ≤ 60 mL/min) to prevent potential serious adverse reactions, including neurotoxicity. Your healthcare provider will monitor your kidney function and adjust the dose accordingly.

Recent Clinical Evidence

Cefepime, a fourth-generation cephalosporin, continues to be a cornerstone in the treatment of serious bacterial infections, including complicated urinary tract infections (cUTIs), hospital-acquired pneumonia (HAP), ventilator-associated pneumonia (VAP), and febrile neutropenia. Recent clinical evidence and updated guidance emphasize strategies to optimize its efficacy in the face of increasing antimicrobial resistance.


Optimization of Administration

To improve the drug's effectiveness against challenging pathogens like Pseudomonas aeruginosa, infectious disease guidelines often recommend extended-infusion therapy (e.g., infusion over 3-4 hours rather than 30 minutes) to ensure that the drug concentration remains above the bacterial minimum inhibitory concentration (MIC) for a longer period. This approach is particularly relevant for critically ill patients.


Novel Combination Therapies

Significant research focuses on new combinations to overcome beta-lactamase-mediated resistance, which can render cefepime ineffective. Two notable examples in clinical development are:

  • Cefepime-Enmetazobactam: This combination is an established option in some regions for treating complicated UTIs and HAP/VAP, including those caused by certain extended-spectrum beta-lactamase (ESBL)-producing bacteria. Clinical trials demonstrated superiority over piperacillin-tazobactam in achieving favorable outcomes for cUTIs.
  • Cefepime-Taniborbactam: Clinical data has demonstrated that this agent is effective for cUTIs, including acute pyelonephritis, and shows promising activity against a very broad range of multi-drug resistant (MDR) Gram-negative bacteria. This combination is currently undergoing regulatory review in various regions.

These combination drugs aim to preserve cefepime's activity and offer carbapenem-sparing options for infections caused by resistant organisms.

Frequently Asked Questions (FAQ)

Common questions about Цефепим (FAQ)


Q: Can Цефепим affect the kidneys or liver?

Official product information indicates that the drug is mainly cleared by the kidneys. If kidney function is impaired and the dose isn't adjusted, there is a serious risk of neurotoxicity, which can include seizures or encephalopathy. Additionally, elevated liver enzymes ( ALT and AST), which are markers of liver function, have been reported as a common adverse reaction.


Q: Is Цефепим safe for use in children and infants?

The safety and effectiveness of Цефепим have been established for pediatric patients 2 months of age and older. However, official regulatory documents state that the use of this drug is not established for infants younger than 2 months of age.


Q: Are there any specific medical tests required before starting Цефепим?

Because the dosage must be adjusted for patients with impaired kidney function (renal impairment), official guidance states that monitoring kidney function is required throughout the treatment. This is done to help prevent the accumulation of the drug, which is associated with serious neurological side effects.


Q: What should I tell my healthcare provider about my medical history before starting Цефепим?

Official patient counseling information highlights the importance of discussing your medical history with a healthcare professional. Regulatory documents identify prior history of hypersensitivity (allergic reactions) to beta-lactam antibiotics, any existing kidney impairment, and concurrent use of certain medications like Aminoglycosides or potent diuretics as key information to share.


Q: How is the safety of Цефепим described for patients with a history of gut inflammation?

Like many antibiotics, Цефепим carries a warning for extitClostridioides difficile-associated diarrhea ( CDAD), a serious type of secondary infection that can occur during or after treatment. The product information notes that colitis (gut inflammation) is a disease interaction to be considered by the prescribing professional.


Q: Can Цефепим affect blood sugar levels in people with diabetes?

Official regulatory information indicates that Цефепим can cause a false-positive result for glucose in the urine when tested using certain copper-reduction methods (like Clinitest tablets). To avoid inaccurate readings, official labeling specifies that tests based on enzymatic glucose oxidase reactions should be used. No statement is made regarding the drug's effect on actual blood sugar levels.


Q: How does Цефепим differ from penicillin-based antibiotics?

Цефепим is classified as a fourth-generation cephalosporin antibiotic. While both cephalosporins and penicillins belong to the wider beta-lactam class of drugs, the cephalosporin class is distinct from the penicillin class, often due to differences in their chemical structure.


Q: Can Цефепим treat viral infections?

No, Цефепим is an antibacterial drug. The official regulatory indications specify that it is intended for treating infections that are proven or strongly suspected to be caused by susceptible bacteria.


Q: Is it normal to feel tired or dizzy after receiving Цефепим?

While not listed as common side effects in the initial clinical trials, official postmarketing reports have included instances of dizziness and a general feeling of tiredness or weakness. The regulatory documents note that these effects were reported in the postmarketing setting.


Q: What are the signs of an allergic reaction to Цефепим?

Official patient counseling information describes key signs of a serious allergic reaction, which include hives, rash, swelling of the face, lips, or tongue, or difficulty breathing. Hypersensitivity reactions, including life-threatening anaphylaxis, are a documented safety risk associated with the drug.


Q: Does Цефепим interact with heart or blood pressure medications?

Official interaction documents state that Цефепим interacts with potent diuretics (such as Furosemide), which are sometimes prescribed for high blood pressure or heart conditions. Using the two together is associated with an increased potential for nephrotoxicity, meaning kidney damage.


Q: How long does Цефепим stay in the body after the last dose?

In healthy adults with normal kidney function, the elimination half-life of Цефепим is approximately 2 hours. This is the time it takes for the concentration of the drug in the body to be reduced by half. The majority of the drug (about 85%) is excreted unchanged from the body via the urine.


Q: Is there a generic version of Цефепим, and is it the same as the brand name?

Yes, the active ingredient is Cefepime Hydrochloride, and it is available in generic form as Cefepime for Injection. The original brand name formulation is MAXIPIME. Both generic and brand name versions contain the same active ingredient.


Q: Why do doctors sometimes switch patients from another antibiotic to Цефепим?

According to official usage guidance, the decision to modify or switch antibiotic therapy is based on clinical and laboratory findings. This often occurs when results regarding the susceptibility of the bacteria are known, or if the initial treatment is not providing adequate coverage against the identified pathogen.


Q: What are the official recommendations regarding the use of Цефепим with vaccines?

Regulatory summaries indicate that co-administration with certain products is not recommended. This includes intravesical BCG for bladder carcinoma and some live bacterial vaccines, such as those for cholera and typhoid. These restrictions are in place due to potential concerns about safety or reduced vaccine efficacy.


Q: Is there any evidence about the long-term safety profile of Цефепим?

Official regulatory information addresses long-term use by cautioning that prolonged use of Цефепим, like other antibiotics, may lead to the overgrowth of non-susceptible microorganisms (known as superinfection). Because of this risk, the label specifies that repeated evaluation of the patient's condition is necessary during therapy.


Q: What should I do if my infection symptoms do not improve after a few days of taking Цефепим?

Official guidance indicates that a patient's condition requires repeated evaluation by a healthcare provider if symptoms do not improve after a few days. Failure of the infection to respond may indicate the bacteria is not susceptible to the drug, or that a secondary infection (superinfection) has developed.


How should Цефепим be stored and disposed of?

Storage and Disposal Requirements for Cefepime

The storage and disposal of Cefepime (as a sterile powder for injection) are subject to official regulatory requirements to ensure product stability and safety.

Storage Conditions

The dry powder must be stored at Controlled Room Temperature (20°C to 25°C / 68°F to 77°F) and protected from light.

Once reconstituted, the solution's stability is time-dependent on the storage temperature:

Storage Environment Maximum Stability Period
Refrigeration (2°C to 8°C) Up to 7 days
Controlled Room Temperature Up to 24 hours

Thawed solutions must not be refrozen, and containers should be handled with care. The medication must be stored out of the sight and reach of children.

Disposal Mandates

Unused or expired Cefepime must be disposed of in accordance with applicable governmental regulations. The product must not be released into the environment, which includes avoiding disposal into drains, sewers, or waterways.

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

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