Promox LA

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Medically reviewed

Marina Burgos

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 Promox LA

Property Description
Active ingredient Amoxicillin (as Amoxicillin trihydrate)
Form Suspension for Injection (Long-Acting)
Pharmacological class \beta-Lactam Antibiotic (Penicillin Class)
General purpose Elimination of susceptible bacterial infections
Origin Semisynthetic

What Type of Antibiotic is Promox LA?

Promox LA is definitively classified as a dedicated veterinary medicinal product, belonging to the \beta-Lactam antibiotic group, which is a subdivision of the Penicillin-class antibacterials. Its core component is the semisynthetic compound, Amoxicillin, often supplied as Amoxicillin trihydrate. Amoxicillin is globally recognized as an established broad-spectrum penicillin derivative with bactericidal activity, confirming its use as a systemic antibacterial agent used exclusively in animal medicine, targeting production animals such as cattle, sheep, and pigs.

Understanding the Long-Acting (LA) Formulation

This preparation is a sterile Suspension for Injection at a standard concentration of 150 mg/mL Amoxicillin. The crucial "LA" designation means it is an Extended-release or Long-Acting formulation, a key feature that differentiates it from standard Amoxicillin products. This differentiating factor is achieved by suspending the Amoxicillin trihydrate within a specialized, non-aqueous, oily base. This specific composition is clinically recognized for providing prolonged therapeutic plasma concentrations, ensuring the single active ingredient product maintains consistent activity for an extended period following intramuscular administration.

What is the General Purpose of Promox LA?

The general purpose of Promox LA is to deliver a sustained and powerful bactericidal effect systemically to eliminate susceptible bacterial infections. The Amoxicillin component works by critically interfering with bacterial cell wall synthesis. This action grants the preparation broad-spectrum efficacy against a wide range of bacteria, providing sustained antimicrobial support for the animal's recovery. The long-acting profile is specifically designed for its target audience, ensuring continuous systemic antibacterial benefit while minimizing the need for frequent re-dosing, which is critical in veterinary care settings.

Regulatory References

  1. FAO/WHO Guidance

What side effects are possible with Promox LA?

Possible side effects and safety information

The safety profile of Promox LA (long-acting Amoxicillin for injection) is documented through official regulatory classifications based on the drug’s pharmacological class, the beta-Lactam antibiotics.

Frequency-Classified Adverse Reactions

The officially listed adverse effects are grouped by their documented frequency of occurrence:

  • Common: The most frequently documented reaction is a local tissue reaction at the site of injection.
  • Uncommon: Adverse reactions affecting the Immune system, particularly hypersensitivity reactions, are classified as uncommon.
  • Rare: Reactions documented as rare include systemic effects such as anaphylaxis, gastrointestinal disturbances (e.g., vomiting and diarrhea), and the skin disorder exfoliative dermatitis.

Safety Considerations and Restrictions

Side effects are formally classified across several physiological systems, including General disorders and administration site conditions, Disorders of the Immune system, Gastrointestinal disorders, and Disorders of the Skin and subcutaneous tissue.

The local tissue reaction documented as common is explicitly noted in regulatory documents as being transient (short-lived).

Serious adverse reactions officially documented, though rare, involve anaphylaxis and severe forms of hypersensitivity reactions.

Formal restrictions on use are detailed in the regulatory safety information. The product is strictly contraindicated in animals with a known history of hypersensitivity to penicillins (the beta-Lactam class) or other components of the formulation. Furthermore, a specific safety constraint exists for small herbivore species (such as rabbits, guinea pigs, and hamsters), for which the medication is also contraindicated.

Overdose and Emergency Response

Overdose and When to Seek Help

The official regulatory documents define the manifestations of Amoxicillin overdose primarily through effects on the gastrointestinal and urinary systems. Documented clinical signs commonly include nausea, vomiting, and diarrhea. More critical urinary system presentations involve the development of crystalluria (crystals in the urine), which can result in decreased or bloody urine output and changes in urine clarity.

Severe Manifestations and Risk Factors Overdose exposure is officially associated with the potential for severe outcomes, particularly seizures or convulsions, especially when very high doses are involved. Pre-existing impaired renal function is explicitly documented as a key risk factor that significantly increases the likelihood of toxicity due to elevated systemic drug levels. The unmanaged progression of crystalluria is an official risk for the development of acute kidney failure.

Mandated Emergency Action Government health authorities specify that immediate medical attention is required for any severe or life-threatening event. Urgent help must be sought if the individual is collapsed, experiences a seizure, has trouble breathing, or cannot be awakened.

Supportive Procedures Management procedures are strictly supportive and symptomatic, beginning with drug discontinuation. Official guidelines include maintaining high fluid intake and close monitoring of urine output to help mitigate the crystalluria risk. In cases of significant toxicity, Amoxicillin can be effectively removed from the body using hemodialysis.

Therapeutic Uses of Promox LA

What Promox LA Treats: Main Uses and Benefits

The medication is used for managing infections caused by susceptible organisms in the targeted production animals (cattle, sheep, and pigs). This treatment is commonly used across conditions presenting with acute episodes that are driven by susceptible bacterial pathogens.

Promox LA is applied for both systemic bacterial diseases and localized infections. Indications include the management of respiratory tract infections (like bacterial pneumonia), skin and soft tissue infections (such as abscesses and infected wounds), and musculoskeletal conditions, including infectious arthritis (joint ill) and acute foot rot.

The treatment primarily helps to address the widespread bacterial cause, contributing to easing the overall symptom load associated with symptoms related to systemic imbalance, such as fever and general malaise. For localized issues, the therapy plays a role in managing pain and swelling, which assists with maintaining functional stability.

“A key benefit involves providing sustained antimicrobial support through its long-acting profile.”

This continuous action is considered relevant for managing established infections over an extended period, providing supportive relief when symptoms interfere with routine activities.


Quick Fact: Relief for Localized Inflammation The medication is relevant for addressing symptoms related to inflammatory or irritative states, such as swelling, heat, and pain, that are caused by susceptible bacterial infections in soft tissues and joints.

Regulatory References

  1. UK Veterinary Medicines Directorate product information

Eligibility and Restrictions for Use

Promox LA's official eligibility profile, based on veterinary regulatory documents, establishes strict rules regarding its appropriate use. The medicine is formally approved for use in specific target production animals, namely Cattle, Sheep, and Pigs, and can generally be used in pregnant and lactating animals within these species.

Contraindications

Several populations are strictly contraindicated for use. The medicine must not be administered to any animal with a known hypersensitivity to penicillins or any other beta-Lactam antibiotic class, such as cephalosporins. Absolute prohibition extends to certain species, including all small herbivores (such as rabbits, guinea pigs, and chinchillas) and equidae (horses).

Use is also contraindicated in animals suffering from severe renal dysfunction accompanied by anuria or oliguria. The product must not be given intravenously or intrathecally.

Restrictions

Specific restrictions apply regarding production status: the product is not authorised for use in ewes producing milk intended for human consumption. Use requires caution in animals with any non-severe degree of renal impairment.

What should I know about interactions with other medicines?

Interaction Map: Interactions with other medicines and products — official regulatory information for Promox LA

Category Details (Strictly from Regulatory Labeling)
Medicinal product categories with documented interactions: Oral Anticoagulants (e.g., Warfarin); Uricosuric Agents (e.g., Probenecid); Xanthine Oxidase Inhibitors (e.g., Allopurinol); Hormonal Contraceptives.
Specific interacting medicines (if explicitly listed): Probenecid; Warfarin; Allopurinol.
Mechanistic basis of interactions (only if stated in label): Probenecid decreases the renal tubular secretion of the drug, which may increase blood levels; interference with intestinal flora may reduce the reabsorption of estrogens from hormonal contraceptives.
Interaction-related restrictions: Co-administration with Probenecid is not recommended due to resulting increased and prolonged systemic exposure of the drug.

Interaction classifications (high-level)

Classification Details (As defined in official documents)
Interaction severity classification (as defined in official documents): Not Recommended (Probenecid); Require Monitoring/Adjustment (Oral Anticoagulants); Increased Incidence of Adverse Event (Allopurinol).
Interaction-context constraints (as defined in official documents): The use of oral anticoagulants concomitantly may cause an abnormal prolongation of prothrombin time, necessitating appropriate monitoring. Use of Allopurinol increases the likelihood of an allergic skin rash.

Resulting interaction structure

Official regulatory documents define the product’s interaction structure by classifying outcomes based on two types of effects: the alteration of the product's concentration and the interference with the therapeutic action of other agents. The pharmacokinetic interaction with Probenecid results in a specific regulatory “not recommended” caution. The pharmacodynamic interferences with oral anticoagulants and hormonal contraceptives result in requirements for close clinical and laboratory monitoring or the consideration of alternative non-hormonal contraception methods.

Mechanism of Action

How Promox LA Works: Mechanism of Action

Promox LA's mechanism of action is focused on the irreversible inhibition of specific bacterial enzymes. The active component, Amoxicillin, acts as an inhibitor of Penicillin-Binding Proteins (PBPs), a group of transpeptidases essential for building the rigid structure of the bacterial cell wall. The beta-lactam nucleus of Amoxicillin covalently binds to the active site of the PBP, neutralizing its function.

This molecular interaction directly interrupts the final stages of the Peptidoglycan Synthesis Pathway, halting the essential cross-linking required for structural integrity. The resulting defective cell wall triggers a cascade of events, leading to a loss of osmotic stability and activating bacterial Autolytic Enzymes. The ultimate physiological consequence is cell lysis, the irreversible destruction of susceptible bacterial populations.

Amoxicillin exhibits high selective toxicity as it targets molecular structures entirely absent in host animal cells. The functional range of this mechanism is constrained by bacterial defenses, primarily the production of beta-Lactamase enzymes, which hydrolyze the drug's core structure, rendering the mechanism ineffective against resistant strains.

Dosage and Administration Information

How Promox LA is Used: Official Administration Guidelines

Promox LA, an Amoxicillin Long-Acting 150 mg/mL Suspension for Injection, is administered according to a precise protocol to ensure the prolonged systemic delivery of the active ingredient.

Administration Scope

Feature Official Instruction Summary
Route of administration Deep Intramuscular (IM) injection for major production animals (cattle, sheep, pigs). The subcutaneous (SC) route may be used for dogs and cats. The suspension is not suitable for intravenous (IV) administration.
Dosing schedule The standard regimen is 15 mg Amoxicillin per kilogram (mg/kg) of body weight, which is equivalent to 1.0 mL of suspension per 10 kg body weight. Accurate weight determination is necessary for correct dosing.
Frequency and Timing Administration begins with a single initial dose. A repeat dose may be given, if needed, 48 hours after the initial injection, reflecting the extended-release profile of the formulation.
Preparation requirements The vial must be shaken vigorously immediately before use to ensure the suspension is fully mixed. Use of a dry sterile needle and syringe is required to prevent contamination and hydrolysis of the active substance.
Special procedural conditions Maximum volume limits must be observed for a single injection site: up to 20 mL for cattle, 5 mL for pigs, and 4 mL for sheep. Larger volumes must be divided and injected into separate anatomical sites. The injection site should be massaged immediately after administration.

Resulting Procedural Structure

Official use is defined by a sequence of steps: Vigorously shake the vial; calculate the required volume based on the 15 mg/kg standard; administer the volume via deep intramuscular injection, adhering to the site volume limits; and massage the area post-injection. If a subsequent administration is necessary, it is given 48 hours later at a separate site.

Recent Clinical Evidence

Research evidence / Overview of studies for Promox LA


Evidence for Use in Respiratory Tract Infections

Research has been studied for respiratory infections in production animals, such as bacterial pneumonia in cattle and pigs. The evidence base includes historical field observations and studies that look at how the drug works in the body (Pharmacokinetic or PK) and how it affects bacteria (Pharmacodynamic or PD). PK/PD modeling reported that drug levels were sustained above the Minimum Inhibitory Concentration (T > MIC), the concentration often monitored in research to predict antimicrobial activity. Studies reported patterns of clinical recovery, such as changes in temperature and improved breathing. Research reports note that comparative evidence is limited from large-scale, controlled clinical trials that directly compare this long-acting injection against newer antibiotic classes.


Evidence for Use in Localized and Acute Infections

Promox LA was studied in the context of localized conditions, such as infectious arthritis and foot rot. PK studies reported that the long-acting drug was distributed into the target tissues, maintaining concentrations predicted to be relevant for the targeted pathogens. Clinical observations described short-term resolution patterns related to outcomes linked to inflammatory or irritative states, such as swelling and lameness. However, data for certain groups remain insufficient for specific localized issues, as the evidence often is extrapolated from the overall research on the Amoxicillin class.


Evidence for Use in Systemic Bacterial Diseases

Evidence for broad systemic bacterial diseases focuses heavily on the drug's movement through the body and mandatory regulatory research, including Bioavailability and Residue Depletion Studies. Findings indicate the formulation delivered drug levels consistent with the definition of an extended-release product. Residue Depletion studies reported the time needed for the drug to clear from edible tissues; this data is used for establishing official withdrawal periods. The basis for the clinical evidence is often the established relationship between drug concentration and antimicrobial activity (the PK/PD correlation).


What Is Still Uncertain About the Research for Promox LA

The broader evidence landscape highlights several areas where certainty remains low. A key limitation is the limited comparative evidence that directly measures the performance of this long-acting formulation against modern alternatives in blinded, controlled field trials. The sample sizes were modest in some of the older trials relied upon. Furthermore, clinical evidence is often synthesized from multiple sources, meaning evidence quality varies across studies.

Key Studies & References

  1. UK Veterinary Medicines Directorate Product Information Summary for Long-Acting Amoxicillin (SPC_124261)
  2. FAO/WHO Guidance on Prudent Use of Antimicrobial Agents in Animals

Frequently Asked Questions (FAQ)

Common questions about Promox LA (FAQ)

Q: Can Promox LA be taken long-term?

A: The official dosing guidelines for Promox LA define the course of treatment as a short duration, starting with a single dose and allowing for a possible repeat dose 48 hours later. Regulatory documents do not contain information or authorization for continuous or chronic (long-term) administration.


Q: Do the side effects of Promox LA usually go away over time?

A: According to official regulatory documents, the most frequently documented side effect is a local tissue reaction at the injection site. This common reaction is explicitly described as transient (short-lived), meaning it is expected to go away over time without the need for additional treatment.


Q: Does the time of day I take Promox LA matter?

A: The official instructions focus on the interval between injections rather than a specific time of day. The key is maintaining the required 48-hour spacing between the initial dose and the potential repeat dose, if one is administered.


Q: What is the difference in mechanism of action between Promox LA and other similar medicines?

A: Promox LA, being a penicillin-class antibiotic, is understood to act by interfering with the synthesis of the bacterial cell wall. This beta-lactam action is distinct from other antibiotic classes that may target different functions, such as stopping the bacteria from building proteins or copying their DNA.


Q: What are the signs of an allergic reaction to Promox LA?

A: Official product information classifies hypersensitivity reactions and, rarely, anaphylaxis as potential adverse effects. Hypersensitivity reactions generally involve symptoms like skin rash, itching, or swelling. Anaphylaxis is a severe form of allergic reaction that is noted as a serious potential event in regulatory documents.


Q: Do I need blood tests while taking Promox LA?

A: Monitoring with blood tests is not universally required, but is specifically documented in regulatory sources if the medicine is administered alongside oral anticoagulants (medications used to manage blood clotting). This testing helps check for an abnormal prolongation of prothrombin time, which is related to the drug's interaction profile.


Q: Are there any dietary restrictions while taking Promox LA?

A: Since Promox LA is formulated as a parenteral injection (given by shot) and not taken orally, food and diet are not factors that affect its administration or absorption. Regulatory documents do not list any specific dietary restrictions.


Q: Does Promox LA have a risk of dependence or addiction?

A: Regulatory safety information classifies Promox LA as a penicillin-class antibiotic, and its pharmacological properties do not include risks of dependence or addiction. Official documents contain no warnings regarding addictive potential.


Q: Can Promox LA cause weight gain or weight loss?

A: Official documents do not list weight gain or weight loss as specific adverse reactions. However, rare side effects noted in regulatory documents include gastrointestinal disturbances, such as vomiting and diarrhea. These documented gastrointestinal side effects are the closest related effects noted in the regulatory safety data.


Q: Is drowsiness a common side effect of Promox LA?

A: Official adverse reaction classifications focus on immune system, skin, and gastrointestinal effects. Regulatory documents do not list central nervous system effects like drowsiness or sedation as documented side effects with a classified frequency.


Q: What should I do if I experience an unexpected side effect while on Promox LA?

A: Official documents specify that any observed or unexpected adverse effect must be brought to the attention of the appropriate authorities. The appropriate channels for reporting include the prescribing veterinarian and the national pharmacovigilance authority responsible for drug safety surveillance.


Q: Does Promox LA interact with alcohol?

A: Promox LA is a veterinary medicinal product used exclusively in animals. Because of this intended use, the regulatory documentation does not contain information on or assess any potential interaction with alcohol (ethanol) in human patients.


Q: Are there any vitamins or supplements that interact with Promox LA?

A: Regulatory documents focus on known drug-to-drug interactions, specifically listing agents like oral anticoagulants and Probenecid. Official product information does not typically list specific warnings or restrictions concerning common vitamins, minerals, or herbal supplements.


Q: Is Promox LA suitable for people with liver problems?

A: Regulatory documents specify important restrictions for animals with renal (kidney) dysfunction due to the drug's elimination pathway. However, official prescribing information does not list restrictions, warnings, or dose adjustments specifically related to liver (hepatic) problems.


Q: Where can I find the official prescribing information for Promox LA?

A: The most up-to-date and complete official prescribing information, such as the Summary of Product Characteristics (SmPC) or the FDA Label, is maintained and published on the website of the national regulatory authority that authorized the drug.


Q: Does Promox LA require a special authorization or is it easily prescribed?

A: Regulatory authorities assign a legal status to this product, which typically requires a veterinary prescription for its supply and administration. This classification ensures the medicine is used under the supervision and authorization of a qualified veterinary professional.


Q: Is it normal to feel fatigued when first starting Promox LA?

A: The list of officially documented adverse reactions does not classify or describe fatigue or tiredness under any frequency of occurrence. Reported side effects are instead categorized by their impact on systems like the immune system and the gastrointestinal tract.


Q: Does Promox LA affect sleep?

A: Official regulatory documents list adverse effects related to various physiological systems, but they do not specifically categorize or describe disturbances related to sleep, such as insomnia or excessive sedation, as documented side effects.


Q: Why do doctors often start patients on a lower dose of Promox LA?

A: The official regulatory instructions define a standard fixed dose based on the recipient's body weight. These guidelines do not describe or require a process for starting treatment with a lower dose that is gradually increased over time (titration).


Q: Does Promox LA have a generic available?

A: Regulatory bodies maintain public drug registers that provide information on authorized products. These registers confirm the legal status of the medicine and verify whether a specific, formally authorized generic equivalent of this long-acting formulation exists.


Q: What is the role of Promox LA in maintenance treatment?

A: The product's approved role is defined in regulatory documents as a short-course bactericidal antibiotic intended to eliminate active bacterial infections. It is not indicated or authorized for long-term chronic management or for a maintenance treatment role.


Q: Can Promox LA affect mood?

A: Regulatory safety information classifies adverse reactions based on physiological systems, such as the immune and gastrointestinal systems. There are no documented adverse reactions classified that relate to changes in mood, behavior, or other psychiatric effects in the recipient species.


Q: Does Promox LA interact with grapefruit juice?

A: Since Promox LA is a formulation intended for injection rather than oral consumption, regulatory documents do not contain information assessing or listing any interaction with grapefruit juice or other oral food substances.


Q: What does the Risk Evaluation and Mitigation Strategy (REMS) program involve for Promox LA, if any?

A: Regulatory agencies require certain high-risk products to have a formal risk management program. Official regulatory registers will confirm whether a specific risk mitigation strategy, such as the US REMS program or its equivalent in other territories, is required for this particular product.


Q: Have there been any warnings or recalls associated with Promox LA?

A: Official government bodies, such as national drug regulatory agencies, are responsible for issuing and publicizing any specific drug safety warnings, alerts, or recalls that may be associated with pharmaceutical products.


Q: Can taking Promox LA affect fertility?

A: Regulatory documents state that Promox LA can generally be used in pregnant and lactating animals, indicating a lack of significant reproductive toxicity in the target species. Specific adverse effects related to fertility are not listed in the official safety information.


Q: Does Promox LA need to be tapered off when stopping?

A: Official regulatory instructions for this short-course antibiotic do not include any specific process for tapering off the dose. The administration course is defined by the initial dose and a potential follow-up dose 48 hours later, with no requirements for gradual withdrawal.

How should Promox LA be stored and disposed of?

Promox LA (Amoxicillin 150 mg/ mL suspension for injection) must be stored and handled according to its specific regulatory label. This is a veterinary medicinal product, and its storage constraints are defined to maintain its shelf-life and stability.

Required Storage and Stability

  • Temperature and Light: Do not store the product above 25 C. The suspension must be protected from light to maintain its integrity.
  • Unopened Shelf Life: The shelf life of the veterinary medicinal product as packaged for sale is 3 years.
  • In-Use Stability: After the first opening of the vial, the product has a limited shelf life of 28 days. Any unused suspension remaining after this period must be discarded.
  • Child Safety: The product must be kept out of the sight and reach of children.

Official Disposal Rules

Disposal of unused or expired Promox LA and related waste materials must follow strict environmental guidance:

  • Restrictions: Do not dispose of the medicine via wastewater or household waste.
  • Compliance: Disposal must be executed in accordance with local requirements and any applicable national collection systems for veterinary medicinal products.

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

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