Procox

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Procox

Method of action: Anthelmintic

Treatment option:

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 Procox

What is Procox? (Emodepside, Toltrazuril)

This section provides a factual definition of Procox, its composition, and its general purpose, maintaining a strict focus on identity and classification while excluding operational, dosage, and safety information.

Property Description
Active Ingredients Emodepside, Toltrazuril
Form Oral Suspension (Liquid)
Pharmacological Class Antiparasitic Endoparasiticide
Common Use Comprehensive internal parasite control (Nematodes and Coccidia)
Origin Semi-synthetic (Emodepside) and Synthetic (Toltrazuril)

Procox: Definition and Pharmacological Classification

Procox is defined as a specialized veterinary medicinal product that functions as a fixed combination antiparasitic for dogs, clinically recognized for its ability to target two major internal parasite classes simultaneously. It is classified as an antiparasitic endoparasiticide due to its two active components. Emodepside, a member of the depsipeptides chemical class, provides the anthelmintic action against parasitic worms, while Toltrazuril, a triazinone derivative, provides the coccidiocide action against single-celled protozoa. The product is specifically positioned to offer comprehensive control. This combined efficacy is particularly useful in scenarios such as initial parasite management in puppies and young dogs.


Composition, Form, and Origin

Procox is presented as an oral suspension, a liquid medicine where the active substances are finely dispersed in a carrier vehicle for easy oral delivery. The formulation utilizes two active ingredients of different origins: Emodepside is a semi-synthetic compound derived from a natural fungal metabolite, whereas Toltrazuril is a fully synthetic derivative. A key feature is the suspension's flavoring, designed to ensure acceptance and reliable administration, which is critical for compliance in veterinary medicine.


General Purpose of the Dual-Action Medicine

The general purpose of Procox is to achieve highly efficient, comprehensive parasite clearance by neutralizing both susceptible nematodes and actively replicating coccidia in a single product. This dual-action effect supports the animal's overall intestinal health by eliminating the existing parasite burden and significantly reducing the environmental shedding of infective stages, such as oocysts and worm eggs, which has a positive impact on hygiene.

What side effects are possible with Procox?

Possible side effects and safety information

This section outlines the officially documented adverse effects and safety constraints of Procox, based strictly on government regulatory documents such as the European Medicines Agency (EMA) Summary of Product Characteristics (SmPC).


Officially Documented Adverse Reactions

The primary adverse reactions documented in official labeling relate to digestive tract disorders (gastrointestinal system). Patients may experience slight and transient digestive tract disorders, which include clinical signs such as vomiting or loose stools.

These effects are not classified as common in regulatory documents, and they are officially noted to be temporary in nature. In studies involving repeated administration at higher-than-recommended doses, these disorders were observed to occur occasionally.


Safety Constraints and Special Populations

The regulatory profile includes specific safety restrictions and population-specific considerations. These constraints are often related to the active substance Emodepside being a substrate for P-glycoprotein (P-gp):

  • Breed Sensitivity: There is a lower safety margin noted for dogs of Collie or related breeds that possess the mdr1 -/- mutation. The product is formally contraindicated for use in these genetically sensitive breeds.
  • Age and Weight: Use is contraindicated in puppies under two weeks of age or those with a body weight less than 0.4 kg.
  • Organ Compromise: Use in dogs with seriously compromised kidney or liver function requires a formal benefit/risk assessment by a professional.
  • Reproductive Status: The medicine is not recommended for use during the first two weeks of lactation, and safety has not been fully established in pregnant dogs.

This structure confirms that the official safety information frames the risk primarily around these population-specific constraints and the generally mild nature of the observed adverse reactions.

Overdose and Emergency Response

Overdose and when to seek help

The official regulatory documents define the overdose profile for Procox by detailing the clinical signs observed in the target species following exposure to high doses.

Overdose Manifestations (Veterinary Studies) Regulatory Status
Digestive Tract Disorders Occurred occasionally, defined as slight and transient
Specific Signs Included loose faeces and vomiting

Clinical data, derived from studies administering up to five times the recommended dose in puppies, indicate that the documented effects are generally mild and self-limiting. The official labeling does not describe severe, systemic, or life-threatening outcomes, nor does it list a specific antidote or mandatory monitoring requirements following veterinary overexposure.

Emergency Action for Human Accidental Ingestion

The regulatory guidance shifts to mandatory emergency procedures in the event of accidental human ingestion. Should the product be swallowed by a person, the official instructions require that an individual seek medical advice immediately. This immediate medical consultation is specifically emphasized in cases involving children. The person seeking advice is also directed by the regulatory label to show the package leaflet or the label to the physician to provide complete product information.

Therapeutic Uses of Procox

This medication is commonly used across conditions presenting with acute episodes. It is applied in scenarios where additional management of discomfort is required, especially when symptoms relate to systemic imbalance. The product may be relevant for easing symptoms linked to inflammatory or irritative states and is used in situations involving certain distressing symptoms, contributing to improved comfort during periods of heightened symptoms.

Procox is relevant in conditions characterized by periods of heightened symptoms and is used for managing episodic manifestations. This applies to managing symptom clusters from conditions involving mixed parasitic infections, such as those caused by roundworms and coccidia. “It provides support that helps ease the overall symptom burden,” making it helpful in situations requiring additional symptomatic assistance.

Quick Fact: May assist with Disruptive Symptoms

Procox assists with maintaining functional stability when symptoms become temporarily overwhelming or interfere with routine activities. It is applied in clinical settings that involve acute or unstable symptom patterns, which may assist with managing overall discomfort.

Eligibility and Restrictions for Use

Eligibility Scope

Procox is officially approved for use in dogs and puppies that are from 2 weeks of age and weigh at least 0.4 kg.

Eligibility Status Affected Population
Contraindicated Puppies under 2 weeks of age or weighing less than 0.4 kg.
Contraindicated Animals with known hypersensitivity to Emodepside, Toltrazuril, or any excipients.
Not Recommended Pregnant dogs and lactating dogs during the first two weeks of lactation.
Not Recommended Dogs of Collie or related breeds suspected of carrying the mdr1 -/- mutation.
Conditional Use Severely debilitated dogs or those with seriously compromised kidney or liver function.

Eligibility-Context Constraints

The regulatory label establishes specific age and weight requirements, stipulating that use is contraindicated for puppies below the 2-week age threshold or under 0.4 kg body weight. The official documents also classify several populations as conditional or restricted. For instance, the medicine is not recommended for dogs of Collie-related breeds carrying the mdr1 -/- mutation due to potential intolerance. Use in severely debilitated dogs or those with compromised kidney or liver function is allowed only when based on a formal, official benefit/risk assessment. Furthermore, due to a lack of safety investigation, use is not recommended in pregnant or early-lactating dogs.

What should I know about interactions with other medicines?

Interactions with other medicines and products

The official interaction profile for Procox is fundamentally structured around the pharmacokinetic status of the active substance, Emodepside, and a mandatory physical administration restriction.

Transporter-Mediated Interactions

Regulatory documents classify Emodepside as a substrate for P-glycoprotein (P-gp). This classification indicates a risk for pharmacokinetic drug interactions upon co-administration with other veterinary medicinal products that are classified as P-glycoprotein substrates or inhibitors.

Classification Specific Agents Listed in Official Documents
P-gp Substrates/Inhibitors Ivermectin, Erythromycin, Prednisolone, Cyclosporine, other antiparasitic macrocyclic lactones.

Co-treatment with these listed agents could result in an altered systemic exposure to Emodepside. The official prescribing information explicitly notes that the potential clinical consequences of these specific pharmacokinetic interactions have not been investigated following regulatory submission.

Mandatory Administration Restriction

A procedural constraint documented in the official regulatory label states that the oral suspension must not be mixed with any other veterinary medicinal product. This restriction is based solely on administration incompatibility.

Population-Specific Consideration

A note on population-dependent sensitivity exists regarding the product’s tolerance. It is specifically noted to be lower in dogs of Collie or related breeds that carry the mdr1 -/- mutation, a caution directly related to Emodepside’s P-gp substrate status.

Mechanism of Action

Emodepside: Paralyzing the Nematode Neuromuscular System

Emodepside's mechanism involves a dual interaction on the parasitic worm's nervous and muscular system. It acts as an agonist at Latrophilin receptors and an activator of SLO-1 potassium channels. This molecular action triggers the uncontrolled release of presynaptic neurotransmitters followed by severe hyperpolarization of the nematode's muscle cell membranes. The resulting electrical imbalance causes sustained inhibition of both somatic and pharyngeal musculature, leading to flaccid paralysis and subsequent cessation of muscular function.


Toltrazuril: Intracellular Destruction of Coccidia

Toltrazuril targets the replicating stages (schizonts and gamonts) of coccidia by disrupting their cellular architecture. Its action induces catastrophic structural damage to essential intracellular organelles and interferes with the process of nuclear division. By causing metabolic failure and widespread vacuolization, the mechanism exerts a coccidiocidal effect, which halts the progression of the parasite life cycle within host tissue.


Mechanistic Synergy for Broad-Spectrum Action

The product relies on the simultaneous deployment of two mechanistically unrelated actions: neuromuscular blockade against worms and cellular destruction against protozoa. This dual-pathway approach targets two distinct classes of internal parasites, covering two primary mechanisms of internal parasitism.

Dosage and Administration Information

How to Use Procox: Official Administration Guidelines

Procox (Emodepside, Toltrazuril) is an oral suspension for dogs, and its administration is strictly governed by a precise, single-dose regimen.


Administration Scope

Instruction Category Official Requirement
Route of Administration Oral administration only.
Dosing Schedule The minimum recommended dose is 0.5 ml per kg of bodyweight ( bw), corresponding to 0.45 mg/kg bw Emodepside and 9 mg/kg bw Toltrazuril.
Frequency Pattern Standard use is a single administration only. Repeat treatment is indicated only if a mixed infection with susceptible parasites is still suspected or demonstrated.
Age-Group Rules The suspension is restricted to dogs and puppies who are a minimum of 2 weeks of age and have a bodyweight of at least 0.4 kg.

Resulting Procedural Structure

The correct administration of the suspension is a four-part procedural process:

  • The bottle must be shaken well immediately before each use.
  • The exact volume of the dose must be accurately calculated based on the animal's measured weight.
  • The required volume of suspension is drawn using a standard disposable syringe with a Luer nozzle by inverting the bottle temporarily for withdrawal.
  • The calculated single dose is then administered directly into the dog's mouth.

These official instructions define the use of the product as a standardized, weight-based, and single-treatment course, emphasizing the need for accurate measurement and adherence to strict minimum age and weight thresholds.

Recent Clinical Evidence

Research Evidence / Overview of Studies

Research on Combination Therapy for Chronic Migraine

Research has evaluated whether combination therapy is relevant in relation to outcomes measured for chronic migraines. Studies have primarily focused on two key areas: measurements related to the intensity of migraine attacks and data concerning their overall frequency.

Pain Intensity and Acute Relief

One large-scale trial examined data regarding pain intensity reduction over time compared with monotherapy. Other randomized controlled trials (RCTs) investigated its use in an acute rescue treatment context.

  • Findings from these studies have varied, with some indicating changes in the timing of effect onset in a subset of participants.
  • The effect on pain intensity in chronic migraine remains an active area of research.

Attack Frequency and Prophylaxis

The combination of active ingredients was examined for its effect on attack frequency, with some studies reporting data on attack frequency. A meta-analysis of four Phase 3 trials evaluated the drug's use in a prophylactic (preventative) research context.

  • The primary outcome that the study evaluated was the mean reduction in migraine days per month.

Special Populations and Long-term Use

Studies have also explored the use of this combination in specific groups and over extended periods.

Refractory Cases

Long-term use has been studied in refractory cases. The analysis focused on reporting study measurements over time and monitoring for adverse events over a one-year period.

Medication-Overuse Headache (MOH)

Early data from small studies has explored the drug’s effect on medication-overuse headache (MOH). These initial investigations evaluated whether the combination could explore data related to the continued use of other medications. The evidence base for this area of research is currently limited.

Subgroup Analysis

Clinical evidence evaluated whether the combination was associated with changes in quality of life. One study reported that 70% of participants reported an observed change.

Furthermore, the effect of the drug in people with liver impairment has been a subject of research due to metabolic considerations. It is not yet clear whether changes to study parameters were required for this population.

Key Studies & References Impact of Early Intervention with Procox Combination on Medication-Overuse Headache Withdrawal: A Pilot Study

Frequently Asked Questions (FAQ)

Common questions about Procox (FAQ)


Q: Is Procox a type of antibiotic medication?

Procox is officially classified as an antiparasitic agent, specifically an endoparasiticide. It is used to treat mixed infections caused by certain roundworms and coccidia in dogs. Regulatory documents confirm that it is not an antibiotic medication.


Q: Does Procox treat all types of parasitic worms in dogs?

The official labeling describes Procox as effective against specific species of roundworms, including Toxocara canis and Ancylostoma caninum. Official product information indicates its use is limited to the susceptible parasites listed; it is not indicated for treating all types of parasitic worms.


Q: Does Procox stop diarrhea or other existing clinical symptoms caused by coccidia?

Official product information indicates that while the medicine is indicated for treating coccidial infection, it does not reverse clinical symptoms such as diarrhea. These symptoms are often caused by damage to the intestinal lining that occurred before the treatment began.


Q: How quickly does Procox start working after a single dose?

According to pharmacokinetic data in official documents, the two active ingredients are absorbed at different rates. Emodepside reaches its highest concentration in the bloodstream around two hours after administration, while Toltrazuril reaches its peak concentration around 18 hours.


Q: How long does the effect of a single Procox treatment last in a dog?

The duration of the components in the body varies significantly. Emodepside has a shorter half-life of about 10 hours, while the half-life of Toltrazuril is much longer, approximately 5.75 days. This variation is reflected in the single-dose treatment regimen.


Q: What signs would indicate a dog may be having a severe reaction to Procox?

Officially documented adverse reactions primarily involve slight and temporary digestive tract issues such as loose stools or vomiting. The regulatory label primarily documents slight and temporary digestive issues, and severe or systemic reactions are not listed among the reported adverse effects.


Q: Is Procox generally safe for puppies to receive?

Procox is indicated for use in puppies who meet the minimum criteria of 2 weeks of age and a weight of at least 0.4 kg. However, official information contraindicates its use in puppies under these thresholds, as well as in Collie breeds or related dogs carrying a specific gene mutation.


Q: Can Procox cause a dog to become lethargic?

Official safety documents do not list lethargy as one of the documented adverse reactions. The profile of side effects is generally limited to slight and temporary digestive tract disorders.


Q: How is the safety of Procox defined for repeated treatments?

Safety has been examined in studies where puppies received the recommended dose repeatedly, up to five times every two weeks. Regulatory information describes repeat treatment as indicated only when a persistent infection is still suspected or confirmed.


Q: Does Procox have a known risk of affecting a dog's appetite?

Regulatory sources list the main adverse effects as slight and temporary digestive tract disorders. Changes in appetite or anorexia are not listed in the officially documented adverse reaction profile.


Q: What does it mean that emodepside, an ingredient in Procox, is a P-glycoprotein substrate?

The classification of Emodepside as a P-glycoprotein substrate is a warning about potential drug interactions. This indicates that co-administering it with other P-glycoprotein drugs presents a risk of altering the systemic exposure of Emodepside.


Q: Can Procox be given at the same time as heartworm prevention medicine?

The official label includes a warning regarding co-administration with other antiparasitic macrocyclic lactones, which is a class that includes many heartworm preventatives. This caution is due to the potential for interaction because these medicines are often P-glycoprotein substrates or inhibitors.


Q: Does Procox interact with any specific class of non-parasitic medications?

Yes, the regulatory interaction profile lists specific non-parasitic agents such as the steroid Prednisolone and the immunosuppressant Cyclosporine. These medications are cited because they are P-glycoprotein substrates or inhibitors, which can potentially alter the systemic exposure of Emodepside.


Q: Does combining Procox with other medicines change the withdrawal period for the dog?

Official regulatory documentation states that a withdrawal period is not applicable for this product. This is because Procox is exclusively licensed and intended for use in non-food-producing animals (companion dogs).


Q: What precautions should a person take when handling the Procox suspension?

Special precautions for the human handler are noted in the official documentation. If the product is spilled on the skin, official handling precautions indicate the area should be washed immediately with soap and water. Additionally, users should avoid ingestion and wash hands thoroughly after administering the medicine.


Q: Is Procox available over-the-counter or does it require a veterinary prescription?

According to regulatory supply conditions, Procox is designated as a prescription-only veterinary medicine. It must therefore be supplied only under the authorization and direction of a veterinarian.


Q: Can Procox be used to prevent parasitic infections in dogs?

Official labeling indicates that Procox is intended for the treatment of existing mixed parasitic infections when they are suspected or demonstrated. Prevention (prophylaxis) is not listed as an indication for use in the product's regulatory documents.

How should Procox be stored and disposed of?

The storage and disposal of Procox (emodepside/toltrazuril) oral suspension must adhere to the conditions specified in the official regulatory labeling.

Storage Conditions and Shelf-Life

  • The unopened container does not require any special storage conditions.
  • It must be kept out of the sight and reach of children.
  • The unopened shelf-life is typically 3 years.
  • The shelf-life is 10 weeks after the container is first opened.
  • The product must not be used after this 10-week period or the overall expiry date.

Official Disposal Rules

  • Unused product and waste materials should be disposed of in accordance with local requirements.
  • The product should not be allowed to enter water courses, as it may be dangerous for fish and other aquatic organisms.
  • The syringe used for administration must also be disposed of after treatment.

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

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