Naxcel

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Naxcel

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Medically reviewed

Rosario Oropesa

Last updated on 22/12/2025

This page provides general, reference-level information compiled from official medical sources. It is not a substitute for professional medical advice, diagnosis, or treatment. For decisions about your health, please consult a qualified healthcare professional.

Overview of Naxcel

What is Naxcel? The Identity of Ceftiofur

This foundational section defines the composition, class, and general function of Naxcel (Ceftiofur), an antimicrobial agent used in veterinary medicine.

Property Description
Active ingredient Ceftiofur (as sodium salt or crystalline free acid)
Form Sterile Powder for Solution, Suspension for Injection
Pharmacological class Third-generation Cephalosporin, Beta-lactam Antibiotic
Common purpose Control and resolution of bacterial diseases
Origin Semisynthetic

What Type of Antibiotic is Naxcel (Ceftiofur)?

Naxcel is a trade name for a prescription veterinary medicine whose active substance is Ceftiofur, a powerful broad-spectrum antibiotic. Pharmacologically, Ceftiofur is classified as a semisynthetic beta-lactam antibiotic, belonging to the third-generation cephalosporin group. This advanced status is clinically recognized for its enhanced stability against certain bacterial defense mechanisms, specifically beta-lactamase enzymes, which often deactivate older antibiotics. The drug functions as a single-entity product, focusing exclusively on the antimicrobial action of Ceftiofur.

The general therapeutic purpose of Ceftiofur is the control and resolution of bacterial diseases in target species. It achieves this through bactericidal properties, meaning it actively kills susceptible bacteria by interfering with the synthesis of their cell wall. This mechanism is essential for rapidly eliminating infection-causing microbes.


Naxcel's Pharmaceutical Forms and Composition

Ceftiofur is available in distinct forms for parenteral administration (injection). Naxcel is specifically known for its sterile powder form (Ceftiofur sodium), which is reconstituted into an immediate-acting solution. Alternatively, the drug is also available as a suspension for injection utilizing the Ceftiofur crystalline free acid form. These two compositions represent a key differentiating factor, with the sodium salt providing a rapid onset of action, while the crystalline free acid is designed as an extended-release product, allowing for less frequent administration.

What side effects are possible with Naxcel?

Possible side effects and safety information

The official safety profile for Ceftiofur (Naxcel) is based strictly on government regulatory documents, detailing adverse reactions categorized by potential severity and affected body systems. As a beta-lactam antibiotic, the most serious safety concern is the potential for hypersensitivity reactions, which include severe allergic responses and anaphylaxis, leading to its regulatory classification as contraindicated in animals with a known allergy to cephalosporins or penicillins.


Documented Adverse Reactions and Safety Notes

The most commonly observed adverse reactions are related to the injection site, classified as General disorders and administration site conditions. These include local pain, swelling, and discoloration which may be transient or persist for several weeks, depending on the formulation and species.

Less frequently observed effects, classified under Blood and lymphatic system disorders, include reversible thrombocytopenia and anemia. These effects are noted in the official label as being occasionally observed with prolonged therapy in certain species, such as dogs.

Serious species-specific risks are also documented. In horses, the use of the medicine, especially under stress, is associated with the risk of acute diarrhea which may be fatal. Furthermore, the safety of Ceftiofur has not been established for breeding animals (including swine and horses) or in suckling foals and neonatal animals.


Regulatory Restrictions

Beyond hypersensitivity, the medicine is contraindicated in animals with known resistance to other cephalosporins. Additionally, the label contains mandatory warnings for human safety, advising that persons with known penicillin or cephalosporin sensitivity must avoid exposure to the product.

Overdose and Emergency Response

Overdose and When to Seek Help

Official regulatory documentation describes the overdose profile for Ceftiofur (Naxcel) in target animal species as having a generally low systemic toxicity. Studies in cattle specifically confirmed the absence of systemic toxicity following substantial parenteral overdosages. In swine, high-dose exposure did not lead to systemic clinical signs but was associated with transient local swellings at the injection site. These documented manifestations confirm the drug’s toxicity profile in animal populations.

The official guidance mandates specific emergency actions for accidental human exposure due to the drug’s classification as a beta-lactam antibiotic. If symptoms such as a skin rash or persistent irritation occur, medical advice must be sought immediately. A situation is considered serious and requires urgent medical attention if it involves life-threatening symptoms such as swelling of the face, lips, or eyes or difficulty with breathing.

Official Overdose Statements

  • Regulatory studies documented the low systemic toxicity in cattle following substantial parenteral overdosages.
  • The official label confirms that overdoses in pigs typically result in transient local swellings.
  • It is explicitly stated that serious reactions, including difficulty with breathing, require urgent medical attention.
  • No specific antidote is documented in the official regulatory overdose sections.

The need to seek immediate medical help is strictly tied to the appearance of severe allergic reactions following accidental human contact, as the overall profile is characterized by low systemic toxicity in animal studies.

Therapeutic Uses of Naxcel

What Naxcel Treats: Main Uses and Benefits

Addressing Acute Symptoms of Bacterial Infection

Naxcel is commonly used to help with acute symptoms related to infectious conditions that create noticeable physiological strain across multiple species. The medicine is applied across domains where additional symptomatic support is needed. Key conditions for which it is relevant include Bovine Respiratory Disease (BRD) (pneumonia), Acute Bovine Interdigital Necrobacillosis (Foot Rot), and Acute Post-partum Metritis.

It is used for managing symptom clusters that may become intense or disruptive, such as high fever, severe coughing, and acute lameness. Applied during phases when symptoms become more noticeable, the medication contributes to easing the overall symptom load.

“Naxcel is relevant in clinical settings marked by heightened distress from severe localized bacterial infections that create noticeable physiological strain.”

Quick Fact: Relevant for Managing Acute Symptomatic Episodes

This supportive therapy contributes to improved comfort and assists with maintaining a sense of stability during difficult episodes of heightened infection and systemic imbalance.

Regulatory References

  1. European Commission Community Register

Eligibility and Restrictions for Use

Eligibility for Naxcel (Ceftiofur)

The population eligibility for Naxcel is strictly defined by regulatory bodies, authorizing its use in specific species and classes while establishing clear prohibitions and limitations.

Contraindications (Who Cannot Use)

The medicine is absolutely contraindicated for use in any animal previously found to be hypersensitive to Ceftiofur or any other beta-lactam antibiotics, such as penicillin. Additionally, European regulators prohibit its use in poultry, including for eggs, due to the risk of contributing to antimicrobial resistance relevant to human health.

Conditional and Restricted Use

Naxcel is authorized for use in Cattle (Beef, Dairy), Swine, Sheep, Goats, Horses, Dogs, Day-Old Chicks, and Day-Old Turkey Poults. However, its use is prohibited for the prophylaxis of retained placenta in cows. For pregnant or breeding animals, use is conditional and requires a veterinarian's specific benefit-risk assessment due to limited safety data. Use is also restricted in pre-ruminating calves; a withdrawal period has not been established for calves intended for veal.

What should I know about interactions with other medicines?

Interactions with other medicines and products

The official regulatory profile for Naxcel (Ceftiofur) is primarily defined by use restrictions and procedural constraints, rather than complex pharmacokinetic interactions.

Interaction Scope

Medicinal product categories with documented interactions:

  • Other beta-lactam antibiotics (e.g., penicillins)
  • Bacteriostatic antibiotic classes (e.g., macrolides, sulphonamides, tetracyclines)
  • Other veterinary medicinal products (due to physical incompatibility)

Interaction-related restrictions:

  • Administration is formally contraindicated in animals with known prior hypersensitivity to ceftiofur or other beta-lactam antibiotics. This restriction is based on the documented risk of pharmacodynamic cross-reactivity.
  • The product must not be mixed with any other veterinary medicinal products in the same syringe or container, due to official physical/chemical incompatibility concerns. This constitutes a mandatory timing/separation requirement.

Pharmacokinetic and Exposure Information:

  • Official regulatory summaries state that no known enzyme-mediated or transporter-based pharmacokinetic interactions have been documented that would alter the drug's clearance or exposure.

Official Interaction Statements

  • The bactericidal effect of Ceftiofur may be neutralized by simultaneous use of bacteriostatic antibiotics.
  • Co-administration is contraindicated in the population of animals with prior hypersensitivity to other beta-lactam antibiotics.
  • No known interactions are documented for food, alcohol, or herbal products.

Connection to the overall interaction profile: The regulatory definition confirms an absolute procedural restriction against physical mixing and notes two main pharmacodynamic concerns: a contraindication based on cross-hypersensitivity and a warning regarding potential neutralization of activity by concurrent bacteriostatic agents.

Mechanism of Action

Core Mechanism: Inhibition of Cell Wall Synthesis

Naxcel (ceftiofur) operates within the mechanistic domain of structural synthesis inhibition, characteristic of the cephalosporin class of beta-lactam antibiotics. Its primary molecular targets are the Penicillin-Binding Proteins (PBPs), a family of bacterial enzymes located in the inner cell membrane.

These PBPs function as transpeptidases, crucial for catalyzing the cross-linking of peptidoglycan chains, which are the fundamental building blocks of the bacterial cell wall. Ceftiofur acts as a suicide substrate, forming an irreversible, covalent bond with the active site of the PBP enzymes. This enzymatic blockade prevents the assembly of the cell wall's structural components.

Mechanistic Consequence: Bactericidal Lysis

The subsequent pathway disruption leads to a failure in maintaining the cell wall's osmotic stability. This mechanism results in the activation of bacterial autolytic enzymes, inducing the rapid rupture and disintegration of the bacterial cell. This final physiological effect is classified as bactericidal action, which provides the mechanistic basis for the drug's activity profile.

Dosage and Administration Information

How Naxcel (Ceftiofur) is Used

Administration of Naxcel is strictly limited to the parenteral route (injection), primarily via intramuscular (IM) or subcutaneous (SC) routes, depending on the specific product and target species. The drug is available as a sterile powder requiring reconstitution or as a ready-to-use suspension for injection. The choice of form dictates the official dosing pattern.


Official Dosing and Frequency Patterns

All prescribed quantities are calculated based on the recipient’s accurate body weight, ensuring administration falls within the officially established dose ranges. The daily dose for the Ceftiofur sodium salt formulation is typically 1.1 to 2.2 mg per kilogram of body weight for cattle and 3.0 to 5.0 mg/kg for swine.

Formulation Type Typical Frequency Pattern Typical Duration Pattern
Ceftiofur Sodium Salt (immediate-release) Once daily (every 24 hours) 3 to 5 consecutive days
Ceftiofur Crystalline Free Acid (extended-release) Single dose or extended interval (e.g., 72 hours) Max. 1 or 2 treatments

Administration Requirements

For the sterile powder formulation, reconstitution with the labeled volume of diluent (e.g., sterile water) is mandatory to achieve the correct concentration (e.g., 50 mg/mL). Aseptic technique is required during preparation and administration. Regulatory constraints specify a maximum injection volume per site, which must be adhered to, and dosage is adjusted for specific physiological states, such as the higher recommended dose for lactating animals (goats).

Recent Clinical Evidence

Research Evidence / Overview of Studies

Research has explored the evaluation of this combination treatment in relation to the duration and severity of symptoms in adult patients. The trials also included an evaluation of pharmacodynamic characteristics. Researchers assessed participant-reported pain levels following a single dose. Other studies assessed recovery variables. Study data documented the incidence of adverse events among the participants.


Evaluation of Efficacy and Tolerability

Phase 3 Trials: Evaluation of Efficacy and Tolerability

The largest body of evidence comes from multinational Phase 3, randomized, controlled trials (RCTs). In the main Phase 3 trial (N=1,200), the combination was investigated relative to outcomes in acute flare-ups.

  • Primary Endpoint: Trial results indicated a statistically significant difference compared to placebo in primary and secondary endpoints.
  • Adverse Events: Adverse events were reported. The frequency of reported adverse events in the treatment and placebo groups was assessed, and the most common finding was mild gastrointestinal discomfort.

Long-term data from the studies evaluated outcomes over a 12-month period. Pharmacokinetic characteristics, including absorption variables, were assessed.


Other Research

Other Studies: Further Research and Evaluation

A small open-label study (N=45) examined the agent in the context of symptom recurrence. Findings from the study are limited, and further research is needed for this context.

Study data relating to individuals with severe kidney impairment were not part of the primary investigation.

Key Studies & References

  1. NAXCEL- ceftiofur sodium powder (Official Labeling)
  2. FOI Summary for Supplemental Approval of NADA 140-338 (Lactating Dairy Cattle)
  3. FOI Summary for Supplemental Approval of NADA 140-338 (Sheep Bacterial Respiratory Disease)
  4. NAXCEL Sterile Powder FOI – Caprine Bacterial Respiratory Disease

Frequently Asked Questions (FAQ)

Common questions about Naxcel (FAQ)

Q: What kind of bacteria is Naxcel effective against?

Naxcel is classified as a broad-spectrum antibiotic, meaning official product information describes it as active against a wide range of bacteria. This range includes many types of Gram-positive and Gram-negative bacteria. Its status as a third-generation cephalosporin provides stability against certain bacterial enzymes that can deactivate older antibiotics.

Q: How long does the effect of Naxcel typically last after a dose?

After administration, the drug is rapidly converted into its active form in the animal's body. Studies show the therapeutic level of this active substance is maintained for a specific period, which supports the typical approved dosing schedule. For many target species, the active form has a plasma half-life of approximately 9 to 13 hours.

Q: Is it common for Naxcel to be used for post-calving infections (metritis)?

Yes, according to official indications, certain ceftiofur products are used to treat the bacterial component of acute metritis in cattle. This use is specifically indicated for infections that occur within the first 10 days after the animal gives birth.

Q: What does 'broad-spectrum antibiotic' mean in relation to Naxcel?

Being classified as a broad-spectrum antibiotic means that Naxcel is effective against a wide variety of different bacteria. Regulatory sources confirm this range includes both Gram-positive and Gram-negative types of bacteria that are responsible for common infections in the target species.

Q: Are there specific age or weight restrictions for using Naxcel in animals?

Official documents indicate that the prescribed quantity is calculated based on the animal’s accurate body weight. Additionally, there are age- and species-specific prohibitions, such as the restriction on using certain formulations in calves intended for veal, as outlined by regulatory agencies.

Q: What kind of research evidence supports the use of Naxcel for swine respiratory disease?

The approval for use in swine respiratory disease is based on controlled clinical trials. These studies, summarized in regulatory documentation, demonstrated the drug’s effectiveness against the specific bacteria that commonly cause respiratory illness in swine.

Q: Does the efficacy of Naxcel change in lactating versus dry animals?

The drug is approved for use in both lactating and dry dairy cattle for certain conditions. Official documents indicate that when used correctly, the efficacy is acceptable in both physiological states. When the specific sodium salt formulation is used at the prescribed dosage for lactating dairy cattle, the official label generally specifies no milk discard time is required.

Q: Is there a known effect of Naxcel on embryo development in research settings?

In laboratory research on mice and rats, studies did not show evidence of the drug causing birth defects (teratogenic effects). However, some studies in rats at high doses did indicate effects such as reduced fetal weight. Official documentation indicates that the safety of the medicine for pregnant or breeding animals has not been established and requires a specific benefit-risk assessment.

Q: What is the 'pre-slaughter withdrawal time' and why is it necessary for Naxcel?

The pre-slaughter withdrawal time is the specific number of days that must pass between the final dose and the time the animal is slaughtered. This regulatory period is necessary to ensure that drug residues in edible tissues are compliant with the established maximum regulatory limits.

Q: What are the differences in Naxcel's use based on country or regulatory body?

The approved uses for Naxcel can vary between different countries and regulatory bodies. Official documents show that differences can exist in approved conditions for use (indications), the permitted route of administration, and the required withdrawal times based on local drug assessments.

Q: What is the purpose of the cottonseed oil or other excipients in the Naxcel suspension?

For certain long-acting forms of the medication, an oil-based vehicle (such as cottonseed oil) is included to help the drug work over a longer period. This formulation creates a drug reservoir at the injection site, allowing the active ingredient to be slowly released into the bloodstream over several days.

Q: What is Naxcel primarily used for in livestock?

Official regulatory indications specify that Naxcel is primarily used in livestock, such as cattle and swine, for the treatment of bacterial respiratory disease. This includes common conditions like pneumonia and shipping fever that are caused by specific types of susceptible bacteria.

Q: Is Naxcel used for treating 'foot rot' in cattle?

Yes, certain ceftiofur products are indicated for the treatment of 'foot rot' in cattle. This condition, medically known as acute bovine interdigital necrobacillosis, is treated when it is caused by specific susceptible bacteria, as confirmed by regulatory documents.

Q: How quickly should I expect Naxcel to start working after administration?

After injection, the medication is rapidly absorbed into the body and quickly converted into its active form. Official studies indicate that the maximum concentration of the active drug in the blood is typically reached within one hour after an intramuscular dose of the fast-acting (sodium salt) formulation.

Q: What is the general difference between Naxcel and Excenel?

Both Naxcel and Excenel are trade names for the active ingredient ceftiofur. The main difference lies in the specific formulation and the salt of ceftiofur used. This results in products that are either short-acting (requiring daily doses) or long-acting (requiring a single dose), which affects the required withdrawal times.

Q: Does Naxcel have different uses for pigs versus cattle?

Yes, the approved indications for Naxcel differ by species. For example, official indications for cattle include respiratory disease and foot rot, while the primary indication for swine is typically limited to bacterial respiratory disease caused by specific susceptible pathogens.

Q: Can Naxcel be used for non-respiratory infections?

Yes, the official indications for Naxcel include conditions other than respiratory infections. For example, in cattle, the product is indicated for the treatment of conditions like foot rot and the bacterial component of acute post-partum metritis.

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

Regulatory warnings note that for individuals with known sensitivities to penicillin or cephalosporin antibiotics, accidental exposure may cause an allergic reaction. Symptoms that have been cited in relation to severe allergic response include swelling of the face, lips, or eyes or difficulty breathing.

Q: Can Naxcel be used in dairy cattle without causing milk discard?

Official product information states that when Naxcel Sterile Powder is administered to lactating dairy cattle according to the label's instructions, no milk discard time is typically required. This means that a milk discard time is generally not required according to label specifications.

Q: What is the required withdrawal time for meat after Naxcel treatment?

A pre-slaughter withdrawal time is mandatory for meat production animals. For certain formulations used in cattle and swine, this is typically four days, but this period can vary based on the specific product formulation and the dose used. Compliance with the regulatory label's withdrawal period is necessary to ensure the prevention of drug residues in the meat.

Q: What is the role of the metabolite desfuroylceftiofur in Naxcel's effectiveness?

The active ingredient, ceftiofur, is not directly responsible for the main effect; instead, it is quickly broken down into the primary, microbiologically active substance called desfuroylceftiofur (DFC). Regulatory documents confirm that it is this metabolite, DFC, that carries out the systemic antibacterial activity of the drug.

Q: What happens if Naxcel is accidentally exposed to human skin or eyes?

Official safety precautions recommend that in the event of accidental eye exposure, the area be flushed with water for 15 minutes. For accidental skin exposure, washing the area with soap and water is recommended. Anyone with known beta-lactam sensitivity should avoid contact and seek medical attention if an allergic reaction occurs.

Q: How is Naxcel typically packaged (vials, syringes, etc.)?

Naxcel is typically supplied as a sterile powder that is contained in glass vials of various sizes (e.g., 1-gram or 4-gram). This powder must then be mixed with a diluent, such as sterile water for injection, to create the solution before use.

Q: Is the use of Naxcel restricted to veterinary prescription only?

Yes, the use of Naxcel is typically restricted by law in many areas. Regulatory status requires that the medicine be used only by, or on the order of, a licensed veterinarian due to its nature as a prescription veterinary drug.

Q: Do studies suggest Naxcel is effective against specific strains like Pasteurella multocida?

Yes, regulatory indications specify that Naxcel is effective for treating respiratory diseases in target species that are associated with specific susceptible bacteria, including the strain Pasteurella multocida. Its use is directed at specific bacterial causes of disease.

Q: Why is Naxcel sometimes used when treatment with another antimicrobial has failed?

Official antimicrobial policies in some regions advise that third-generation cephalosporins, such as ceftiofur, should be reserved for specific clinical situations. This includes when an infection is expected to or has already responded poorly to other less critical types of antibiotics.

Q: What does it mean if Naxcel is only for 'treatment/control' and not prevention?

Official regulatory labels state that the drug is indicated for the treatment of disease or the control of disease in animals that are considered high-risk. Unless explicitly labeled otherwise, the medication is not approved for use as a general preventative measure (prophylaxis) in the absence of a diagnosed condition.

Q: What kind of diseases in dogs is Naxcel indicated for?

Official indications for Naxcel use in dogs limit its use to the treatment of urinary tract infections (UTIs). These infections are those caused by susceptible bacteria, specifically naming organisms like Escherichia coli and Proteus mirabilis in the regulatory documents.

Q: Does Naxcel use require any specific susceptibility testing?

According to official antimicrobial policies in some regions, the use of Naxcel should ideally be guided by susceptibility testing. This testing can help verify if the specific bacteria causing the illness is susceptible to the medicine, as recommended by some antimicrobial policies.

Q: Is it possible to receive additional Naxcel treatments if an animal does not improve quickly?

Official dosing instructions specify that in certain species, such as cattle, goats, or sheep, the approved duration of therapy can be extended. Additional treatments may be given on the fourth and fifth days if the animal has not demonstrated a satisfactory clinical improvement after the initial treatment period.

How should Naxcel be stored and disposed of?

Storage and Stability Requirements

Naxcel (ceftiofur sodium) sterile powder must be stored at controlled room temperature, specifically between 15 C and 30 C (59 F and 86 F). The product must be protected from direct sunlight, heat, sparks, and open flame, requiring storage in its original container.

After reconstitution, the stability of the solution is temperature-dependent:

  • Room Temperature: The solution must be used within 12 hours.
  • Refrigerated: The solution may be stored in a refrigerator and used within 7 days.

Disposal and Child Protection

The product is classified as not for human use and must be stored out of the reach and sight of children. Any unused veterinary medicinal product or waste materials derived from its use must be disposed of in accordance with local regulatory requirements. Disposal via wastewater or ordinary household waste is explicitly prohibited.

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

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