Avycaz

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Avycaz

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Medically reviewed

Laura Arias

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 Avycaz

Property Description
Active Ingredients Ceftazidime, Avibactam
Form Powder for injection (reconstituted for IV infusion)
Pharmacological Class Cephalosporin and beta-lactamase inhibitor combination
Origin Synthetic
General Purpose Management of severe drug-resistant bacterial infections

Avycaz (Ceftazidime and Avibactam) is a synthetic anti-infective agent that is administered as a sterile powder for injection prepared for intravenous (IV) infusion. It is classified as a fixed-dose combination product belonging to the pharmacological class of a beta-lactam antibacterial (a cephalosporin) and a novel beta-lactamase inhibitor combination. This prescription-only medicine is intended for use in specialized settings to manage serious infections caused by designated susceptible Gram-negative organisms.

What Are the Active Ingredients and General Purpose?

The composition of Avycaz contains two distinct active ingredients: the antibiotic Ceftazidime and the protective compound Avibactam. Ceftazidime is the core cephalosporin antibiotic component, responsible for the bactericidal effect by interfering with the synthesis of the bacterial cell wall. The general purpose of this medicine is to provide an effective therapeutic option against certain severe bacterial infections, specifically where the pathogens exhibit resistance to established treatments. Pharmacological studies have confirmed the synergistic activity of this combination against multidrug-resistant pathogens.

How Does This Combination Differ from Standard Antibiotics?

This product is fundamentally different from standard, single-agent antibiotics because the inclusion of Avibactam creates a protective, synergistic action critical for overcoming bacterial defenses. Avibactam functions as a potent beta-lactamase inhibitor, neutralizing the bacterial enzymes that typically degrade and inactivate the antibiotic, thereby shielding Ceftazidime from destruction. This mechanism allows the Ceftazidime component to remain potent and exert its full effect, which is crucial for managing contemporary drug-resistant bacteria that threaten older, non-protected antibiotics.

What side effects are possible with Avycaz?

Possible Side Effects and Safety Information

The safety profile of Avycaz is defined by adverse reactions officially documented and classified by regulatory authorities. These reactions are typically categorized by the frequency of occurrence and the physiological system affected.

Frequency-Classified Adverse Reactions

The most frequently reported effects, classified as Common (affecting ge 1/100 to < 1/10 patients), include Diarrhea, Nausea, Vomiting, Headache, Fever, and Dizziness. Laboratory findings often included Eosinophilia, Thrombocytopenia, and increases in liver enzymes (ALT, AST) and blood creatinine.

Reactions classified as Uncommon (affecting ge 1/1,000 to < 1/100 patients) include fungal infections such as Candidiasis, localized injection site reactions, rash, and pruritus. More significant reactions, also listed as Uncommon, include Seizures, Encephalopathy, Tremor, Myoclonus, and Clostridioides difficile-associated diarrhea (CDAD).

Serious Safety Considerations

Serious Adverse Reactions highlighted in regulatory documents include severe Hypersensitivity Reactions, which can include anaphylaxis, and severe Neurotoxicity. The neurological adverse reactions, such as Seizures and Encephalopathy, are associated with excessive systemic exposure, particularly in patients with renal impairment where the drug's clearance is reduced.

Regulatory Restrictions

Avycaz is contraindicated in individuals with a history of severe hypersensitivity to Ceftazidime, Avibactam, any other cephalosporins, or other beta-lactam antibacterial agents. This restriction prevents use where a prior severe allergic reaction has been documented.

Overdose and Emergency Response

Overdose and When to Seek Help

The official regulatory documents define the overdose profile of Avycaz based on the potential for central nervous system (CNS) toxicity resulting from excessive drug accumulation. This accumulation is primarily a concern in patients with reduced kidney function where appropriate dosage adjustments are not implemented.

Category Official Regulatory Statement
Documented Manifestations Neurological events, including seizures (convulsions), encephalopathy, myoclonia, tremor, asterixis, and coma are officially documented sequelae.
Risk Factor Renal impairment significantly increases the risk of these severe neurological events if the regimen is not adjusted for the degree of reduced kidney function.

Immediate Action and Management

Immediate medical attention is required upon suspicion of an overdose or the appearance of any CNS-related reactions. The combination is classified as being without a specific antidote. Management focuses on supportive measures and removing the drug from the bloodstream. Both active components, ceftazidime and avibactam, are officially documented as being removable through haemodialysis (hemodialysis). This procedural step is described as an available measure to reduce systemic concentrations in an overdose situation.

Therapeutic Uses of Avycaz

What Avycaz Treats: Main Uses and Benefits

This specialized medication is commonly used for conditions presenting with systemic or localized discomfort, focusing on managing severe, complicated infections of the urinary tract, abdomen, and lungs (pneumonia acquired in the hospital or while on a ventilator). It is considered relevant when the causative Gram-negative bacteria are suspected to be multidrug-resistant, where other established options may not be appropriate.

Its use is relevant for managing these severe infections, helping to address symptom clusters related to systemic imbalance, such as persistent high fever and chills. It is often applied in clinical settings that involve acute or unstable symptom patterns, such as the Intensive Care Unit (ICU), to provide appropriate symptomatic support. In managing these conditions, this treatment contributes to improved comfort during periods of heightened symptoms and assists with maintaining functional stability.

“It is often applied to assist with difficult episodes.”


Quick Fact: Relief for Heightened Symptom Burden

The medication is utilized when infections cause symptoms that create noticeable physiological strain and symptoms related to systemic imbalance, assisting with managing the associated discomfort in acute care settings.


Eligibility and Restrictions for Use

The official regulatory guidelines for Avycaz define eligibility based on patient history, age, and organ function, strictly governing who may and may not receive the medicine.

Eligibility Scope

Classification Population or Condition
Contraindicated Patients with known serious hypersensitivity to ceftazidime, avibactam, or any cephalosporin-class antibacterial agents [1.7]
Allowed Adults (18 years) and Pediatric patients at least 31 weeks gestational age [2.1]
Conditional Use Patients with renal impairment (Creatinine Clearance leq 50 mL/ min for adults) [2.2, 1.2]
Limited Data Pediatric patients younger than 2 years of age with renal impairment [2.1]
Caution Required Patients with a history of non-severe penicillin allergy [1.4]

Official Eligibility Rules

Use is prohibited for any patient with a documented history of a severe allergic reaction to the drug components or any cephalosporin. For adults and children, eligibility begins at 31 weeks gestational age for approved uses. Treatment is conditional upon renal function; patients with kidney impairment must have their dosage determined by their Creatinine Clearance ( CrCl), as documented by the regulator [2.2]. Use in pregnancy and lactation is permitted only if clearly needed, due to limited human data [1.2]. The use of Avycaz in young children (under 2 years) with renal impairment has insufficient information to recommend a safe dosing regimen, restricting its use in this population [2.1].

What should I know about interactions with other medicines?

The interaction profile for Avycaz (Ceftazidime and Avibactam) is focused primarily on substances that affect how the active ingredients are cleared from the body. Official regulatory documents do not list any medicinal products that are formally contraindicated for co-administration due to interaction risk.

Transporter-Mediated and Pharmacodynamic Interactions

Interacting Substance/Class Official Interaction Description Classification
Probenecid Co-administration reduces the renal clearance of both ceftazidime and avibactam, leading to a formal increase in their plasma concentrations. Pharmacokinetic
Nephrotoxic Agents (e.g., Aminoglycosides) Concurrent use may potentially increase the risk of adversely affected renal function. Pharmacodynamic

Neither ceftazidime nor avibactam is significantly metabolized by Cytochrome P450 (CYP) enzymes, and official labeling states there is no clinically significant interaction with food. The medication's reliance on renal excretion means that its clearance is substantially reduced in patients with existing renal impairment. For patients receiving intermittent hemodialysis, the regulatory constraint is to administer Avycaz only after the completion of the dialysis session, as the procedure removes the active drug from the system.

Mechanism of Action

Synergistic Disruption of Bacterial Structural Integrity

Avycaz exerts its bactericidal effect through a coordinated synergistic mechanism involving two distinct compounds. The core action is the inhibition of bacterial Penicillin-Binding Proteins (PBPs), primarily PBP3, by the Ceftazidime component. These enzymes are crucial for constructing the structural integrity of the bacterial cell wall (the peptidoglycan layer). By binding covalently and inactivating the PBPs, Ceftazidime prevents the final essential cross-linking step, which triggers cellular instability and the subsequent lysis and terminal cellular compromise.

Enzymatic Protection and Mechanism Expression

The second component, Avibactam, functions as a highly specific, but reversible, inhibitor of key bacterial defense enzymes known as β-lactamases (Ambler Classes A, C, and certain D). Avibactam sequesters these enzymes, blocking the hydrolysis of the Ceftazidime β-lactam ring. This protective action allows the PBP-inhibitory function to be expressed in strains that are otherwise resistant, facilitating the necessary bactericidal cascade and resulting in the cellular clearance of the microbial component.

Molecular and Permeability-Based Limitations

The mechanism has biological boundaries defined by the molecular structure of Avibactam, which makes it inactive against Metallo-β-lactamases (MBLs). Furthermore, bacterial counter-mechanisms, such as overexpressed efflux pumps or mutations in cell membrane porins, can physically constrain the amount of drug that reaches the intracellular PBP targets, thereby limiting the engagement of the mechanism. This failure to achieve PBP-binding prevents the cellular lysis cascade and results in the sustained viability of the target microbe.

Dosage and Administration Information

How to Use Avycaz

Avycaz (ceftazidime and avibactam) is a combination medication for severe bacterial infections whose usage protocol is strictly defined, focusing on administration method, dosing schedule, and necessary adjustments.


Administration Scope

Feature Official Instruction
Route of administration Administered strictly by Intravenous (IV) infusion only.
Standard Adult Dosing 2.5 grams (Ceftazidime 2 g / Avibactam 0.5 g) per dose, typically given Every 8 hours.
Dose Adjustment The dose and frequency must be adjusted for renal impairment based on the patient's estimated Creatinine Clearance (CrCl), with specific, reduced regimens mandated for lower CrCl values.
Infusion Timing The entire dose, including any adjusted dose, must be administered over a fixed 2-hour period.
Duration of Course Treatment duration ranges from 5 to 14 days, depending on the specific infection being treated. Complicated intra-abdominal infections (cIAI) are typically 5 to 14 days, while complicated urinary tract infections (cUTI) and pneumonia (HABP/VABP) are typically 7 to 14 days.
Pediatric Use Dosing is based on the patient's weight (mg/kg) for patients 3 months and older who have normal renal function.
Procedural Requirements The sterile powder must first be reconstituted and then further diluted prior to infusion. For cIAI, Avycaz must be co-administered with metronidazole.

Connection to the Overall Use Protocol

These official instructions define Avycaz as a high-control medication requiring precise preparation and administration within a supervised clinical environment. The protocol mandates a short-interval dosing frequency (q8h), a non-negotiable, fixed 2-hour infusion time, and obligatory adjustments based on the patient’s kidney function. This structured approach ensures adherence to the standardized use.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Avycaz

This overview summarizes the formal clinical research and studies that have been conducted to evaluate Avycaz, based on information reported by regulators and scientific literature. The purpose is to describe the types of research available, what they measured, and what remains unclear, without offering any clinical advice or interpretation.


Evidence for Complicated Urinary Tract Infections (cUTI)

The research landscape for complicated urinary tract infections, which includes kidney infections (pyelonephritis), primarily involves large-scale, short-term Randomized Controlled Trials (RCTs). These studies were designed to compare Avycaz against other established treatments. Researchers examined both adults and pediatric patients (including infants) in the study populations.

In these trials, studies monitored outcomes related to both symptom resolution and microbiological clearance in patients with cUTI and pyelonephritis. Studies monitored patterns of change in symptoms during the defined treatment period and reported favorable clinical and microbiological response rates at a specific follow-up visit after treatment completion.


Evidence for Complicated Intra-abdominal Infections (cIAI)

The evidence for treating complicated infections inside the abdomen relies on key Randomized Controlled Trials (RCTs) where Avycaz (used in combination with another antibiotic called metronidazole) was studied against standard regimens. These studies monitored outcomes related to physical discomfort and systemic imbalance in hospitalized adults and pediatric patients.

Studies monitored key outcomes, including the rate of a favorable clinical response (resolution of infection signs) at a post-treatment assessment visit and the patient’s 28-day all-cause mortality. Studies explored clinical response rates in the Avycaz groups. Research also described the rates at which microbiological clearance was observed.


Long-term Follow-up and Research Gaps

The majority of key studies for Avycaz were short-term and focused on acute infection outcomes, such as clinical response at the end of treatment or 28-day mortality. Therefore, the long-term effects are not fully established, and there is limited information regarding the durability of the clinical or microbiological response months after treatment has been completed.

Data for certain groups, such as those with severe or end-stage kidney disease, remain insufficient because these groups were often excluded from the initial trials. The certainty of evidence varies across studies, particularly for infections due to highly resistant organisms, where the reliance on non-randomized data means that conclusions are drawn with lower certainty. Research is ongoing to further contribute to the broader evidence landscape and fill these knowledge gaps.

Key Studies & References

  1. Ceftazidime-Avibactam Therapy Versus Ceftazidime-Avibactam-Based Combination Therapy in Patients With Carbapenem-Resistant Gram-Negative Pathogens: A Meta-Analysis

Frequently Asked Questions (FAQ)

Common questions about Avycaz (FAQ)


Q: Is Avycaz considered a strong antibiotic?

Official information indicates that Avycaz is specifically approved for treating serious infections caused by certain multi-drug resistant (MDR) bacteria for which treatment options may be limited. Its intended use is generally reserved for situations where a potent agent is necessary to overcome bacterial resistance.


Q: Does Avycaz cause diarrhea or stomach problems?

Regulatory documents list diarrhea, nausea, and vomiting as common side effects. Like most antibiotics, Avycaz is associated with a risk of developing Clostridioides difficile-associated diarrhea (CDAD), which is a serious condition that can be potentially life-threatening.


Q: Is it normal to feel dizzy or lightheaded while on Avycaz?

Dizziness is listed as a common adverse reaction in official product information. More serious, uncommon effects involving the nervous system, such as seizures or encephalopathy (a disorder affecting brain function), have been reported, particularly in patients with reduced kidney function.


Q: What are the signs of a severe side effect from Avycaz that I should watch for?

Serious adverse reactions highlighted in regulatory documents include signs of severe allergic reactions (like swelling of the face or throat, or a serious skin rash), signs of neurotoxicity (such as confusion, tremors, or muscle twitching), and severe, non-stop diarrhea that might be bloody. If any severe signs appear, it is important to contact a healthcare professional right away.


Q: Are there any common tests or monitoring needed while receiving Avycaz?

Monitoring of kidney function may be necessary during treatment, particularly for patients with reduced function, as the dosage needs to be adjusted based on their creatinine clearance. Healthcare staff also typically observe patients for potential nervous system side effects.


Q: Does Avycaz interact with common pain relievers like Tylenol or Advil?

The regulatory label advises caution when Avycaz is used concurrently with nephrotoxic agents (drugs that could potentially harm the kidneys), a class that includes some NSAIDs (like Advil/Ibuprofen). The label focuses on known nephrotoxic agents; acetaminophen is not specifically mentioned as a known interacting substance.


Q: Does Avycaz interact with common acid reflux medications like omeprazole?

Regulatory studies show that the active ingredients in Avycaz are not significantly metabolized by the CYP enzymes (a group of liver enzymes that process many drugs). For this reason, official information suggests that the potential for a clinically significant interaction with many acid reflux medications is generally considered low.


Q: Is it possible to develop a yeast infection (thrush) while on Avycaz?

Fungal infections like Candidiasis (yeast infections) are listed in regulatory documents as uncommon adverse reactions. As with most broad-spectrum antibiotics, there is a risk of developing a yeast infection, which can sometimes manifest as oral thrush.


Q: How is Avycaz different from other antibiotics used for resistant infections?

Avycaz is a combination medicine that pairs an antibiotic (ceftazidime, a cephalosporin) with a beta-lactamase inhibitor (avibactam). The addition of avibactam is key because it protects the ceftazidime from being destroyed by certain bacterial defense enzymes, allowing the antibiotic to remain effective against resistant bacteria.


Q: Does Avycaz treat 'superbugs' or highly resistant bacteria?

Official documents confirm that Avycaz is used to treat infections caused by specific multi-drug resistant Gram-negative bacteria. This includes organisms that produce certain bacterial enzymes like ESBLs (Extended-Spectrum beta-Lactamases) and KPC (Klebsiella pneumoniae Carbapenemase).


Q: Does Avycaz have a generic version available?

No, according to the official FDA Approved Drug Products records, a generic version of Avycaz (ceftazidime and avibactam) is not currently available.


Q: Is Avycaz a penicillin-type drug?

No, Avycaz is not a penicillin; the antibiotic component, ceftazidime, belongs to the cephalosporin class of antibiotics. However, because both are beta-lactam drugs, Avycaz is contraindicated (prohibited) for anyone with a history of a severe allergy to penicillin or any beta-lactam antibacterial agent.


Q: What is the difference between Avycaz and a carbapenem antibiotic?

Avycaz is chemically classified as a cephalosporin combination, whereas carbapenems (such as meropenem) are a separate, distinct class of beta-lactam antibiotics. Both types of medications are used for serious resistant infections, and their use is often compared in official treatment guidelines.


Q: Does Avycaz cause headaches or migraines?

Headache is listed as a common adverse reaction in regulatory safety information. However, the official documents do not specifically state whether the drug is a known cause of migraines.


Q: Do older adults react differently to Avycaz compared to younger patients?

The overall safety profile is similar across age groups, but regulatory documents note that older patients are more likely to have reduced kidney function. Since Avycaz is cleared by the kidneys, dosage adjustments may be required for older adults to prevent high drug levels.


Q: Can people with diabetes safely use Avycaz?

Official patient information notes that Avycaz, like other cephalosporin antibiotics, may cause a false-positive result when testing for sugar in the urine. It may be important for individuals with diabetes to inform their healthcare team that they are receiving Avycaz if they are undergoing certain urine tests for sugar.


Q: Can Avycaz be used during pregnancy?

Official labeling states that use during pregnancy is conditional; it should only occur if the potential benefit is judged to justify the potential risk to the fetus. This caution is advised due to limited human data and because the antibiotic component is known to cross the placenta.


Q: Why is Avycaz often used as a last resort for infections?

Regulatory guidance recommends reserving the use of Avycaz for infections caused by susceptible organisms when limited or no alternative antibacterial drugs are available. This approach is intended to help reduce the development of further drug-resistant bacteria in the overall population.


Q: Does Avycaz cause changes in taste?

Changes in taste (dysgeusia) and loss of taste (ageusia) have been reported as rare side effects associated with the medicine, according to clinical data reviewed by regulatory authorities.


Q: Is the rash sometimes linked to Avycaz dangerous?

A minor rash is listed as an uncommon side effect. However, the drug label highlights that Avycaz can cause severe hypersensitivity reactions (severe allergic reactions) which can include serious skin conditions that require immediate medical attention.


Q: Is it normal to have some pain or irritation at the IV insertion site with Avycaz?

Localized reactions at the site of the IV infusion, such as pain, redness, or swelling, are listed in official documents as uncommon side effects.


Q: Is Avycaz safe for use in children?

Avycaz is FDA-approved for treating complicated infections in pediatric patients mathbf3 months of age and older for certain uses. Use in children requires careful consideration of the child’s weight and kidney function, as indicated in the product information.

How should Avycaz be stored and disposed of?

How to Store and Dispose of Avycaz

Storage of Avycaz (ceftazidime and avibactam) for injection must adhere strictly to regulatory conditions to ensure product stability.

Storage Requirements

  • Unopened Vials: Must be stored at 25 C (77 F), with permitted excursions between 15 C and 30 C. Vials must be stored in the original container and protected from light.
  • Child Safety: The product must be stored out of reach of children.

Stability and Use Time

The sterile powder is reconstituted and then diluted for intravenous infusion. The initial reconstituted solution must be used within 30 minutes. The final diluted solution is stable for up to 12 hours at room temperature or up to 24 hours when refrigerated (2 C to 8 C). The solution must be visually inspected for particulate matter before administration.

Disposal

Any unused portion of the prepared solution must be discarded. Disposal of the product and associated waste must be carried out in accordance with applicable local, state, and federal regulations.

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

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