Plegicil

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Plegicil

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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 Plegicil

Quick Facts

Property Description
Active ingredient Acepromazine maleate
Form Injectable solution, Oral preparations (tablets, gels)
Pharmacological class Phenothiazine Tranquilizer
General purpose Behavioral management; promoting calm
Origin Synthetic compound

Plegicil: What is This Tranquilizing Substance?

Plegicil is the trade name for the active pharmaceutical ingredient Acepromazine, a substance primarily classified as a tranquilizer. It belongs to the Phenothiazine class of psychotropic agents, which influence the central nervous system. This class of drugs is clinically recognized for its potent calming effects. Its core purpose is to promote a state of generalized calm and help manage agitation or high levels of anxiety, confirming its role in behavioral management.

Synthetic Compound and Available Forms

Acepromazine is a synthetic chemical compound, manufactured under controlled conditions to ensure consistent purity and potency. As a single-active ingredient product, its composition is straightforward: the active drug plus an inert base or vehicle. The drug is available in various forms, including an injectable solution for rapid parenteral administration and oral preparations (such as tablets or gels) used for longer-term management. These different forms allow the medication to be used effectively in diverse application settings.

The General Principle of Plegicil's Action

Plegicil works conceptually by calming the central nervous system to slow down the body’s reaction to stressful stimuli. This action involves dampening the intense emotional responses associated with anxiety and fear. The general benefit of this action is the controlled promotion of tranquility and a reduction in anxious behaviors, which facilitates easier handling and cooperation. While it causes calmness, Plegicil is classified as a tranquilizer, and its fundamental purpose is not to act as a primary sleeping aid or pain reliever.

What side effects are possible with Plegicil?

Possible Side Effects and Safety Information

The safety profile of Plegicil (Acepromazine maleate) is officially documented by regulatory agencies, focusing primarily on its effects on the cardiovascular and nervous systems, consistent with its classification as a phenothiazine tranquilizer.

Adverse Reactions by System and Frequency

The most commonly documented adverse reactions are associated with its intended effects, including sedation and ataxia (incoordination). A key safety characteristic is hypotension (low blood pressure), which is a common effect on the cardiovascular system.

System-Organ Class Common/Expected Reactions Rare/Serious Reactions
Cardiovascular System Hypotension Cardiovascular Collapse
Nervous System Sedation, Ataxia Convulsive Seizures
Psychiatric Disorders Paradoxical Excitation
Reproductive System Penile Prolapse/Paralysis
Blood/Lymphatic System Transient blood count decreases

Serious Safety Constraints and Cautions

The regulatory safety text highlights several absolute constraints and cautions for use. Serious adverse reactions documented in official labeling include the potential for cardiovascular collapse as a consequence of severe hypotension. Convulsive seizures are also listed as a risk, particularly in predisposed individuals.

Use is contraindicated in patients with pre-existing conditions such as severe hypotension or post-traumatic shock, and in those with a history of epilepsy or a tendency to convulsions. Furthermore, the drug is contraindicated in patients with certain haematological disorders or anaemia.

Population-specific cautions require careful consideration of patients with documented hepatic disease (liver dysfunction) or cardiac disease. The official profile also notes that the use of Epinephrine is explicitly contraindicated for treating hypotension caused by Plegicil.

Overdose and Emergency Response

Overdose and when to seek help

Overdose with Plegicil is officially documented by regulatory authorities as a severe condition characterized by primary effects on the central nervous system and cardiovascular system.

Manifestations Documented in Overdose Required Emergency Actions
CNS/Neurological: Deep sleepiness (somnolence) progressing to coma, disorientation, convulsions (seizures), and severe involuntary movements (extrapyramidal symptoms). Seek medical help right away or call emergency services immediately if the person has collapsed, experienced a seizure, has trouble breathing, or cannot be awakened.
Cardiovascular: Severe drop in blood pressure (hypotension), a pounding heartbeat, and life-threatening irregular heart rhythms (cardiac arrhythmias). Temperature changes such as fever or hypothermia may also occur. Do not induce vomiting due to the official warning concerning aspiration risk. Inform medical staff immediately if an overdose is suspected.

Overdose management is symptomatic and supportive, as no specific antidote is available according to official regulatory labeling. Treatment requires continuous medical observation, including monitoring of vital signs and an electrocardiogram (ECG) to assess for cardiac changes and severe rhythm disturbances. Overdose may lead to serious, life-threatening outcomes such as respiratory failure, cardiac collapse, or the development of Neuroleptic Malignant Syndrome (NMS). Regulatory warnings also note an increased risk of death in elderly patients with dementia-related psychosis.

Therapeutic Uses of Plegicil

Plegicil (Chlorpromazine) is used to treat a wide variety of conditions.

Plegicil is commonly used to address significant symptoms related to heightened physiological activity, including severe anxiety, extreme restlessness, and disruptive agitation, as well as symptoms related to systemic imbalance, such as intense, persistent nausea and uncontrollable vomiting. It is applied in clinical settings that involve acute or unstable symptom patterns, such as when symptoms escalate suddenly.

Key Uses and Therapeutic Benefits

The therapeutic domains include symptomatic support for acute agitation and emotional distress and relief from severe nausea and vomiting. The supportive treatment contributes to easing the overall symptom load and helps patients cope more steadily with difficult episodes. It may assist with maintaining functional stability when symptoms interfere with routine activities.

“Plegicil is relevant in situations involving symptomatic discomfort where short-term symptom management is appropriate.”

Quick Fact: Relief for Acute Distress

Quick Fact: Relief for Acute Distress Plegicil helps manage groups of symptoms that may become intense or disruptive, offering symptomatic relief that supports patients during episodes of heightened discomfort. It is commonly used across conditions characterized by periods of heightened symptoms.

Regulatory References

  1. DailyMed: CHLORPROMAZINE HYDROCHLORIDE tablet, film coated

Eligibility and Restrictions for Use

Regulatory documents define the eligibility for Plegicil (Chlorpromazine) based on absolute prohibitions, age, and existing medical conditions.

Populations Prohibited from Use

Plegicil is contraindicated in patients with a known hypersensitivity to phenothiazines or components of the drug, those in a comatose state, or those with severe Central Nervous System (CNS) depression due to substances like narcotics or alcohol. It is also contraindicated for older adults with dementia-related psychosis due to increased mortality risk, and for patients with severe bone marrow depression.


Restrictions and Limitations

Population/Condition Eligibility Status (Regulatory)
Children under 1 year Use not established or not recommended (insufficient safety data).
Children 1 to 12 years Approved for treating severe behavioral problems and hyperactivity.
Pregnant Patients Not recommended unless the benefit clearly outweighs risk; safety not established.
Organ Impairment Requires caution in patients with severe hepatic or renal impairment.
Comorbidities Use is generally avoided or requires caution in patients with epilepsy, Parkinson's disease, prostatic hypertrophy, and certain cardiovascular diseases.

What should I know about interactions with other medicines?

Plegicil Interactions with other medicines and products

The official regulatory profile for Plegicil (Chlorpromazine) defines multiple interaction patterns, classified by their physiological and pharmacokinetic outcomes.

Contraindicated and High-Risk Combinations: Co-administration is formally restricted with medicines known to prolong the QTc interval, such as specific antiarrhythmics, due to the documented risk of additive cardiac effects. Other agents, including Amisulpride and certain strong CYP2D6 inhibitors (e.g., Mavorixafor), are also restricted due to documented severe interaction risks.

Pharmacokinetic and Pharmacodynamic Effects: Interactions that increase drug exposure involve CYP1A2 and CYP2D6 inhibitors, which reduce clearance and lead to higher plasma concentrations of Plegicil. Conversely, absorption is documented to be decreased by both antacids and food consumption. The combination with other Central Nervous System (CNS) depressants, including alcohol, results in a potentiation of sedative effects, which is a key pharmacodynamic interaction. Additionally, the drug must be discontinued 24 hours prior to the administration of Metrizamide due to an officially described procedural constraint.

Population Considerations: In elderly patients, official labeling notes an increased susceptibility to pharmacodynamic interactions, such as orthostatic hypotension. Those with severe hepatic or renal impairment have a heightened, documented risk of drug accumulation due to impaired clearance.

Mechanism of Action

Plegicil (Acepromazine maleate) exerts its physiological influence by functioning as a non-selective antagonist across multiple key neurotransmitter receptor systems, leading to a coordinated suppression of central arousal and peripheral vascular tone.

The molecule's core mechanism involves targeting and blocking post-synaptic D2 Dopamine and H1 Histamine Receptors within the brain. This antagonism dampens activity in the Reticular Activating System (RAS) and arousal pathways, resulting in a physiological reduction in spontaneous activity and central depression.

Concurrently, Plegicil modulates the autonomic nervous system by blocking alpha1-Adrenergic Receptors located on vascular smooth muscle. This mechanism prevents norepinephrine signaling, leading to peripheral vasodilation and a subsequent reduction in systemic vascular resistance and blood pressure. A specific action involves D2 Dopamine Receptor blockade within the Chemoreceptor Trigger Zone (CTZ) of the brainstem, which disrupts the chemical signals that normally initiate the vomiting reflex, causing a functional inhibition of the emetic cascade.

Dosage and Administration Information

Plegicil (Acepromazine maleate) is administered according to strict protocols that govern its use as a short-term veterinary tranquilizer. The medicine is available in various official forms, including oral preparations (tablets, gels) and parenteral injection (intramuscular, subcutaneous, or intravenous).


Official Administration Guidelines

Feature Official Labeled Instruction
Route of administration Oral (PO), Intramuscular (IM), Subcutaneous (SC), and Intravenous (IV).
Dosing schedule Dosage is strictly calculated based on the animal’s body weight and species. Oral doses are generally numerically higher than the parenteral doses required for a comparable effect.
Frequency pattern Primarily intended for single-dose, situational use (e.g., pre-anesthesia, examination, transport). It is not approved for chronic daily use.

Procedural and Population Requirements

Use requires high procedural adherence, starting with the accurate determination of body weight to prevent dosing errors, followed by the use of the minimum effective dose. When the intravenous route is utilized, the solution must be administered slowly to meet proper administrative conditions.

Furthermore, official labels mandate a reduced dose for specific patient groups. This modification applies to geriatric or debilitated animals and those with documented hepatic dysfunction.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Plegicil

Evidence for Acute Agitation and Emotional Distress

Plegicil (Acepromazine maleate) was evaluated in early research exploring management of acute agitation in certain human populations decades ago, but the research base is limited. Modern studies do not include formal large-scale clinical trials assessing the compound's therapeutic effect for this purpose. The available evidence includes historical reports from early psychiatric settings and contemporary case reports focusing on patients who experienced acute exposure or toxicity. Early research explored how symptoms evolved, and historical studies examined changes in behavior, describing patterns such as a general state of reduced emotional response in individuals observed. More recent toxicology data provides context regarding how the compound interacts with the human body, but the findings are not derived from therapeutic evidence.


Evidence for Relief from Severe Nausea and Vomiting

There are no formal human clinical trials that research examined Plegicil specifically as an antiemetic (anti-nausea/vomiting) agent. Therefore, the research supporting this indication in humans is based on an understanding of the phenothiazine pharmacological class, as well as controlled studies conducted in veterinary medicine. The broader drug class is associated with outcomes related to systemic or functional imbalance, as studies explored its activity in systems related to the control of vomiting. Controlled studies in animal models monitored the occurrence of vomiting, and findings describe patterns observed in the studies related to changes in episode frequency when the compound was observed in tested animal populations.


Limitations and Research Gaps

The overall evidence base for the use of Plegicil (Acepromazine maleate) in humans is limited, and the certainty regarding its therapeutic application remains low. A key limitation is the absence of modern human randomized controlled trials (RCTs) to evaluate efficacy for the requested indications. Follow-up durations were limited in the existing human reports, meaning long-term effects are not fully established. Research examined the compound's effects in specific groups like pediatric and adult patients observed in acute settings, but data for older adults and other special populations remains insufficient.

Key Studies & References

  1. CHLORPROMAZINE HYDROCHLORIDE tablet, film coated (DailyMed/NLM)

Frequently Asked Questions (FAQ)

Common questions about Plegicil (FAQ)

Q: What kind of health problem is Plegicil officially approved to address?

According to official regulatory documents, Plegicil (Acepromazine maleate) is primarily approved for short-term tranquilization and behavioral management in veterinary use for certain animal species. While the compound has been historically referenced in human case reports and toxicology data, the medication is not approved for therapeutic use in human patients by major modern regulatory agencies.


Q: Does Plegicil have any known effects on sleep patterns?

Plegicil is classified as a Central Nervous System (CNS) depressant, and its primary effect is causing sedation and a reduction in spontaneous activity. This influence on the central nervous system may lead to changes in an individual's typical patterns of rest or wakefulness.


Q: Is it normal to feel slight dizziness when first starting Plegicil?

Official product information describes that the medication can cause hypotension (low blood pressure) and ataxia (incoordination). Since these effects can lead to feelings such as light-headedness or unsteadiness, the potential for light-headedness or unsteadiness exists.


Q: What should a patient look out for when taking Plegicil for the first time?

The drug’s official safety profile documents serious adverse reactions that require vigilance. These include signs of cardiovascular collapse (severe drop in blood pressure), convulsive seizures, or unusual agitation known as paradoxical excitation.


Q: Are there different strengths or formulations of Plegicil available?

Official product information states that Plegicil is supplied in different formulations. These include an injectable solution for parenteral administration and various oral preparations, such as tablets and gels.


Q: Can Plegicil affect the results of other medical tests?

Regulatory documents specify a procedural constraint related to certain medical testing. A procedural constraint exists, requiring the medication to be discontinued 24 hours prior to the administration of Metrizamide, a specific contrast agent used in certain imaging procedures.


Q: What defines the typical patient who is prescribed Plegicil?

The official profile specifies approved use for children aged 1 to 12 years for the treatment of severe behavioral problems and hyperactivity. Conversely, use is restricted or contraindicated in many other patient groups, including older adults with dementia-related psychosis and those with severe CNS depression.


Q: What is the latest research finding about Plegicil safety?

Studies and official information indicate that the overall evidence base for the use of this compound in humans is limited. A key regulatory finding is the noted absence of modern randomized controlled trials (RCTs), meaning the drug’s long-term effects on human populations are not fully established.


Q: How long does it typically take for Plegicil to start showing an effect?

According to regulatory pharmacokinetics data, following oral administration, the onset of observable effects typically occurs relatively quickly. This effect is often documented to begin within 10 to 15 minutes after use.


Q: How long does one use of Plegicil generally last in the body?

Official product information describes a relatively prolonged duration of action for Plegicil. The effects generally last for several hours (documented between 4 to 7 hours), with the total duration being dependent upon the specific dose administered.


Q: Is Plegicil available as a generic version?

Plegicil is the brand name for the active ingredient, which is Acepromazine maleate. This substance is widely known and referenced by its generic name in the pharmaceutical industry.


Q: Is it necessary to have routine blood work or monitoring while taking Plegicil?

Official regulatory text highlights risks such as transient blood count decreases. Furthermore, the label includes a specific caution for patients with documented hepatic (liver) or renal (kidney) impairment due to a potential risk of drug accumulation from impaired clearance.


Q: Is Plegicil a controlled substance?

The active ingredient in Plegicil, Acepromazine maleate, is not typically listed as a federally controlled substance. It is not classified in the schedules set by the US Drug Enforcement Administration (DEA).


Q: Are Plegicil's side effects temporary or do they often continue with use?

Official product information notes that certain adverse reactions are documented to be temporary. For example, a decrease in blood count (transient blood count decreases) is officially reported as a non-permanent effect.


Q: Is there a risk of overdose with Plegicil?

Official regulatory text confirms that in cases of accidental overdose, a risk of adverse effects exists. These include transient dose-dependent hypotension (a temporary drop in blood pressure). The label notes that in such cases, close monitoring and supportive care are necessary.


Q: Is Plegicil a prescription-only medicine?

Yes, Plegicil is classified as a drug subject to federal law restrictions. This means it can only be dispensed by or on the order of a licensed healthcare professional (such as a licensed veterinarian or physician) and is not available over the counter.

How should Plegicil be stored and disposed of?

Plegicil must be stored in accordance with official regulatory requirements to ensure its stability and potency.

Storage Requirements

The medicine is required to be stored at controlled room temperature, specifically between 20 C and 25 C (68 F and 77 F). Storage conditions must protect the product from light, and the injectable solution must not be frozen. All forms must be kept in the original container and oral preparations should be tightly closed.

If the injectable solution changes color, becoming yellow or pink, it must not be used due to compromised stability. The product is also required to be stored out of the reach of children.

Disposal Instructions

Unused or expired Plegicil must be discarded using a drug take-back program or by following federal guidelines for household disposal. It is officially prohibited to flush the medicine down the toilet or pour it down a drain.

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

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