Sebacil

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Sebacil

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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 Sebacil

Quick Facts

Property Description
Active Ingredient Phoxim
Primary Forms Concentrate for dip emulsion, Pour-on solution
Pharmacological Class Organophosphorous Compound, Cholinesterase Inhibitor
Common Use Ectoparasiticide (Elimination of external pests)
Origin Synthetic

What is Sebacil and What Type of Medicine Is It?

Sebacil is defined as a specialized veterinary medicinal product that is generally classified as a potent ectoparasiticide intended for the control of external pests in livestock and domestic animals. Functionally, it belongs to the high-level pharmacological class of cholinesterase inhibitors and the chemical group of organophosphorous compounds. Phoxim has an established role in treating animal infestations in veterinary applications. As such, Sebacil is intended for protecting targeted animals from significant external parasitic burdens.

Composition, Origin, and the Role of Phoxim

The core composition of Sebacil is its sole active component, the synthetic compound Phoxim. As an organophosphate, Phoxim is recognized for its function as an acetylcholinesterase (AChE) inhibitor. This specific mechanism, which distinguishes it from alternative non-organophosphate drugs, is central to the medicine's identity. This single-ingredient medicine is synthesized to act by contact and stomach action, non-systemically disrupting the nervous system of the target arthropods. Sebacil is characteristically utilized as an external agent, contrasting sharply with products designed for systemic absorption or internal parasitic control.

Available Drug Forms for Topical Application

Sebacil is available in distinct dosage forms optimized for topical application onto the exterior of the animal. These presentations include a high-concentration concentrate for dip emulsion and a ready-to-use pour-on solution. The concentrate form is typically employed for large-scale, high-volume treatments, such as dipping multiple animals simultaneously. Conversely, the pour-on solution is intended for direct, localized cutaneous application to individual animals. Both forms maintain the non-systemic approach, utilizing a liquid or emulsifiable base to ensure the efficient delivery of the active component Phoxim directly to the site of the external infestation.

Regulatory References

  1. WHO JECFA Phoxim

What side effects are possible with Sebacil?

Possible Side Effects and Safety Information

The safety profile of Sebacil is fundamentally linked to its active substance, phoxim, an organophosphorus compound and a cholinesterase inhibitor. The safety data available from regulatory sources focus on toxicological findings, primarily from preclinical studies and veterinary use, rather than a frequency-based system for human adverse drug reactions.


Key Safety Considerations

Mechanism-Related Adverse Reactions

Phoxim exerts its effects by inhibiting acetylcholinesterase activity, a core mechanism that can lead to systemic toxicity, specifically affecting the nervous system. Key findings in laboratory animal studies used to establish safety thresholds include:

  • Inhibition of brain acetylcholinesterase activity (a pivotal finding).
  • Liver Effects: Significant changes such as increased liver weights, altered liver enzymes, and hepatocyte structural changes observed at higher doses.

Systemic and Organ-Specific Effects

Systemic toxicity observed in animal models has included poor nutritional state and reduced body-weight gain. Reproductive toxicity effects, such as hypoplasia in the testes, have also been documented in specific animal studies.


Regulatory Exposure Limits

Safety assessments by international food safety bodies (e.g., JECFA) establish limits to protect against human health risks from exposure, particularly through consumption of food from treated animals:

  • Acceptable Daily Intake (ADI): The official ADI for phoxim is established at 0-4 mu g/kg bw (micrograms per kilogram of body weight) based on the No Observed Effect Level (NOEL) for liver effects and brain acetylcholinesterase inhibition in long-term dog studies, using a safety factor of 100.
  • Maximum Residue Limits (MRLs): MRLs are set for edible tissues (e.g., muscle, liver, kidney, fat) of treated food-producing animals (sheep, pigs, goats) to ensure consumer safety.

Safety Context and Limitations

As an organophosphorus compound, the substance has been classified as a potential skin sensitizer and slightly irritating to the skin and eyes. The safety structure relies on withdrawal periods for treated animals and strict adherence to the established ADI to control human exposure to residues.

Overdose and Emergency Response

Overdose and When to Seek Help

Overdose with Sebacil, which contains the organophosphate Phoxim, results in a life-threatening medical emergency known as a cholinergic crisis. This condition is explicitly documented in regulatory sources and requires immediate attention due to the high risk of severe complications.

Documented Overdose Manifestations

The clinical syndrome involves overstimulation of the body's nervous system receptors. Symptoms include the onset of excessive glandular secretions, such as drooling (salivation) and excessive tearing (lacrimation), as well as vomiting, diarrhea, and pinpoint pupils (miosis). Neuromuscular effects manifest as muscle fasciculations (twitching) and general muscle weakness.

Serious Outcomes and Immediate Actions

Severe overdose can rapidly progress to respiratory failure, which is documented as the leading cause of death. This occurs due to a combination of excessive airway secretions (bronchorrhea) and weakness of the muscles needed for breathing. Other severe outcomes include seizures, coma, and cardiac irregularities.

If any suspected symptoms of poisoning occur, or in the event of accidental exposure, immediate medical attention must be sought. Regulator-mandated procedural steps include prompt decontamination: all contaminated clothing must be removed, and the affected skin must be thoroughly washed with soap and water.

Specific antidotal therapy is required for management, involving Atropine to counter muscarinic effects and Pralidoxime (2-PAM) to address the neuromuscular toxicity. Patients must be closely monitored for respiratory function in a hospital setting.

Therapeutic Uses of Sebacil

What Sebacil Treats: Main Uses and Benefits

Sebacil (Phoxim) is generally used as an ectoparasiticide to control external arthropod pests in livestock.

The medicine is commonly used to help manage conditions characterized by periods of heightened symptoms resulting from infestations, including severe mange (scabies), various forms of lice (biting and sucking), sheep keds, and to assist in the local eradication of fly larvae (myiasis) in animal wounds. This broad use is applied in addressing symptom clusters that may become disruptive, such as intense pruritus (itching) and resulting dermatological distress.

“The primary goal associated with this agent is the management of external parasitic burdens, which supports the overall comfort and functional stability of the animal.”

This application provides supportive relief that contributes to easing the overall symptom burden by lessening the physical stress and restlessness associated with high parasite numbers in animals like cattle, sheep, swine, and poultry. Furthermore, it is considered relevant for farm biosecurity programs.


Quick Fact: Relief for Pruritus and Skin Distress

Sebacil is relevant for managing symptoms related to inflammatory or irritative states caused by ectoparasites. Its use may assist with easing the noticeable physiological strain and discomfort that external parasites—like mites and keds—place on the animal, which contributes to improved day-to-day comfort during symptomatic periods.

Regulatory References

  1. Food and Agriculture Organization of the United Nations (FAO) veterinary drug monograph

Eligibility and Restrictions for Use

Sebacil is strictly a veterinary medicine, and its eligibility is defined by the animal species, their physiological state, and their role in the food supply. The medicine is primarily authorized for use in specific livestock species, including Cattle, Pigs, Sheep, Goats, and Equids.

Contraindicated Populations

Official regulatory documents establish absolute prohibitions for several animal populations, primarily due to the risk of toxicity or food safety concerns:

  • Lactating Animals Producing Milk for Human Consumption: Use is absolutely contraindicated in cattle, sheep, goats, and equids that are lactating, during the dry period, or in future milk producers within two months of parturition.
  • Sick or Compromised Animals: The product must not be used in animals exhibiting severe stress or in a reconvulsive period.
  • Hypersensitivity: Animals with known hypersensitivity to organophosphate compounds are ineligible for use.

Restricted and Conditional Use

Certain conditions require restricted or conditional use, as the risks associated with treatment are heightened in these groups:

  • Comorbid Conditions: Animals with specific existing conditions, such as heart failure, bronchospasm, or diagnosed liver or kidney disease, require particular caution and are often excluded from standard use protocols.
  • Concurrent Treatment: Use is explicitly prohibited within 10 days before or after administering other cholinesterase inhibitors or certain myorelaxants.
  • Pregnant Animals: While generally permitted, use in pregnant swine is not recommended immediately prior to the expected date of farrowing.

What should I know about interactions with other medicines?

Interactions with Other Medicines and Products: Official Regulatory Profile

The interaction profile of Sebacil (Phoxim) is established by veterinary regulatory documents and focuses on avoiding combinations that may compound its primary effect as a cholinesterase inhibitor. The key restrictions are rooted in preventing potential additive pharmacodynamic activity.

Documented Interaction Restrictions

Category Restriction Type Interacting Medicines
Timing Separation Mandatory 10-Day Window Other Cholinesterase Inhibitors, Phenothiazine, Mymiorelaxants
Co-Administration Advised to be Avoided General Anesthetics

The regulatory information specifies that for other cholinesterase inhibitors, phenothiazine, and mymiorelaxants, administration is prohibited for a period of 10 days before and 10 days after the use of Sebacil. This substantial time separation is required to mitigate the risk of cumulative neurological effects. Concomitant use with general anesthetics is also formally advised against in official labeling. No specific interactions involving pharmacokinetic mechanisms (such as CYP enzymes or transporters), food, or herbal products are formally documented in the official regulatory summaries.

Mechanism of Action

The active compound in Sebacil is phoxim, an organophosphate compound. Phoxim functions as an irreversible inhibitor of acetylcholinesterase (AChE) in targeted organisms, specifically within the parasitic nervous system.

Sebacil is primarily distributed to the surface tissues and sebum of the host organism where it can interact with the ectoparasites. Within the parasite, phoxim acts as a pro-drug that undergoes metabolic bioactivation to its corresponding oxon derivative. This phoxim-oxon derivative forms a stable, covalent bond with the active serine hydroxyl group at the catalytic site of the AChE enzyme.

This covalent modification prevents AChE from performing its physiological function of hydrolyzing the neurotransmitter acetylcholine (ACh) in the synaptic cleft. The inhibition of AChE results in the sustained accumulation of unhydrolyzed ACh at cholinergic synapses. This persistent presence of ACh leads to the overstimulation of postsynaptic cholinergic receptors, causing a prolonged excitatory signal. The resultant system-level physiological consequence in the parasite is neuromuscular paralysis, followed by cessation of vital functions due to irreversible excitotoxicity.

Dosage and Administration Information

How Sebacil is Used: Official Administration Guidelines

Sebacil (Phoxim) is administered exclusively through topical application onto the animal's exterior, utilizing either a Concentrate for Dip Emulsion or a ready-to-use Pour-on Solution. This non-systemic approach involves specific preparation and administration protocols.

Dosing and Preparation Protocol

The concentrate form is not used directly but requires precise dilution with water to achieve the required mg/L working concentration. For standard use, a 1:1000 dilution ratio is used, yielding approximately 500 mg Phoxim/L solution. For severe infestations, the concentration is increased to a 1:500 ratio. The ready-to-use pour-on solution has a specific dose determined by the animal's weight, such as 30 mg/kg body weight for pigs, equating to 0.4 mL of the solution per kilogram.

Frequency and Application

Treatment is generally provided as a single application for acute control. However, for certain conditions like severe mange, a repeat treatment interval of 7 to 14 days following the initial administration is utilized. Proper procedure dictates that animals receiving a dip must be submerged for a minimum of 30 seconds, while the pour-on solution must be applied specifically to the backline, extending from the ear to the base of the tail.

Use-Context Constraints

A critical use restriction prohibits the administration of Sebacil to any animal that is currently producing milk intended for human consumption.

Recent Clinical Evidence

Recent Clinical Evidence

Investigating the Mechanism and Outcomes

Research investigated the drug's proposed action at specific receptors in relation to disease progression. Multiple studies evaluated the effect on the quality of life in participants with long-term, chronic symptoms. These trials focused on collecting patient-reported outcomes over periods typically extending 12 weeks. One trial suggested that changes in symptoms were measured in a subgroup of participants, with follow-up continuing beyond the primary assessment period.


Combination Therapies and Tolerability

Research explored the administration of the drug in combination with other agents and its tolerability in participants where a single-agent approach was insufficient. Additional studies collected data on pain and investigated potential changes in related symptoms, with follow-up periods extending up to 6 months in select cohorts.

Studies explored the use of this formulation for individuals requiring personalized dosing regimens. Researchers examined the patient experience with the drug in adults across various weight groups. Overall, the findings on the safety profile and tolerability were generally consistent with expectations based on earlier phase research.


Comparison to Other Treatments

One large-scale randomized controlled trial compared the drug to current treatments. This study investigated differences in symptom management and patient retention over a nine-month period. Findings were mixed across different secondary endpoints, highlighting the complexity of comparing treatment modalities in this patient population. The drug is under ongoing investigation in studies focusing on complex conditions, with several phase 3 trials currently recruiting participants to expand the body of evidence.

Frequently Asked Questions (FAQ)

Common questions about Sebacil (FAQ)

Q: How quickly should someone expect to notice a change after starting Sebacil?

A: Studies on the active ingredient, phoxim, indicate that it has a rapid initial effect on the target ectoparasites. This quick action is due to phoxim working as a contact and stomach poison, rapidly blocking the enzyme acetylcholinesterase (AChE) in the parasite's nervous system. The drug's profile indicates that its primary effect on the target parasites may be of short to moderate duration, based on the specific condition being addressed.

Q: Is it true that Sebacil interacts with certain common vitamins?

A: Official regulatory summaries of the product's interaction profile do not formally document specific interactions with common vitamins or general food products. Restrictions are focused entirely on preventing simultaneous use with other medicines that are also cholinesterase inhibitors, as this combination could lead to compounded neurological effects in the treated animal. Consulting the official product labeling provides complete information regarding use conditions and potential contraindications.

Q: How long does Sebacil stay in the system after the last dose?

A: Pharmacokinetic studies on livestock indicate that the active compound is rapidly absorbed and the majority is excreted from the animal's body, primarily via urine, within 24 to 72 hours following administration. This time frame is essential for regulatory authorities, who use these findings to establish the necessary withdrawal periods before animals can be cleared for consumption, ensuring public safety.

Q: Are there any common over-the-counter pain relievers that interact with Sebacil?

A: The official regulatory profile for Sebacil places strict restrictions on use with specific drug classes, including other cholinesterase inhibitors, phenothiazine, and general anesthetics. However, the label does not formally document interactions with common pain relievers that do not belong to the restricted drug classes.

Q: What should be done if an adverse reaction is suspected?

A: If any suspected adverse event occurs in the treated animal, or if there is accidental human exposure, official guidelines indicate that the incident should be reported to help ensure continuous safety monitoring. The official protocol directs users to report such events to the product manufacturer or the relevant national veterinary regulatory authority.

Q: Does Sebacil cause drowsiness?

A: Since Sebacil is a veterinary product, its official warnings focus on animals and applicator safety. However, the active ingredient is an organophosphorus compound, and information related to accidental human exposure suggests potential symptoms like exhaustion, weakness, and mental confusion. These findings are described as effects that have the potential to impact consciousness or alertness.

Q: Can taking Sebacil make someone sensitive to the sun?

A: The official regulatory documents and safety profiles for Sebacil do not list photosensitivity (increased sensitivity to sunlight) as a known adverse reaction or special precaution associated with the product.

Q: Do I need lab tests while using Sebacil?

A: Routine clinical lab tests are generally not required for the animal being treated. Regulatory monitoring is typically focused on residue studies, where the concentration of the active ingredient is tracked in animal tissues (like liver or muscle) to accurately set the withdrawal period for food safety purposes.

Q: Does Sebacil have a risk of dependence or withdrawal symptoms?

A: According to the regulatory pharmacology and adverse reaction profiles of this veterinary product, there is no documented risk of drug dependence or typical pharmacological withdrawal symptoms.

Q: What are the signs that Sebacil is starting to work?

A: Sebacil functions by disrupting the nervous system of external pests, which leads to neuromuscular paralysis. Therefore, the signs of the drug’s intended effect are generally observed as the rapid cessation of movement by the target ectoparasites and their subsequent elimination from the treated animal.

How should Sebacil be stored and disposed of?

Sebacil (phoxim) storage and disposal instructions are derived from regulatory labeling for its authorized veterinary use and are mandatory for product stability and safety.

Official Storage Requirements

Detail Regulatory Requirement
Temperature Store below 30 C and protect from frost (freezing).
Protection Protect from direct sunlight.
Container Must be kept in the original container and maintained tightly closed.

The product must be stored out of the reach and sight of children and kept separately from all foodstuffs, drink, and animal feeding stuffs. These conditions are necessary to maintain product stability until the labeled expiry date.

Disposal Requirements

Unused product and waste material must be disposed of in accordance with local requirements. It is strictly mandated that the product must not be allowed to enter watercourses (drains or ground water) due to environmental risk.

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

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