Teflaro

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Teflaro

Medically reviewed

Marina Burgos

Last updated on 10/01/2026

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 Teflaro

Property Description
Active Ingredient Ceftaroline Fosamil
Form Sterile Powder for Solution (for Intravenous Infusion)
Pharmacological Class Fifth-Generation Cephalosporin Antibiotic
Common Use Treating serious bacterial infections
Origin Semi-synthetic Prodrug

What Type of Antibiotic is Teflaro (Ceftaroline)?

Teflaro is a modern, prescription-only anti-infective drug categorized as a beta-lactam antibacterial agent. More specifically, it is a semi-synthetic compound classified as a fifth-generation cephalosporin antibiotic, a newer class designed to address bacterial resistance patterns. The active medicinal component in Teflaro is Ceftaroline Fosamil, which is initially an inactive compound. Teflaro is used to treat certain bacterial infections in the skin and lungs. This indicates that the medicine is reserved for combating specific, serious bacterial illnesses.

Composition and Form: The Active Ingredient and its Delivery

The single active medicinal component, Ceftaroline Fosamil, functions chemically as a prodrug and is supplied as a sterile powder for solution in a single-use vial. As a prodrug, it requires enzymatic conversion within the body to yield the pharmacologically active molecule, Ceftaroline. Ceftaroline demonstrated potent activity against key bacterial pathogens, including Staphylococcus aureus. This supports the compound's strength against common and certain difficult-to-treat germs. Due to this specific formulation, the medicine must be reconstituted and administered solely via Intravenous (IV) Infusion.

What is the General Purpose of This Newer Antibiotic?

The fundamental purpose of this medicine is to provide a systematic, bactericidal defense against susceptible bacteria causing infection. A key differentiating factor for this fifth-generation agent is its enhanced binding affinity to certain bacterial proteins, which supports its effectiveness against organisms resistant to many other beta-lactams. This includes demonstrated activity against Methicillin-Resistant Staphylococcus aureus (MRSA), making it a valuable therapeutic option for managing infections where this level of resistance is a concern.

Regulatory References

  1. U.S. National Library of Medicine
  2. MedlinePlus
  3. European Medicines Agency
  4. EMA Public Assessment Report

What side effects are possible with Teflaro?

Official Classification of Possible Side Effects

The regulatory safety profile for ceftaroline fosamil classifies potential effects based on the frequency observed in clinical trials and the body system affected. Adverse reactions are grouped using standardized categories, such as Common and Uncommon, which reflect their documented rate of occurrence.

Key areas of effect listed in official labeling include the Gastrointestinal disorders (e.g., diarrhea and nausea), changes in Laboratory Investigations (such as increased liver enzymes and hypokalemia), and reactions related to the Skin and subcutaneous tissue (such as rash).

Serious Adverse Reactions

Regulatory documents highlight the potential for serious adverse reactions. These include serious and occasionally fatal hypersensitivity (anaphylactic) reactions, which formally contraindicate the use of the medicine in individuals with a known allergy to ceftaroline or other cephalosporins. Severe Cutaneous Adverse Reactions (SCARs), such as Stevens-Johnson Syndrome (SJS) and DRESS, have also been documented in the post-marketing setting.

Safety notes also include the risk of developing Clostridium difficile-associated diarrhea (CDAD), which can occur even up to two months after the medicine is given. Other serious outcomes reported include neurological adverse reactions such as seizures and encephalopathy.

Population-Specific Safety Considerations

The official labeling includes specific notes for certain patient groups. For individuals with renal impairment, neurological adverse reactions have been documented, and the drug’s primary excretion via the kidneys requires careful attention. The most frequently observed effects in pediatric patients were diarrhea, rash, vomiting, fever, and nausea.

Overdose and Emergency Response

Overdose and When to Seek Help

The official regulatory documentation for Teflaro (ceftaroline fosamil) defines the overdose profile based on the potential for severe neurological adverse reactions associated with high drug exposure. The overall management strategy is based on symptomatic and supportive care.


Documented Overdose Manifestations

The most critical manifestations of over-exposure, particularly when the drug reaches high systemic concentrations, involve the Central Nervous System (CNS). Officially reported severe neurological adverse reactions associated with high systemic levels include seizures and encephalopathy. These documented presentations are the primary concern in an overdose scenario.

A significant, regulator-cited risk factor for these adverse neurological manifestations is renal impairment. Patients with compromised kidney function who do not receive the appropriate dosage adjustment are at a heightened risk of experiencing the signs of overdose due to reduced drug clearance.


Regulator-Mandated Emergency Actions

In the event of a suspected or confirmed overdose, the regulatory guidance mandates immediate and essential clinical actions:

  • The medicine must be discontinued promptly by a healthcare professional.
  • General supportive treatment should be initiated to manage the patient’s clinical status and symptoms.
  • Urgent medical attention is required for the assessment and management of any severe neurological signs.

The official documentation confirms that no specific antidote is known for Ceftaroline. However, the drug is documented to be removable from the systemic circulation by hemodialysis, which is the procedural option available for management in cases of severe over-exposure.

Therapeutic Uses of Teflaro

What Teflaro Treats: Main Uses and Benefits

Teflaro (ceftaroline fosamil) is commonly used for managing severe, acute bacterial infections in patients requiring hospitalization. The therapeutic value is in its ability to address infections where symptoms relate to systemic imbalance and local tissue damage, is applied in situations involving resistant pathogens. This medication is indicated for Acute Bacterial Skin and Skin Structure Infections (ABSSSI) and Community-Acquired Bacterial Pneumonia (CABP).

In clinical practice, it is applied across domains where additional symptomatic support is needed, particularly when infection with resistant pathogens, such as Methicillin-Resistant Staphylococcus aureus (MRSA), is suspected. This antibiotic helps address symptom clusters that may become intense or disruptive, including extensive redness, painful swelling, and difficulty breathing in pneumonia. It supports the patient during difficult episodes by easing distress and contributes to maintaining functional stability during the acute phase.


Clinical Context: Supporting Symptom Management

Teflaro is relevant in clinical settings marked by temporary physiological imbalance. It assists with managing pronounced symptoms like fever and cough in supporting the patient through conditions characterized by periods of heightened symptoms, which provides support that helps ease the overall symptom burden.

Eligibility and Restrictions for Use

Who can and cannot use Teflaro?

Eligibility for Teflaro (ceftaroline fosamil) is defined by official regulatory documentation, focusing on hypersensitivity, age, and kidney function.


Absolute Non-Eligibility (Contraindications)

Official prescribing information contraindicates use in patients with a known serious hypersensitivity to ceftaroline or to other antibiotics in the cephalosporin class. Caution is advised when administering the medicine to patients with a history of any severe allergic reaction to other beta-lactam antibiotics, such as penicillins or carbapenems.


Eligibility Based on Age and Condition

Population Group Approved Eligibility Status Condition-Based Restriction
Adult Patients (ge 18 years) Eligible for both indications. Dose adjustment required if Creatinine Clearance (CrCL) is le 50 mL/min (renal impairment).
Pediatric CABP (Pneumonia) Eligible if ge 2 months of age. Safety and effectiveness not established below 2 months of age.
Pediatric ABSSSI (Skin Infection) Eligible if ge 34 weeks gestational age and ge 12 days postnatal age. Safety and effectiveness not established below these age/gestation limits.
Pregnant/Nursing Women Use is restricted and only recommended if the potential clinical benefit justifies the potential risk, due to a lack of adequate human studies. No specific restriction is necessary for patients with hepatic impairment.

What should I know about interactions with other medicines?

Teflaro Interactions with Other Medicines and Products

Official regulatory information indicates that Teflaro (ceftaroline fosamil) has a minimal potential for drug-drug interactions, particularly those involving major metabolic enzyme systems.

Documented Interaction Patterns

The primary documented interaction involves substances that compete for the kidney's clearance mechanisms. The active component, ceftaroline, is primarily eliminated via active renal tubular secretion.

Interaction Type Interacting Substance Official Effect
Exposure Modification Probenecid Increases plasma levels of ceftaroline by competing for renal tubular clearance.
Metabolic Potential CYP450 Inhibitors/Inducers Minimal potential for interaction with these substances, as stated in regulatory labels.

Interaction-Related Constraints and Restrictions

No medicinal combinations are formally classified as contraindicated due to an interaction risk with Teflaro. However, specific restrictions apply to the preparation and administration of the intravenous solution:

  • Physical Incompatibility: Due to the risk of physical incompatibility, the Teflaro solution must not be mixed with or physically added to solutions that contain other medicines. This restriction ensures that the drug retains its stability and integrity during infusion.
  • Food and Supplements: Official regulatory documents do not list any interactions between Teflaro and food, alcohol, or herbal products.

Mechanism of Action

The core mechanism of Ceftaroline involves the targeted, covalent inhibition of Penicillin-Binding Proteins (PBPs), a family of bacterial enzymes essential for cell wall synthesis. Ceftaroline blocks the final transpeptidation step of the peptidoglycan pathway, which prevents the necessary molecular cross-linking that provides structural rigidity. This structural failure causes the bacterial cell to lose its integrity and succumb to internal osmotic pressure, triggering rapid cell lysis and death (a bactericidal effect).

Ceftaroline's differentiating mechanism lies in its ability to bind with high affinity to specific, altered bacterial proteins, including PBP2a in MRSA and modified PBPs in drug-resistant S. pneumoniae. This precise molecular engagement provides a targeted action against these resistance factors, facilitating the continuation of the bactericidal mechanism.

The functionality of this mechanism is constrained by certain bacterial resistance factors. Ceftaroline is vulnerable to hydrolytic inactivation by several beta-lactamase enzymes, such as ESBLs and some AmpC cephalosporinases, which degrade the drug and terminate the bactericidal mechanism against those specific strains.

Dosage and Administration Information

How to use Teflaro (Ceftaroline Fosamil): Official Administration Guidelines

Teflaro (ceftaroline fosamil) is administered exclusively as an Intravenous (IV) Infusion by a healthcare professional in a controlled setting. The medicine is supplied as a sterile powder for injection and requires two-step preparation: reconstitution with a compatible diluent, followed by further dilution into an infusion bag (typically 50 mL to 250 mL) using aseptic technique.

Standard Dosing and Administration

The standard adult dose (ge 18 years) for patients with normal renal function (Creatinine Clearance, or CrCl, > 50 mL/min) is 600 mg administered every 12 hours (q12 h). The infusion is typically given over 5 to 60 minutes.

Indication Adult Dose (CrCl > 50 mL/min) Frequency Duration of Treatment
Acute Bacterial Skin and Skin Structure Infections (ABSSSI) 600 mg Every 12 hours 5 to 14 days
Community-Acquired Bacterial Pneumonia (CABP) 600 mg Every 12 hours 5 to 7 days

Dosing Adjustments for Special Populations

Dosage adjustments are required for adults with reduced kidney function, as the drug is primarily eliminated by the kidneys. These adjustments are based on the patient's estimated CrCl (calculated using the Cockcroft-Gault formula), as outlined in clinical guidelines.

For example, patients with moderate renal impairment (CrCl > 30 to le 50 mL/min) receive 400 mg every 12 hours. Patients on hemodialysis receive 200 mg every 12 hours, and the dose must be administered after the hemodialysis session on those days. Pediatric patients receive a weight-based dose and may be dosed q8 h.

Recent Clinical Evidence

Research evidence / Overview of Studies for Teflaro

Evidence for Acute Bacterial Skin and Skin Structure Infections (ABSSSI)

The clinical evaluation for ceftaroline fosamil in severe skin and skin structure infections primarily involved pivotal Phase 3 randomized controlled trials (RCTs). These studies were applied in research contexts involving hospitalized adults with complex infections, such as deep cellulitis or major abscesses. Researchers compared the study drug's administration against another standard antibiotic regimen (vancomycin plus aztreonam) in these trials. The main focus was to measure Clinical Response (categorized by investigators as favorable or unfavorable outcome) at a follow-up visit, typically occurring eight to fifteen days after the last dose.

Findings describe patterns observed in the studies where the measurements of Clinical Response for the study drug fell within the pre-defined range of non-inferiority when compared to the active control regimen in ABSSSI trials involving adults. The research was able to establish non-inferiority between the study drug and the established standard of care in the observed adult populations. The trials also tracked Early Clinical Response, based on indicators like fever and local signs, which showed similar patterns of response across the groups studied.

Evidence for Community-Acquired Bacterial Pneumonia (CABP)

The research supporting ceftaroline fosamil for community-acquired bacterial pneumonia also relies on pivotal Phase 3 randomized controlled trials. These studies were evaluated in hospitalized adults with moderate to severe pneumonia. Research examined outcomes related to systemic or functional imbalance by tracking the Clinical Response at the Test of Cure visit. Findings describe patterns observed in these studies where the measurements of Clinical Response for the study drug fell within the pre-defined range of non-inferiority when compared to the active control regimen (ceftriaxone).

Areas of Research Uncertainty

What remains uncertain is that the pivotal adult trials were specifically designed only to demonstrate non-inferiority (not worse than the comparator), and they were not designed to demonstrate superiority. Therefore, the evidence does not provide certainty regarding whether the study drug is superior to the established standard treatments. The evidence for treating CABP specifically caused by Methicillin-Resistant Staphylococcus aureus (MRSA) has not been conclusively established through these large-scale pivotal RCTs. Furthermore, data for pediatric patients is primarily descriptive, and long-term effects are not fully established by the primary regulatory evidence.

Key Studies & References

  1. Ceftaroline fosamil versus vancomycin plus aztreonam in hospitalized adults with acute bacterial skin and skin structure infections: Pooled analysis of two phase 3 trials (CANVAS 1 and 2)

Frequently Asked Questions (FAQ)

Common questions about Teflaro (FAQ)


Q: Why is Teflaro often called a 'fifth generation' cephalosporin?

A: Teflaro is classified as a fifth-generation cephalosporin because of its distinct ability to combat certain highly resistant bacteria, including Methicillin-Resistant Staphylococcus aureus (MRSA). This activity profile is what places it into the newer generation of cephalosporins.


Q: Does Teflaro treat all types of skin infections?

A: Regulatory documents state that Teflaro is indicated only for the treatment of Acute Bacterial Skin and Skin Structure Infections (ABSSSI) caused by susceptible bacteria. As a bactericidal agent, its approved use is limited to certain bacterial infections and does not extend to non-bacterial conditions like viral or fungal skin infections.


Q: Why is Teflaro commonly reserved for more complicated infections?

A: Official guidance recommends that this medicine be used only when the infection is proven or strongly suspected to be caused by susceptible bacteria. This selective use is a public health recommendation intended to help mitigate the development of drug resistance.


Q: Is it normal to feel dizzy or lightheaded during or after a Teflaro infusion?

A: Dizziness or lightheadedness are included in the list of adverse reactions that have been reported with this medicine. If these effects are experienced, it is important to notify a healthcare professional.


Q: What are the signs of a potential allergic reaction to Teflaro?

A: Regulatory safety notes describe potential signs of a serious allergic reaction, which may include hives, swelling of the face, lips, tongue, or throat, hoarseness, or difficulty breathing. If any of these signs appear, it is considered a medical emergency requiring immediate professional attention.


Q: Can Teflaro lead to changes in blood test results, such as white blood cell count?

A: Official product information indicates that Teflaro can cause seroconversion in a blood test called the Direct Coombs’ test. If anemia (a low red blood cell count) develops, healthcare providers may perform a specific workup to check for drug-induced hemolytic anemia.


Q: Are headaches a frequent side effect mentioned in official documents?

A: Yes, headache is an adverse reaction that has been reported in clinical trials involving both adult and pediatric patients receiving Teflaro. It is listed among the documented side effects in the official product information.


Q: Does Teflaro interact with blood-thinning medications like warfarin?

A: Official documents state that Teflaro has a minimal potential for drug-drug interactions. Due to general considerations with this class of antibiotics, healthcare providers may utilize close monitoring when the medicine is co-administered with anticoagulants.


Q: Are there common vitamins or supplements that should be avoided when using Teflaro?

A: Official regulatory documents do not list any specific interactions with common vitamins or non-herbal supplements. As a standard safety practice, patients are advised to inform their healthcare provider of all products being used, including supplements.


Q: Does Teflaro interfere with the results of any standard laboratory tests?

A: Official information states that Teflaro may interfere with the results of a specific blood test known as the Direct Coombs' test. This change in test results has been observed in some clinical trials.


Q: How quickly should signs of an infection begin to improve after starting Teflaro?

A: Studies tracked initial response by measuring key indicators of improvement, such as the absence of fever and the cessation of lesion spread, as early as Study Day 3 for some infections. The timeframe for clinical improvement is highly variable based on the patient and the type of infection being treated.


Q: How long does the drug stay in the body after the final dose is given?

A: According to official pharmacology data, the active drug, ceftaroline, is primarily eliminated by the kidneys. The drug's concentration in the blood decreases over time with a measured half-life of approximately 2.6 hours.


Q: Is Teflaro considered suitable for elderly patients?

A: Teflaro can be used in the elderly population. Official documents state that since older patients are more likely to have reduced kidney function, healthcare professionals typically exercise care in selecting the appropriate dose, and monitoring of kidney function may be advised.


Q: How long has Teflaro been available on the market since its initial approval?

A: Teflaro was first approved by the U.S. Food and Drug Administration (FDA) for the treatment of Acute Bacterial Skin and Skin Structure Infections and Community-Acquired Bacterial Pneumonia on October 29, 2010.


Q: What does the 'fosamil' part of the name ceftaroline fosamil mean?

A: The name ceftaroline fosamil reflects that the drug is supplied as an inactive form called a prodrug. The 'fosamil' group is a chemical modification that allows the body to convert the prodrug into the active antibacterial molecule, ceftaroline, once it is administered.


Q: Why is Teflaro only administered by injection and not available as an oral tablet?

A: Official product information states that Teflaro is formulated as a sterile powder for solution and must be given by Intravenous (IV) Infusion. This method of administration is necessary to ensure the active drug, ceftaroline, reaches appropriate therapeutic concentrations by being absorbed directly into the bloodstream.


Q: What is the recommendation for breastfeeding while receiving Teflaro?

A: Official documents state that it is not known whether the active ingredient, ceftaroline, is excreted into human milk. Due to this uncertainty, caution is advised when the medicine is administered to a nursing woman.


Q: Is there a general explanation for why careful monitoring might be needed during Teflaro treatment?

A: Careful monitoring may be needed to ensure the appropriate dose is being given, as adjustments based on kidney function are necessary for many patients. Monitoring also serves to check for signs of serious adverse reactions, such as neurological effects and severe allergic reactions.


Q: Is it acceptable to take over-the-counter pain relievers while receiving Teflaro?

A: No specific interactions with common over-the-counter pain relievers are listed in the official drug information. As a safety measure, patients should notify their healthcare provider of all medications being taken, including any non-prescription drugs.


Q: Is Teflaro known to affect how birth control pills work?

A: Antibiotics, including those in the cephalosporin class, may potentially reduce the effectiveness of hormonal contraceptives like birth control pills. It is important for patients to discuss their birth control method and any concerns with their healthcare professional.


Q: Is Teflaro considered a broad-spectrum or narrow-spectrum antibiotic?

A: According to official product information, Teflaro is described as a broad-spectrum cephalosporin. This description reflects its antibacterial activity against both Gram-positive bacteria, including MRSA, and certain Gram-negative bacteria.

How should Teflaro be stored and disposed of?

How to Store and Dispose of Teflaro

Teflaro (ceftaroline fosamil) Sterile Powder for Solution requires specific environmental controls to maintain product integrity, as defined by regulatory labeling.

Storage Requirements

Product State Temperature Requirement Stability Limit
Unopened Vials Store under refrigeration (2 C to 8 C). Storage up to 25 C is allowed for up to seven days. Not Applicable (Shelf Life)
Prepared Solution Store refrigerated (2 C to 8 C). Do not freeze. Use within 24 hours (or 6 hours at room temperature).

Unopened vials must be kept in the original package to protect from light and stored out of the sight and reach of children.

Disposal

Any unused medicine, waste material, or empty containers must be disposed of in accordance with local, state, or national legislation for pharmaceutical waste. The product should never be poured down drains, sewers, or water courses.

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

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