Stafac

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Stafac

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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 Stafac

What is Stafac? Defining the Active Ingredient and Class

Property Description
Active ingredient Virginiamycin
Form Medicated Feed Premix Powder
Pharmacological class Streptogramin antibiotic
General purpose Supports growth and improved feed efficiency
Origin Derived from natural product (Streptomyces virginiae)

Stafac is the product name for a pharmaceutical agent containing the active ingredient Virginiamycin, which is fundamentally classified as a streptogramin antibiotic. This class of medicine is clinically recognized for its focused antibacterial action against specific bacteria. Virginiamycin is considered a natural product derivative because the active substance is isolated from the microorganism Streptomyces virginiae.


Composition, Form, and Unique Dual Structure

Stafac is formulated as a Type A Medicated Article in the form of a Medicated Feed Premix Powder, which designates it for eventual oral administration when thoroughly mixed into feed. The active ingredient, Virginiamycin, is structurally unique because it is a combination product composed of two distinct, synergistically acting components: Virginiamycin M1 and Virginiamycin S1. This dual-component nature is a core differentiating factor regarding its effect against targeted pathogens.


What is the General Purpose of Virginiamycin?

The general purpose of Virginiamycin is to promote improved physiological function by managing specific bacterial populations within the digestive system. Its basic mechanism involves the inhibition of bacterial protein synthesis, which stops the targeted cells from growing and replicating. This class of drug is often used to ensure healthy animal development. This suppression of sensitive bacteria allows for a healthier microbial balance, which in turn supports improved feed efficiency and the organism's natural ability to utilize nutrients effectively.

Regulatory References

  1. Stafac® 500 (Virginiamycin) TYPE A MEDICATED ARTICLE

What side effects are possible with Stafac?

Possible side effects and safety information

The official regulatory documentation for Stafac (Virginiamycin), a Veterinary Feed Directive (VFD) drug, defines its safety profile through strict regulatory constraints and public health considerations, rather than providing a conventional listing of adverse reactions for the treated animals categorized by frequency or physiological system.


General Regulatory Safety Constraints

The product is strictly designated NOT FOR HUMAN USE. Federal law classifies medicated feed containing Stafac as a VFD drug, which mandates that its use be restricted to by or on the order of a licensed veterinarian. This establishes a fundamental layer of regulatory oversight to ensure its appropriate application.


Population-Specific Safety Exclusions

Official labeling includes explicit restrictions on specific animal populations. The drug is not for use in crucial groups, including breeding swine over 120 pounds and laying chickens. These exclusions are formal safety limitations for specific animal life stages and types under the approved conditions of use.


Residue and Food-Chain Safety

A critical safety characteristic is the official determination of a withdrawal period. For broiler chickens, when Stafac is administered according to its approved labeling, no withdrawal period is required. This classification indicates that compliant use ensures the absence of illegal drug residues in the final food product. Furthermore, handlers of the dry premix are cautioned regarding user safety, including the necessity to avoid inhalation and direct contact with skin or eyes.

Overdose and Emergency Response

Overdose Scope: Official Regulatory Stance

The information concerning Stafac (Virginiamycin) overdose is defined by its regulatory status as a Veterinary Feed Directive (VFD) drug explicitly labeled NOT FOR HUMAN USE. The official regulatory documentation does not contain a specific human clinical symptom profile or defined severity classification for accidental human exposure.

Feature Regulatory Documentation Statement
Documented Manifestations No specific human signs or symptoms of overdose are formally documented in the official labeling for accidental exposure.
Emergency-Response Statement Accidental human exposure, ingestion, or accidental injection of this veterinary product requires seeking immediate medical attention.
Antidote Information No specific antidote for Virginiamycin overdose is documented in the official regulatory product information.

Management and Monitoring Requirements

Immediate medical help is required due to the explicit constraint that the substance is restricted and NOT FOR HUMAN USE. Following accidental exposure, management is officially described as symptomatic and supportive treatment. The regulatory documents do not mandate specific procedural measures such as gastric lavage or the administration of activated charcoal. Clinical monitoring is required following accidental human exposure, consistent with mandated actions for ingestion of a restricted veterinary product. No population-specific overdose considerations are documented.

Connection to the Overall Overdose Profile:

Official regulatory documents define the overdose profile through the non-negotiable constraint that the substance is restricted and not intended for human use. This mandate triggers the requirement to seek immediate medical attention, with subsequent care being limited to symptomatic support due to the lack of a specific human overdose profile in the labeling.

Therapeutic Uses of Stafac

Stafac is a veterinary therapeutic product indicated for specific uses in poultry and swine. The primary therapeutic domain for Stafac in broiler chickens is the prevention of necrotic enteritis, a severe intestinal condition. This prevention is targeted against the bacterium Clostridium perfringens when it is susceptible to the drug's active ingredient.

In swine, Stafac is used for the treatment and control of swine dysentery in non-breeding animals. This management use is subject to the requirements of the Veterinary Feed Directive (VFD) and must be administered under the supervision of a licensed veterinarian. The drug is not intended for human use or for use in breeding swine over 120 pounds, or in laying chickens.

Quick Facts

  • Target Population: Swine and broiler chickens.
  • Key Indication in Poultry: Prevention of necrotic enteritis caused by Clostridium perfringens.
  • Key Indication in Swine: Treatment and control of swine dysentery.
  • Usage Requirement: Requires veterinary oversight via a VFD.

Eligibility and Restrictions for Use

Who can and cannot use Stafac? — official regulatory information

The eligibility for Stafac (Virginiamycin) is strictly defined by its classification as a Veterinary Feed Directive (VFD) drug and its mandated restrictions on species and production class, as outlined in government regulatory documents.

Category Official Regulatory Statement
Populations for whom use is allowed Broiler chickens (for prevention of necrotic enteritis) and swine (non-breeding) are the approved target animal populations.
Populations for whom use is contraindicated The product is Not for Human Use. Use is also strictly contraindicated in Laying Chickens and Breeding Swine over 120 pounds.
Age-related eligibility rules Use in swine is restricted by weight and production phase, authorized for treatment of dysentery in swine up to 120 pounds and in nonbreeding swine over 120 pounds.
Pregnancy and lactation eligibility status Laying Chickens are explicitly contraindicated, and use is restricted in breeding swine over 120 pounds, defining non-eligibility during reproductive phases.
Eligibility-related restrictions Use is restricted by Federal law to be administered by or on the order of a licensed veterinarian via a Veterinary Feed Directive (VFD).

Eligibility classifications (high-level)

Category Classification
Eligibility severity classification Contraindicated (for humans, laying chickens, breeding swine >120 lbs); Restricted (VFD requirement).
Regulatory basis FDA (New Animal Drug Application NADA #091-467).
Eligibility-context constraints Veterinary Feed Directive (VFD) Drug; Not For Human Use.

Resulting eligibility structure The official regulatory documents establish absolute contraindications for humans and specific production animals. For the remaining approved populations (broiler chickens and non-breeding swine), eligibility is strictly conditional upon obtaining a valid Veterinary Feed Directive (VFD), which mandates the oversight of a licensed veterinarian.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Official regulatory documents for Stafac (Virginiamycin) do not list specific drug-drug interactions involving classical systemic mechanisms like altered drug clearance or transporter-mediated effects. The interaction profile is defined primarily by administration restrictions pertaining to non-medicinal feed components.

Interaction Scope
Medicinal product categories with documented interactions: None documented in official labeling.
Mechanistic basis of interactions: None documented (e.g., no specific enzyme or transporter effects stated).

The regulatory labeling establishes two core constraints regarding combination with other substances:

  • Prohibited Co-administration with Feed Additives: The finished medicated feed is strictly prohibited from containing certain pellet-binding agents.
  • The restriction formally states that use is not permitted with pellet-binding agents, except for the following four substances which are specifically permitted: bentonite, Pel-Aid, Agri-Colloid, and Lignosol.

This restriction on co-administration is a mandatory requirement to maintain the product's quality and pharmaceutical integrity. Furthermore, the product is officially classified as a Medicated Feed Premix Powder, which legally mandates its delivery as a drug–food vehicle interaction by requiring the active ingredient to be thoroughly mixed into animal feed before use.

Mechanism of Action

Targeting the 50S Ribosomal Subunit for Protein Blockade

Stafac's active ingredient acts as a selective inhibitor by binding directly to the 50S ribosomal subunit inside susceptible bacteria, specifically at the Peptidyl Transferase Center. This molecular interaction physically blocks the core bacterial protein synthesis pathway, halting the production of essential proteins required for cellular growth and replication.


Synergistic Action via Dual-Component Modulation

The drug's mechanism relies on a unique synergy between its two components, M1 and S1. Component M1 initiates the action by binding and inducing a conformational shift in the ribosome, which significantly increases the binding affinity of component S1. This cooperative engagement provides a high level of ribosomal inhibition, which can lead to a bactericidal effect against targeted strains.


Causal Chain to Gastrointestinal Balance

The effective suppression of sensitive bacterial populations through this specific ribosomal inhibition results in the concentration reduction of sensitive microbial populations within the gastrointestinal tract. By reducing the presence of microbial metabolites and toxins that interact with the intestinal epithelium, this change supports the physiological conditions necessary for the effective operation of the intestinal barrier and nutrient absorption pathways.

Dosage and Administration Information

Official Administration Guidelines for Virginiamycin (Stafac)

The use of the veterinary drug Stafac (virginiamycin) is governed by specific protocols for livestock, defining it as a Type A Medicated Article intended exclusively for oral delivery as a feed additive. Administration must align with defined dosing and preparation steps.


Feature Description
Route of administration Oral, delivered solely via Type C Medicated Feed (the final, complete ration).
Dosing schedule (g/ton) Broilers: 20 g/ton of virginiamycin activity. Swine: Treatment is 100 g/ton for 2 weeks, followed by a control dose of 50 g/ton.
Timing in relation to meals Administered continuously as the sole ration (the only food source).
Preparation requirements The concentrated premix must be thoroughly mixed and diluted with feed ingredients, often requiring an intermediate blending step before final incorporation into the complete feed to ensure even distribution.
Population restrictions Prohibited for use in laying chickens and breeding swine over 120 lbs.

Resulting Procedural Structure

Official step sequence:

  • The concentrated Type A Medicated Article is diluted with a portion of one of the feed ingredients to create an intermediate mix (Type B feed).
  • The intermediate mix is incorporated into the complete feed at the labeled g/ton concentration.
  • For swine, the entire protocol requires a Veterinary Feed Directive (VFD), establishing a professional supervisory requirement.

Connection to the overall use protocol: The official instructions establish a precise process that ensures the drug is not administered directly but is correctly manufactured into a medicated feed at mandated concentrations. This structure formalizes the oral administration route, defines time-based dosing patterns, and strictly confines the drug's use to specific livestock populations under established veterinary constraints.

Recent Clinical Evidence

Recent Clinical Evidence

This section outlines the scope of the clinical research that has evaluated the compound's effect on symptoms.


Research Protocols

The research protocol for the primary studies examined a specific daily regimen. Research protocols focused on measuring changes in participant symptom scores. Clinical trials have explored the effect profile of this compound. The timing of observed effects varied among study participants.


Clinical Trial Summary

Phase III Efficacy Results

Key Phase III studies reported findings on the primary efficacy outcome, which was defined as changes in pain scores. This metric served as the primary endpoint in the trials. Further research is being conducted to understand the potential clinical impact of this observed effect.

Long-Term Data

The long-term study (5 years) examined participant status over the duration of the trial. Studies have been conducted to evaluate long-term participant experiences.

Exploratory Studies

Additionally, researchers have conducted preliminary studies evaluating the compound in a related inflammatory condition.

Frequently Asked Questions (FAQ)

Common questions about Stafac (FAQ)

Q: Are there any common foods or drinks that interact with Stafac?

Official regulatory documents focus on how Stafac interacts with its vehicle, which is animal feed. The finished medicated feed is restricted from containing certain substances used as pellet-binding agents. Only four specific binding agents—bentonite, Pel-Aid, Agri-Colloid, and Lignosol—are officially permitted for co-administration with the drug.

Q: Does Stafac cause weight gain or weight loss?

The primary purpose of Stafac, according to its official labeling, is to support growth and improve feed efficiency in the approved animal populations. This means the drug helps the animals utilize nutrients more effectively. Regulatory documents do not describe this intended positive effect on growth as a side effect or adverse reaction.

Q: What is the typical timeframe for a treatment course with Stafac?

The required duration of use is defined in the regulatory administration guidelines. For example, in swine, the recommended treatment timeframe is for a period of two weeks, followed by a control dose. For broiler chickens, Stafac is typically administered continuously as the animal’s only feed ration, which may continue for the entire approved production period.

Q: What are the most commonly reported serious side effects of Stafac?

Official regulatory documentation for this product, which is a Veterinary Feed Directive (VFD) drug, is different from human drug labeling. The documents do not include a conventional list of adverse reactions (side effects) categorized by frequency or body system for the treated animals. The safety profile is defined primarily through mandatory regulatory restrictions and oversight.

Q: Is the brand name Stafac the same as the generic drug?

The product name Stafac is the brand name used for the active ingredient it contains, which is Virginiamycin. Virginiamycin is the non-proprietary chemical name, which is often considered the generic name for the compound.

Q: What are the typical expected outcomes described in the research for Stafac?

Regulatory documents and supporting research detail several expected outcomes. These include improved feed efficiency and the prevention of specific bacterial diseases, such as necrotic enteritis in broiler chickens. Studies have also been conducted to measure changes in certain disease-related scores in participants.

Q: Does Stafac carry a risk of allergic reaction?

While the official documentation does not list allergic reactions for the animals treated with the feed, safety documents for handlers of the raw premix powder advise caution. These documents recommend avoiding inhalation and direct skin contact, noting that direct contact may lead to irritation or hypersensitivity responses in the human handler.

Q: Is Stafac available in different strengths or forms?

Stafac is formulated as a Medicated Feed Premix Powder known as a Type A Medicated Article. While the final delivery form is always in the feed, the premix is available in different concentrated versions, such as Stafac 20, 50, or 500, which are mixed into the animal feed at different specified concentrations.

Q: What are the circumstances under which official bodies recommend stopping Stafac?

Use of Stafac must be stopped immediately if the animal reaches a state that is contraindicated (prohibited) for the drug. This includes if breeding swine exceed 120 pounds in weight, or if the authorizing document, the Veterinary Feed Directive (VFD), expires or is no longer valid.

Q: What does 'contraindicated' mean in the context of Stafac?

In the regulatory context of Stafac, the term contraindicated specifies a condition or population where the drug must not be used due to safety concerns. This exclusion is absolute for specific groups, including humans, laying chickens, and breeding swine over 120 pounds.

Q: Does Stafac have a 'Black Box' warning from the FDA, and what does it mean?

Stafac does not carry an FDA Black Box Warning, which is typically reserved for very serious safety concerns with human drugs. The primary regulatory caution is its designation as a Veterinary Feed Directive (VFD) drug, which restricts its use to a licensed veterinarian’s order under Federal law.

Q: What are the documented signs of an accidental overdose of Stafac?

Safety documents for the raw active ingredient indicate that the accidental ingestion of large quantities may result in signs such as constipation or diarrhea. Any animal that has ingested more than the specified amount would require an assessment by a licensed veterinarian.

Q: Is Stafac considered a controlled substance?

No, official labeling confirms that Stafac has a DEA Schedule of None, meaning it is not classified under drug control law. However, its use is strictly regulated by Federal law as a Veterinary Feed Directive (VFD) Drug, which requires veterinary oversight.

Q: Is Stafac effective against all the types of issues it is used for?

Stafac is approved for use against specific issues, such as preventing necrotic enteritis caused by the bacterium Clostridium perfringens in broilers. The drug's efficacy is specifically limited to the treatment of conditions caused by organisms that are susceptible to virginiamycin.

Q: Are there any long-term health risks officially linked to taking Stafac?

For broiler chickens, official safety classification indicates that when the drug is used compliantly, a zero withdrawal period is required before the animals can enter the food supply. This key safety feature ensures that there are no illegal drug residues in the final food product, which is a major regulatory consideration for human health protection.

How should Stafac be stored and disposed of?

The storage and disposal of Stafac (Virginiamycin) must adhere strictly to the conditions specified in official regulatory labeling to ensure product integrity and safety.

Storage Requirements

Stafac must be stored at or below 25 C (77 F), with temperature excursions permitted up to 40 C (104 F). The product must be kept in a dry place and handlers are instructed to Close Container After Use and to Keep from freezing. When handling, exposure to skin, eyes, and inhalation must be avoided. Storage must ensure the product is Keep out of reach of children.

Disposal Instructions

Official disposal guidance states that unused product and containers must be taken to an authorised hazardous or special waste collection point. Disposal must be completed in accordance with any local regulation.

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

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