DRAXXIN

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DRAXXIN

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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 DRAXXIN

Property Description
Active Ingredient Tulathromycin
Form Sterile Injectable Solution (Parenteral)
Pharmacological Class Semi-synthetic Macrolide / Triamilide Antibiotic
General Purpose Treatment and control of susceptible bacterial infections in livestock
Origin Semi-synthetic (modified natural base)

What Type of Medicine is DRAXXIN? (Identity and Classification)

DRAXXIN is a specialized, prescription-only veterinary medicinal product that functions as an antibiotic and anti-infective agent, manufactured by Zoetis. Its fundamental purpose is the treatment and control of susceptible bacterial infections in livestock, primarily cattle and swine.

This drug is categorized within the anti-infectives group for use in large animal health. Its dispensing status is strictly "Rx" (Prescription Animal Drug), requiring that administration be performed under the order of a licensed veterinarian.

Composition and Form: The Semi-Synthetic Tulathromycin

The single active ingredient in DRAXXIN is tulathromycin, a compound that determines the drug’s identity and specialized application. Tulathromycin is categorized as a semi-synthetic macrolide, a modified compound derived from a natural macrolide base to optimize its therapeutic profile. This chemical modification places it into the distinct triamilide subclass.

The medicine is supplied as a ready-to-use sterile parenteral preparation in the physical form of an Injectable Solution. This proprietary solution contains the active ingredient tulathromycin as the free base in a clear Propylene Glycol-based vehicle, designed for delivery via the parenteral route.

How Tulathromycin’s Class Leads to Long-Acting Effect (General Mechanism/Benefit)

The specialized triamilide structure provides tulathromycin's primary practical advantage: a long duration of action.

This extended persistence in the body allows the medicine to maintain its anti-infective concentration over a prolonged timeframe after a single administration. This sustained therapeutic profile is intended to simplify the management of bacterial infections, such as those common in production animals, by supporting infection resolution.

Regulatory References

  1. Label: DRAXXIN- tulathromycin injection, solution - DailyMed
  2. NADA 141-244 DRAXXIN Injectable Solution (tulathromycin) - Animal Drugs @ FDA

What side effects are possible with DRAXXIN?

Possible side effects and safety information

The safety profile of DRAXXIN (tulathromycin) is officially categorized by frequency and the body systems affected, based on regulatory documentation. The most frequently documented adverse events are local reactions occurring at the administration site.

Frequency-Classified Adverse Reactions

The majority of documented adverse effects are classified as Very Common, meaning they affect more than 1 in 10 animals, and relate primarily to the site of injection. These reactions include localized swelling, oedema, pain, haemorrhage, and the formation of persistent fibrous tissue (fibrosis).

Classification System-Organ Class Specific Reactions (Examples)
Very Common General Disorders and Administration Site Conditions Injection site pain, swelling, oedema, haemorrhage, and fibrosis.
Infrequent Respiratory, Thoracic and Mediastinal Disorders Dyspnea (difficult breathing) has been observed in clinical trials.

Serious Adverse Reactions and Safety Constraints

The regulatory safety profile includes documentation of rare but serious systemic reactions. Post-approval experience has included reports of Anaphylaxis and anaphylactoid reactions, which are classified under Immune System Disorders. This risk dictates that the medicine is formally contraindicated for use in animals with a known hypersensitivity to tulathromycin or other antibiotics of the macrolide class.

Official regulatory labels also note that the safety of the medicine has not been established for use in pregnant or lactating animals, or in animals intended for breeding. Furthermore, a constraint exists regarding co-administration with other macrolides or lincosamides, as regulatory sources note that cross-resistance between these antibiotic classes may occur.

Overdose and Emergency Response

DRAXXIN Overdose and when to seek help

The official regulatory information for tulathromycin details specific findings observed in target animal species following the administration of doses several times greater than the therapeutic maximum.

Documented Clinical Manifestations

Overdose in target animals often presents with transient clinical signs. These documented manifestations include restlessness, head-shaking, pawing the ground, and a brief decrease in feed intake in cattle. Young pigs may also exhibit excessive vocalisation and increased restlessness. Across multiple species, transient injection site discomfort is consistently noted as a local reaction following high-dose exposure.

Severe Pathological Outcomes

At higher multiples of the recommended dose, specifically five to six times the standard amount, studies in cattle have documented evidence of mild myocardial degeneration. This finding indicates an official, adverse effect on the cardiac system linked to high-dose exposure and is highlighted in the regulatory profile.

Mandatory Emergency Action for Human Exposure

The official labeling includes strict requirements for human safety. In the event of accidental self-injection with DRAXXIN, the individual must seek medical advice immediately. Furthermore, the regulatory guidance requires that the individual show the package leaflet or the label to the physician upon seeking urgent care. The official regulatory text confirms that no specific antidote is documented for tulathromycin overdose.

Therapeutic Uses of DRAXXIN

What DRAXXIN Treats: Main Uses and Benefits

DRAXXIN (tulathromycin) is commonly used to help manage conditions characterized by periods of heightened symptoms related to bacterial infections in livestock. The medicine is indicated for the treatment and metaphylaxis of respiratory and locomotor diseases in cattle, pigs, and sheep.

The therapy is relevant across several therapeutic domains, including addressing Bovine Respiratory Disease (BRD), Swine Respiratory Disease (SRD), bovine foot rot (Interdigital Necrobacillosis), and Infectious Bovine Keratoconjunctivitis (pinkeye). It is applied in clinical settings that involve acute or unstable symptom patterns, such as sudden fever, respiratory distress, or severe infectious lameness.

The medication is applied in scenarios where additional management of discomfort is required for disease control (metaphylaxis) in high-risk groups, assisting with maintaining functional stability across the population. The long-acting nature of the therapy is particularly valuable in contexts that require a prolonged therapeutic effect from a single intervention, and may assist with making symptomatic management more manageable. The therapy provides support that helps ease the overall symptom burden and contributes to improved comfort during symptomatic periods.


Quick Fact: Relief for Systemic Discomfort The medicine is commonly used to help alleviate systemic symptoms like fever (pyrexia) that often accompany acute bacterial respiratory infections, and is relevant for easing symptoms related to systemic imbalance.


Regulatory References

  1. EMA therapeutic overview

Eligibility and Restrictions for Use

DRAXXIN (tulathromycin) is a prescription veterinary medicine with specific eligibility rules determined by the animal's species, production status, and physical condition, as mandated by regulatory documents.

Populations Excluded from Use

Contraindications (Must Not Use):

  • Hypersensitivity: Animals with a known sensitivity to macrolide antibiotics or any of the product's excipients.
  • Milk Production: Cattle currently producing milk for human consumption are strictly contraindicated.
  • Age Restriction: Female dairy cattle 20 months of age or older are prohibited from using the medicine (per U.S. labeling).
  • Species: The product is not for use in chickens or turkeys.
  • Concurrent Use: Do not administer simultaneously with other macrolide or lincosamide antimicrobials.

Restricted and Conditional Use

  • Target Species: The medicine is approved for use in Cattle, Pigs (Swine), and Sheep.
  • Pregnancy: Do not use in pregnant cows or heifers intended to produce milk for human consumption within 2 months of expected parturition.
  • Reproductive Safety: The effects on bovine and porcine reproductive performance, pregnancy, and lactation have not been determined (Use Not Established).
  • Disease Stage: Use in sheep for foot rot is restricted; the drug should only be given at an early stage of the disease, not chronic cases.

What should I know about interactions with other medicines?

Interactions with other medicines and products

The official regulatory documentation for DRAXXIN (tulathromycin) defines its interaction profile primarily through prohibitions related to preserving antimicrobial efficacy and maintaining the stability of the injectable formulation.


Documented Interaction Restrictions

Restriction Type Interacting Substance/Class Official Rationale
Co-administration Prohibition Other Macrolide Antibiotics Risk of cross-resistance (MLSB) due to similar mode of action.
Co-administration Prohibition Lincosamide Antibiotics Risk of cross-resistance (MLSB) due to similar mode of action.
Physical Incompatibility Other Veterinary Products Must not be mixed in the same syringe or container.

Pharmacodynamic and Timing Constraints

The most significant interaction involves a pharmacodynamic conflict with other macrolide and lincosamide antibiotics. Regulatory agencies require that these antibiotic classes must not be administered simultaneously with tulathromycin. This mandatory restriction exists to minimize the potential for bacteria to develop shared resistance to both classes of antimicrobials. Furthermore, the sterile injectable solution has a specific physical incompatibility restriction, meaning it must not be physically combined or diluted with any other medicinal products.

Official labels do not document specific pharmacokinetic interactions, such as those related to CYP enzymes or drug transporters, nor are interactions documented with food, alcohol, or herbal products.

Mechanism of Action

The mechanism of action for tulathromycin, the active component in DRAXXIN, involves a dual mechanism: direct antimicrobial activity complemented by modulation of the host's inflammatory response.

The core antimicrobial mechanism involves the selective engagement of the bacterial 50S ribosomal subunit. By binding to this structure, tulathromycin inhibits the biosynthesis of essential bacterial proteins, specifically by stimulating the dissociation of peptidyl-tRNA during translocation. This molecular cascade results in the cessation of bacterial protein synthesis and limits cell proliferation.

In addition to its antimicrobial effect, the molecule exerts an immunomodulatory effect by accumulating in host immune cells, specifically neutrophils and macrophages. This action promotes the timely apoptosis and clearance of excessive neutrophils (efferocytosis) and actively shifts the local environment by reducing pro-inflammatory signals (e.g., CXCL-8) while enhancing pro-resolving mediators (e.g., Lipoxin A4). This modulation promotes the transition from the acute inflammatory state toward the resolution phase and regulates cellular processes that contribute to tissue response.

The unique triamilide structure allows the molecule to concentrate and persist within target phagocytic cells, allowing for a sustained mechanistic effect. However, the mechanism is subject to constraints, including the potential for bacterial ribosomal resistance (e.g., 23S rRNA methylation) and a **reduced antimicrobial activity in highly acidic environments.

Dosage and Administration Information

DRAXXIN (tulathromycin) is administered via a single-injection protocol. The medicine is supplied as a sterile injectable solution, available in a 100 mg/mL concentration.

Administration Route and Dose

The route of administration is defined by the species. For cattle, the medicine is administered via Subcutaneous (SC) injection, whereas for swine, the route is Intramuscular (IM) injection. In all cases, the injection is given into the neck region. The standardized dosage for approved species is a single treatment of 2.5 mg of tulathromycin per kg of body weight (2.5 mg/kg BW). Accurate body weight determination is required to ensure the calculated volume is correct.

Procedural Constraints and Follow-up

The treatment consists of a single administration; re-treatment is not indicated. There is a constraint on the injection volume administered per site: for the 100 mg/mL product in cattle, the SC volume is not to exceed 10 mL at one site, requiring dose division into multiple sites if necessary. Intravenous and intra-arterial routes are avoided. Under the standardized protocol, the clinical response to the single dose is evaluated 48 hours after administration, with a transition to a different antimicrobial if signs are unsatisfactory. This structured approach ensures adherence to the usage model.

Recent Clinical Evidence

Research evidence / Overview of Studies for DRAXXIN

The research for DRAXXIN (tulathromycin) is primarily derived from clinical trials and comparative studies authorized and reviewed by regulatory bodies like the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). These studies was used in research exploring how symptoms change over time to understand how the medicine was observed in specific infectious conditions and what findings describe patterns observed in the studies over short- to intermediate-term follow-up periods.


Evidence for Use in Bovine Respiratory Disease (BRD)

Studies were conducted during periods of increased symptom activity and focused on cattle presenting with clinical BRD. These included large Randomized Controlled Trials (RCTs) and comparative field studies. Researchers monitored outcomes related to outcomes reflecting daily functioning or activity level, such as survival and clinical success, which was defined for study purposes by measurements including attitude scores, respiratory distress indices, and recorded body temperature. Research also explored the metaphylactic use of the medicine, which involved evaluating the treatment when administered to high-risk cattle upon arrival at a feedlot for use in disease control studies. Data show patterns related to a higher percentage of clinical success measurements compared to controls that received no treatment. Studies report data patterns related to an observation of a lower incidence of BRD (fewer animals later needing therapeutic treatment) compared to groups that did not receive the control measure.


Evidence for Use in Swine Respiratory Disease (SRD)

The research for SRD was evaluated in feeder pigs and growing swine. Research examined outcomes related to outcomes linked to inflammatory or irritative states, including clinical success scores and post-mortem lung lesion scores to measure the extent of respiratory tissue damage. Studies reported patterns related to increased measurements of clinical success compared to non-treated control groups when used for treatment.


What Remains Uncertain About DRAXXIN's Research

Follow-up durations were limited in most primary trials, meaning that long-term effects are not fully established, particularly concerning health patterns beyond two months post-treatment. Research concerning the medicine's use or effects on reproductive function in breeding animals, or in pregnant or actively lactating cows, appears to be limited or was excluded from the initial core regulatory trials. Therefore, results apply only to the populations studied and do not offer comprehensive data for these special physiological states.

Key Studies & References

  1. Draxxin, INN-Tulathromycin - European Commission Community Register of Veterinary Medicinal Products (Regulatory Monograph)
  2. Comparative efficacy of DRAXXIN® or Nuflor® for the treatment of undifferentiated bovine respiratory disease in feeder cattle (Comparative BRD Study)

Frequently Asked Questions (FAQ)

Common questions about DRAXXIN (FAQ)


Q: Is DRAXXIN approved for use in humans?

Official product labels and regulatory documents contain explicit warnings stating that DRAXXIN is for use in animals only and not for human use. The drug is a prescription veterinary medicine whose administration is strictly controlled by licensed veterinarians.


Q: What is the difference between DRAXXIN and DRAXXIN Plus?

DRAXXIN is a single-ingredient product containing only the antibiotic tulathromycin. DRAXXIN Plus is a different formulation that combines the antibiotic tulathromycin with ketoprofen, which is a nonsteroidal anti-inflammatory drug (NSAID).


Q: What are the main diseases DRAXXIN is used to treat in cattle and swine?

Official product information states that DRAXXIN is indicated for the treatment and control of Bovine Respiratory Disease (BRD) in cattle and Swine Respiratory Disease (SRD) in pigs. In cattle, it is also approved for treating specific infections such as Pinkeye and Foot Rot.


Q: Are there any diseases DRAXXIN is used to treat in sheep?

Yes, regulatory documents authorize the use of DRAXXIN in sheep for the treatment of infectious foot rot in its early stages. This specific use is restricted to certain types of susceptible bacteria.


Q: Does DRAXXIN have bacteriostatic or bactericidal action?

As a member of the macrolide class of antibiotics, tulathromycin is primarily considered bacteriostatic, which means it works by inhibiting the growth and multiplication of bacteria. However, official information notes that it may exhibit bactericidal (bacteria-killing) activity against certain specific types of pathogens.


Q: What is the meaning of the 'withdrawal period' for DRAXXIN, and what are the required times?

The withdrawal period is the mandatory waiting time that must pass after the last drug administration before an animal can be slaughtered for human consumption. This period is set by regulatory bodies to prevent drug residues in the meat. Official labels state the required times vary, but typically fall within ranges such as 18 to 22 days for cattle and 5 to 13 days for swine, depending on the specific product formulation and region of use.


Q: Is the meat from animals treated with DRAXXIN safe for human consumption after the withdrawal period? / Are there risks of drug residues in food products after treatment?

Regulatory agencies mandate the withdrawal period specifically to ensure that the meat from treated animals is compliant with established safe limits for drug residues (MRLs). If the official withdrawal period is strictly followed, the meat is considered compliant and meets regulatory compliance standards for human consumption.


Q: What is the typical timeframe for seeing the drug's effect after use?

Official guidelines recommend that the animal's clinical response to the single treatment be evaluated within 48 hours after administration. This 48-hour timeline serves as the official benchmark for veterinarians to determine if the treatment has been satisfactory or if a change in antimicrobial therapy is necessary.


Q: How long does the antibiotic stay active in the treated animal's system?

Studies indicate that the unique chemical structure of the drug allows it to persist in the animal’s system. Official product information indicates it maintains a concentration intended for therapeutic effect for approximately 9 to 14 days after a single injection.


Q: What kind of local reactions are seen at the injection site in pigs?

Regulatory documents classify injection site reactions in pigs as very common adverse effects. These reactions can include swelling, edema, hemorrhage (bruising), and the formation of fibrosis (persistent fibrous tissue), which may last for approximately 30 days after injection.


Q: Are there different formulations or concentrations of DRAXXIN available?

Yes, the drug is manufactured in different formulations designed for various applications and animal sizes. It is typically available as a 100 mg/ mL concentration, but a lower concentration of 25 mg/ mL is also approved and available for use in smaller animals.


Q: What happens if a person has accidental skin contact, gets the drug in their eyes, or has accidental self-injection?

Official safety information directs that in case of eye contact, the eyes should be flushed with clean water. For skin contact, the area should be washed with soap and water. If accidental self-injection occurs, the label states the person must immediately seek medical advice.


Q: What are the known potential adverse effects if a person were to swallow the drug?

Safety data sheets document the requirement that a physician or poison control center be contacted if the product is swallowed. Potential effects from oral exposure are generally associated with gastrointestinal irritation, which may include vomiting and diarrhea.


Q: Why is it recommended to wear protective gear when handling DRAXXIN?

Official precautions are recommended to minimize the risk of human exposure. It is advised to wear protective gloves and wash hands after use, as the product is an eye irritant and carries a risk of causing sensitization (allergic reactions) upon contact with the skin.


Q: Is DRAXXIN considered an antimicrobial important for human medicine?

Yes. While DRAXXIN is only for veterinary use, its active ingredient, tulathromycin, belongs to the macrolide class of antimicrobials. This class is formally classified by global organizations like the World Health Organization (WHO) as highly important or critically important for use in human medicine.


Q: How long has DRAXXIN been approved by regulatory bodies like the FDA or EMA?

Regulatory documents indicate a long-standing approval. For example, the European Medicines Agency (EMA) first authorized the use of the medicine in the European Union in 2008, establishing its timeline of regulatory oversight.

How should DRAXXIN be stored and disposed of?

Storage and Disposal Requirements for DRAXXIN

Official labeling defines specific conditions for storing and handling DRAXXIN (tulathromycin) injection to maintain its quality and efficacy.

Storage Conditions

The product must be stored at or below 30, C (86, F), and users are required to avoid freezing the solution. Containers should be protected from light and kept tightly closed when not in use. Once the vial is initially opened or punctured, a shortened in-use shelf life applies; the product must typically be used within 28 days (EMA) or 56 days (FDA/DRAXXIN KP) of the first puncture.

Handling and Disposal

For safety, the product must always be stored out of the sight and reach of children. The vial stopper is designed to withstand a maximum of 20 punctures. All unused veterinary medicinal product and waste materials must be discarded strictly in accordance with local regulatory requirements for pharmaceutical waste.

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

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