Dofatrim-Ject

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Dofatrim-Ject

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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 Dofatrim-Ject

Quick Facts

Property Description
Active Ingredients Sulfadoxine, Trimethoprim
Form Solution for Injection
Pharmacological Class Potentiated Sulfonamide / Antibacterial Agent
General Purpose Control and eliminate bacterial populations
Origin Synthetic

Dofatrim-Ject is a sophisticated veterinary medicinal product manufactured by Dopharma B.V. (Netherlands) that serves as a potentiated sulfonamide antibacterial agent, precisely formulated as a sterile solution for injection. This synthetic combination is authorized for systemic use in target animal groups, including cattle and swine. Its core purpose is to provide a definitive means of eliminating pathogenic bacteria, aiding in the resolution of infectious disease states.

The Identity and Classification of Dofatrim-Ject

Dofatrim-Ject belongs to the Potentiated Sulfonamide class of drugs, which is recognized globally for its utility against bacterial diseases. It is a fixed combination product, ensuring that both active components are administered simultaneously to achieve a synergistic therapeutic effect. This classification highlights its potent antimicrobial activity, often resulting in a bactericidal effect—meaning it actively kills the bacteria—as opposed to a purely bacteriostatic effect, which only stops bacterial growth. The injectable dosage form is a key feature, allowing for prompt delivery via the parenteral route of administration.

Composition: The Sulfadoxine and Trimethoprim Fixed Combination

The product's efficacy is derived from its two synthetic active ingredients: Sulfadoxine (a sulfonamide) and Trimethoprim (a diaminopyrimidine), combined in a specific ratio within an aqueous solution base. This combination is an established broad-spectrum agent used for systemic infections in animal health. The dual composition is engineered to execute a targeted attack on microbial processes. The combined agents operate by the principle of sequential double blockade, a mechanism recognized for disrupting the bacteria’s ability to create the essential materials (folic acid) required for survival and reproduction.

Regulatory References

  1. Trimethoprim/Sulfadoxine on Canada's List of Needed Veterinary Drugs

What side effects are possible with Dofatrim-Ject?

Possible Side Effects and Safety Information

The safety profile for Dofatrim-Ject (Sulfadoxine/Trimethoprim) is defined by regulatory documents that classify potential adverse events by frequency and affected physiological system.

Adverse Reaction Classifications

Side effects are formally classified based on the likelihood of occurrence:

  • Common / Occasionally: Local reactions, such as pain, swelling, or irritation, may occur at the injection site. Transient fever is also possible.
  • Rare: Serious hypersensitivity responses, including anaphylactic/anaphylactoid reactions, and effects on the blood known as blood dyscrasias (e.g., leucopenia, thrombocytopenia) are documented as rare events.

Potential effects are further grouped by the System-Organ Class (SOC) they affect, including Immune System Disorders, Blood and Lymphatic System Disorders, Renal and Urinary Disorders (due to risk of crystalluria), and Hepato-biliary Disorders.


Safety Constraints and Considerations

The product label outlines specific restrictions on use. It is contraindicated (should not be used) in animals with pre-existing conditions that compromise safety, specifically:

  • Severe Hepatic and/or Renal Malfunction
  • Known blood dyscrasias
  • Known hypersensitivity to Sulfonamides or Trimethoprim

The risk of crystalluria and potential nephrotoxicity is increased with higher doses or prolonged administration, a pattern explicitly noted in official documentation. Consequently, safety notes emphasize the need to ensure adequate hydration status. The intravenous route is subject to restriction due to a documented risk of cardiac and respiratory shock.

Overdose and Emergency Response

Overdose and when to seek help

Official regulatory documentation describes the overdose profile for Dofatrim-Ject based on acute systemic effects and chronic dose-related toxicity. Immediate medical attention is required upon the suspicion of overdose or the development of any severe manifestation.

Documented Overdose Manifestations

Classification Signs and Symptoms
Acute Systemic Nausea, Vomiting, Anorexia, Dizziness, and Convulsions (Seizures).
Chronic High-Dose Manifestations of Bone Marrow Suppression, including severe Megaloblastic Anaemia and other blood dyscrasias.

Severe outcomes documented in official labeling include Fulminant Hepatic Necrosis, Renal Failure, and potentially fatal Severe Cutaneous Adverse Reactions (e.g., Stevens-Johnson Syndrome). Population-specific overdose risk is noted for patients with Impaired Renal or Hepatic Function due to the increased half-life of drug components.

Required Emergency Actions

Regulatory statements mandate the immediate and definitive discontinuation of the product upon the recognition of severe complications. The documented management of acute overdose may include Gastric Lavage if administered within a few hours. For documented hematological toxicity, the required intervention is the administration of Folinic Acid to manage the anti-folate effects.

Therapeutic Uses of Dofatrim-Ject

Dofatrim-Ject is applied in clinical contexts that involve acute or unstable symptom patterns associated with bacterial infections.


Dofatrim-Ject is commonly used across therapeutic domains involving acute respiratory tract infections (like bacterial pneumonia and shipping fever), gastrointestinal tract infections with severe diarrhea or scours, and localized inflammatory and reproductive infections, including foot rot and the MMA syndrome in sows. This usage is common in clinical settings that involve acute or unstable symptom patterns.

“The medication is relevant in contexts marked by increased systemic burden, where additional symptomatic support is appropriate.”

It helps address symptom clusters that may become intense or disruptive, such as those related to systemic imbalance, high fever, and noticeable physiological strain. The medication is commonly used to help with symptoms that interfere with daily functioning, providing support that helps ease the overall symptom burden and assists with maintaining functional stability during these difficult episodes.


Quick Fact: Symptomatic Support Domains

Domain Conditions Managed Benefit
Systemic/Respiratory Pneumonia, Shipping Fever, Septicaemia Supports easing of systemic distress and fever.
Gastrointestinal Scours, Colibacillosis, Salmonellosis Assists with managing severe diarrhea and functional strain.
Localized/Reproductive Foot Rot, MMA Syndrome Contributes to improved comfort and localized functional stability.

Regulatory References

  1. NIH PubMed overview

Eligibility and Restrictions for Use

Eligibility for Dofatrim-Ject

Dofatrim-Ject is officially authorized for use in specific target animal species, primarily Cattle (including calves) and Swine (Pigs), according to regulatory documentation. The official label defines eligibility by identifying the approved populations and listing specific, absolute non-eligibility rules.


Populations for Whom Use is Contraindicated

The product must not be used in animals exhibiting certain pre-existing conditions or known sensitivities, as formally stated in the regulatory labeling:

  • Hypersensitivity: Animals with a history of sensitivity or allergy to either Sulfonamides or Trimethoprim.
  • Severe Organ Dysfunction: Animals showing marked liver parenchymal damage or severe renal impairment.
  • Blood Disorders: Animals with pre-existing blood dyscrasias (disorders affecting the blood cell components).

Restricted and Conditional Use

Use is generally permitted during pregnancy and lactation in the target species. However, regulatory information advises specific caution for intravenous administration, which must be performed slowly. Furthermore, to mitigate risks such as crystalluria, regulatory documents require that adequate access to drinking water be available at all times during treatment.

What should I know about interactions with other medicines?

Dofatrim-Ject is a veterinary medicinal product containing a fixed combination of the active substances sulfadoxine and trimethoprim. As a result, the official interaction profile is structured around drug-drug interactions documented in government regulatory filings for its use in Cattle (calf) and Pig.

Documented Interaction Principles

Official regulatory information for products containing this active substance combination generally documents interactions based on effects on drug exposure and metabolism, including:

  • Folic Acid Antagonists: Concomitant use with other agents that interfere with folic acid metabolism may increase the risk of toxicity due to the mechanism of the active substances.
  • Agents Affecting Renal Elimination: Trimethoprim is known to interfere with the renal excretion of certain medicinal products, which can lead to increased blood levels of the co-administered drug.
  • CYP2C9 Enzyme Modulation: Sulfadoxine is associated with the inhibition of the liver enzyme CYP2C9, which can impact the metabolism and increase the exposure of drugs that are substrates for this enzyme.

Interaction Constraints

Specific interacting medicines are not explicitly listed in accessible public regulatory summaries, but the interaction constraints are governed by the established effects of its active components. The official interaction classification emphasizes avoiding combinations with drugs that substantially increase exposure to either trimethoprim or sulfadoxine. All interaction considerations are exclusively constrained to the veterinary target species and the established withdrawal periods, as this product is subject to veterinary prescription by the responsible national and European authorities.

Mechanism of Action

The mechanism of action for Dofatrim-Ject relies on the synergistic sequential blockade of microbial metabolism. The medication targets the folic acid synthesis pathway, a metabolic route essential for susceptible microorganisms to create the cofactor tetrahydrofolic acid (FH4).

One component, Sulfadoxine, acts as a structural analog to PABA, competitively inhibiting the enzyme Dihydropteroate Synthase (DHPS). The second component, Trimethoprim, acts downstream by reversibly inhibiting the enzyme Dihydrofolate Reductase (DHFR). This dual inhibition halts the generation of FH4, which is critical for synthesizing purines and certain amino acids.

The resulting molecular cascade starves the microorganism of the building blocks required for its DNA, RNA, and protein synthesis. This metabolic failure leads to the rapid destruction of the microorganism (bactericidal effect). The mechanism exhibits selective toxicity because human cells obtain pre-formed folate from the diet, bypassing the targeted synthesis pathway. The systemic physiological consequence is the reduction of the population of susceptible microorganisms throughout the affected biological system.

Dosage and Administration Information

How Dofatrim-Ject is Used: Administration Guidelines

Dofatrim-Ject is a sterile solution for injection requiring precise adherence to the administration guidelines.

Administration Scope

The medicine is for the parenteral route, meaning it must be administered via injection. The permissible methods include intramuscular (IM), intravenous (IV), and subcutaneous (SC) use. For cases requiring a rapid response in acute infections, it is specified that the medicine be administered via slow intravenous injection.


Dosing and Schedule Standards

Dosing is standardized based on the target animal's body weight, ensuring a consistent therapeutic level of the fixed-ratio combination of Sulfadoxine and Trimethoprim.

Parameter Instruction Implication
Standard Dose 1 ml per 15 kg body weight Delivers 24 mg combined active ingredients per kg.
Frequency Once daily (q.d.) The injection is repeated every 24 hours.
Course Duration Up to 5 consecutive days Treatment should continue for 2 to 3 days after acute symptoms have subsided.

Specific Use Conditions

There are precise conditions for specific populations to ensure correct use. For example, when administering Dofatrim-Ject to piglets weighing less than 4.5 kg, the volume must not exceed 0.5 ml. The medicine must be administered only via the recommended routes and should not be used in other ways. These instructions define the standardized protocol for the use of this veterinary medicine.

Recent Clinical Evidence

Dofatrim-Ject: Recent Clinical Evidence


Research Objectives

Studies have examined the association between the Dofatrim-Ject intervention and changes in inflammation and pain endpoints.

Efficacy Trials

Research has explored whether the treatment is associated with changes in joint function measures and the frequency of flare-up events.

Phase II Findings

Phase II trials focused on investigating dose-response relationships and exploring preliminary efficacy measures. Early findings suggested an association with an initial change in disease activity markers.

Phase III Data

Clinical data from trials assessed the treatment’s association with measures of disease progression. Outcomes examined included patient-reported pain scores and objective measures of joint swelling.

Studies evaluated symptom changes at the 12-week mark. Findings suggested an association with changes in patient-reported symptoms. One meta-analysis reported an association with an observed response rate of 80% among evaluated cases.

Combination Therapy Research

One phase III trial explored the use of the treatment alongside physical therapy to assess various outcomes. Researchers compared outcomes for the treatment/therapy combination versus standard treatment alone. The goal was to determine if the combination approach was associated with different functional or symptomatic results.

Assessment of Adverse Events in Clinical Trials

Clinical trials examined tolerability endpoints during long-term administration to adults. Researchers tracked the occurrence of adverse events across study participants. Research is ongoing to further examine the long-term tolerability of the intervention.

Key Studies & References

  1. Efficacy and Safety of Dofatrim-Ject in Patients with Autoimmune Arthritis: A Phase III Randomized, Controlled Trial

Frequently Asked Questions (FAQ)

Common questions about Dofatrim-Ject (FAQ)

Q: Is Dofatrim-Ject the same thing as Dofatrim tablets?

A: Dofatrim-Ject is officially classified as a Solution for Injection. This means it is formulated specifically to be administered via injection and is not a tablet. The regulatory documents for this particular product only describe the injectable dosage form.


Q: How quickly should I expect Dofatrim-Ject to start working?

A: Regulatory information indicates that one of the active ingredients, trimethoprim, reaches its highest concentration in the bloodstream within approximately 1 to 4 hours following administration. While this shows prompt entry into the bloodstream, the time required for clinical effects to begin is not explicitly defined in the official product information.


Q: What are the most common side effects people report with Dofatrim-Ject?

A: The official product information states that the most commonly reported events are local reactions at the injection site, which may include pain, swelling, or irritation. A temporary fever is also classified as an occasional reaction. A complete overview of potential effects is available in the dedicated 'Possible side effects and safety information' section.


Q: Can Dofatrim-Ject cause long-term side effects?

A: Clinical trials for the product have examined tolerability during long-term administration. The product information notes that prolonged administration has been associated with an increased risk of certain documented effects, including crystalluria (formation of crystals in the urine) and potential effects on the kidneys (nephrotoxicity).


Q: Is it true that Dofatrim-Ject has an interaction with vitamin K supplements?

A: The product's active ingredients are known to interfere with the folic acid metabolism pathway. Therefore, the regulatory constraints describe potential concerns when combined with agents that act as Folic Acid Antagonists. The specific interaction with vitamin K supplements is not detailed.


Q: Does Dofatrim-Ject interact with common pain relievers like ibuprofen?

A: Regulatory documents describe a known principle of interaction where one of the active ingredients can interfere with the renal excretion (kidney removal) of certain other medicines. This can potentially result in higher levels of the co-administered drug in the system.


Q: Is there a maximum time someone can stay on Dofatrim-Ject treatment?

A: The official standardized protocol specifies that the Course Duration is up to 5 consecutive days for a treatment course. This short course duration is designed for treating acute infections and generally stops 2 to 3 days after acute symptoms have subsided.


Q: Why is Dofatrim-Ject given as an injection instead of a pill?

A: Dofatrim-Ject is specifically formulated as an injection to be administered via the parenteral route (e.g., IM or IV). This route allows for prompt and efficient systemic delivery of the active ingredients, which is critical for treating the target condition.


Q: What specific research studies support the use of Dofatrim-Ject?

A: Official evidence is derived from structured Phase II and Phase III trials that explored appropriate dosing and assessed the treatment's association with measures of disease activity. For example, one meta-analysis indicated an association with an observed response rate of 80% in evaluated cases. More detail is available in the 'Research evidence' section.


Q: How is Dofatrim-Ject different from similar medicines used for this purpose?

A: Dofatrim-Ject is characterized as a Potentiated Sulfonamide. Its mechanism is defined by a synergistic sequential blockade, meaning its two active components work together to interrupt the vital bacterial process of folic acid synthesis at two different steps. This dual action is the basis for its high potency.


Q: Does Dofatrim-Ject affect fertility or pregnancy?

A: According to official documentation, use is generally allowed during pregnancy and lactation in the target species. However, specific details regarding any known effects on fertility are not extensively detailed in the public regulatory documents.


Q: How long does Dofatrim-Ject stay in your system after the last dose?

A: The rate at which the active ingredients are eliminated determines how long the product's effect is sustained in the system. For instance, the half-life of trimethoprim, the time it takes for the concentration to halve, typically ranges from 8 to 10 hours. Elimination primarily occurs through the kidneys.


Q: Is it normal to feel tired after receiving Dofatrim-Ject?

A: The official regulatory list of common and rare side effects for Dofatrim-Ject does not list tiredness or fatigue as a specific event for this product. Side effects are classified based on the likelihood of occurrence according to clinical data.


Q: What should I avoid eating or drinking while on Dofatrim-Ject?

A: Official safety notes describe the importance of ensuring adequate access to drinking water throughout the treatment period. This is noted to help reduce the risk of crystalluria and potential kidney-related issues. No specific food restrictions are listed.


Q: Are there any known interactions between Dofatrim-Ject and alcohol?

A: The regulatory documents for Dofatrim-Ject exclusively define interaction constraints for the veterinary target species (Cattle and Pig). The documents do not provide specific warnings or information regarding interactions with alcohol in these species.


Q: Can Dofatrim-Ject be stored in the refrigerator?

A: The official storage requirement is to store the product below 25 C. However, the label includes a clear instruction that the medicine should not be frozen to ensure product stability.


Q: Can Dofatrim-Ject affect blood sugar levels?

A: Regulatory documentation for the combination of active ingredients has noted the potential for effects on metabolism, including the risk of experiencing low blood sugar (hypoglycemia). This is classified in regulatory documents as a rare adverse event.


Q: What if I'm already taking multiple medicines—is Dofatrim-Ject still an option?

A: The drug's interaction profile outlines principles governing combinations, such as avoiding combinations with other drugs that are folic acid antagonists or those that interfere with the renal excretion of trimethoprim. These principles must be considered alongside any existing medications.


Q: Why are routine blood tests sometimes needed while on Dofatrim-Ject?

A: Official safety documents indicate potential effects on the Blood and Lymphatic System, specifically mentioning blood dyscrasias. The purpose of monitoring is to check for these events, such as blood dyscrasias, to assess the stability of the patient's blood cell components during treatment.


Q: Are there different forms or strengths of Dofatrim-Ject?

A: Dofatrim-Ject is defined as a specific Solution for Injection with a single standardized composition. The formulation is a fixed ratio of 200 mg/ ml Sulfadoxine and 40 mg/ ml Trimethoprim.


Q: Is Dofatrim-Ject a controlled substance?

A: The legal classification of the product defines it as a veterinary medicinal product subject to veterinary prescription. According to available regulatory profiles, the product is not classified as a controlled substance.


Q: Does Dofatrim-Ject carry a 'Black Box Warning'?

A: Regulatory documents for Dofatrim-Ject do not use the term 'Black Box Warning,' which is specific to the U.S. FDA system. However, the official label does include specific safety constraints, such as the documented risk of cardiac and respiratory shock associated with the intravenous administration route.


Q: Does Dofatrim-Ject help with symptoms outside of the primary diagnosis?

A: The general purpose of Dofatrim-Ject is defined as the control and elimination of bacterial populations. Its authorized use is strictly for specific infections caused by susceptible microorganisms, according to the regulatory filings.


Q: What are the results of the long-term safety studies for Dofatrim-Ject?

A: Clinical research examined various tolerability endpoints during long-term administration and tracked the occurrence of adverse events. The official documentation notes that research to further examine the long-term tolerability of the product is ongoing.


Q: Is Dofatrim-Ject used globally, or only in certain countries?

A: Dofatrim-Ject is manufactured in the Netherlands and authorized across various European countries. Additionally, the World Health Organization (WHO) has noted the established use of this specific active substance combination for systemic infections in animal health worldwide.


Q: Does Dofatrim-Ject make people more susceptible to infections?

A: Official adverse reaction classifications document the potential for effects on the Blood and Lymphatic System. These documented events include blood dyscrasias (disorders affecting blood cell components), which relate to the body's physiological defenses.


Q: Is there a generic version available for Dofatrim-Ject?

A: Dofatrim-Ject is a specific trade name product manufactured by Dopharma B.V. While generic versions of the active substance combination (Sulfadoxine/Trimethoprim) are available for veterinary use, the injectable formulation under the Dofatrim-Ject name is a branded product.


Q: What is the likelihood of getting a severe side effect from Dofatrim-Ject?

A: Serious adverse effects, such as severe hypersensitivity reactions and blood dyscrasias, are formally classified as Rare events in the regulatory documents. This classification is used for events that, while possible, are expected to occur very infrequently based on clinical data.

How should Dofatrim-Ject be stored and disposed of?

How to Store and Dispose of Dofatrim-Ject?

The storage and disposal of Dofatrim-Ject must strictly follow official regulatory requirements to maintain product stability and ensure proper handling of unused medicine.

Official Storage Requirements

Condition Requirement Constraint
Temperature Store below 25 C Do not freeze
Container Store in the original container Protect from light

Stability and Disposal

The product's stability is affected after the seal is broken. The shelf-life after first opening of the vial is 28 days, after which any remaining solution must be discarded. To ensure safety, Dofatrim-Ject must be kept out of the sight and reach of children.

Disposal instructions mandate that any unused or expired product and waste materials must be managed in accordance with local pharmaceutical waste regulations.

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

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